(12) United States Patent (10) Patent No.: US 9,539.216 B2 Miller (45) Date of Patent: *Jan

USO09539216 B2

(12) United States Patent (10) Patent No.: US 9,539.216 B2 Miller (45) Date of Patent: *Jan. 10, 2017

(54) MULTI-PHASE, MULTI-COMPARTMENT, (58) Field of Classification Search CAPSULAR DELIVERY APPARATUS AND CPC ... A61 K9/4808: A61K 9/4833; A61K 45/06; METHODS FOR USING SAME B29C 39/10; A61J 3/072; A61J 3/074 See application file for complete search history. (71) Applicant: INNERCAP TECHNOLOGIES, INC., Tampa, FL (US) (56) References Cited (72) Inventor: Fred H. Miller, Tampa, FL (US) U.S. PATENT DOCUMENTS 6,380,175 B1 4/2002 Hussain et al. (73) Assignee: INNERCAP TECHNOLOGIES, INC., 7,670,612 B2 * 3/2010 Miller ...... B29C 39/10 Tampa, FL (US) 424/400 (Continued) (*) Notice: Subject to any disclaimer, the term of this patent is extended or adjusted under 35 U.S.C. 154(b) by 0 days. OTHER PUBLICATIONS This patent is Subject to a terminal dis Tramer et al., Cannabinoids for the control of chemotherapy claimer. induced nausea and vomiting: quantitive systematic review, BMJ 2001; pp. 1-8; vol. 323. (21) Appl. No.: 15/005,508 Primary Examiner — Aradhana Sasan (22) Filed: Jan. 25, 2016 (74) Attorney, Agent, or Firm — Hudak, Shunk & Farine Co. LPA (65) Prior Publication Data (57) ABSTRACT US 2016/O1361OO A1 May 19, 2016 A multi-compartment capsule, comprising, a first receiving Related U.S. Application Data chamber comprising at least one ingredient having a first physical state, wherein said ingredient is selected from the (63) Continuation of application No. 14/036,521, filed on group consisting of a nutraceutical, a vitamin, a dietary Sep. 25, 2013, now Pat. No. 9,241,911, which is a Supplement and a mineral; and a second receiving chamber (Continued) comprising at least one ingredient having a second physical state, wherein said ingredient is selected from the group (51) Int. C. consisting of a nutraceutical, a vitamin, a dietary Supplement A6 IK 9/48 (2006.01) and a mineral; wherein said first physical state of said A6 IK 45/06 (2006.01) ingredient of said first receiving chamber being different (Continued) from said second physical state of said ingredient of said (52) U.S. C. second receiving chamber; and said ingredient of said first CPC ...... A61K 9/4808 (2013.01); A61K 9/4833 receiving chamber being different from said ingredient of (2013.01); A61K 45/06 (2013.01); B29C 39/10 said second receiving chamber. (2013.01); A61J 3/072 (2013.01); A61J 3/074 (2013.01) 10 Claims, 13 Drawing Sheets

US 9,539.216 B2 Page 2

Related U.S. Application Data continuation-in-part of application No. 13/746,743, filed on Jan. 22, 2013, now abandoned, which is a continuation of application No. 12/689,669, filed on Jan. 19, 2010, now Pat. No. 8,361,497, which is a continuation of application No. 10/804,576, filed on Mar. 19, 2004, now Pat. No. 7,670,612, which is a continuation-in-part of application No. PCT/US03/ 10816, filed on Apr. 9, 2003. (51) Int. Cl. 46.3/07 (2006.01) B29C 39/10 (2006.01) (56) References Cited U.S. PATENT DOCUMENTS 8,361,497 B2 * 1/2013 Miller ...... B29C 39,10 424/400 9,241,911 B2 * 1/2016 Miller ...... A61K 9.4808 * cited by examiner U.S. Patent Jan. 10, 2017 Sheet 1 of 13 US 9,539.216 B2

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92 US 9,539,216 B2 1. 2 MULTI-PHASE, MULTI-COMPARTMENT, Oral administration has become one of the most frequent CAPSULAR DELIVERY APPARATUS AND routes for delivering one or more active ingredients or METHODS FOR USING SAME medicaments to the body. Active ingredients or medica ments, such as nutritional or therapeutic agents, may be RELATED APPLICATIONS orally administered in a variety of physical states (i.e., Solid, liquid or gas). Tablets and capsules are generally the most This application is a continuation of U.S. patent applica common vehicle for the oral delivery of medicaments. As tion Ser. No. 14/036,521, filed Sep. 25, 2013, which is a appreciated, a tablet may be broadly characterized as a continuation of U.S. patent application Ser. No. 10/804,576, compressed powder or granular solid. Prior to compression filed Mar. 19, 2004, and entitled “MULTI-COMPART 10 of the granular powder comprising the medicament into MENT CAPSULAR DELIVERY APPARATUS AND tablet form, the presence of one or more excipients may be METHODS FOR USING THE SAME, which is a con required. An excipient includes any inert Substance (i.e., tinuation-in-part of PCT/US/03/10816 filed Apr. 9, 2003, gum arabic, starch or the like) combined with a principal and entitled “MULTI-PHASE, MULTI-COMPARTMENT ingredient to facilitate the preparation of an agreeable or CAPSULAR SYSTEM”, the contents of which are hereby 15 convenient dosage form of the active or medicament. Func incorporated by reference in their entirety. This application tional characteristics of excipients may include, for example, incorporates herein by reference U.S. Provisional Applica disintegration, lubrication, appearance, palatability, shelf tion Ser. No. 60/371,448, filed Apr. 10, 2002, and entitled stability or the like. INTEGRATED CAPSULE DELIVERY APPARATUS Those skilled in the art also developed capsules as a AND METHOD.” This application further claims the ben contrivance for containing a solid or liquid dosage form of efit of U.S. application Ser. No. 10/369,427, filed Feb. 18, a medicament. Traditional capsular embodiments include a 2003, entitled “MULTI-PHASE, MULTI-COMPART first containment section referred to as a base, and a second MENT CAPSULAR DELIVERY APPARATUS AND containment section referred to as a cap. The two pieces of METHODS FOR USING SAME,” which is hereby incor the capsule are usually formulated and designed in a manner porated herein by reference. This application further claims 25 such that the material to be encapsulated may be introduced the benefit of U.S. application Ser. No. 10/368,951, filed into the base section, whereas the open end of the cap section Feb. 18, 2003, entitled “PROCESS FOR ENCAPSULAT may be correspondingly positioned over the open end of the ING MULTI-PHASE, MULTI-COMPARTMENT CAP base. The walls of the cap and base are generally in physical SULES, which is hereby incorporated herein by reference. contact with one another to form a single internal cavity. A This application further claims the benefit of U.S. applica 30 means for structurally sealing the cap in relation to the base tion Ser. No. 10/369,244, filed on Feb. 18, 2003, and entitled may also be incorporated during manufacture to insure “MULTI-PHASE, MULTI-COMPARTMENT CAPSULAR non-tampering of the capsule. In this regard, those skilled in DELIVERY APPARATUS FORTHERAPEUTIC COMPO the art developed sealing technology which contemplates SITIONS AND METHODS FORUSING SAME, which is banding, heat fusion (spot-welding) and Snap seals which hereby incorporated herein by reference. This application 35 utilize a "tongue and groove' scheme. further claims the benefit of U.S. application Ser. No. The outer walls of a capsule are preferably formed of a 10/369,247, filed Feb. 18, 2003, and entitled “PROCESS soluble ingredient, such as, for example, gelatin (animal FOR ENCAPSULATING MULTI-PHASE, MULTI-COM based product), starch, hydrophillic polymer or hydroxypro PARTMENT CAPSULES FORTHERAPEUTIC COMPO pyl methyl-cellulose (HPMC), which provides a barrier for SITIONS,” which is hereby incorporated herein by refer 40 containing the active ingredient or medicament, in powder CCC. or liquid form, within the internal periphery of the capsule walls. Traditionally, hard gelatin capsules may be manufac FIELD OF THE INVENTION tured by dipping plates of stainless steel pins into a pool of gelatin Solution. The pins are then removed from the gelatin The present invention relates to delivery of active ingre 45 and rotated while the gelatin is dried in a kiln with forced, dients or medicaments and, more particularly, to novel humidity-controlled air. Once dried, the gelatin capsules are capsular delivery apparatus and methods for delivering one typically stripped from the pins, trimmed to a suitable length or more active ingredients or medicaments having diverse and then joined together (e.g. base and cap) and packaged physical states (e.g., Solid, liquid, gas or dispersion) into a for production use. single dosage, multi-compartment capsule. 50 With the advent of automated encapsulation machinery, The present invention further relates to methods for the the responsibility to produce encapsulated products shifted administration of a plurality of heterogenous chemical and mainly to industrial manufacturers. Contemporaneous with biological compounds to animals and humans using a mul the development of the encapsulation industry, those skilled ticompartment delivery system for treatment of different in the art have advanced the state of the encapsulation art. conditions or the same condition or diseases (different or 55 For example, several significant improvements in encapsu same) in one or more organ systems. lation technology have been seen over the last forty years. These technological improvements have included, for BACKGROUND OF THE INVENTION example, the development of soft elastic capsules, film coating techniques, micro-encapsulation and multiple-com As appreciated by those skilled in the art, the contempla 60 partment technology. tion, design, testing and manufacture of chemicals and Soft elastic capsules, often referred to as soft gelatin biomolecules for administration to humans and animals, as capsules, were developed in an effort to provide means for nutritional or therapeutic agents, requires a thorough inte encapsulating liquids and other medicaments which are gration of clinically contemplated delivery principles and typically poorly soluble in water. In preferred design, soft modalities. Chemicals and biomolecules that may be admin 65 elastic capsules are made from a thicker and more plastic istered to humans and animals are often referred to herein as gelatin having an increased flexibility due to the addition of “actives.” “active ingredients’ or “medicaments.” a polyol. Such as glycerin or Sorbitol. The addition of Such US 9,539,216 B2 3 4 plasticizers has been found, however, to have the potential capsule formulation which contains three different compart disadvantage of increasing the risk for microbial growth. ments of active medicaments for administration to the Thus an antimicrobial. Such as a paraben or Sorbic acid, may vaginal and rectal areas. In preferred structure, the formu be added to the soft elastic capsule shell in order to address lation outer, rapid-release layer may contain an active medi any microbial concern. cament and excipient; the middle, intermediate-release layer Prior art film-coating techniques generally involve a plat may include a powder form of active medicament; and the ing process, whereby a thin, uniform film may be deposited inner, slow-release layer may contain pellets or granules of onto the outer surface of the of the delivery vehicle (e.g., active medicament. tablet or capsule). Several Successive layers may be depos Also taught in the prior art are multi-compartment cap ited onto the outer surface of the vehicle, if desired, in an 10 effort to facilitate various desirable properties. For example, Sules having groups of spheroids with pH-dependent coat Sugar-coating, a precursor to film-coating, has been used by ings which are encapsulated within a hard gelatin shell and those skilled in the art for more than one hundred years to provided for treating female yeast infection. The first spher make tablets more palatable. Other advantages or properties oid is preferably uncoated and may be in a powder form; the of film-coating may include for example, but not by way of 15 second spheroid may contain a pH sensitive coat; and the limitation, protection from moisture, oxidation, controlling inner spheroid may include a pH insensitive coat. microbial contamination and inhibiting modification of the In addition to pH-sensitive coatings, hydrogels and other chemical properties of the active ingredient. As further gastric retention technologies have been developed by those appreciated by those skilled in the art, prior art film-coating skilled in the art in an effort to retard the progression of the may form an interfacial barrier between two chemicals or delivery vehicle during enteric transit. This retarding action, chemical compounds that might otherwise react when they presumably, allows the full amount of active medicament to come into contact. be released and/or targeted to a specific area of the gastro Enteric coatings and Sustained-release formulations are intestinal tract. Hydrogel and related gastric retention contemplated as variations on prior art film-coating tech devices of the prior art generally rely upon the imbibing of niques. In particular, enteric coating describes a process 25 water into a center core which is filled with cellulose or where the delivery vehicle (e.g., tablet or capsule) is coated similar water absorbent material. In preferred operation, the with one or more layers of chemicals that are somewhat material Swells and releases multiple compartments of active resistant to extreme pH conditions. For example, conditions medicament. The concept of using bulk size to slow transit of extremely low pH are commonly encounter in the stom of single active medicament in a single physical state is thus ach. Many active ingredients or medicaments are in the form 30 appreciated. of a pharmaceutical salt and thus highly Susceptible to ionization in the presence of hydrogen ions. Thus, the In an effort to administer active ingredients or medica presence of an enteric coating generally provides a level of ments to a specific location in the body to treat a specific protection as to degradation of the active ingredient or disorder caused by a specific pathogen, those skilled in the medicament until transit from the stomach into the Small 35 art have used targeted-release systems using multi-compart intestine is accomplished. ment capsular technology. For example, a method for car Film coatings have also led to the development of deliv rying out a triple therapy against the microorganisms Heli ery vehicles (e.g., tablets and capsules) having Sustained cobacter pylori, a known infectious agent which is believed release properties. Mixtures of waxes, cellulose, silicone and largely responsible for the development of gastric ulcer similar resins have been found useful by those skilled in the 40 disease, was developed which comprises the steps of oral art for creating-Sustained release coatings. In principle, these administration of a pharmaceutical dosage form comprising prior art coatings function to delay the release of the active an internal capsule placed inside an external capsule, ingredient or medicament to the targeted body system, wherein the external capsule comprises a soluble salt of thereby facilitating a timed, absorption rate in the body. bismuth and a first antibiotic, and the internal capsule Furthermore, the entire daily dosage of an active or medi 45 comprises a second antibiotic. In addition, multi-compart cament may be contained in a single, Sustained-release mental capsules were developed which combine, a nutrient delivery vehicle (e.g., tablet or capsule), whereas the imme Supplement with a viable direct-fed microbial (i.e., gastro diate absorption of the entire dosage could possibly lead to intestinal microorganisms, including bacteria, live cell an overdosage of the medicament. Thus, by layering quanta yeasts, fungi or a combination thereof) for the purpose of of medicament with differential coatings, the dosage under 50 treating livestock for feeding disorders and improving feed goes a controlled release over specified time period. The efficiency. application of Sustained-release film coating technology A disadvantage with prior art encapsulation technology is therefore may inherently facilitate the delivery of a total when the base and corresponding cap of a capsule are joined, daily dosage amount of an active or medicament to be dead space Volume is typically created within the internal released to the body in controlled increments. 55 periphery of the capsule. Internal capsular dead space may Over the last several years, a considerable amount of be filed with an air bubble which may ultimately react with attention has been focused on the further development of one or more of the active ingredients or medicaments multi-compartment capsule technology for the delivery of introduced within the capsule, thereby potentially degrading therapeutic and diagnostic agents. Series formulations teach the quality and effectiveness of the active ingredients. the use of membranes or other types of barriers to cordon a 60 Although the prior art discloses multiple compartment, line of separate chambers within a single encapsulating capsular delivery technology, these manifestations generally shell. As appreciated, the purpose of Such multi-compart includes one of two approaches. For example, one approach ment delivery devices is the administration of multiple contemplates the introduction of a single active or medica dosages. Moreover, multiple-compartment delivery mecha ment into multiple capsular compartments to vary the tem nisms of the prior art were developed to circumvent or 65 poral release of the medicament and ultimately the absorp diminish the effects of harsh pH environments within tion rate into the body. Another approach contemplates the humans. For example, the prior art contemplates a hard introduction of a plurality of active ingredients or medica US 9,539,216 B2 5 6 ments into different compartments of a single capsule for Providing active ingredients or medicaments in separate delivery to a specific area of the body to treat a targeted capsules may also be undesirable in the context of patient illness or condition. compliance. Geriatric and pediatric populations in particular The use or contemplation of multiple-compartment cap disfavor the handling and consumption of multiple capsules sular delivery apparatus or methods which deliver different of active ingredients. Patient compliance is essential in physical forms of the same active or medicament, or a maintaining patient health in many dosage regimens. For variation in physical forms of different actives or medica example, deviations from accurate dosing and consistent ments in a single dosage, however, has not heretofore been consumption of immunosuppressant therapies can result in contemplated in the art. As appreciated by those skilled in severe or even lethal consequences for a patient. Providing 10 combined dosages of active ingredients would result in the art, active ingredients or medicaments may take the fewer capsules a patient or consumer would have to take, physical form of a solid (e.g., pill, tablet, capsule (both hard and thereby contribute to an overall increase in compliance. and Soft elastic), powder, granulation, flakes, troches (loz Therefore, it would be desirable to provide a multi enges and pastilles), Suppositories and semi-solid ointments, compartment capsular delivery apparatus and methods that pastes, emulsions and creams), a liquid (e.g., solution, 15 provide active ingredients or medicaments having diverse spirits, elixir, syrups, sprays and fluid extracts), a gas or a physical properties (e.g., Solid, liquid, gas or dispersion), dispersion. A dispersion is a system in which a dispersed which mayor may not be properly combined or stored phase is distributed through a continuous phase (e.g., aero together into a unitary structure (i.e., multi-compartment sols (liquid or Solid in gas), Suspensions (Solid in liquid), capsule) for usage in a single dosage form. The present emulsion (liquid in liquid), foam (gas in liquid), Solid foam invention, in overcoming the shortcomings of the prior art, (Solid in gas) or gel (liquid or solid in Solid)). Dispersions satisfies these and other objectives. can be classified as molecular, colloidal and coarse, depend The art and practice of pharmacy can be divided into four ing on size. In many circumstances, however, the different distinct divisions. Pharmacology is the study of interactions physical forms or phases of more than one active ingredient occurring between the pharmacologic agent, or medicament or medicament may not be Suitably combined or mixed 25 and specific targeted cells in the body. More specifically, the together without altering the individual desirable properties interaction between an active agent and a cellular receptor of the active ingredient or medicament. For example, along with the resulting change in cell physiology is exam although it would be possible and desirable to formulate a ined. Medicinal chemistry is largely concerned with the dispersion by combining a first active ingredient in the Solid identification of naturally occurring and synthetic com state with a second active ingredient that exists as a liquid, 30 pounds which possess medicinal characteristics. adverse chemical interactions between the active ingredients Pharmacotherapeutics is the holistic application of phar may adversely affect various characteristics of the ingredi macy practice to specific pathologies, illnesses, and other ents, including but not limited to, their shelf lives. The body functions. Finally, Pharmaceutical Science ascertains resulting chemical decomposition—and the potential forma or regulates the composition of medicinal Substances, and is tion of any unwanted side products—could result in dimin 35 largely directed to the development of new mechanisms for ished drug potency or even toxicity to a patient. delivering chemicals and biomolecules into animals and Additionally, the physical properties of crystalline active humans. A Subcategory of pharmaceutical Science is called ingredients could be drastically altered in scenarios where it pharmacokinetics and sometimes generally referred to as is desirable to co-administer a crystalline active ingredient biopharmaceutics. with a liquid or semi-liquid different active ingredient. In 40 A.D.M.E. is an acronym often used to describe the four this context, the control of physical properties Such as active essential components to pharmaceutical Science: absorption, ingredient dissolution rate and solubility is often a critical distribution, metabolism, and elimination, respectively. One factor in determining the overall bioavailability of the active way to differentiate between pharmacology and pharmaceu ingredient. It is well established in the art that different tical science is that the former is primarily concerned with polymorphs or Solvates of the same crystalline active ingre 45 the effect of the medicament on the body, whereas, the latter dient exhibit dramatically different solubility and dissolution is primarily concerned with the delivery and time-course of rates. Thus, combining a crystalline active agent with a the medicament on its journey through the body. liquid or semi-liquid active agent could give rise to an In clinical applications, chemicals and biomolecules are equilibrium between concentrations of different polymorphs often referred to as active ingredients or medicaments. and/or Solvates of the crystalline active ingredient, and 50 Medicaments may include “pharmaceuticals, nutraceuticals, thereby frustrate efforts at tailoring an active ingredient biotechnicals, vitamins, minerals and dietary Supplements.” mixture to its intended purpose as a medicament. Oral administration is the most frequent route for delivery of Another shortcoming with co-administering plural active medicaments. Medicaments may be orally administered in a ingredients in different physical forms in an intimate mixture variety of physical states, including, Solid, liquid, dispersion, is the potential for adverse in Vivo drug-drug interactions 55 and gaseous forms. As appreciated, tablets and capsules are upon administration. The desire to co-administer these the most common vehicle for oral delivery of medicaments. active ingredients would be offset by the one active ingre Frequently, a medical or Surgical patient may receive a dient, for example as in a liquid or semi-liquid (e.g., a paste, plurality of concurrent medicaments. Data has been accu Solution, or syrup) form, becoming rapidly available. In this mulated to demonstrate that patients undergoing a Surgical context, the active ingredient may adversely react with a 60 procedure may receive ten (10) or more medicaments during co-administered drug, for example a less bioavailable Solid the Surgery and the resulting Surgical recovery period. Some or semi-solid, in a physiological environment. Thus, the true patients who have undergone organ transplantation or who therapeutic benefit resulting from the pharmacological have contracted human immunodeficiency virus (HIV) may effects of the individual active agents may never be realized. receive three (3) or more medicaments which require mul It would be desirable to co-administer plural active ingre 65 tiple administrations per day. HIV patients often receive dients while insuring against the potential of Such harmful many more than three (3) medicaments. These medicaments drug-drug interactions. may be necessary for the treatment of several conditions US 9,539,216 B2 7 8 occurring in a plurality of organ systems or they may be ering a plurality of medicaments to animals and humans necessary to treat a single condition or some combination using a multi-chambered delivery apparatus are contem thereof. plated herein. In some cases, it may be desirous to combine a plurality of medicaments because of a synergistic interaction between 5 BRIEF SUMMARY AND OBJECTS OF THE a plurality of medicaments. This synergy may enhance the INVENTION efficacy of one or more of the medicaments. Medicaments may be combined to increase the intensity of response or In view of the foregoing, it is a primary object of the efficacy. A plurality of medicaments, in combination, may be present invention to provide novel integrated capsule deliv 10 ery apparatus and methods for delivering diverse physical homergic (i.e., elicit the same quality of effect). In many states (e.g., Solid, liquid, gas or dispersion) of a single active cases, a plurality of homergic medicaments may also be ingredient or medicament, or a plurality of active ingredients homo dynamic (i.e., interact with the same receptor). A or medicaments, in a single dosage form, wherein at least plurality of homergic medicaments may be additive, Supra two of the active ingredients or medicaments have physical additive and infra-additive. A plurality of combined medi 15 states that differ. caments which do not produce the same quality of response It is also an object of the present invention to provide may be called, heterergic. When heterergy is found to be a novel integrated capsule delivery apparatus and methods positive effect (i.e., at least one medicament enhances the which facilitate various desirable properties including, for response to another medicament), this may be called syn example, controlling time-release of key active ingredients ergism and is sometimes called synergy. or medicaments, prolonging shelf-life of the active ingredi In further cases, it maybe desirous to combine a plurality ents or medicaments, improving palatability, reducing over of medicaments to decrease their individual dosages and all production costs and, accordingly, reducing the number possibility for toxicity. It may also be desirous to combine of capsules consumed by a patient or consumeras nutritional a plurality of medicaments to target the treatment of a or therapeutic agents. disease, illness or condition from divergent angles. It may be 25 Further, it is an object of the present invention to provide desirous to combine a plurality of medicaments to minimize novel integrated capsule delivery apparatus and methods for the side effects and adverse effects of one or more medica delivering one or more active ingredients or medicaments ments. It may be still further desirous to combine a plurality (e.g., pharmaceutical, biotechnical, nutraceutical, vitamin, of medicaments to alter the pharmacokinetic characteristics dietary Supplement, mineral or combination thereof) in the 30 form of a single dosage, multi-compartment capsule having of one or more medicaments. For example, alterations in the one or more active ingredients in a primary capsule, and one absorption, distribution, metabolism or elimination of one or or more active ingredients introduced into a secondary more medicaments. Smaller capsule having a size sufficient for being selectively Fixed combinations of a plurality of medicaments have positionable within the primary capsule, wherein the active been generally disfavored due to any number of perceived 35 ingredient(s) within the primary capsule comprises a physi disadvantages. These disadvantages may include, for cal state (e.g., Solid, liquid, gas or dispersion) that is different example: (1) complicating the interpretation of safety and from the physical state of the active ingredient(s) in the efficacy in therapeutic regimens, (2) there may be inter secondary capsule. patient differences to fixed combinations, (3) there may be It is an additional object of the present invention to difficulties in dosage titration, and (4) the delivery platforms 40 provide novel integrated capsule delivery apparatus and for fixed combinations have generally been found to be methods for delivering one or more active ingredients or uneconomical to produce. medicaments (e.g., pharmaceutical, biotechnical, nutraceu On the other hand, fixed combinations of a plurality of tical, vitamin, dietary Supplement, mineral or combination medicaments may lead to several therapeutic advantages, thereof) in the form of a single dosage, multi-compartment including, for example, but not by way of limitation: (1) 45 capsule having one or more active ingredients in a primary increasing patient compliance with therapy, (2) increasing capsule and the same active ingredient(s) introduced into a efficacy by optimizing timing of medicaments, (3) minimi Smaller secondary capsule having a size Sufficient for being zation of side effects and adverse effects, (4) enhancement of positionable within the primary capsule, wherein the active pharmacokinetic characteristics of one or more medica ingredient(s) in the primary capsule comprises a physical ments in a fixed combination, (5) increased patient quality of 50 state (e.g., Solid, liquid, gas or dispersion) different from the life, (6) optimization of institutional resources by minimiz active ingredient(s) in the secondary capsule. ing the amount of medicament administrations, and (7) It is a further object of the present invention to provide minimizing patient length of stay in institutional facilities by novel integrated capsule delivery apparatus and methods for optimizing therapy. delivering one or more active ingredients or medicaments Prior art therapeutic technologies contain isolated 55 (e.g., pharmaceutical, biotechnical, nutraceutical, vitamin, examples of pharmaceutical formulations containing fixed dietary Supplement, mineral or combination thereof) in the combinations of medicaments. However, therapeutic tech form of a single dosage, multi-compartment capsule wherein nologies of the prior art teach a fixed combination, wherein at least one of the primary and secondary capsules include a plurality of medicaments are placed into a single receiving a time-release coating for controlling the release of the chamber in the delivery formulation (i.e., no separation 60 active ingredient(s) contained therein. between the plurality of medicaments). It is also another object of the present invention to provide In view of the state of the technology as it exists today, novel integrated capsule delivery apparatus and methods for generally, therapeutic apparatus and methods are needed to delivering one or more active ingredients or medicaments provide a plurality of medicaments for medical and Surgical (e.g., pharmaceutical, biotechnical, nutraceutical, vitamin, conditions, as well as maintenance of normal health function 65 dietary Supplement, mineral or combination thereof) in the for delivery to animals and humans using a multi-chambered form of a single dosage, multi-compartment capsule having delivery apparatus. Such apparatus and methods for deliv one or more active ingredients in the capsular body, wherein US 9,539,216 B2 10 the capsule includes a longitudinally extending body and at methods for delivering a single dosage, multi-compartment least one dividing wall formed along a length of the extend capsule comprising a capsular base and cap configuration, ing body to form a first chamber and an opposing second wherein the size and shape of the cap, relative to its sealing chamber within the capsular body and introducing at least relationship with the base, generally eliminates or Substan one active ingredient or medicament having a first physical tially reduces any potential dead space Volume within the state into the first chamber and at least one active ingredient internal periphery of the capsule, thereby functionally negat or medicament having a second physical state into a second ing the opportunity for reaction between an air bubble and chamber, whereas the physical state (e.g., Solid, liquid, gas one or more active ingredients introduced into the capsule or dispersion) of the ingredient(s) in the first chamber is and, accordingly, improving stability of the capsular ingre different from the physical state of the ingredient(s) in the 10 dient(s). second chamber. Consistent with the foregoing objects, and in accordance It is an additional object of the present invention to with the invention as embodied and broadly described provide novel integrated capsule delivery apparatus and herein, one presently preferred embodiment of the novel methods for delivering one or more active ingredients or integrated capsule delivery apparatus and methods of the medicaments (e.g., pharmaceutical, biotechnical, nutraceu 15 present invention comprises a multi-compartment capsule tical, vitamin, dietary Supplement, mineral or combination including a primary capsule and a secondary capsule selec thereof) in the form of a single dosage, multi-compartment tively positionable within an internal periphery of the pri capsule having a longitudinally extending body and one or mary capsule. The secondary capsule may include a base, a more dividing walls disposed along the length of the lon corresponding cap and one or more receiving chambers. gitudinally extending body of the capsule, wherein the Each of the receiving chambers of the secondary capsule capsule and one or more of the dividing walls contained may be formed having an internal periphery sufficient for therein may include time-release coatings for controlling the receiving at least one active ingredient or medicament (e.g., release of the active ingredients or medicaments contained pharmaceutical, biotechnical, nutraceutical, vitamin, dietary therein, respectively. Supplement, mineral or combination thereof) therein. Simi It is a further object of the present invention to provide 25 larly, the primary capsule may be formed having a base, a novel integrated capsule delivery apparatus and methods for corresponding cap and one or more receiving chambers. The delivering one or more active ingredients or medicaments receiving chambers of the primary capsule may be formed (e.g. pharmaceutical, biotechnical, nutraceutical, vitamin, having an internal periphery Sufficient for receiving the dietary Supplement, mineral or combination thereof) in the secondary capsule and one or more active ingredients or form of a single dosage, multi-compartment capsule having 30 medicaments (e.g., pharmaceutical, biotechnical, nutraceu a plurality of active ingredients or medicaments having the tical, vitamin, dietary Supplement, mineral or combination physical form of a solid (e.g. pill, tablet, capsule (both hard thereof) having a physical state (i.e., solid, liquid, gas or and Soft elastic), powder, granulation, flakes, troches (loz dispersion) different from the physical state of the active enges and pastilles), Suppositories and semi-solid ointments, ingredient(s) housed within the receiving chamber of the pastes, emulsions and creams), a liquid (e.g., solution, 35 secondary capsule. spirits, elixir and fluid extracts), a gas or a dispersion (e.g., As further contemplated herein, a multi-compartment aerosols (liquid or Solid in gas), Suspensions (solid in liquid), capsule is provided comprising a base, a corresponding cap emulsion (liquid in liquid), foam (gas in liquid), Solid foam and one or more dividing walls positionable between the (Solid in gas) or gel (liquid or Solid in Solid), wherein the base and the cap. Structurally, the size, shape and position physical form of the active ingredients differ between a 40 ing of the dividing walls relative to the base and correspond primary and secondary capsule, and between one or more ing cap facilitates the formation of at least two, independent dividing walls disposed in spaced-apart relationship along and separate receiving chambers. Each of the receiving the length of a longitudinally extending capsular body. chambers having an internal periphery sufficient for receiv It is a still further object of the present invention to ing one or more active ingredients or medicaments (e.g. provide novel integrated capsule delivery apparatus and 45 pharmaceutical, biotechnical, nutraceutical, vitamin, dietary methods for delivering one or more active ingredients or Supplement, mineral or combination thereof) therein. In medicaments (e.g., pharmaceutical, biotechnical, nutraceu preferred design, the physical state (e.g., Solid, liquid, gas or tical, vitamin, dietary Supplement, mineral or combination dispersion) of the active ingredient(s) in the first receiving thereof) in the form of a single dosage, multi-compartment chamber is different from the physical state of the active capsule, wherein an encapsulation process comprises the 50 ingredient(s) in the second receiving chamber. After intro steps of: (1) providing a capsule comprising a first end, a ducing one or more active ingredients or medicaments into second end, a longitudinally extending body having a length each receiving chamber, the cap may be selectively posi disposed between the first and second ends, and a plurality tioned in sealing relationship with the base to form one of dividing walls spaced apart along the length of the presently preferred embodiment of the single, dosage multi extending body, wherein the dividing walls form a plurality 55 compartment capsule. of receiving chambers; (2) introducing at least one active One presently preferred embodiment of an encapsulation ingredient having a first physical state into a first receiving process for forming a multi-compartment capsule may com chamber; (3) introducing at least one active ingredient prise the steps of: (1) providing a primary capsule having a having a second physical state into a second receiving base, a corresponding cap and a receiving chamber; (2) chamber; (4) introducing at least one active ingredient 60 providing a secondary capsule having a base, a correspond having a third physical state into a third receiving chamber, ing cap and a receiving chamber; (3) introducing at least one wherein the physical states of at least two of the active ingredient or medicament (e.g., pharmaceutical, biotechni ingredients introduced into the first, second or third receiv cal, nutraceutical, vitamin, dietary Supplement, mineral or ing chambers differ, and (5) sealing the first and second ends combination thereof) having a first physical State (e.g., Solid, of said capsule. 65 liquid, gas or dispersion) into at least a portion of the Additionally, it is an object of the present invention to receiving chamber of the secondary capsule and selectively provide novel integrated capsule delivery apparatus and positioning the cap in sealing relationship with the base; (4) US 9,539,216 B2 11 12 introducing at least one ingredient or medicament (e.g., contact area of the primary and secondary capsules or the pharmaceutical, biotechnical, nutraceutical, vitamin, dietary sealing band may be color-coded to assist in branding, if Supplement, mineral or combination thereof) having a sec desired. ond physical state (e.g., Solid, liquid, gas or dispersion) into It is further contemplated herein that a multi-compartment at least a portion of the receiving chamber of the primary 5 capsule of the present invention may comprise component capsule, wherein the first physical state of the ingredient(s) parts of the capsule having various time-release coatings to in the secondary capsule is different from the second physi facilitate the release and ultimately the absorption of those cal state of the ingredient(s) in the primary capsule; and (5) active ingredients introduced into the different receiving introducing the secondary capsule into at least a portion of chambers of the multi-compartment capsule to release at the receiving chamber of the primary capsule and selectively 10 different release rates. In particular, a primary capsule may positioning the cap in sealing relationship with the base to be formed having a conventional time-release coating that form a single dosage multi-compartment capsule. dissolves and releases the active ingredient(s) contained In alternate presently preferred embodiments of the pres therein before the timed-release of the active ingredient(s) ent invention, a tertiary capsule comprising a base, a corre contained within a secondary capsule. Likewise, the divid sponding cap and a receiving chamber having an internal 15 ing walls disposed within the internal periphery of the base periphery sufficient for receiving one or more active ingre of a capsule may be formed having conventional time dients or medicaments (e.g., pharmaceutical, biotechnical, release coatings that dissolve and release the active ingre nutraceutical, vitamin, dietary Supplement, mineral or com dients within each receiving chamber defined by the divid bination thereof) may be selectively introduced within an ing walls at different rates, thereby delivering the active internal periphery of at least one receiving chamber of the ingredients or medicaments contained within a multi-com secondary capsule. After the introduction of at least one partment capsule at different rates. Certain active ingredients active ingredient into one or more receiving chambers of a or medicaments may, therefore, be delivered at a selected tertiary capsule pursuant to an encapsulation process of the interval, while other ingredients may be released at a later present invention, the cap of the tertiary capsule may be interval. In this way, the novel design of the multi-compart selectively positioned in sealing relationship with the base 25 ment capsules of the present invention may facilitate preci and then introduced into at least a portion of the internal sion delivery of active ingredients to targeted areas of the periphery of the secondary capsule, together with one or COSU. more active ingredients therein. It is contemplated herein Still further, a primary object of the present invention is that at least two of the active ingredients introduced within to provide novel delivery apparatus and methods for affect the receiving chambers of the primary, secondary and ter 30 ing multiple organ systems in animals or humans using a tiary capsules, respectively, comprise at least two different plurality of medicaments delivered by a pharmaceutical physical States (e.g., Solid, liquid, gas or dispersion). formulation comprising a multi-chambered apparatus. In preferred structural design, the primary capsule may Accordingly, the present invention provides novel delivery comprise a cap having a generally U-shaped configuration apparatus and administration techniques or methods aimed adapted to provide a sealing relationship when engaging the 35 at affecting multiple organ systems in an animal or human corresponding base, thereby reducing dead space Volume in using a plurality of medicaments. A delivery apparatus may the internal periphery of the cap and receiving chamber of be in any multi-chambered apparatus, but preferably in a the base. A cap having a configuration adapted to generally capsular formulation. Thus, a plurality of medicaments may eliminate or Substantially reduce potential dead space Vol be encapsulated and stored separately within a larger capsule ume of the cap and receiving chamber of the base may, 40 until the time of ingestion, consumption, or the like. Upon accordingly, function—to negate the potential for a reaction consumption, the capsule walls of one or more dividing between an air bubble and one or more active ingredient(s) walls of a capsule may dissolve to release their contents. introduced into the base of the primary capsule. Different methods of encapsulation may be used to deliver Alternatively, a multi-compartment capsule of the present their respective contents, including but not limited to, dis invention may include the introduction of a filling material 45 Solution, melting, ablation or biodegradation of the encap into the cap of the primary capsule, the cap having a general Sulating wall. In certain embodiments and as contemplated cylindrical configuration adapted to provide a sealing rela herein, the medicaments retained in the multicompartment tionship when engaging the corresponding base. An amount capsule may actually diffuse through one or more of the of filling material may be introduced into at least a portion encapsulating walls. of the internal periphery of the cap to fill, either partially or 50 In one embodiment of the present invention there is a completely, the inner Volume of the cap, thereby reducing multi-compartment capsule, comprising a first receiving the dead space Volume in the cap and the internal periphery chamber comprising at least one ingredient having a first of the receiving chamber of the base. In this regard, the physical state, wherein said ingredient is selected from the introduction of a filling material relative to the internal group consisting of a nutraceutical, a vitamin, a dietary periphery of the cap may generally eliminate or Substantially 55 Supplement and a mineral; and a second receiving chamber reduce the potential dead space Volume, thus functionally comprising at least one ingredient having a second physical negating the potential for a reaction between an air bubble state, wherein said ingredient is selected from the group and one or more active ingredient(s) introduced into the base consisting of a nutraceutical, a vitamin, a dietary Supplement of the primary capsule. and a mineral; said first physical state of said ingredient of The primary, secondary or tertiary capsules, in accordance 60 said first receiving chamber being different from said second with the present invention, may be formed having the same physical State of said ingredient of said second receiving or different colors. Moreover, the base and corresponding chamber. cap of a single capsule may be formed having different In another embodiment of the present invention, there is colors in an effort to enhance the aesthetics of the capsule to a multi-compartment capsule as defined above, further com the consumer. In one presently preferred embodiment of a 65 prising a base and a corresponding cap, wherein said cap is multi-compartment capsule of the present invention, the configured to provide a sealing relationship when engaging dosage may be banded, sealed or easily dividable in a said base. US 9,539,216 B2 13 14 In another embodiment of the present invention, there is physical state selected from the group consisting of a solid, a multi-compartment capsule as defined above, wherein said a liquid, a gas and a dispersion. cap comprises a configuration adapted to reduce dead vol In another embodiment of the present invention, there is ume space within said first receiving chamber. a multi-compartment capsule as defined above, wherein said In another embodiment of the present invention, there is third receiving chamber comprises a time-release coating. a multi-compartment capsule as defined above, further com In another embodiment of the present invention, there is prising a filling material introduced into said cap to reduce a multi-compartment capsule, comprising a primary capsule dead volume space within said first receiving chamber. comprising at least one ingredient having a first physical In another embodiment of the present invention, there is state, wherein said ingredient is selected from the group a multi-compartment capsule as defined above, wherein said 10 consisting of a nutraceutical, a vitamin, a dietary Supplement filling material is selected from the group consisting of and a mineral; a secondary capsule comprising at least one gelatin, starch, casein, chitosan, Soya bean protein, safflower ingredient having a second physical state, wherein said protein, alginates, gellan gun, carrageenan, Xanthan gum, ingredient is selected from the group consisting of a nutra phtalated gelatin, Succinated gelatin, cellulosephtalate-ac ceutical, a vitamin, a dietary Supplement and a mineral; said etate, polyvinylacetate, hydroxypropyl methyl cellulose, 15 first physical state of said ingredient of said primary capsule oleoresin, polyvinylacetate-phtalate, polymerisates of being different from said second physical state of said acrylic or methacrylic esters and combinations thereof. ingredient of said secondary capsule; and said primary In another embodiment of the present invention, there is capsule comprising an internal periphery Sufficient for a multi-compartment capsule as defined above, wherein said receiving said ingredient and said secondary capsule therein. first receiving chamber comprises no dead volume space. In another embodiment of the present invention, there is In another embodiment of the present invention, there is a multi-compartment capsule as defined above, wherein said a multi-compartment capsule as defined above, wherein said primary capsule further comprises a base and a correspond physical state of said ingredient in said first receiving ing cap, wherein said cap is configured to provide a sealing chamber is selected from the group consisting of a Solid, a relationship when engaging said base. liquid, a gas and a dispersion. 25 In another embodiment of the present invention, there is In another embodiment of the present invention, there is a multi-compartment capsule as defined above, wherein said a multi-compartment capsule as defined above, wherein said primary capsule comprises no dead volume space. physical State of said ingredient in said second receiving In another embodiment of the present invention, there is chamber is selected from the group consisting of a Solid, a a multi-compartment capsule as defined above, wherein said liquid, a gas and a dispersion. 30 first physical state of said ingredient in said primary capsule In another embodiment of the present invention, there is is selected from the group consisting of a solid, a liquid, a a multi-compartment capsule as defined above, wherein said gas and a dispersion. Solid is selected from the group consisting of a pill, a tablet, In another embodiment of the present invention, there is a capsule, a powder, granulation, flakes, a troche, a Supposi a multi-compartment capsule as defined above, wherein said tory, an ointment, a paste, an emulsion and a cream. 35 second physical state of said ingredient in said secondary In another embodiment of the present invention, there is capsule is selected from the group consisting of a Solid, a a multi-compartment capsule as defined above, wherein said liquid, a gas and a dispersion. liquid is selected from the group consisting of a solution, a In another embodiment of the present invention, there is spirit, an elixir, a spray, a syrup and a fluid extract. a multi-compartment capsule as defined above, wherein said In another embodiment of the present invention, there is 40 primary capsule comprises a time-release coating. a multi-compartment capsule as defined above, wherein said In another embodiment of the present invention, there is dispersion is selected from the group consisting of an a multi-compartment capsule as defined above, wherein said aerosol, a Suspension, an emulsion, a foam, a solid foam and secondary capsule comprises a time-release coating. a gel. In another embodiment of the present invention, there is In another embodiment of the present invention, there is 45 a multi-compartment capsule as defined above, wherein said a multi-compartment capsule as defined above, wherein said time-release coating of said secondary capsule is different first receiving chamber comprises a time-release coating. from said time-release coating of said primary capsule. In another embodiment of the present invention, there is In another embodiment of the present invention, there is a multi-compartment capsule as defined above, wherein said a multi-compartment capsule as defined above, wherein said second receiving chamber comprises a time-release coating. 50 third receiving chamber comprises a time-release coating. In another embodiment of the present invention, there is In another embodiment of the present invention, there is a multi-compartment capsule as defined above, wherein said a multi-compartment capsule as defined above, wherein said time-release coating of said second receiving chamber is primary capsule is formed of a material selected from the different from said time-release coating of said primary group consisting of gelatin, starch, casein, chitosan, Soya capsule. 55 bean protein, safflower protein, alginates, gellan gum, cara In another embodiment of the present invention, there is geenan, Xanthan gum, phtalated gelatin, Succinated gelatin, a multi-compartment capsule as defined above, further com cellulosephtalate-acetate, oleoresin, polyvinylacetate, prising a third receiving chamber comprising at least one hydroxypropyl methyl cellulose, polymerisates of acrylic or ingredient. methacrylic esters, polyvinylacetate-phtalate and combina In another embodiment of the present invention, there is 60 tions thereof. a multi-compartment capsule as defined above, wherein said In another embodiment of the present invention, there is ingredient in said third receiving chamber is selected from a multi-compartment capsule as defined above, wherein said the group consisting of a nutraceutical, a vitamin, a dietary primary capsule further comprises a soft elastic capsule Supplement and a mineral. formed of a material selected from the group consisting of In another embodiment of the present invention, there is 65 glycerin and Sorbitol. a multi-compartment capsule as defined above, wherein said In another embodiment of the present invention, there is ingredient in said third receiving chamber comprises a an encapsulation process as defined above, wherein said soft US 9,539,216 B2 15 16 elastic capsule includes an antimicrobial selected from the In another embodiment of the present invention, there is group consisting of paraben and Sorbic acid. a multi-compartment capsule as defined above, wherein said In another embodiment of the present invention, there is dividing wall comprises a time-release coating. a multi-compartment capsule as defined above, wherein said In another embodiment of the present invention, there is secondary capsule is formed of a material selected from the a multi-compartment capsule as defined above, wherein said group consisting of gelatin, starch, casein, chitosan, Soya time-release coating of said dividing wall is different from bean protein, Safflower protein, alginates, gellan gum, car said time-release coating of said capsule. rageenan, Xanthan gum, phtalated gelatin, Succinated gela In another embodiment of the present invention, there is tin, cellulosephtalate-acetate, oleoresin, polyvinylacetate, a multi-compartment capsule as defined above, wherein said hydroxypropyl methyl cellulose, polymerisates of acrylic or 10 third receiving chamber comprises a time-release coating. In another embodiment of the present invention, there is methacrylic esters, polyvinylacetate-phtalate and combina a multi-compartment capsule as defined above, wherein said tions thereof. capsule is formed of a material selected from the group In another embodiment of the present invention, there is consisting of gelatin, starch, casein, chitosan, Soya bean a multi-compartment capsule as defined above, wherein said 15 protein, safflower protein, alginates, gellan gum, carra ingredient introduced in said primary capsule comprises a geenan, Xanthan gum, phtalated gelatin, Succinated gelatin, moisture content in the range of about 0% to 6% by weight. cellulosephtalate-acetate, oleoresin, polyvinylacetate, In another embodiment of the present invention, there is hydroxypropyl methyl cellulose, polymerisates of acrylic or a multi-compartment capsule as defined above, wherein said methacrylic esters, polyvinylacetate-phtalate and combina ingredient introduced in said secondary capsule comprises a tions thereof. moisture content in the range of about 0% to 6% by weight. In another embodiment of the present invention, there is In another embodiment of the present invention, there is a multi-compartment capsule as defined above, wherein said a multi-compartment capsule as defined above, wherein said capsule further comprises a soft elastic capsule formed of a primary and secondary capsules contain at least one phar material selected from the group consisting of glycerin and maceutically acceptable lubricant in the range of about 0% 25 sorbitol. to 1.0% by weight. In another embodiment of the present invention, there is In another embodiment of the present invention, there is a multi-compartment capsule as defined above, wherein said a multi-compartment capsule as defined above, wherein said dividing wall is formed of a material selected from the group lubricant is selected from the group consisting of alumini consisting of gelatin, starch, casein, chitosan, Soya bean umstearate, calciumstearate, magnesiumstearate, tinstearate, 30 protein, safflower protein, alginates, gellan gum, carra talc, sodium lauryl Sulfate, lecithins, mineral oils, Stearic geenan, Xanthan gum, phtalated gelatin, Succinated gelatin, acid, silicones and mixtures thereof. cellulosephtalate-acetate, oleoresin, polyvinylacetate, In another embodiment of the present invention, there is hydroxypropyl methyl cellulose, polymerisates of acrylic or a multi-compartment capsule as defined above, wherein said methacrylic esters, polyvinylacetate-phtalate and combina primary and secondary capsules have different colors. 35 tions thereof. In another embodiment of the present invention, there is In another embodiment of the present invention, there is a multi-compartment capsule as defined above, wherein said a multi-compartment capsule as defined above, wherein said primary capsule is formed having a first color. ingredient introduced in said first receiving chamber com In another embodiment of the present invention, there is prises a moisture content in the range of about 0% to 6% by a multi-compartment capsule as defined above, wherein said 40 weight. secondary capsule is formed having a second color different In another embodiment of the present invention, there is from said first color of said primary capsule. a multi-compartment capsule as defined above, wherein said In another embodiment of the present invention, there is ingredient introduced in said second receiving chamber a multi-compartment capsule as defined above, wherein said comprises a moisture content in the range of about 0% to 6% capsule further comprises a base and a corresponding cap, 45 by weight. wherein said cap is configured to provide a sealing relation In another embodiment of the present invention, there is ship when engaging said base. a multi-compartment capsule as defined above, wherein said In another embodiment of the present invention, there is capsule contains at least one pharmaceutically acceptable a multi-compartment capsule as defined above, wherein said lubricant in the range of about 0% to 10% by weight. base and said cap are formed having different colors. 50 In another embodiment of the present invention there is, In another embodiment of the present invention, there is an encapsulation process for forming a multi-compartment a multi-compartment capsule as defined above, wherein said capsule, said process comprising the steps of providing a sealing relationship between said base and corresponding primary capsule having a base and a cap; providing a cap comprises no dead volume space. secondary capsule having a base and a cap; introducing at In another embodiment of the present invention, there is 55 least one ingredient having a first physical state into said a multi-compartment capsule as defined above, wherein said secondary capsule, wherein said ingredient introduced into physical state of said ingredient in said first receiving said primary, capsule is selected from the group consisting chamber is selected from the group consisting of a Solid, a of a nutraceutical, a vitamin, a dietary Supplement and a liquid, a gas and a dispersion. mineral; positioning said cap of said secondary capsule in In another embodiment of the present invention, there is 60 sealing relationship with said base; introducing at least one a multi-compartment capsule as defined above, wherein said ingredient having a second physical state into said primary physical State of said ingredient in said second receiving capsule, wherein said ingredient introduced into said pri chamber capsule is selected from the group consisting of a mary capsule is selected from the group consisting of a Solid, a liquid, a gas and a dispersion. nutraceutical, a vitamin, a dietary Supplement and a mineral; In another embodiment of the present invention, there is 65 and wherein said first physical state of said ingredient of said a multi-compartment capsule as defined above, wherein said secondary capsule is different from said second physical capsule comprises a time-release coating. state of said ingredient of said primary capsule; introducing US 9,539,216 B2 17 18 said secondary capsule into said base of said primary In another embodiment of the present invention, there is capsule; and positioning said cap of said primary capsule in an encapsulation process as defined above, wherein said sealing relationship with said base. tertiary capsule comprises a time-release coating. In another embodiment of the present invention there is, In another embodiment of the present invention, there is an encapsulation process as defined above, further compris 5 an encapsulation process as defined above, wherein said ing the step of reducing dead volume space within said primary capsule is formed of a material selected from the primary capsule. group consisting of gelatin, starch, casein, chitosan, Soya In another embodiment of the present invention, an bean protein, saflower protein, alginates, gellan gum, car encapsulation process as defined above, further comprising rageenan, Xanthan gum, phtalated gelatin, Succinated gela 10 tin, cellulosephtalate-acetate, polyvinylacetate, hydroxypro the step of introducing a filling material into said cap of said pyl methyl cellulose, oleoresin, polymerisates of acrylic or primary capsule to reduce dead volume space. methacrylic esters, polyvinylacetate-phtalate and combina In another embodiment of the present invention, there is tions thereof. an encapsulation process as defined above, wherein said In another embodiment of the present invention, there is filling material is selected from the group consisting of 15 an encapsulation process as defined above, wherein said gelatin, starch, casein, chitosan, Soya bean protein, safflower primary capsule further comprises—a soft elastic capsule protein, alginates, gellan gum, carrageenan Xanthan gum, formed of a material selected from the group consisting of phtalated gelatin, Succinated gelatin, cellulosephtalate-ac glycerin and Sorbitol. etate, polyvinylacetate, hydroxypropyl methyl cellulose, In another embodiment of the present invention, there is oleoresin, polyvinylacetate-phtalate, polymerisates of an encapsulation process as defined above, wherein said acrylic or methacrylic esters and combinations thereof. secondary capsule is formed of a material selected from the In another embodiment of the present invention, an group consisting of gelatin, starch, casein, chitosan, Soya encapsulation process as defined above, wherein said cap of bean protein, saflower protein, alginates, gellan gum, car said primary capsule comprises a configuration Sufficient for rageenan, Xanthan gum phtalated gelatin, Succinated gelatin, reducing dead volume space within the primary capsule. 25 cellulosephtalate-acetate, polyvinylacetate, hydroxypropyl In another embodiment of the present invention, there is methyl cellulose, oleoresin, polymerisates of acrylic or an encapsulation process as defined above, wherein said methacrylic esters, polyvinylacetate-phtalate and combina physical state of said ingredient in said primary capsule is tions thereof. selected from the group consisting of a solid, a liquid, a gas In another embodiment of the present invention, there is and a dispersion. 30 an encapsulation process as defined above, wherein said In another embodiment of the present invention, there is secondary capsule further comprises a Soft elastic capsule an encapsulation process as defined above, wherein said formed of a material selected from the group consisting of physical state of said ingredient in said secondary capsule is glycerin and Sorbitol. selected from the group consisting of a solid, a liquid, a gas In another embodiment of the present invention, there is and a dispersion. 35 an encapsulation process as defined above, wherein said In another embodiment of the present invention, there is ingredient introduced in said primary capsule comprises a an encapsulation process as defined above, wherein said moisture content in the range of about 0% to 6% by weight. ingredient introduced into said primary capsule is the same In another embodiment of the present invention, there is as said ingredient introduced into said secondary capsule. a multi-compartment capsule as defined above, wherein said In another embodiment of the present invention, there is 40 ingredient introduced in said secondary capsule comprises a an encapsulation process as defined above, wherein said moisture content in the range of about 0% to 6% by weight. primary capsule comprises a time-release coating. In another embodiment of the present invention, there is In another embodiment of the present invention, there is an encapsulation process as defined above, wherein said an encapsulation process as defined above, wherein said primary and secondary capsules contain at least one phar secondary capsule comprises a time-release coating. 45 maceutically acceptable lubricant in the range of about 0% In another embodiment of the present invention, there is to 10% by weight. an encapsulation process as defined above, wherein said In another embodiment of the present invention, there is time-release coating of said secondary capsule is different an encapsulation process as defined above, wherein said from said time-release coating of said primary capsule. lubricant is selected from the group consisting of alumini In another embodiment of the present invention, there is 50 umstearate, calciumstearate, magnesiumstearate, tinstearate, an encapsulation process as defined above, further compris talc, sodium lauryl Sulfate, lecithins, mineral oils, Stearic ing the steps of providing a tertiary capsule having a base acid, silicones and combinations thereof. and a cap; introducing at least one ingredient having a third In another embodiment of the present invention, there is physical state into said tertiary capsule; positioning said cap an encapsulation process as defined above, wherein said of said secondary capsule in sealing relationship with said 55 primary and secondary capsules are formed having different base; and introducing said tertiary capsule into said base of colors. said secondary capsule. In another embodiment of the present invention, there is In another embodiment of the present invention, there is an encapsulation process for forming a multi-compartment an encapsulation process as defined above, wherein said capsule, said process comprising the steps of providing a ingredient in said tertiary capsule is selected from the group 60 capsule comprising a cap, a base configured having a consisting of a nutraceutical, a vitamin, a dietary Supplement longitudinally extending body including a length and at least and a mineral. one dividing wall formed along said length of said extending In another embodiment of the present invention, there is body, said dividing wall adapted to form a first receiving an encapsulation process as defined above, wherein said chamber and a second receiving chamber; introducing at ingredient in said tertiary capsule comprises a physical state 65 least one ingredient having a first physical state into said selected from the group consisting of a solid, a liquid, a gas second receiving chamber, wherein said ingredient intro and a dispersion. duced into said primary capsule is selected from the group US 9,539,216 B2 19 20 consisting of a nutraceutical, a vitamin, a dietary Supplement physical state selected from the group consisting of a solid, and a mineral; introducing at least one ingredient having a a liquid, a gas and a dispersion. second physical state into said first receiving chamber, In another embodiment of the present invention, there is wherein said ingredient introduced into said primary capsule an encapsulation process as defined above, wherein said is selected from the group consisting of a nutraceutical, a dispersion is selected from the group consisting of an Vitamin, a dietary Supplement and a mineral, and wherein aerosol, a Suspension, an emulsion, a foam, a solid foam and said first physical state of said ingredient of said second a gel. receiving chamber being different from said second physical In another embodiment of the present invention, there is state of said ingredient of said first receiving chamber, and an encapsulation process as defined above, wherein said positioning said cap in sealing relationship with said base. 10 third receiving chamber comprises a time-release coating. In another embodiment of the present invention, there is an encapsulation process as defined above, further compris In another embodiment of the present invention, there is ing the step of reducing dead volume space within said an encapsulation process as defined above, wherein said primary capsule. capsule is formed of a material selected from the group In another embodiment of the present invention, there is 15 consisting of gelatin, starch, casein, chitosan, Soya bean an encapsulation process as defined above, further compris protein, safflower protein, alginates, gellan gum, carra ing the step of introducing a filling material into said cap to geenan, Xanthan gum, phtalated gelatin, Succinated gelatin, reduce said dead volume space. cellulosephtalate-acetate, polyvinylacetate, hydroxypropyl In another embodiment of the present invention, there is methyl cellulose, oleoresin, polymerisates of acrylic or an encapsulation process as defined above, wherein said methacrylic esters, polyvinylacetate-phtalate and combina filling material is selected from the group consisting of tions thereof. gelatin, starch, casein, chitosan, Soya bean protein, safflower In another embodiment of the present invention, there is protein, alginates, gellan gum, carrageenan, Xanthan gum, an encapsulation process as defined above, wherein said phtalated gelatin, Succinated gelatin, cellulosephtalate-ac capsule further comprises a soft elastic capsule formed of a etate, polyvinylacetate, hydroxypropyl methyl cellulose, 25 material selected from the group consisting of glycerin and oleoresin, polyvinylacetate-phtalate, polymerisates of sorbitol. acrylic or methacrylic esters and combinations thereof. In another embodiment of the present invention, there is In another embodiment of the present invention, there is an encapsulation process as defined above, wherein said an encapsulation process as defined above, wherein said cap primary and secondary capsules contain at least one phar comprises a configuration Sufficient for reducing dead vol 30 maceutically acceptable lubricant in the range of about 0% ume space within said capsule. to 10% by weight. In another embodiment of the present invention, there is an encapsulation process as defined above, wherein said In another embodiment of the present invention, there is physical state of said ingredient in said receiving chamber is an encapsulation process as defined above, wherein said selected from the group consisting of a solid, a liquid, a gas 35 lubricant is selected from the group consisting of alumini and a dispersion. umstearate, calciumstearate, magnesiumstearate, tinstearate, In another embodiment of the present invention, there is talc, sodium lauryl Sulfate, lecithins, mineral oils, Stearic an encapsulation process as defined above, wherein said acid, silicones and combinations thereof. physical State of said ingredient in said second receiving In another embodiment of the present invention, there is chamber is selected from the group consisting of a Solid, a 40 an encapsulation process as defined above, wherein said liquid, a gas and a dispersion. base and said cap of said capsule are formed having different In another embodiment of the present invention, there is colors. an encapsulation process as defined above, wherein said first In another embodiment of the present invention, there is receiving chamber comprises a time-release coating. an encapsulation process as defined above, further compris In another embodiment of the present invention, there is 45 ing the step of introducing two or more dividing walls an encapsulation process as defined above, wherein said adapted to form a plurality of receiving chambers into said second receiving chamber comprises a time-release coating. base of said capsule. In another embodiment of the present invention, there is In another embodiment of the present invention, there is an encapsulation process as defined above, wherein said an encapsulation process as defined above, further compris time-release coating of said second receiving chamber is 50 ing the step of introducing a capsule into one of said different from said time-release coating of said first receiv plurality of receiving chambers. ing chamber. In another embodiment of the present invention, there is In another embodiment of the present invention, there is an encapsulation process as defined above, wherein said an encapsulation process as defined above, further compris capsule may comprise a multi-compartment capsule. ing the steps of positioning a second dividing wall along said 55 length of said extending body, said second dividing wall In another embodiment of the present invention, there is adapted to form a third receiving chamber, and introducing a multi-compartment capsule, comprising a first receiving at least one ingredient having a third physical state into said chamber comprising at least one ingredient having a first third receiving chamber. physical state; and a second receiving chamber comprising In another embodiment of the present invention, there is 60 at least one ingredient having a second physical state, an encapsulation process as defined above, wherein said wherein said first physical state of said ingredient of said ingredient in said third receiving chamber is selected from first receiving chamber being different from said second the group consisting of a nutraceutical, a vitamin, a dietary physical State of said ingredient of said second receiving Supplement and a mineral. chamber. In another embodiment of the present invention, there is 65 In another embodiment of the present invention, there is an encapsulation process as defined above, wherein said a multi-compartment capsule as defined above, wherein said ingredient in said third receiving chamber comprises a first receiving chamber comprises no dead space. US 9,539,216 B2 21 22 In another embodiment of the present invention, there is consisting of a pharmaceutical, a biotechnical, a nutraceu a multi-compartment capsule as defined above, wherein said tical, a vitamin, a dietary Supplement and a mineral. cap is configured to reduce dead volume space within said In another embodiment of the present invention, there is first receiving chamber. a multi-compartment capsule as defined above, wherein said In another embodiment of the present invention, there is ingredient in said secondary capsule is selected from the a multi-compartment capsule as defined above, further com group consisting of a pharmaceutical, a biotechnical, a prising a filling material introduced into said cap to reduce nutraceutical, a vitamin, a dietary Supplement and a mineral. dead volume space within said first receiving chamber. In another embodiment of the present invention, there is In another embodiment of the present invention, there is a multi-compartment capsule as defined above, wherein said 10 ingredient in said first receiving chamber comprises a phar a multi-compartment capsule as defined above, wherein said maceutical and said ingredient in said second receiving ingredient in said first receiving chamber is selected from chamber comprises a pharmaceutical. the group consisting of a pharmaceutical, a biotechnical, a In another embodiment of the present invention, there is nutraceutical, a vitamin, a dietary Supplement and a mineral. a multi-compartment capsule as defined above, wherein said In another embodiment of the present invention, there is 15 ingredient introduced in said primary capsule comprises a a multi-compartment capsule as defined above, wherein said moisture content in the range of about 0% to 6% by weight. ingredient in said second receiving chamber is selected from In another embodiment of the present invention, there is the group consisting of a pharmaceutical, a biotechnical, a a multi-compartment capsule as defined above, wherein said nutraceutical, a vitamin, a dietary Supplement and a mineral. ingredient introduced in said secondary capsule comprises a In another embodiment of the present invention, there is moisture content in the range of about 0% to 6% by weight. a multi-compartment capsule as defined above, wherein said In another embodiment of the present invention, there is ingredient in said first receiving chamber comprises a phar a multi-compartment capsule as defined above, wherein said maceutical and said ingredient in said second receiving primary and secondary capsules contain at least one phar chamber comprises a pharmaceutical. maceutically acceptable lubricant in the range of about 0% In another embodiment of the present invention, there is 25 to 10% by weight. a multi-compartment capsule as defined above, wherein said In another embodiment of the present invention, there is ingredient in said first receiving chamber comprises a phar a multi-compartment capsule as defined above, wherein said maceutical and said ingredient in said second receiving lubricant is selected from the group consisting of alumini chamber is selected from the group consisting of a biotech umstearate, calciumstearate, magnesiumstearate, tinstearate, nical, a nutraceutical, a vitamin, a dietary Supplement and a 30 talc, sodium lauryl Sulfate, lecithins, mineral oils, Stearic mineral. acid, silicones and mixtures thereof. In another embodiment of the present invention, there is In another embodiment of the present invention, there is a multi-compartment capsule as defined above, wherein said a multi-compartment capsule as defined above, wherein said physical state of said ingredient in said first receiving primary and secondary capsules have different colors. chamber is selected from the group consisting of a Solid, a 35 In another embodiment of the present invention, there is liquid, a gas and a dispersion. a multi-compartment capsule as defined above, wherein said In another embodiment of the present invention, there is primary capsule is formed having a first color. a multi-compartment capsule as defined above, wherein said In another embodiment of the present invention, there is physical State of said ingredient in said second receiving a multi-compartment capsule as defined above, wherein said chamber is selected from the group consisting of a Solid, a 40 secondary capsule is formed having a second color different liquid, a gas and a dispersion. from said first color of said primary capsule. In another embodiment of the present invention, there is In another embodiment of the present invention, there is a multi-compartment capsule as defined above, wherein said a multi-compartment capsule, comprising a capsule com time-release coating of said second receiving chamber is prising a longitudinally extending body having a length; at different from said time-release coating of said primary 45 least one dividing wall formed along said length of said capsule. extending body, said dividing wall forming a first receiving In another embodiment of the present invention, there is chamber and a second receiving chamber, said first receiv a multi-compartment capsule, comprising a primary capsule ing chamber comprising at least one ingredient having a first comprising at least one ingredient having a first physical physical state; said second receiving chamber comprising at state; a secondary capsule comprising at least one ingredient 50 least one ingredient having a second physical state; and said having a second physical state; said first physical state of first physical state of said ingredient of said first receiving said ingredient of said primary capsule being different from chamber being different from said second physical state of said second physical State of said ingredient of said second said ingredient of said second receiving chamber. ary capsule; and said primary capsule comprising an internal In another embodiment of the present invention, there is periphery sufficient for receiving said ingredient and said 55 a multi-compartment capsule as defined above, wherein said secondary capsule therein. capsule further comprises a base and a corresponding cap, In another embodiment of the present invention, there is wherein said cap is configured to provide a sealing relation a multi-compartment capsule as defined above, wherein said ship when engaging said base. primary, capsule further comprises a base and a correspond In another embodiment of the present invention, there is ing cap, wherein said cap is configured to provide a sealing 60 a multi-compartment capsule as defined above, wherein said relationship when engaging said base. base and said cap are formed having different colors. In another embodiment of the present invention, there is In another embodiment of the present invention, there is a multi-compartment capsule as defined above, wherein said a multi-compartment capsule as defined above, wherein said primary capsule comprises no dead volume space. sealing relationship between said base and corresponding In another embodiment of the present invention, there is 65 cap comprises no dead volume space within said capsule. a multi-compartment capsule as defined above, wherein said In another embodiment of the present invention, there is ingredient in said primary capsule is selected from the group a multi-compartment capsule as defined above, wherein said US 9,539,216 B2 23 24 ingredient in said first receiving chamber comprises a phar In another embodiment of the present invention, there is maceutical and said ingredient in said second receiving an encapsulation process as defined above, wherein said cap chamber comprises a pharmaceutical. of said primary capsule comprises a configuration Sufficient In another embodiment of the present invention, there is for reducing dead volumen space within the primary cap a multi-compartment capsule as defined above, wherein said Sule. ingredient in said first receiving chamber comprises a phar In another embodiment of the present invention, there is maceutical and said ingredient in said second receiving an encapsulation process as defined above, wherein said chamber is selected from the group consisting of a biotech ingredient introduced into said primary capsule is selected nical, a nutraceutical, a vitamin, a dietary Supplement and a from the group consisting of a pharmaceutical, a biotechni mineral. 10 In another embodiment of the present invention, there is cal, a nutraceutical, a vitamin, a dietary Supplement and a a multi-compartment capsule as defined above, wherein said mineral. first physical state of said ingredient in said first receiving In another embodiment of the present invention, there is chamber is selected from the group consisting of a Solid, a an encapsulation process as defined above, wherein said liquid, a gas and a dispersion. 15 physical state of said ingredient in said primary capsule is In another embodiment of the present invention, there is selected from the group consisting of a solid, a liquid, a gas a multi-compartment capsule as defined above, wherein said and a dispersion. second physical state of said ingredient in said second In another embodiment of the present invention, there is receiving chamber capsule is selected from the group con an encapsulation process as defined above, wherein said sisting of a solid, a liquid, a gas and a dispersion. ingredient in said secondary capsule is selected from the In another embodiment of the present invention, there is group consisting of a pharmaceutical, a biotechnical, a a multi-compartment capsule as defined above, wherein said nutraceutical, a vitamin, a dietary Supplement and a mineral. capsule comprises a time-release coating. In another embodiment of the present invention, there is In another embodiment of the present invention, there is an encapsulation process as defined above, wherein said a multi-compartment capsule as defined in above, wherein 25 physical state of said ingredient in said secondary capsule is said capsule is formed of a material selected from the group selected from the group consisting of a solid, a liquid, a gas consisting of gelatin, starch, casein, chitosan, Soya bean and a dispersion. protein, safflower protein, alginates, gellan gum, cara In another embodiment of the present invention, there is geenan, Xanthan gum, phtalated gelatin, Succinated gelatin, an encapsulation process as defined above, wherein said cellulosephtalate-acetate, polyvinylacetate, hydroxypropyl 30 ingredient in said primary capsule comprises a pharmaceu methyl cellulose, oleoresin, polymerisates of acrylic or tical and said ingredient in said secondary capsule is selected methacrylic esters, polyvinylacetate-phtalate and mixtures from the group consisting of a pharmaceutical. thereof. In another embodiment of the present invention, there is In another embodiment of the present invention, there is an encapsulation process as defined above, wherein said a multi-compartment capsule as defined above, wherein said 35 ingredient in said primary capsule comprises a pharmaceu capsule further comprises a soft elastic capsule formed of a tical and said ingredient in said secondary capsule is selected material selected from the group consisting of glycerin and from the group consisting of a biotechnical, a nutraceutical, sorbitol. a vitamin, a dietary Supplement and a mineral. In another embodiment of the present invention, there is In another embodiment of the present invention, there is a multi-compartment capsule as defined above, wherein said 40 an encapsulation process as defined above, wherein said lubricant is selected from the group consisting of alum ingredient introduced into said primary capsule is the same iniumstearate, calciumstearate, magnesiumnstearate, tin as said ingredient introduced into said secondary capsule. Stearate, talc, sodium lauryl Sulfate, lecithins, mineral oils, In another embodiment of the present invention, there is Stearic acid, silicones and mixtures thereof. an encapsulation process as defined above, wherein said In another embodiment of the present invention, there is 45 time-release coating of said secondary capsule is different an encapsulation process for forming a multi-compartment from said time-release coating of said primary capsule. capsule, said process comprising the steps of providing a In another embodiment of the present invention, there is primary capsule having a base and a cap; providing a an encapsulation process as defined above, further compris secondary capsule having a base and a cap; introducing at ing the steps of providing a tertiary capsule having a base least one ingredient having a first physical state into said 50 and a cap; introducing at least one ingredient having a third secondary capsule; positioning said cap of said secondary physical state into said tertiary, capsule; positioning said cap capsule in sealing relationship with said base; introducing at of said secondary capsule in sealing relationship with said least one ingredient having a second physical state into said base; and introducing said tertiary capsule into said base of primary capsule, wherein said first physical state of said said secondary capsule. ingredient of said secondary capsule is different from said 55 In another embodiment of the present invention, there is second physical state of said ingredient of said primary an encapsulation process as defined above, wherein said capsule; introducing said secondary capsule into said base of ingredient in said tertiary capsule is selected from the group said primary capsule; and positioning said cap of said consisting of a pharmaceutical, a biotechnical, a nutraceu primary capsule in sealing relationship with said base. tical, a vitamin, a dietary Supplement and a mineral. In another embodiment of the present invention, there is 60 In another embodiment of the present invention, there is an encapsulation process as defined above, further compris an encapsulation process as defined above, wherein said ing the step of reducing dead volume space within said ingredient in said tertiary capsule comprises a physical state primary capsule. selected from the group consisting of a solid, a liquid, a gas In another embodiment of the present invention, there is and a dispersion. an encapsulation process as defined above, further compris 65 In another embodiment of the present invention, there is ing the step of introducing a filling material into said cap of an encapsulation process as defined above, wherein said said primary capsule to reduce dead volume space. tertiary capsule comprises a time-release coating. US 9,539,216 B2 25 26 In another embodiment of the present invention, there is maceutical and said ingredient in said second receiving an encapsulation process as defined above, wherein said chamber is selected from the group consisting of a pharma lubricant is selected from the group consisting of alum ceutical. inumstearate, calciumstearate, magnesiumstearate, tinstear In another embodiment of the present invention, there is ate, talc, sodium lauryl Sulfate, lecithins, mineral oils, Stearic an encapsulation process as defined above, wherein said acid, silicones and combinations thereof. time-release coating of said second receiving chamber is In another embodiment of the present invention, there is different from said time-release coating of said first receiv an encapsulation process as defined above, wherein said ing chamber. primary and secondary capsules are formed having different In another embodiment of the present invention, there is colors. 10 an encapsulation process as defined above, further compris In another embodiment of the present invention, there is ing the steps of positioning a second dividing wall along said an encapsulation process for forming a multi-compartment length of said extending body of said base, said second capsule, said process comprising the steps of providing a dividing wall adapted to form a third receiving chamber; and capsule comprising a cap, a base configured having a introducing at least one ingredient having a physical state longitudinally extending body including a length and at least 15 into said third receiving chamber. one dividing wall formed along said length of said extending In another embodiment of the present invention, there is body, said dividing wall adapted to form a first receiving an encapsulation process as defined above, wherein said chamber and a second receiving chamber, introducing at ingredient introduced into said third receiving chamber is least one ingredient having a first physical state into said selected from the group consisting of a pharmaceutical, a second receiving chamber, introducing at least one ingredi biotechnical, a nutraceutical, a vitamin, a dietary Supplement ent having a second physical state into said first receiving and a mineral. chamber, wherein said first physical state of said ingredient In another embodiment of the present invention, there is of said second receiving chamber being different from said an encapsulation process as defined above, wherein said second physical state of said ingredient of said first receiving physical state of said ingredient introduced into said third chamber; and positioning said cap in sealing relationship 25 receiving chamber is selected from the group consisting of with said base. a solid, a liquid, a gas and a dispersion. In another embodiment of the present invention, there is In another embodiment of the present invention, there is an encapsulation process as defined above, further compris an encapsulation process as defined above, wherein said ing the step of reducing dead volume space within said second dividing wall comprises a time-release coating. primary capsule. 30 In another embodiment of the present invention, there is In another embodiment of the present invention, there is an encapsulation process as defined above, wherein said an encapsulation process as defined above, wherein said capsule further comprises a soft elastic capsule formed of a filling material is selected from the group consisting of material selected from the group consisting of glycerin and gelatin, starch, casein, chitosan, Soya bean protein, safflower sorbitol. protein, alginates, gellan gum, carrageenan, Xanthan gum, 35 In another embodiment of the present invention, there is phtalated gelatin, Succinated gelatin, cellulosephtalate-ac an encapsulation process as defined above, wherein said etate, polyvinylacetate, hydroxypropyl methyl cellulose, lubricant is selected from the group consisting of alumini polyvinylacetate-phtalate, polymnerisates of acrylic or umstearate, calciumstearate, magnesiumstearate, tinstearate, methacrylic esters and combinations thereof. talc, sodium lauryl Sulfate, lecithins, mineral oils, Stearic In another embodiment of the present invention, there is 40 acid, silicones and combinations thereof. an encapsulation process as defined above, wherein said cap In another embodiment of the present invention, there is comprises a configuration Sufficient for reducing dead vol an encapsulation process as defined above, wherein said ume space within said capsule. base and said cap of said capsule are formed having different In another embodiment of the present invention, there is colors. an encapsulation process as defined above, wherein said 45 ingredient in said first receiving chamber is selected from BRIEF DESCRIPTION OF THE DRAWINGS the group consisting of a pharmaceutical, a biotechnical, a nurtraceutical, a vitamin, a dietary Supplement and a min The foregoing and other objects and features of the eral. present invention will become roe fully apparent from the In another embodiment of the present invention, there is 50 following description and appended claims, taken in con an encapsulation process as defined above, wherein said junction with the accompanying drawings. Understanding physical state of said ingredient in said receiving chamber is that these drawings depict only typical embodiments of the selected from the group consisting of a solid, a liquid, a gas invention and are, therefore, not to be considered limiting of and a dispersion. its scope, the invention will be described with additional In another embodiment of the present invention, there is 55 specificity and detail through use of the accompanying an encapsulation process as defined above, wherein said drawings in which: ingredient in said second receiving chamber is selected from FIG. 1 is a flow diagram illustrating one presently pre the group consisting of a pharmaceutical, a biotechnical, a ferred embodiment of a process of the present invention nutraceutical, a vitamin, a dietary Supplement and a mineral. comprising the steps of introducing at least one active In another embodiment of the present invention, there is 60 ingredient or medicament having a solid physical state into an encapsulation process as defined above, wherein said a secondary capsule and introducing the secondary capsule physical State of said ingredient in said second receiving into a primary capsule further including at least one active chamber is selected from the group consisting of a Solid, a ingredient or medicament having a liquid physical state; liquid, a gas and a dispersion. FIG. 2 is a cross-sectional view illustrating another pres In another embodiment of the present invention, there is 65 ently preferred embodiment of a multi-compartment capsule an encapsulation process as defined above, wherein said of the present invention wherein a primary capsule houses a ingredient in said first receiving chamber comprises a phar secondary capsule and a secondary capsule houses a tertiary US 9,539,216 B2 27 28 capsule, wherein each of the capsules include one or more FIG. 9 is a perspective view illustrating yet another active ingredients or medicaments and the active ingredient presently preferred embodiment of a multi-compartment (s) introduced into at least two of the capsules comprise capsule of the present invention wherein the multi-compart different physical states; ment capsule shown in FIG. 7 is introduced within the FIG. 3 is a perspective view illustrating yet another internal periphery of a receiving chamber of a primary presently preferred embodiment of a multi-compartment capsule having one or more active ingredients also contained capsule comprising a base, a cap and a dividing wall therein; positioned between the base and the cap, wherein the FIG. 10 is a cross-sectional view illustrating a presently dividing wall facilitates the formation of at least two, preferred embodiment of a multi-compartment capsule of independent receiving chambers for receiving one or more 10 active ingredients or medicaments having different physical the present invention including a secondary capsule having States: one or more active ingredients or medicaments selectively FIG. 4 is a cross-sectional view of the multi-compartment introduced into the internal periphery of a primary capsule capsule shown in FIG. 3 wherein the base, the dividing wall having one or more active ingredients or medicaments, defining the two receiving chambers and the cap are 15 wherein the active ingredient(s) introduced into the primary assembled to form a capsule of the present invention and capsule comprises a physical state (e.g., Solid, liquid, gas or wherein one or more active ingredients or medicaments dispersion) which differs from the physical state of the active having different physical states are introduced into the ingredient(s) introduced into the internal periphery of the receiving chambers; secondary capsule, the primary capsule further comprising a FIG. 5 is a perspective view illustrating an alternate cap having a generally U-shaped configuration adapted to presently preferred embodiment of a multi-compartment provide a sealing relationship when engaging the corre capsule of the present invention having a primary capsule sponding base, thereby reducing dead space Volume in the comprising a capsular base configured with a longitudinally internal periphery of the receiving chamber of the base; extending body, a corresponding cap and a series of dividing FIG. 11 is a perspective view illustrating yet another walls disposed in spaced apart relationship along the length 25 presently preferred embodiment of a multi-compartment of the longitudinally extending body of the base, wherein the capsule of the present invention including a secondary dividing walls define a plurality of independent receiving capsule having one or more active ingredients or medica chambers having an internal periphery sufficient for intro ments and having a size and shape Sufficient for being ducing one or more active ingredients or medicaments selectively introduced into the internal periphery of a pri having different physical states therein and for introducing a 30 mary capsule having one or more active ingredients or secondary capsule, having one or more active ingredients medicaments, wherein the active ingredient(s) introduced contained therein, within at least one of said receiving into the primary capsule comprises a physical state (e.g., chambers; Solid, liquid, gas or dispersion) which differs from the FIG. 6 is a cross-sectional view of the multi-compartment physical state of the active ingredient(s) introduced into the capsule shown in FIG. 5 wherein the base and the cap are 35 internal periphery of the secondary capsule, the primary assembled to form a single dosage capsule having a series of capsule further comprising a filling material introduced into dividing walls that define a plurality of chambers for receiv the internal periphery of the cap having a general conical ing one or more active ingredients or medicaments, wherein configuration and adapted to provide a sealing relationship the active ingredient(s) in at least two of the receiving when engaging the corresponding base, thereby reducing chambers comprise different physical states; 40 dead space Volume in the internal periphery of the receiving FIG. 7 is a perspective view illustrating yet another chamber of the base; presently preferred embodiment of a multi-compartment FIG. 12 is a cross-sectional view of the multi-compart capsule of the present invention having a primary capsule ment capsule shown in FIG. 11 wherein a sufficient amount comprising a capsular base configured with a longitudinally of filling material is introduced into the internal periphery of extending body, a corresponding cap and a series of dividing 45 the cap, thereby functioning to eliminate or significantly walls disposed in spaced apart relationship, both vertically reduce the dead space Volume in the receiving chamber of and horizontally, along the length of the longitudinally the primary capsule; and extending body of the base, wherein the dividing walls FIG. 13 is a cross-sectional view illustrating an alternate define a plurality of independent receiving chambers having presently preferred embodiment of a multi-compartment an internal periphery sufficient for introducing one or more 50 capsule of the present invention comprising a tertiary cap active ingredients or medicaments having different physical Sule having one or more active ingredients or medicaments states therein; and having a size a shape Sufficient for being introduced into FIG. 8 is a perspective view illustrating an alternate at least a portion of the internal periphery of the receiving preferred embodiment of the multi-compartment capsule chamber of a secondary capsule having one or more active shown in FIG. 7, wherein the multi-compartment capsule 55 ingredients or medicaments also introduced therein, the size includes a primary capsule comprising a capsular base and shape of the secondary capsule Sufficient for being configured with a longitudinally extending body, a corre selectively introduced into the internal periphery of a pri sponding cap and a series of dividing walls disposed in mary capsule having one or more active ingredients or spaced apart relationship, both vertically and horizontally, medicaments, wherein the active ingredient(s) introduced along the length of the longitudinally extending body of the 60 into the primary capsule comprises a physical state (e.g., base, wherein the dividing walls define a plurality of inde Solid, liquid, gas or dispersion) which differs from the pendent receiving chambers having an internal periphery physical state of the active ingredient(s) introduced into the Sufficient for introducing one or more active ingredients or receiving chambers of the secondary and tertiary capsules, medicaments having different physical States therein and for the primary capsule further comprising a filling material introducing a secondary capsule, having one or more active 65 introduced into the internal periphery of the cap laving a ingredients contained therein, within at least one of said general conical configuration and adapted to provide a receiving chambers; sealing relationship when engaging the corresponding base, US 9,539,216 B2 29 30 thereby reducing dead space Volume in the internal periph capsule 20 into at least a portion of the receiving chamber 18 ery of the receiving chamber of the base of the primary of the primary capsule 11 and selectively positioning the cap capsule. 12 in Sealing relationship with the base 14 to form a single dosage multi-compartment capsule. DETAILED DESCRIPTION OF THE As shown, a solid is selectively introduced within at least PREFERRED EMBODIMENTS a portion of the internal periphery of the receiving chamber 28 of the secondary capsule 20 and a liquid is selectively It will be readily understood that the components of the introduced within at least a portion of the internal periphery present invention, as generally described and illustrated in of the receiving chamber 18 of the primary capsule 11. the Figures herein, could be arranged and designed in a wide 10 Although the ingredient(s) introduced into the receiving variety of different configurations and process steps. Those chamber 18 of the primary capsule 11 may be the same or of ordinary skill in the art will, of course, appreciate that different from the ingredient(s) introduced into the receiving various modifications to the details herein may easily be chamber 28 of the secondary capsule, the active ingredient made without departing from the essential characteristics of (s) in the primary capsule 11 have a physical state (i.e., Solid, the invention, as described. Thus, the following more 15 liquid, gas or dispersion) that varies from the physical state detailed description of the embodiments of apparatus and of the active ingredient(s) in the secondary capsule 20. methods of the present invention, as represented in FIGS. 1 Accordingly, those skilled in the art will readily recognize through 13, is not intended to limit the scope of the inven other possible modifications and adaptations relative to the tion, as claimed, but it is merely representative of the contemplated variations in physical states of the active presently preferred embodiments of the invention. ingredient(s) selectively positionable within the receiving The presently preferred embodiments of the invention chambers 18, 28 of the primary and secondary capsules, will be best understood by reference to the drawings, respectively, which are consistent with the spirit and scope wherein like parts are designated by like numerals through of the present invention. It is intended, therefore, that the Out. figures and examples provided herein be viewed as exem One presently preferred embodiment of the present inven 25 plary of the principles of the present invention, and not as tion, designated generally at 10, is best illustrated in FIG. 1. restrictive to a particular structure or method for implement As shown, a multi-compartment capsule 10 is illustrated ing those principles. comprising a primary capsule 11 and a secondary capsule 20 Referring now to FIG. 2, an alternate presently preferred selectively introduced within at least a portion of an internal embodiment of a multi-compartment capsule 110 is shown periphery of the primary capsule. The secondary capsule 20 30 comprising a primary capsule 111, a secondary capsule 120 includes a base 24, a corresponding cap 22 and a receiving and a tertiary capsule 130. The tertiary capsule 130 includes chamber 28 formed between the base and cap. The receiving a base 134, a corresponding cap 132 and a receiving chamber 28 is configured having an internal periphery chamber 138 formed between the base and cap. The receiv Sufficient for receiving at least one active ingredient or ing chamber 138 is preferably formed having an internal medicament (e.g., pharmaceutical, biotechnical, nutraceuti 35 periphery Sufficient for receiving at least one active ingre cal, Vitamin, dietary Supplement, mineral or combination dient or medicament (e.g., pharmaceutical, biotechnical, thereof) therein. In similar structural design, the primary nutraceutical, vitamin, dietary Supplement, mineral or com capsule 11 may be formed having a base 14, a corresponding bination thereof). Structurally, the tertiary capsule 130 is cap 12 and a receiving chamber 18 formed between the base configured having a size Sufficient for being selectively and cap. The receiving chamber 18 of the primary capsule 11 40 introduced within at least a portion of an internal periphery is preferably formed having an internal periphery sufficient of a receiving chamber 128 defined between a base 124 and for receiving the secondary capsule 20, together with at least a corresponding cap 122 of the secondary capsule 120. One one active ingredient or medicament (e.g., pharmaceutical, or more active ingredients or medicaments (e.g., pharma biotechnical, nutraceutical, vitamin, dietary Supplement, ceutical, biotechnical, nutraceutical, Vitamin, dietary Supple mineral or combination thereof) therein. 45 ment, mineral or combination thereof) may be introduced Still referring to FIG. 1, one presently preferred embodi into at least a portion of the receiving chamber 128 of the ment of an encapsulation process for forming a multi secondary capsule 120, together with the introduction of the compartment capsule 10 is comprising the steps of: (1) tertiary capsule 130 comprising its active ingredient(s). The providing a primary capsule 11 having a base 14, a corre secondary capsule 120 having its active ingredient(s) and sponding cap 12 and a receiving chamber 18; (2) providing 50 housing the tertiary capsule 130 with its active ingredient(s) a secondary capsule 20 having a base 24, a corresponding may then be selectively introduced within at least a portion cap 22 and a receiving chamber 28; (3) introducing at least of an internal periphery of a receiving chamber 118 of the one ingredient or medicament (e.g., pharmaceutical, bio primary capsule 111 defined between a base 114 and a technical, nutraceutical, vitamin, dietary, Supplement, min corresponding cap 112. Preferably, the receiving chamber eral or combination thereof) having a first physical state 55 118 of the primary capsule 111 may also include one or more (e.g., Solid, liquid, gas or dispersion) into at least a portion active ingredients or medicaments (e.g., pharmaceutical, of the receiving chamber 28 of the secondary capsule 20 and biotechnical, nutraceutical, vitamin, dietary Supplement, selectively positioning the cap 22 in sealing relationship mineral or combination thereof) introduced therein. with the base 24; (4) introducing at least one ingredient or Still referring to FIG. 2, another presently preferred medicament (e.g., pharmaceutical, biotechnical, nutraceuti 60 embodiment of an encapsulation process for forming a cal, Vitamin, dietary Supplement, mineral or combination multi-compartment capsule 110 may comprise the steps of thereof) having a second physical state (e.g., Solid, liquid, (1) providing a primary capsule 111 having a base 114, a gas or dispersion) into at least a portion of the receiving corresponding cap 112 and a receiving chamber 118 defined chamber 18 of the primary capsule 11, wherein the first between the base and cap; (2) providing a secondary capsule physical state of the ingredient(s) in the secondary capsule 65 120 having a base 124, a corresponding cap 122 and a is different from the second physical state of the ingredient receiving chamber 128 defined between the base and cap: (s) in the primary capsule; and (5) introducing the secondary (3) providing a tertiary capsule 130 having a base 134, a US 9,539,216 B2 31 32 corresponding cap 132 and a receiving chamber 138 defined Referring now to FIGS. 3 and 4, another presently pre between the base and cap; (4) introducing at least one ferred embodiment of a multi-compartment capsule 210 is ingredient (e.g., pharmaceutical, biotechnical, nutraceutical, shown comprising a base 214, a corresponding cap 212 and Vitamin, dietary Supplement, mineral or combination a dividing wall 216 positionable between the base and the thereof) having a first physical state (e.g., Solid, liquid, gas cap. Structurally, the size, shape and positioning of the or dispersion) into at least a portion of the receiving chamber dividing wall 216 relative to the base 214 and corresponding 138 of the tertiary capsule 130 and selectively positioning cap 212 facilitates the formation of at least two, independent the cap 132 in sealing relationship with the base 134; (5) and separate receiving chambers 218a, 218b, each having an introducing at least one ingredient (e.g., pharmaceutical, internal periphery sufficient for receiving one or more active 10 ingredients or medicaments (e.g., pharmaceutical, biotech biotechnical, nutraceutical, vitamin, dietary Supplement, nical, nutraceutical, vitamin, dietary Supplement, mineral or mineral or combination thereof) having a second physical combination thereof) therein. As best shown in FIG. 4, the state (e.g., Solid, liquid, gas or dispersion) into at least a dividing wall 216 seats within the internal periphery of both portion of the receiving chamber 128 of the secondary the base 214 and the corresponding cap 212. After intro capsule 120, wherein the first physical state of the ingredient 15 ducing one or more active ingredients or medicaments into (s) in the tertiary capsule 130 are the same as the second receiving chamber 218b and disposing the dividing wall 216 physical state of the ingredient(s) in the secondary capsule relative thereto, one or more active ingredients or medica 120; (6) introducing the tertiary capsule 130 into at least a ments (e.g. pharmaceutical, biotechnical, nutraceutical, Vita portion of the receiving chamber 218 of the secondary min, dietary Supplement, mineral or combination thereof) capsule 120 and selectively positioning the cap 122 in may be introduced into receiving chamber 218a and the cap sealing relationship with the base 124; (7) introducing at may be selectively positioned in Sealing relationship with least one ingredient (e.g., pharmaceutical, biotechnical, the base 214 to form one presently preferred embodiment of nutraceutical, vitamin, dietary Supplement, mineral or com the single, dosage multi-compartment capsule 210. More bination thereof) having a third physical state (e.g., Solid, over, the dividing wall 216 may functionally assist in liquid, gas or dispersion) into at least a portion of the 25 forming a sealing relationship between the base 214 and receiving chamber 118 of the primary capsule 111, wherein corresponding cap 212 of the multi-compartment capsule the third physical state of the ingredient(s) in the primary 210, if desired. capsule are different from the first and second physical states In one presently preferred embodiment of the multi of the ingredient(s) in the tertiary capsule 130 and the compartment capsule 211 of the present invention, a solid secondary capsule 120, respectively; and (8) introducing the 30 may be selectively introduced into at least a portion of the secondary capsule 120 into at least a portion of the receiving internal periphery of the receiving chamber 218a and a chamber 118 of the primary capsule 111 and selectively liquid may be selectively introduced into at least a portion of positioning the cap 112 in Sealing relationship with the base the internal periphery of the receiving chamber 218b. 114 to form a single dosage multi-compartment capsule. Although the ingredient(s) introduced into the receiving In the presently preferred embodiment illustrated in FIG. 35 chamber 218a may be the same or different from the 2, a liquid may be selectively introduced into at least a ingredient(s) introduced into the receiving chamber 218, the portion of the internal periphery of the receiving chamber active ingredient(s) in the first receiving chamber 218a 118 of the primary capsule 11, a solid may be selectively preferably comprise a physical State (e.g., Solid, liquid, gas introduced into at least a portion of the internal periphery of or dispersion) that is different from the physical state of the the receiving chamber 128 of the secondary capsule 120 and 40 active ingredient(s) in the second receiving chamber 218b. a solid may be selectively introduced into at least a portion Those skilled in the art will readily recognize other possible of the receiving chamber 138 of the tertiary capsule 130. modifications and adaptations relative to the contemplated Although the ingredient(s) selectively introduced into the variations in physical states (e.g., Solid, liquid, gas and receiving chambers 118, 128, 138 of the primary, secondary dispersion) of the active ingredient(s) selectively position and tertiary capsules 111, 120, 130, respectively, may be the 45 able within the receiving chambers 218a, 218b which are same or different, the active ingredient(s) in at least two of consistent with the spirit and scope of the present invention. the receiving chambers comprise at least two different It is intended, therefore, that the figures and examples physical states (e.g., Solid, liquid, gas or dispersion). It is provided herein be viewed as exemplary of the principles of further contemplated herein as an alternate embodiment that the present invention, and not as restrictive to a particular the active ingredient(s) introduced in the receiving chamber 50 structure or method for implementing those principles. 118 of the primary capsule 111 comprises a physical state Referring now to FIGS. 5 and 6, another presently pre (e.g., Solid, liquid, gas or dispersion) different from the ferred embodiment of a multi-compartment capsule, desig physical state of the active ingredient(s) contained within the nated as 310, is shown including a primary capsule 311 receiving chamber 128 of the secondary capsule 120 which comprising a capsular base 314 configured having an elon is different from the physical state of the active ingredient(s) 55 gated or longitudinally extending body, a corresponding cap contained within the receiving chamber 138 of the tertiary 312 and a plurality of dividing walls 316 selectively dis capsule 130. Those skilled in the art will readily recognize posed along the length of the longitudinally extending body other possible modifications and adaptations relative to of the base. Preferably, the structural size, shape and posi contemplated variations in physical states of the active tioning of the dividing walls 316a, 316b, 3.16c along the ingredient(s) selectively introduced within the receiving 60 length of the elongated body of the base 314 facilitate the chambers 118, 128, 138 of the primary, secondary and formation of a plurality of independent receiving chambers tertiary capsules, respectively, which are consistent with the 3.18a, 318b, 318d, 318d. Each receiving chamber 318a, spirit and scope of the present invention. It is intended, 318b, 318c, 318d of the primary capsule 311 having an therefore, that the figures and examples provided herein be internal periphery sufficient for receiving one or more active viewed as exemplary of the principles of the present inven 65 ingredients or medicaments (e.g., pharmaceutical, biotech tion, and not as restrictive to a particular structure or method nical, nutraceutical, vitamin, dietary Supplement, mineral or for implementing those principles. combination thereof) therein. US 9,539,216 B2 33 34 As best shown in FIG. 6, the dividing walls 316a, 316b, exemplary of the principles of the present invention, and not 3.16c are preferably seated within the internal periphery of as restrictive to a particular structure or method for imple the base 314 of the primary capsule 311 and in a spaced apart menting those principles. relationship along the length of the longitudinally extending Another presently preferred embodiment of a multi-com body and form four independent receiving chambers 318a, 5 partment capsule of the present invention, generally desig 318b, 318c, 318d. In one presently preferred embodiment of nated as 410 in FIG. 7, is shown comprising a capsular base the multi-compartment capsule 310 of the present invention, 414 preferably configured having an elongated or longitu each of the receiving chambers 318a, 318b, 318c comprises dinally extending body, a corresponding cap 412 and a at least one active ingredient or medicament having a plurality of dividing walls 416 selectively disposed along the physical state (e.g., Solid, liquid, gas or dispersion) different 10 from the physical state of the ingredient(s) in the other length of the longitudinally extending body of the base, both receiving chambers. horizontally and vertically. In structural design, the size, As illustrated by way of example, and not by way of shape and positioning of the dividing walls 416a, 416b, restriction, a solid may be selectively introduced into at least 416c, 416d, 416e along the length of the longitudinally a portion of the internal periphery of the receiving chamber 15 extending body of the base 414 facilitate the formation of a 3.18a, a dispersion may be selectively introduced into at least plurality of independent receiving chambers 418. a portion of the internal periphery of the receiving chamber In one presently preferred embodiment, the dividing walls 318b, a liquid may be selectively introduced into at least a 416a, 416b, 416C, 416d, 416e are preferably disposed or portion of the internal periphery of the receiving chamber seated in a spaced apart relationship within the internal 318c and a secondary, capsule 320 may be selectively periphery of the base 414 of the primary capsule 411 along introduced into at least a portion of the internal periphery of the length of the longitudinally extending body, whereby the receiving chamber 318d. As contemplated herein, receiv forming five (5) independent receiving chambers 418a, ing chamber 318d may be further configured having an 418b, 418c, 418d, 418e. Each receiving chamber 4.18a, internal periphery sufficient for receiving a secondary cap 418b, 418c, 418d, 418e of the primary capsule 411 are sule 320, together with at least one active ingredient or 25 preferably configured having an internal periphery dimen medicament therein. sionally Sufficient for receiving one or more active ingredi One presently preferred embodiment of an encapsulation ents or medicaments (e.g., pharmaceutical, biotechnical, process, as defined by the structural configuration of the nutraceutical, vitamin, dietary Supplement, mineral or com multi-compartment capsule 310 illustrated in FIGS. 5 and 6. bination thereof) therein. may comprise the steps of: (1) introducing a secondary 30 Still referring to FIG. 7, one presently preferred embodi capsule 320 (e.g., tablet) and one or more active ingredients ment of an encapsulation process, as defined by the struc or medicaments into receiving chamber 318d, (2) selectively tural configuration of the multi-compartment capsule 410. positioning dividing wall 316c along the length of the may comprise the steps of: (1) introducing one or more elongated body of the base 314; (3) introducing one or more active ingredients or medicaments into receiving chamber active ingredients or medicaments (e.g., pharmaceutical, 35 418e defined by dividing walls 416d, 416e which are ver biotechnical, nutraceutical, vitamin, dietary Supplement, tically disposed along the length of the elongated body of the mineral or combination thereof) into receiving chamber base 414; (2) introducing one or more active ingredients or 318c.; (4) selectively positioning dividing wall 316b along medicaments into receiving chamber 418d defined by divid the length of the elongated body of the base 314 in a spaced ing walls 416C, 416d which are vertically disposed along the apart relationship to dividing wall 316c; (5) introducing one 40 length of the elongated body of the base 414; (3) introducing or more active ingredients or medicaments (e.g., pharma one or more active ingredients or medicaments into receiv ceutical, biotechnical, nutraceutical, Vitamin, dietary Supple ing chamber 418c defined by dividing walls 416b, 416C ment, mineral or combination thereof) into receiving cham which are vertically disposed along the length of the elon ber 318b; (6) selectively positioning dividing wall 316a gated body of the base 414; (4) introducing one or more along the length of the elongated body of the base 314 in a 45 active ingredients or medicaments into receiving chamber spaced apart relationship to dividing wall 316b; and (7) 418b defined by dividing walls 416b, 416e which are selectively positioning the cap 312 in sealing relationship vertically disposed along the length of the elongated body of with the base 314 to form a presently preferred embodiment the base 414; (5) disposing dividing wall 416a along the of a single, dosage multi-compartment capsule 310. The length of the elongated body of the base 414 perpendicular dividing wall 316a may also function in the formation of the 50 to the disposition of dividing walls 416b, 416C, 416d, 416e sealing relationship between the base 314 and the corre and introducing one or more active ingredients or medica sponding cap 312, if desired. ments into receiving chamber 418a; and (6) selectively Although the ingredient(s) introduced into one of the positioning the cap 412 in Sealing relationship with the base receiving chambers 318 may be the same ingredient or may 414 to form one presently preferred embodiment of a single, be different from the ingredient(s) introduced into the other 55 dosage multi-compartment capsule 410. As appreciated, the receiving chambers, the active ingredient(s) in at least two dividing wall 416a may also function in the formation of the of the receiving chambers 318 preferably comprise a physi sealing relationship between the base 414 and the corre cal state (e.g., Solid, liquid, gas or dispersion) that is different sponding cap 412, if structurally desired. from the physical state of the active ingredient(s) in one or As illustrated by way of example, and not by way of more of the remaining receiving chambers. Those skilled in 60 restriction, a solid may be selectively introduced into at least the art will readily recognize other possible modifications a portion of the internal periphery of the receiving chamber and adaptations relative to the contemplated variations in 4.18a, a dispersion may be selectively introduced into at least physical states (e.g., Solid, liquid, gas and dispersion) of the a portion of the internal periphery of the receiving chamber active ingredient(s) selectively introduced within the receiv 418b, a liquid may be selectively introduced into at least a ing chambers 318 which are consistent with the spirit and 65 portion of the internal periphery of the receiving chamber scope of the present invention. It is intended, therefore, that 418c, a solid may be selectively introduced into at least a the figures and examples provided herein be viewed as portion of the internal periphery of the receiving chamber US 9,539,216 B2 35 36 418d and a liquid may be selectively introduced into at least chamber 528a, 528b, the cap 522 may be positioned in a portion of the internal periphery of the receiving chamber sealing relationship with the base 524 of the secondary 418e. capsule 520. Although the ingredient(s) introduced into one of the Still referring to FIG. 8, as illustrated by way of example, receiving chambers 418 may be the same ingredient or may and not by way of restriction, a solid may be selectively be different from the ingredient(s) introduced into the other introduced into at least a portion of the internal periphery of receiving chambers, the active ingredient(s) in at least two the receiving chamber 528a and a liquid may be selectively of the receiving chambers 418 preferably comprise a physi introduced into at least a portion of the internal periphery of cal state (e.g., Solid, liquid, gas or dispersion) that is different the receiving chamber 528b. Although the ingredient(s) 10 introduced into one of the receiving chamber 528a may be from the physical state of the active ingredient(s) in one or the same ingredient or maybe different from the ingredient more of the remaining receiving chambers. Those skilled in (s) introduced into receiving chamber 528b, the active the art will readily recognize other possible modifications ingredient(s) in the first receiving chamber 528a comprise a and adaptations relative to the contemplated variations in physical state (e.g., Solid, liquid, gas or dispersion) that is physical states (e.g., Solid, liquid, gas and dispersion) of the 15 different from the physical state of the active ingredient(s) in active ingredient(s) selectively introduced within the receiv receiving chambers 528b. Those skilled in the art will ing chambers 418 which are consistent with the spirit and readily recognize other possible modifications and adapta scope of the present invention. It is intended, therefore, that tions relative to the contemplated variations in physical the figures and examples provided herein be viewed as states (e.g., Solid, liquid, gas and dispersion) of the active exemplary of the principles of the present invention, and not ingredient(s) selectively introduced within the receiving as restrictive to a particular structure or method for imple chambers 528 which are consistent with the spirit and scope menting those principles. of the present invention. It is intended, therefore, that the Referring now to FIG. 8, an alternate presently preferred figures and examples provided herein be viewed as exem embodiment of a multi-compartment capsule 510 includes a plary of the principles of the present invention, and not as capsular base 514 preferably configured having an elongated 25 restrictive to a particular structure or method for implement or longitudinally extending body, a corresponding cap 512 ing those principles. and a plurality of dividing walls 516 selectively disposed One presently preferred embodiment of an encapsulation along the length of the longitudinally extending body of the process, as defined by the structural configuration of the base, both horizontally and vertically. In structural design, multi-compartment capsule 510, may comprise the steps of the size, shape and positioning of the dividing walls 516a, 30 (1) introducing one or more active ingredients or medica 516b, 516c. 516d along the length of the longitudinally ments (e.g., pharmaceutical, biotechnical, nutraceutical, extending body of the base 514 facilitate the formation of a vitamin, dietary supplement, mineral or combination plurality of independent receiving chambers 518. thereof) into receiving chamber 518e defined by dividing In one presently preferred embodiment, the dividing walls walls 516d, 516e which are disposed vertically along the 516a, 516b, 516c, 516d, 516e are preferably disposed or 35 length of the elongated body of the base 514; (2) introducing seated in a spaced apart relationship within the internal a secondary capsule 520 into receiving chamber 518d periphery of the base 514 of the primary capsule 511 along defined by dividing walls 516c. 516d which are disposed the length of the longitudinally extending body, whereby vertically along the length of the elongated body of the base forming five (5) independent receiving chambers 518a, 514; (3) introducing one or more active ingredients or 518b, 518c, 518d, 518e. Each of the receiving chamber 40 medicaments (e.g., pharmaceutical, biotechnical, nutraceu 518a, 518b, 518c,518d, 518e of the primary capsule 411 are tical, vitamin, dietary Supplement, mineral or combination preferably configured having an internal periphery dimen thereof) into receiving chamber 518c defined by dividing sionally Sufficient for receiving one or more active ingredi walls 516b, 516c which are disposed vertically along the ents or medicaments (e.g., pharmaceutical, biotechnical, length of the elongated body of the base 514; (4) introducing nutraceutical, vitamin, dietary Supplement, mineral or com 45 one or more active ingredients or medicaments (e.g., phar bination thereof) therein. Moreover, receiving chamber 518d maceutical, biotechnical, nutraceutical, vitamin, dietary is formed having an internal periphery Sufficient for receiv Supplement, mineral or combination thereof) into receiving ing a secondary capsule 520. The secondary capsule 520 chamber 518b defined by dividing walls 516b, 516e which being configured with a base 524, corresponding cap 522 are disposed vertically along the length of the elongated and a dividing wall 526 defining a first receiving chamber 50 body of the base 514; (5) disposing dividing wall 516a along 528a and a second receiving chamber 528b. The first receiv the length of the elongated body of the base 514 perpen ing chamber 528a is preferably configured having an inter dicular to the disposition of dividing walls 516b, 516c. 516d. nal periphery Sufficient for receiving one or more active 516e and introducing one or more active ingredients or ingredients or medicaments (e.g. pharmaceutical, biotech medicaments (e.g., pharmaceutical, biotechnical, nutraceu nical, nutraceutical, vitamin, dietary Supplement, mineral or 55 tical, vitamin, dietary Supplement, mineral or combination combination thereof) having a first physical state (e.g., Solid, thereof) into receiving chamber 518a; and (6) selectively liquid, gas or dispersion) therein. Similarly, the second positioning the cap 512 in Sealing relationship with the base receiving chamber 528b is configured having an internal 514 to form one presently preferred embodiment of a single, periphery sufficient for receiving one or more active ingre dosage multi-compartment capsule 510. As appreciated, the dients or medicaments (e.g., pharmaceutical, biotechnical, 60 dividing wall 516a may also function in the formation of the nutraceutical, vitamin, dietary Supplement, mineral or com sealing relationship between the base 514 and the corre bination thereof) having a second physical state (e.g., Solid, sponding cap 512, if structurally desired. liquid, gas or dispersion), wherein the physical state of the As illustrated by way of example, and not by way of ingredient(s) in the second receiving chamber varies from limitation, a solid may be selectively introduced into at least the physical state of the ingredient(s) in the first receiving 65 a portion of the internal periphery of receiving chamber chamber. As contemplated and disclosed hereinabove, after 518a, a dispersion may be selectively introduced into at least the ingredients are introduced into the respective receiving a portion of the internal periphery of receiving chamber US 9,539,216 B2 37 38 518b, a liquid may be selectively introduced into at least a Supplement, mineral or combination thereof) into receiving portion of the internal periphery of the receiving chamber chamber 628d defined by dividing walls 626c. 626d which 518c and a liquid may be selectively introduced into at least are vertically disposed along the length of the elongated a portion of the internal periphery of the receiving chamber body of the base 624; (3) introducing one or more active 518e. Although the ingredient(s) introduced into one of the 5 ingredients or medicaments (e.g., pharmaceutical, biotech receiving chambers 518 may be the same ingredient or may nical, nutraceutical, vitamin, dietary Supplement, mineral or be different from the ingredient(s) introduced into the other combination thereof) into receiving chamber 628c defined receiving chambers, the active ingredient(s) in at least two by dividing walls 626b, 626c which are vertically disposed of the receiving chambers 518 preferably comprise a physi along the length of the elongated body of the base 624; (4) cal state (e.g., Solid, liquid, gas or dispersion) that is different 10 introducing one or more active ingredients or medicaments from the physical state of the active ingredient(s) in one or (e.g., pharmaceutical, biotechnical, nutraceutical, vitamin, more of the remaining receiving chambers. Those skilled in dietary Supplement, mineral or combination thereof) into the art will readily recognize other possible modifications receiving chamber 628b defined by dividing walls 626b, and adaptations relative to the contemplated variations in 626e which are vertically disposed along the length of the physical states (e.g., Solid, liquid, gas and dispersion) of the 15 elongated body of the base 624; (5) disposing dividing wall active ingredient(s) selectively introduced within the receiv 626a along the length of the elongated body of the base 624 ing chambers 518 which are consistent with the spirit and perpendicular to the disposition of dividing walls 626b, scope of the present invention. It is intended, therefore, that 626c. 626d. 626e and introducing one or more active ingre the figures and examples provided herein be viewed as dients or medicaments (e.g., pharmaceutical, biotechnical, exemplary of the principles of the present invention, and not nutraceutical, vitamin, dietary Supplement, mineral or com as restrictive to a particular structure or method for imple bination thereof) into receiving chamber 628a; (6) selec menting those principles. tively positioning the cap 622 in Sealing relationship with Referring now to FIG. 9, yet another presently preferred the base 624 of the secondary capsule 620; (7) introducing embodiment of a multi-compartment capsule of the present the secondary capsule 620 and one or more ingredients or invention, generally designated as 610, is shown comprising 25 medicaments (e.g., pharmaceutical, biotechnical, nutraceu a primary capsule 611 and a secondary capsule 620 selec tical, vitamin, dietary Supplement, mineral or combination tively positionable within at least a portion of an internal thereof) into the receiving chamber 618 of the primary periphery of the primary capsule. The primary capsule 611 capsule 611; and (8) selectively positioning the cap 612 in having a receiving chamber 618 preferably formed having sealing relationship with the base 614 of the primary capsule an internal periphery sufficient for receiving the secondary 30 611 to form one presently preferred embodiment of a single, capsule 620, together with one or more active ingredients or dosage multi-compartment capsule 610. medicaments (e.g., pharmaceutical, biotechnical, nutraceu As illustrated by way of example, and not by way of tical, vitamin, dietary Supplement, mineral or combination restriction, a solid may be selectively introduced into at least thereof) therein. The secondary capsule 620 comprising a a portion of the internal periphery of the receiving chamber capsular base 624 preferably configured having an elongated 35 628a, a dispersion may be selectively introduced into at least or longitudinally extending body, a corresponding cap 622 a portion of the internal periphery of the receiving chamber and a plurality of dividing walls 626 selectively disposed 628b, a liquid may be selectively introduced into at least a along the length of the longitudinally extending body of the portion of the internal periphery of the receiving chamber base, both horizontally and vertically. In structural design, 628c, a solid may be selectively introduced into at least a the size, shape and positioning of the dividing walls 626a. 40 portion of the internal periphery of the receiving chamber 626b, 626c. 626d along the length of the longitudinally 628d and a liquid may be selectively introduced into at least extending body of the base 624 facilitate the formation of a a portion of the internal periphery of the receiving chamber plurality of independent receiving chambers 628. 628e of the secondary capsule 620. In addition, a gas may be In one presently preferred embodiment, the dividing walls introduced into at least a portion of the internal periphery of 626a, 626b, 626c. 626d. 426e are preferably disposed or 45 the receiving chamber 618 of the primary capsule 611. seated in a spaced apart relationship within the internal Although the ingredient(s) introduced into one of the periphery of the base 624 of the secondary capsule 620 along receiving chambers 618, 628 of the primary and secondary the length of the longitudinally extending body, whereby capsules, respectively, may be the same ingredient or may be forming five (5) independent receiving chambers 628a, different from the ingredient(s) introduced into the other 628b, 628c. 628d, 628e. Each receiving chamber 628a, 50 receiving chambers, the active ingredient(s) in at least two 628b, 628c. 628d, 628e of the secondary capsule 620 are of the receiving chambers 618, 628 preferably comprise a preferably configured having an internal periphery dimen physical state (e.g., Solid, liquid, gas or dispersion) that is sionally Sufficient for receiving one or more active ingredi different from the physical state of the active ingredient(s) in ents or medicaments (e.g., pharmaceutical, biotechnical, one or more of the remaining receiving chambers. Those nutraceutical, vitamin, dietary Supplement, mineral or com 55 skilled in the art will readily recognize other possible bination thereof) therein. modifications and adaptations relative to the contemplated One presently preferred embodiment of an encapsulation variations in physical states (e.g., Solid, liquid, gas and process, as defined by the structural configuration of the dispersion) of the active ingredient(s) selectively introduced multi-compartment capsule 610, may comprise the steps of within the receiving chambers 618, 628 which are consistent (1) introducing one or more active ingredients or medica 60 with the spirit and scope of the present invention. It is ments (e.g., pharmaceutical, biotechnical, nutraceutical, intended, therefore, that the figures and examples provided Vitamin, dietary Supplement, mineral or combination herein be viewed as exemplary of the principles of the thereof) into receiving chamber 628e defined by dividing present invention, and not as restrictive to a particular walls 626d. 626e which are vertically disposed along the structure or method for implementing those principles. length of the elongated body of the base 624; (2) introducing 65 Another presently preferred embodiment of a multi-com one or more active ingredients or medicaments (e.g., phar partment capsule of the present invention, generally desig maceutical, biotechnical, nutraceutical, vitamin, dietary nated as 710 in FIG. 10, is shown comprising a secondary US 9,539,216 B2 39 40 capsule 720 including one or more active ingredients or and examples provided herein be viewed as exemplary of medicaments (e.g., pharmaceutical, biotechnical, nutraceu the principles of the present invention, and not as restrictive tical, vitamin, dietary Supplement, mineral or combination to a particular structure or method for implementing those thereof) within at least a portion of the internal periphery of principles. a receiving chamber 728 and having a size and shape 5 Referring now to FIGS. 11 and 12, yet another presently sufficient for being selectively introduced within at least a preferred embodiment of a multi-compartment capsule 810 portion of the internal periphery of a receiving chamber 718 of the present invention is shown comprising a secondary of a primary capsule 711. The primary capsule 711 also capsule 820 including one or more active ingredients or includes one or more active ingredients or medicaments medicaments (e.g., pharmaceutical, biotechnical, nutraceu (e.g., pharmaceutical, biotechnical, nutraceutical, vitamin, 10 tical, vitamin, dietary Supplement, mineral or combination dietary Supplement, mineral or combination thereof) intro thereof) within at least a portion of the internal periphery of duced within the internal periphery of the receiving chamber a receiving chamber 828. The secondary capsule 820 being 718, wherein the active ingredient(s) introduced into the preferably formed having a size and shape sufficient for primary capsule comprises a physical state (e.g., Solid, being selectively introduced within at least a portion of the liquid, gas or dispersion) which differs from the physical 15 internal periphery of a receiving chamber 818 of a primary state of the active ingredient(s) introduced into the internal capsule 811. Similarly, the primary capsule 811 includes one periphery of the secondary capsule. In structural design, the or more active ingredients or medicaments (e.g., pharma primary capsule 711 further comprises a cap 712 having a ceutical, biotechnical, nutraceutical, Vitamin, dietary Supple generally U-shaped configuration adapted to provide a seal ment, mineral or combination thereof) introduced within the ing relationship when engaging the corresponding base 714, internal periphery of the receiving chamber 818, together thereby reducing dead space Volume in the internal periph with the secondary capsule 820, wherein the active ingre ery of the receiving chamber 718 of the base. In this regard, dient(s) introduced into the primary capsule comprises a the configuration of the cap 712 generally eliminates or physical state (e.g., Solid, liquid, gas or dispersion) which Substantially reduces the potential dead space Volume within differs from the physical state of the active ingredient(s) the internal periphery of the receiving chamber 718, thus 25 introduced into the internal periphery of the secondary functionally negating the opportunity for reaction between capsule 820. an air bubble and the active ingredient(s) introduced into the In preferred structural design, the primary capsule 811 base 714 of the primary capsule 711. comprises a cap 812 having a general cylindrical configu One presently preferred embodiment of an encapsulation ration adapted to provide a sealing relationship when engag process, as defined by the structural configuration of the 30 ing the corresponding base 814 to form a single dosage, multi-compartment capsule 710, may include the steps of: multi-compartment capsule 810. An amount of filling mate (1) introducing one or more active ingredients or medica rial 840 may be introduced into the internal periphery of the ments (e.g., pharmaceutical, biotechnical, nutraceutical, cap 812 to fill, either partially or completely, the inner Vitamin, dietary Supplement, mineral or combination Volume of the cap, thereby reducing the dead space Volume thereof) into receiving chamber 728; (2) selectively posi 35 in the internal periphery of the receiving chamber 818 of the tioning the cap 722 in sealing relationship with the base 724 base. In this regard, the configuration of the addition of the of the secondary capsule 720; (3) introducing one or more filler material 840 relative to the internal periphery of the cap active ingredients or medicaments (e.g., pharmaceutical, 812 generally eliminates or substantially reduces the poten biotechnical, nutraceutical, vitamin, dietary Supplement, tial dead space volume within the internal periphery of the mineral or combination thereof), together with the second 40 receiving chamber 818, thus functionally negating the ary capsule 720, into the receiving chamber 718 of the potential for a reaction between an air bubble and the active primary capsule 711; and (4) selectively positioning the cap ingredient(s) introduced into the base 814 of the primary 712 having a general U-shaped configuration in sealing capsule 811. relationship with the base 714 of the primary capsule 711 to Preferably, the filling material 840 introduced into at least form a presently preferred embodiment of a single, dosage 45 a portion of the internal periphery of the cap 812 may multi-compartment capsule 710, wherein eliminating or include a hydrophilic polymer, Such as gelatin. It will be Substantially reducing dead space Volume within the internal readily appreciated by those skilled in the art that other periphery of the receiving chamber 718. filling materials may be used, such as, for example, starch, A solid is selectively introduced within at least a portion casein, chitosan, Soya bean protein, safflower protein, alg of the internal periphery of the receiving chamber 728 of the 50 inates, gellan gum, carageenan, Xanthan gum, phtalated secondary capsule 720 and a liquid is selectively introduced gelatin, Succinated gelatin cellulosephtalate-acetate, polyvi within at least a portion of the internal periphery of the nylacetate, hydroxypropyl methyl cellulose, (HPMC), oleo receiving chamber 718 of the primary capsule 711. Although resin, polyvinylacetate-phtalate, polymerisates of acrylic or the ingredient(s) introduced into the receiving chamber 718 methacylic esters, and mixtures thereof, or the like, and/or of the primary capsule 711 may be the same or different from 55 combinations thereof. In other presently preferred embodi the ingredient(s) introduced into the receiving chamber 728 ments of the present invention, the filling material 840 may of the secondary capsule 720, the active ingredient(s) in the include the introduction of an inert compound, for example, primary capsule have a physical state (i.e., Solid, liquid, gas nitrogen gas into at least a portion of the internal periphery or dispersion) that various from the physical state of the of the cap 811. Based on the principals of eliminating or active ingredient(s) in the secondary capsule. Accordingly, 60 reducing the Volume dead space in multi-compartment cap those skilled in the art will readily recognize other possible sules disclosed herein, those skilled in the art will readily modifications and adaptations relative to the contemplated recognize other possible modifications and combinations variations in physical states of the active ingredient(s) which are consistent with the spirit and scope of the present selectively introduced within the receiving chambers 718, invention. It is intended, therefore, that the examples pro 728 of the primary and secondary capsules 711, 720, respec 65 vided herein be viewed as exemplary of the principles of the tively, which are consistent with the spirit and scope of the present invention, and not as restrictive to a particular present invention. It is intended, therefore, that the figures structure or process for implementing those principles. US 9,539,216 B2 41 42 The filling material 840 introduced within at least a at least a portion of the internal periphery of a receiving portion of the internal periphery of the cap 812 of the chamber 938 and having a size and shape sufficient for being primary capsule 811 is generally intended to promote a introduced into the internal periphery of a receiving chamber binding contact with at least a portion of the cap 822 of the 928 of a secondary capsule 920. The secondary capsule 920 secondary capsule 820, thereby seating at least a portion of 5 having one or more active ingredients or medicaments (e.g., the secondary capsule within the cap of the primary capsule pharmaceutical, biotechnical, nutraceutical, vitamin, dietary and forming a molded appearance. As appreciated, the Supplement, mineral or combination thereof) introduced introduction of the filling material 840 into the cap 812 of within at least a portion of the internal periphery of a the primary capsule 811 prior to the joining and sealing receiving chamber 928, together with the tertiary capsule process may prevent the opportunity for a reaction between 10 930. The secondary capsule 920 preferably formed having a an air-bubble and the active medicament(s) within the receiving chamber 818 of the primary capsule, while pre size and shape sufficient for being selectively introduced serving the overall rounded shape of the multi-compartment within at least a portion of the internal periphery of a capsule 910 for ease of Swallowing by a consumer. receiving chamber 918 of a primary capsule 911. Similarly, As best illustrated in FIG. 12, one presently preferred 15 the primary capsule 911 may include one or more active embodiment of an encapsulation process, as defined by the ingredients or medicaments (e.g., pharmaceutical, biotech structural configuration of the multi-compartment capsule nical, nutraceutical, vitamin, dietary Supplement, mineral or 810, may include the steps of: (1) introducing one or more combination thereof) introduced within the internal periph active ingredients or medicaments (e.g., pharmaceutical, ery of the receiving chamber 818, together with the second biotechnical, nutraceutical, vitamin; dietary Supplement, ary capsule 920 which houses the tertiary capsule 930. In mineral or combination thereof) into at least a portion of the one presently preferred embodiment, the active ingredient(s) receiving chamber 828; (2) selectively positioning the cap introduced into the secondary capsule 920 comprises a 822 in sealing relationship with the base 824 of the second physical state (e.g., Solid, liquid, gas or dispersion) which ary capsule 820; (3) introducing one or more active ingre differs from the physical state of the active ingredient(s) dients or medicaments (e.g., pharmaceutical, biotechnical, 25 introduced into the internal periphery of the primary capsule nutraceutical, vitamin, dietary Supplement, mineral or com 911 and the internal periphery of the tertiary capsule 930. bination thereof), together with the secondary capsule 820, In preferred structural design, the primary capsule 911 into at least a portion of the receiving chamber 818 of the comprises a cap 912 having a general cylindrical configu primary capsule 811; (4) introducing a filling material 840 ration adapted to provide a sealing relationship when engag into at least a portion of the internal periphery of the cap 812 30 ing the corresponding base 914 to form a single dosage, (i.e., filling the cap); and (5) selectively positioning the cap multi-compartment capsule 910. An amount of filling mate 812 having a general conical configuration in sealing rela rial 940 may be introduced into at least a portion of the tionship with the base 814 of the primary capsule 811 to internal periphery of the cap 912 to fill, either partially or form one presently preferred embodiment of a single, dosage completely, the inner Volume of the cap, thereby reducing multi-compartment capsule 810, wherein eliminating or 35 the dead space Volume in the cap and the internal periphery Substantially reducing dead space Volume within the internal of the receiving chamber 918 of the base. In this regard, the periphery of the cap 812 and the receiving chamber 818, configuration of the addition of the filler material 940 respectively. relative to the internal periphery of the cap 912 may gen A solid may be selectively introduced within at least a erally eliminate or substantially reduce the potential dead portion of the internal periphery of the receiving chamber 40 space Volume within the internal periphery of the receiving 828 of the secondary capsule 820 and a liquid may be chamber 918, thus functionally negating the potential for a selectively introduced within at least a portion of the internal reaction between an air bubble and the active ingredient(s) periphery of the receiving chamber 818 of the primary introduced into the base 914 of the primary capsule 911. capsule 811. Although the ingredient(s) introduced into the Preferably, the filling material 940 introduced into at least receiving chamber 818 of the primary capsule 811 may be 45 a portion of the internal periphery of the cap 912 may the same or different from the ingredient(s) introduced into include a hydrophilic polymer, Such as gelatin. It will be the receiving chamber 828 of the secondary capsule 820, the readily appreciated by those skilled in the art that other active ingredient(s) in the primary capsule have a physical filling materials may be used, such as, for example, starch, state (i.e., Solid, liquid, gas or dispersion) that various from casein, chitosan, Soya bean protein, safflower protein, alg the physical state of the active ingredient(s) in the secondary 50 inates, gellan gum, carrageenan, Xanthan gum, phtalated capsule. Accordingly, those skilled in the art will readily gelatin, Succinated gelatin, cellulosephtalate-acetate, poly recognize other possible modifications and adaptations rela vinylacetate, hydroxypropyl methylcellulose, oleoresin, tive to the contemplated variations in physical states of the polyvinylacetate-phtalate, polymerisates of acrylic or meth active ingredient(s) selectively introduced within the receiv acrylic esters, and mixtures thereof, or the like, and/or ing chambers 818, 828 of the primary and secondary cap 55 combinations thereof. In other presently preferred embodi sules 811, 820, respectively, which are consistent with the ments of the present invention, the filling material 840 may spirit and scope of the present invention. It is intended, include the introduction of an inert compound, for example, therefore, that the figures and examples provided herein be nitrogen gas into at least a portion of the internal periphery viewed as exemplary of the principles of the present inven of the cap 912. Based on the principals of eliminating or tion, and not as restrictive to a particular structure or method 60 reducing the Volume dead space in multi-compartment cap for implementing those principles. sules disclosed herein, those skilled in the art will readily Referring now to FIG. 13, another presently preferred recognize other possible modifications and combinations embodiment of a multi-compartment capsule, generally des which are consistent with the spirit and scope of the present ignated at 910, is shown comprising a tertiary capsule 930 invention. It is intended, therefore, that the examples pro including one or more active ingredients or medicaments 65 vided herein be viewed as exemplary of the principles of the (e.g., pharmaceutical, biotechnical, nutraceutical, vitamin, preset invention, and not as restrictive to a particular struc dietary Supplement, mineral or combination thereof) within ture or process for implementing those principles. US 9,539,216 B2 43 44 The filling material 940 introduced within at least a provided herein be viewed as exemplary of the principles of portion of the internal periphery of the cap 912 of the the present invention, and not as restrictive to a particular primary capsule 911 is generally intended to promote a structure or method for implementing those principles. binding contact with at least a portion of the cap 922 of the Generally referring to FIGS. 1-13, the component parts of secondary capsule 920, thereby seating at least a portion of 5 the presently preferred embodiments of the multi-compart the secondary capsule within the cap of the primary capsule ment capsules (i.e., capsular base, corresponding cap and and forming a molded appearance. As appreciated, the dividing walls) of the present invention may comprise a introduction of the filling material 940 into the cap 912 of hydrophilic polymer, Such as gelatin (marine or animal the primary capsule 911 prior to the joining and sealing based product). Other suitable materials forming the cap process tends to prevent the opportunity for a reaction 10 Sules may include starch, casein, chitosan, Soya bean pro between an air bubble and the active medicament(s) within tein, Safflower protein, alginates, gellan gum, carageenan, the receiving chamber 918 of the primary capsule, while Xanthan gum, phtalated gelatin, Succinated gelatin, cellu preserving the overall rounded shape of the multi-compart losephtalate-acetate, polyvinylacetate, hydroxypropyl ment capsule 910 for ease of swallowing by a consumer. methyl cellulose (HPMC), oleoresins, polyvinylacetate As best illustrated in FIG. 13, one presently preferred 15 phtalate, polymerisates of acrylic or methacrylic esters, and embodiment of an encapsulation process, as defined by the mixtures thereof, or the like, and/or combinations thereof. structural configuration of the multi-compartment capsule The material comprising the capsular components may 910, may include, the steps of: (1) introducing one or more further include between about 0% to 40% of pharmaceuti active ingredients or medicaments (e.g., pharmaceutical, cally acceptable plasticizers based upon the weight of the biotechnical, nutraceutical, vitamin, dietary Supplement, hydrophilic polymer. Plasticizers that may be employed mineral or combination thereof) into at least a portion of the include, for example and not by way of limitation, polyeth receiving chamber 938 of a tertiary capsule 930; (2) selec ylene glycol, glycerol, Sorbitol, dioctyl-Sodium sulfo Succi tively positioning the cap 932 in sealing relationship with nate, triethyl citrate, tributyl citrate, 1,2-propyleneglycol, the base 934 of the tertiary capsule 930; (3) introducing one mono-acetates, di-acetates, or tri-acetates of glycerol, mix or more active ingredients or medicaments (e.g., pharma 25 tures thereof, or the like, and/or combinations thereof. As ceutical, biotechnical, nutraceutical, Vitamin, dietary Supple appreciated, plasticizers may also be used in the develop ment, mineral or combination thereof), together with the ment of a soft elastic shell, often referred to as a soft gelatin tertiary capsule 930, into at least a portion of the receiving capsule or 'soft gel capsule, for a primary capsule, a chamber 928 of the secondary capsule 920; (4) selectively secondary capsule and/or a tertiary capsule. positioning the cap 922 in Sealing relationship with the base 30 The capsular shell material may contain pharmaceutically 924 of the secondary capsule 920; (5) introducing one or acceptable lubricants in the range of about 0% to 10%, based more active ingredients or medicaments (e.g., pharmaceu upon the weight of the hydrophilic polymer. Lubricants that tical, biotechnical, nutraceutical, vitamin, dietary Supple may be used include, for example and not by way of ment, mineral or combination thereof), together with the limitation, aluminum Stearate, calcium Stearate, magnesium secondary capsule 920, into at least a portion of the receiv 35 Stearate, tin Stearate, talc, sodium lauryl Sulfate, lecithins, ing chamber 918 of the primary capsule 911; (6) introducing mineral oils, Stearic acid, silicones, mixtures thereof, or the a filling material 940 into at least a portion of the internal like, and/or combinations thereof. One presently preferred periphery of the cap 912 (i.e., preferably filling the cap); and embodiment of the multi-compartmental capsules of the (7) selectively positioning the cap 912 having a general present invention (e.g., primary capsule, secondary capsule, conical configuration in seating relationship with at least a 40 tertiary capsule, etc.) may include, for example, LICAPS(R) portion of the secondary capsule 920 and sealing the base capsules (for poorly soluble compounds), VCAPSTM cap 914 of the primary capsule 911 to form one presently sules (made from cellulosic raw materials), CONI-SNAP(a) preferred embodiment of a single, dosage multi-compart capsules and PRESS-FITR) capsules which are all presently ment capsule 910, wherein eliminating or substantially manufactured by Capsugel, a subsidiary of Pfizer, Inc. reducing dead space Volume within the internal periphery of 45 In one presently preferred embodiment of an encapsula the cap 912 and the receiving chamber 918, respectively. tion process, the primary capsule may be kept under con A solid may be introduced within at least a portion of the ditions of low humidity within a filling machine during the internal periphery of the receiving chamber 938 of the contemplated steps of rectifying and assembling. In certain tertiary capsule 930, a liquid may be introduced into at least embodiments, the primary capsule may contain moisture a portion of the internal periphery of the secondary capsule 50 content in the range of approximately 0% to 6% of the total 920 and a solid may be selectively introduced within at least weight. Similarly, a secondary capsule, a tertiary capsule, a portion of the internal periphery of the receiving chamber etc. may be processed in the same manner as the primary 918 of the primary capsule 911. Although the ingredient(s) capsule relative to conditions of low humidity during the introduced into the receiving chambers 918, 928,938 of the steps of rectifying and assembling. As contemplated herein, primary, secondary and tertiary capsules 911, 920, 930, 55 a moisture content of approximately 0% to 3% by weight is respectively, may be the same or different from the ingre preferable. However, capsules having a higher moisture dient(s) introduced into the other receiving chambers, the content than those stated herein are certainly not outside the active ingredient(s) in at least two of the receiving chambers spirit and scope of the present invention. 918, 928, 938 have different physical states (i.e., solid, As illustrated in FIGS. 1-9 and 11-13, the shape of the liquid, gas or dispersion). Those skilled in the art will readily 60 base and corresponding cap of the capsules (e.g., primary, recognize other possible modifications and adaptations rela secondary, tertiary, etc.) of the presently preferred embodi tive to the contemplated variations in physical states of the ments of the multi-compartment capsules are configured active ingredient(s) selectively introduced within the receiv having a general cylindrical shape which defines a diameter ing chambers 918, 928,938 of the primary, secondary and and length sufficient for the introduction of an internal tertiary capsules 911, 920, 930, respectively, which are 65 Smaller capsule or one or more dividing walls along the consistent with the spirit and scope of the present invention. length of the capsular base. It is apparent that other geo It is intended, therefore, that the figures and examples metrical configurations of the cap are likewise Suitable and US 9,539,216 B2 45 46 contemplated herein, Such as the general U-shaped configu The disclosure of secondary and tertiary capsules may be ration of the cap shown in FIG. 10. It is intended, therefore, replaced with other forms of microencapsulation. Microen that the examples provided herein be viewed as exemplary capsulation as previously described, refers to the process of the principles of the present invention, and not as restric whereby minute parcels of a Solid, liquid, gas or dispersion, tive to any particular structure or configuration for imple introduced into one or more of the receiving chambers as menting those principles. active ingredient(s), are film-coated with a secondary mate In one presently preferred embodiment, the clearance rial in order to shield the active ingredient from its surround between the primary capsule and the secondary capsule ing environment. Microcapsules may measure from microns introduced within the internal periphery of the primary to several millimeters, whereas the main purpose being to capsule is preferably greater than +0.2 mm. The clearance 10 facilitate the release of the active ingredients at different between the outer capsular walls of the secondary capsule release rates. and the inner capsular walls of the primary capsule (or the The incorporation of time-release coatings to varying the tertiary capsule and the secondary capsule) may be in the release rates of the active ingredients of a multi-compart range of about 0 mm to 0.5 mm, whereas the outer capsular ment capsule may be used to target key time intervals or walls of the secondary capsule or tertiary capsule may be in 15 events when the body may be most able to utilize the active actual contact with the inner capsular walls of the primary ingredients. In one presently preferred embodiment of the capsule or secondary capsule, respectively. As appreciated, present invention, all of the active ingredients may be in an effort to structural facilitate independent receiving microencapsulated. In alternate presently preferred embodi chambers on opposing sides of a dividing wall introduced ments, only selected ingredients may be microencapsulated within the internal periphery of a base of a capsule, the for delayed release, while other ingredients may be provided perimeter of the dividing wall preferably engages the inner for immediate absorption. Thus, the incorporation of time capsular walls of the capsule to provide a sealing relation release coatings in the encapsulation process when forming ship there between. a multi-compartment capsule may be specifically designed As further contemplated herein, the inner capsular walls to fit the needs and desires of numerous different users of a primary capsule may be treated with an adhesive 25 having similar conditions that are being targeted for treat Sufficient to improve engagement between the primary cap ment. Sule and the outer capsular walls of a secondary capsule. A As contemplated herein, the physical states of active Suitable technique to apply an adhesive may be by way of ingredients are characterized into one of four different states spraying the same on the shells and capsules immediately (e.g., Solid, liquid, gas or dispersion). These four different before assembling the same. Suitable adhesives that may be 30 states are sometimes referred to as “phases” (i.e., Solid used may include, for example, tackidex, an aqueous gelatin phase, liquid phase, gas phase or dispersion phase). For solution, or the like. purposes of the present invention, the term "solid” is defined The primary, secondary or tertiary capsules, in accordance as including, by way of example only and not by way of with the present invention, may be formed having the same limitation, pills, tablets, capsules (including both hard and or different colors. Moreover, the base and corresponding 35 Soft elastic), powders, granulation, flakes, troches (lozenges cap of a single capsule may be formed having different and pastilles), Suppositories and semi-solid pastes, oint colors in an effort to enhance the aesthetics of the capsule to ments, emulsions or creams. The term “liquid” is defined as the consumer. In one presently preferred embodiment of a including, by way of example only and not by way of multi-compartment capsule of the present invention, the limitation, Solutions, spirits, elixirs, sprays, syrups or fluid dosage may be banded, sealed or easily dividable in a 40 extracts. The term “dispersion' is defined as including, by contact area of the primary and secondary capsules or the way of example only and not by way of limitation, aerosols sealing band may be color-coded to assist in branding, if (liquid or solid in gas), Suspensions (solid in liquid), emul desired. sions (liquid in liquid), foams (gas in liquid), Solid foams It is further contemplated herein that a multi-compartment (solid in gas) or gels (liquid or solid in Solid). capsule of the present invention may comprise component 45 The active ingredients or medicaments introduced into the parts of the capsule having various time-release coatings to receiving chambers of the multi-compartment capsules of facilitate the release and ultimately the absorption of those the present invention preferably comprise a pharmaceutical, active ingredients introduced into the different receiving biotechnical, nutraceutical, vitamin, dietary Supplement, chambers of the multi-compartment capsule to release at mineral or combination thereof. For purposes of the present different release rates. In particular, a primary capsule may 50 invention, the term "pharmaceutical' is defined as any be formed having a conventional time-release coating that Substance that affects the structure or functioning of a living dissolves and releases the active ingredient(s) contained organism. Pharmaceuticals, sometimes referred to as therein before the timed-release of the active ingredient(s) 'drugs are widely used for the prevention, diagnosis and contained within a secondary capsule. Likewise, the divid treatment of diseases and for the relief of symptoms. The ing walls disposed within the internal periphery of the base 55 term “biotechnical is defined as any substance that is of a capsule may be formed having conventional time derived from a biotechnology process. Biotechnology, release coatings that dissolve and release the active ingre sometimes shortened to “biotech', is the development of dients within each receiving chamber defined by the divid techniques and methods (e.g., genetic engineering, protein ing walls at different rates, thereby delivering the active engineering genomics, proteomics, monoclonal antibody ingredients or medicaments contained within a multi-com 60 production, polymerase chain reaction, transgenics and the partment capsule at different rates. Certain active ingredients like) for the application of biological processes to the or medicaments may, therefore, be delivered at a selected production of materials of use in medicine, foods, nutrition interval, while other ingredients may be released at a later and industry. The term “nutraceutical is defined as any interval. In this way, the novel design of the multi-compart substance that is a food of a part of a food and provides ment capsules of the present invention may facilitate preci 65 medical or health benefits, including the prevention and sion delivery of active ingredients to targeted areas of the treatment of disease. The term “vitamin' is defined as any of COSU. various organic Substances or compounds that are essential US 9,539,216 B2 47 48 for the normal processes of growth and maintenance (e.g., tion of medicaments thereof. In any regard, said fixed essential for energy transformation and regulation of combinations have not previously been contemplated in the metabolism) of the body which are present in natural food art. stuffs or sometimes produced within the body. The term The following examples will illustrate the invention in "dietary supplement” is defined as any product (other than further detail. It will be readily understood that the various tobacco) intended to supplement the diet that bears or active ingredients or medicaments that may be introduced contains one or more of the following dietary ingredients: into the receiving chambers of the multi-compartment cap (A) a vitamin; (B) a mineral: (C) an herb or other botanical; Sules of the present invention, as generally described and (D) an amino acid; (E) a dietary Substance for Supplement illustrated in the Examples herein, are to be viewed as ing the diet by increasing the total dietary intake; or (F) a 10 exemplary of the principles of the present invention, and not as restrictive to a particular structure or process for imple concentrate, metabolite, constituent, extract or combination menting those principles. Thus, the following more detailed of any ingredient described in (A), (B), (C), (D), or (E) description of the presently preferred embodiments of the hereinabove. If desired, excipients may also be introduced methods, formulations, and compositions of the present into one or more of the receiving chambers of the multi 15 invention, as represented in Examples I-XIV below, is not compartment capsules of the present invention in addition to intended to limit the scope of the invention, as claimed, but the active ingredient(s). For example, in some cases involv is merely representative of presently preferred embodiments ing medicaments with poor water solubility, it may be of the invention. desirous to stabilize the liquids, Solids or dispersions using a lipid, lipoid, lecithin, ghee or the like. Still further by EXAMPLE I example, in Some cases involving active ingredients or medicaments with poor bioavailability, bioeduivalence, or Glucosamine/Chondroitin (Solid) & Vitamin E other undesirous pharmaceutical properties (e.g., poor water (Liquid) solubility, pH lability, physical incompatibility, chemical incompatibility, macromolecular size and the like) Such as 25 As appreciated by those skilled in the art, arthritis is an proteins (e.g., hormones, erythropoeitins, colony stimulating inflammatory condition typically affecting the synovia factors, interferons, interleukins, plasminogen activators, membranes and cartilage of joints. It has been estimated that monoclonal antibodies, vaccines, plant proteins, such as Soy as many as one in three persons may experience symptoms and other therapeutic proteins) or other non-polar or weak associated with arthritis during their lifetime. polar materials, it may be desirous to complement the active 30 In addition to arthritis, various other chronic, debilitating ingredient or medicament in liquid, Solid or dispersion form conditions may afflict the aged. Many of these conditions using a fat, lipid, lipoid, lecithin, ghee, polymers, viral and result from the natural process of aging in humans. The bacterial vectors and the like. natural aging process is partially due to the accumulation It may be demonstrated that as medical and pharmacy and effects of toxic free-radical chemicals. Free-radicals knowledge has continued to expand exponentially, new 35 result from several homeostatic biochemical processes. It is, medicaments, new classes of medicaments and new delivery accordingly, desirable to develop nutraceutical or dietary technologies are becoming available for use in animals and Supplement products which may alleviate multiple chronic, humans who experience particular medical diseases, ill debilitating conditions. It is also desirable to package and nesses or conditions. A disease, illness, or condition may administer Such products in the most economic and conve affect one or more organ systems in an animal or human. 40 nient possible fashion. Organ systems may include, for example: (1) autonomic, (2) The administration of glucosamine, a naturally occurring cardiovascular, (3) neurological, (4) gastro-intestinal, (5) Substance in mucopoly-saccharides, mucoproteins and chi respiratory, (6) renal system, (7) psychiatric, (8) endocrine, tin, is believed to promote the production of cartilage (9) gynecologic, (10) urologic, (11) immunologic, (12) bone components and the repair of damaged cartilage. Clinical and joint systems, (13) ear, nose, and throat, (14) dermato 45 findings support that fibroblast cells increased production of logic, (15) hematologic, (16) infectious defense and (17) mucopolysaccharide and collagen synthesis when glu nutrition and metabolism. In an animal or human who may cosamine was added. be suffering from one disease, illness or condition, it is Chondroitin Sulfates are large polymers of glycosamino common to also be suffering from a disease, illness or glycans, primarily D-glucuronic acid and D-acetylgalac condition affecting one or more of the other organ system(s). 50 tosamine, and disaccharides and may be derived from the These concomitant diseases, illnesses or conditions occur cartilage of bovine trachea. The administration of chondroi ring within a single animal or human are often labeled as tin sulfate has been shown to promote the formation of new "co-morbidities,” a term often shortened and referred to as cartilage matrix. In particular, chondroitin Stimulates the “co-morbid. metabolism of chondrocyte cells and the production of New medicaments and delivery technologies are provid 55 collagen and proteoglycan. ing patients and their health care practitioners with unprec Vitamin E, also known as alpha-tocopherol, is a well edented therapeutic options in managing diseases, illnesses known scavenger of free-radicals in the body. Free-radical and conditions. In spite of this sophistication, there has been Scavengers are sometimes referred to as antioxidants. This no effort to develop new methods of using fixed combina Scavenging process is important for detoxifying the body of tions of medicaments for therapy of co-morbid diseases, 60 chemicals which are known to promote apoptosis, or pro illnesses or conditions. Moreover, there has been no effort to grammed cell death. Apoptosis is a scientific description of develop new methods of using fixed combinations of medi cellular destruction. Although vitamin E is a popular anti caments for management of a single disease, illness or oxidant, it is poorly soluble in water and thus can be condition affecting one or more organ system(s). The afore administered only as a liquid-oil formulation or in an oil mentioned fixed combinations may include a plurality of 65 formulation enclosed in a soft elastic capsule. medicaments, which may be newly discovered and devel In one presently preferred embodiment of the present oped, or have been known for Sometime or some combina invention, therapeutically effective amounts of glucosamine, US 9,539,216 B2 49 50 chondroitin, and vitamin E (active ingredients) may be antidepressant. Over the years, it has also been found that introduced into receiving chambers of a multi-compartment SAMe may assist in alleviating arthritic symptoms, assist in capsule wherein at least two of the active ingredients have the manufacture of melatonin, which is needed to regulate physical States (e.g., Solid, liquid, gas or dispersion) that sleep, help protect DNA from harmful mutations and pre differ. Consistent with the foregoing, multi-compartment, vent certain types of nerve damage. multi-phase capsules and encapsulation technology are As noted above, vitamin E is a popular anti-oxidant, but herein contemplated to produce a delivery vehicle for deliv it is poorly soluble in water and therefore can be adminis ering anti-arthritic and anti-oxidant compounds to the body tered only as a liquid-oil formulation. Vitamin E is typically in a single dosage. A capsular format of the present invention measured in international units (IU) of alpha tocopherol. may include the following composition: 10 In one presently preferred embodiment of the present invention, therapeutically effective amounts of SAMe and Vitamin E (active ingredients) may be introduced into Primary Capsule: receiving chambers of a multi-compartment capsule wherein SAMe comprises a physical state (e.g. solid, liquid, gas or Glucosamine HCI 500 mg 15 500-2000 mg/day dispersion) different from the physical state of vitamin E. As Chondroitin sulfate 400 mg shown in FIGS. 3 and 4, a therapeutically effective amount 400-1600 mg/day of SAMe may be introduced into receiving chamber 218a Secondary Capsule: and a therapeutically effective amount of vitamin E may be Vitamin E 200 IU introduced into receiving chamber 218b of a multi-compart 200-400 IU/day) ment capsule 210 of the present invention. Consistent with the foregoing, multi-compartment, multi-phase capsules and encapsulation technology are herein contemplated to pro The incorporation of time-release coatings to varying the duce a delivery vehicle for delivering mood enhancing, release rates of the active ingredients (e.g., glucosamine anti-arthritic and anti-oxidant compounds to the body in a HCl/chondroitin sulfate and vitamin E) in the primary and 25 single dosage. A capsular format of the present invention secondary capsules, respectively, of the multi-compartment may include the following composition: capsule may be used to target key time intervals or events when the body may be most able to utilize the named active ingredients. Thus, the incorporation of time-release coatings Receiving Chamber (218a): 30 in the encapsulation process when forming a multi-compart S-adenosylmethione 1000 mg ment capsule may be specifically designed to fit the needs 200-1600 mg/day and desires of numerous different users having similar Receiving Chamber (218b): conditions that are being targeted for treatment. Vitamin E 200 IU A therapeutically effective amount of glucosamine HCl/ 200-400 IU/day) chondroitin Sulfate may be introduced into at least a portion 35 of the internal periphery of the receiving chambers of a primary capsule in the form of a Solid and a therapeutically The incorporation of time-release coatings to varying the effective amount of vitamin E may be introduced into at least release rates of the active ingredients (e.g., SAMe and a portion of a secondary capsule in the form of a liquid, if vitamin E) of the multi-compartment capsule 210 may be desired. Since the encapsulation process and multi-compart 40 used to target key time intervals or events when the body ment, multi-phase capsule of the present invention are may be most able to utilize the named active ingredients. configured to apply to an anticipated treatment regime or Thus, the incorporation of time-release coatings in the medicinal design of a single dosage capsule, it will be encapsulation process when forming a multi-compartment readily appreciated that the introduction of one or more capsule may be specifically designed to fit the needs and active ingredients into the receiving chambers of the primary 45 desires of numerous different users having similar condi and secondary capsules, respectively, is anticipated Such that tions that are being targeted for treatment. the various ingredients may be introduced in different According to one presently preferred embodiment of the receiving chambers to accommodate different treatment present invention, a therapeutically effective amount of modalities. For example, a multi-compartment capsule may SAMe may be introduced into at least a portion of the be formulated having glucosamine HCl and chondroitin 50 receiving chamber 218a in the form of a solid and a sulfate introduced into the receiving chambers of the sec therapeutically effective amount of vitamin E may be intro ondary capsule and vitamin E may be introduced into the duced into at least a portion of the receiving chamber 218b receiving chamber of the primary capsule. It is intended, of the primary capsule 211 in the form of a liquid. therefore, that the examples provided herein be viewed as In an alternative presently preferred embodiment of the exemplary of the principles of the present invention, and not 55 present invention, therapeutically effective amounts of as restrictive to a particular structure or method for imple SAMe and vitamin E (active ingredients) may be introduced menting those principles. into receiving chambers of a multi-compartment capsule wherein SAMe comprises a physical state (e.g., Solid, liquid, EXAMPLE II gas or dispersion) different from the physical State of vitamin 60 E. As shown in FIG. 2, a therapeutically effective amount of S-Adenosylmethione (SAMe) (Solid) & Vitamin E SAMe, in the form of a solid, may be introduced into (Liquid) receiving chamber 118 and 138 and a therapeutically effec tive amount of vitamin E, in the form of a liquid, may be S-adenosylmethione (SAMe), may be derived from two introduced into receiving chamber 128 of a multi-compart materials: methionine, a Sulfur-containing amino acid, and 65 ment capsule 110 of the present invention. The material adenosine triphosphate (ATP), the body's main energy com forming the primary capsule shell 111 may be formulated in pound. SAMe was originally developed around 1950 as an a manner allowing for immediate dissolution and release of US 9,539,216 B2 51 52 the of the contents of receiving chamber 118. The material members of the omega-3 group of essential fatty acids and forming the secondary capsule shell 120 may be formulated are found exclusively in marine animals. The best sources in a manner allowing for either an immediate dissolution or for EPA and DH A may be fatty fish such as herring, a time-delayed dissolution and release of the contents of Sardines, salmon and fresh tuna. receiving chamber 128. The material forming the tertiary 5 The recommended daily intake of EPA plus DHA is capsule shell 138 may be formulated in a manner allowing between 650 to 1000 mg/day. Clinical trials have used for time-delayed dissolution and release of the contents of anywhere from 1 g/day to 10 g/day, but little additional receiving chamber 138. In this presently preferred embodi benefit has been observed at levels above 5 g/day of EPA and ment of the present invention, a total daily dosage of SAMe DHA combined. The onset of beneficial effects is variable. may be delivered as two separate dosages within a single Effects on cholesterol may occur in just a few weeks, but it oral dosage form. One presently preferred embodiment of may take there (3) months or longer to see effects in the present invention thus makes for a more convenient degenerative diseases, such as arthritis. dosage form. In one presently preferred embodiment of the present Since the encapsulation process and multi-compartment, invention, therapeutically effective amounts of curcumin, multi-phase capsule of the present invention are configured 15 Holy Basil, zinc and fish oil (active ingredients) may be to apply to an anticipated treatment regime or medicinal introduced into receiving chambers of a multi-compartment design of a single dosage capsule, it will be readily appre capsule wherein curcumin. Holy Basil and Zinc comprise a ciated that the introduction of one or more active ingredients physical state (e.g. Solid, liquid, gas or dispersion) different into receiving chambers defined within a capsule is antici from the physical state of the fish oil. As shown in FIG. 2, pated Such that the various ingredients may be introduced in a therapeutically effective amount of curcumin may be different receiving chambers to accommodate different treat introduced into receiving chamber 138 of a tertiary capsule ment modalities. It is intended, therefore, that the examples 130, a therapeutically effective amount of Holy Basil and provided herein be viewed as exemplary of the principles of Zinc may be introduced into receiving chamber 128 of a the present invention, and not as restrictive to a particular secondary capsule and a therapeutically effective amount of structure or method for implementing those principles. 25 fish oil may be introduced into receiving chamber 118 of a EXAMPLE III primary capsule 111 of a multi-compartment capsule 110 of the present invention. Consistent with the foregoing, multi compartment, multi-phase capsules and encapsulation tech Curcumin, Holy Basil, Zinc (Solid) & Fish Oil nology are herein contemplated to produce a delivery (Omega 3 Fatty Acids DHA & EPA-Liquid) 30 vehicle for delivering anti-neoplastic, anti-inflammatory, Curcumin belong to a class of compounds derived from analgesic and anti-oxidant compounds to the body in a the turmeric root and is a yellow-orange volatile oil. It is single dosage. A capsular format of the present invention believed that curcumin has an inhibitory effect on carcino may include the following composition: genesis, which is the evolution of a normal cell into a 35 cancerous cell. There is clinical evidence to suggest cur cumin may help to prevent stomach, colon, oral, esophageal, Tertiary Capsule (130): breast and skin cancers. Additional studies have been con Curcumin 400 mg 1200-1800 mg/day: 400 mg three times daily ducted to show that curcumin may be helpful in balancing Secondary Capsule: (120): cholesterol levels, protecting against ulcers by inhibition of 40 gastric acid secretion and protection of gastric mucosal Holy Basil 2.5 gms tissue, and anti-inflammatory actions. In one clinical study, 2.5 grams fresh dried leaf powderiday curcumin was found to be as effective as non-steroidal Zinc 15 mg 4-15 mg day anti-inflammatory drugs in the treatment of arthritis and Primary Capsule (111): lost-operative pain. 45 The administration of Holy Basil (Ocimum sanctum) has Fish oil 1000 mg been shown to have an effect on promoting peripherally (Omega 3 fatty acids-DHA & EPA) mediated analgesic effects. This action allows a broad range 650-1000 mg/day of therapeutic effects, including, anti-inflammatory, hypo glycemia, analgesic, anti-ulcer and anti-septic properties. 50 The incorporation of time-release coatings to varying the As known, Zinc is a mineral that occurs in animal and release rates of the active ingredients (e.g., curcumin, Holy plant tissues and is an important co-factor for various Basil, Zinc and fish oil) in the primary, secondary and enzyme reactions in the body, as well as being helpful for the tertiary capsules 111, 120, 130 of one presently preferred reproduction system, and for the manufacture of body pro embodiment of a multi-compartment capsule 110 may be teins. Zinc is also an antioxidant nutrient, similar to Vitamin 55 used to target key time intervals or events when the body E. There is clinical data that suggests that Zinc may be may be most able to utilize the named active ingredients. important to the prostate and other reproductive organs in Thus, the incorporation of time-release coatings in the the body, may help in the contractility of muscles, help encapsulation process when forming a multi-compartment stabilize blood, help maintain the body's alkaline balance capsule may be specifically designed to fit the needs and and aid in the digestion and metabolism of phosphorus. 60 desires of numerous different users having similar condi Over several decades considerable evidence has been tions that are being targeted for treatment. collected to suggest that fish and fish oils are beneficial to the As contemplated herein, a therapeutically effective heart, mental health and in reducing cancer risk. The amount of curcumin may be introduced into at least a portion “active' components of fish oils are eicosapentaenoic acid of the receiving chamber 138 of the tertiary capsule 130 in (EPA), a polyunsaturated fatty acid with a 20 carbon chain, 65 the form of a solid, a therapeutically effective amount of and docosahexaenoic acid (DHA), a polyunsaturated fatty Holy Basil and zinc may be introduced into at least a portion acid with a 22 carbon chain. Both active components are of the receiving chamber 128 of the secondary capsule 120 US 9,539,216 B2 53 54 in the form of a solid and a therapeutically effective amount in the form of a solid and a therapeutically effective amount of fish oil may be introduced into at least a portion of the of vitamin E may be introduced into at least a portion of a primary capsule 111 in the form of a liquid. Since the second receiving chamber in the form of a liquid. Since the encapsulation process and multi-compartment, multi-phase encapsulation process and multi-compartment, multi-phase capsule of the present invention are configured to apply to an capsule of the present invention are configured to apply to an anticipated treatment regime or medicinal design of a single anticipated treatment regime or medicinal design of a single dosage capsule, it will be readily appreciated that the intro dosage capsule, it will be readily appreciated that the intro duction of one or more active ingredients into the receiving duction of one or more active ingredients into the receiving chambers of the primary and secondary capsules, respec chambers of the primary and secondary capsules, respec tively, is anticipated Such that the various ingredients may be 10 tively, is anticipated Such that the various ingredients may be introduced in different receiving chambers to accommodate introduced in different receiving chambers to accommodate different treatment modalities. It is intended, therefore, that different treatment modalities. It is intended, therefore, that the examples provided herein be viewed as exemplary of the the examples provided herein be viewed as exemplary of the principles of the present invention, and not as restrictive to principles of the present invention, and not as restrictive to a particular structure or method for implementing those 15 a particular structure or method for implementing those principles. principles. EXAMPLE IV EXAMPLE V Vitamin C (Solid) & Vitamin E (Liquid) Selenium/Vitamin C (Solid) & Vitamin E/Beta-Carotene/Fish Oil (Omega 3 Fatty Acids It is believed that vitamin C plays an important role as a DHA & EPA) (Liquid) component of enzymes involved in the synthesis of collagen and carnitine. A vital role of vitamin C, however, is believed Selenium is an essential trace mineral in the human body to be that of the primary, water-soluble antioxidant in the 25 and an important part of antioxidant enzymes that protect human body. A daily intake of 6-1000 mg of vitamin C may cells against the effects of free radicals that are produced be adequate for preventive purposes, but far larger quantities during normal oxygen metabolism. As readily known in the may be required to have an effect on halting or reversing art, the body has developed defenses, such as antioxidants, cancer and heart disease. to assist in controlling levels of free radicals which can cause As noted above, vitamin E is a popular anti-oxidant, but 30 damage to cells and contribute to the development of some it is poorly soluble in water and therefore can be adminis chronic diseases. It is also believed that Selenium is essential tered only as a liquid-oil formulation. for normal functioning of the immune system and thyroid In one presently preferred embodiment of the present gland. The recommended dietary allowance for selenium is invention, therapeutically effective amounts of vitamin C 55 mcg/day. and vitamin E (active ingredients) may be introduced into 35 As noted above, it is believed that vitamin C plays an receiving chambers of a multi-compartment capsule wherein important role as a component of enzymes involved in the Vitamin C comprises a physical state (e.g., Solid, liquid, gas synthesis of collagen and carnitine and a vital role as a water or dispersion) different from the physical state of vitamin E. soluble antioxidant in the human body. Vitamin E is another Consistent with the foregoing, multi-compartment, multi important anti-oxidant. phase capsules and encapsulation technology are contem 40 Beta-carotene is a substance found in plants that the body plated herein to produce a delivery vehicle for delivering converts into vitamin A. It is believed that beta-carotene acts anti-oxidant compounds to the body in a single dosage. A as an antioxidant and an immune system booster. There is no capsular format of the present invention may include the RDA for beta-carotene. The most common beta-carotene following composition: supplement intake is about 25,000 IU (15 mg) per day, 45 however supplementation with as much as 100,000 IU (60 mg) per day has been reported. Primary Capsule: It has been suggested that fish and fish oils are beneficial Vitamin C 500 mg to the heart, mental health and in reducing cancer risk. The 60-1000 mg/day recommended daily intake of EPA plus DHA (the active Secondary Capsule: 50 components of fish oil) is between 650 to 1000 mg/day. Clinical trials have used anywhere from 1 g/day to 10 g/day, Vitamin E 200 IU but little additional benefit has been observed at levels above 200-400 IU/day) 5 g/day of EPA and DHA combined. In one presently preferred embodiment of the present The incorporation of time-release coatings to varying the 55 invention, therapeutically effective amounts of selenium, release rates of the active ingredients (e.g., vitamin C and vitamin C, beta-carotene, vitamin E and fish oil (active vitamin E) in different receiving chambers of a multi ingredients) may be introduced into receiving chambers of a compartment capsule may be used to target key time inter multi-compartment capsule wherein selenium and vitamin C vals or events when the body may be most able to utilize the comprise a physical state (e.g., Solid, liquid, gas or disper named active ingredients. Thus, the incorporation of time 60 sion) different from the physical state of vitamin E, beta release coatings in the encapsulation process when forming caroteine and fish oil (omega 3 fatty acids DHA & EPA). a multi-compartment capsule may be specifically designed Specifically, a therapeutically effective amount of selenium to fit the needs and desires of numerous different users and vitamin C may be introduced into one or more receiving having similar conditions that are being targeted for treat chambers of a primary capsule and a therapeutically effec ment and is contemplated herein. 65 tive amount of vitamin E, beta-carotene and fish oil (omega A therapeutically effective amount of vitamin C may be 3 fatty acids DHA & EPA) may be introduced into one or introduced into at least a portion of a first receiving chamber more receiving chambers of a secondary capsule to form a US 9,539,216 B2 55 56 multi-compartment capsule of the present invention. Con condition with other chronic disease states involving the sistent with the foregoing, multi-compartment, multi-phase neurological system, cardiovascular system, respiratory sys capsules and encapsulation technology are herein contem tem, endocrine system, musculoskeletal system, immune plated to produce a delivery vehicle for delivering anti system, genitourinary system and the like. This list is should oxidant compounds to the body in a single dosage. A not be considered exclusive. capsular format of the present invention may include the Administration of Fluoxetine is known by those of skill in following composition: the art to alleviate the signs and symptoms of depression. Fluoxetine belongs to a class of compounds which are given the functional name: selective serotonin reuptake inhibitors Primary Capsule: 10 (SSRIs). This class may include, for example: fluoxetine Selenium 50 mcg (PROZACR), sertraline (ZOLOFTR), paroxetine 50-100 mcg day (PAXIL(R), fluvoxamine (LUVOX(R), citalopram (CEL Vitamin C 500 mg 60-1000 mg/day EXAR) and escitalopram (LEXAPROR). As appreciated, Secondary Capsule: 15 the foregoing list is provided herein as exemplary and should not be considered exclusive or exhaustive. Beta-caroteine 50 mg 30-300 mg/day Fluoxetine is a bicyclic compound, similar in structure to Vitamin E 200 IU phenylpropanolamine. Fluoxetine structure imparts a high 200-400 IU/day) selectivity for interaction with cells of the nervous system Fish oil 1000 mg (Omega 3 fatty acids-DHA & EPA) for the function of preventing the reuptake of serotonin into 650-1000 mg/day pre-synaptic cell storage sites. This action leads to marked increases in Synaptic concentration of serotonin and is facilitative of numerous physiological processes requiring The incorporation of time-release coatings to varying the serotonin neurotransmission. In the pharmaceutical field release rates of the active ingredients (e.g., selenium, Vita 25 Fluoxetine is available as a hydrochloride salt (HCl). min C, vitamin E, beta caroteine and fish oil) in different S-adenosylmethione (SAMe), is derived from two mate receiving chambers of a multi-compartment capsule may be rials: methionine, a Sulfur-containing amino acid, and used to target key time intervals or events when the body adenosine triphosphate (ATP), the body's main energy com may be most able to utilize the named active ingredients. pound. SAMe was originally developed around 1950 as an Thus, the incorporation of time-release coatings in the 30 antidepressant, but it was also found to be helpful in the encapsulation process when forming a multi-compartment alleviation of arthritic symptoms. SAMe is essential for the capsule may be specifically designed to fit the needs and manufacture of melatonin, which is needed to regulate sleep. desires of numerous different users having similar condi It also helps to protect DNA from harmful mutations and tions that are being targeted for treatment and is contem may help prevent certain types of nerve damage. Current plated herein. 35 A therapeutically effective amount of selenium and vita clinical research is beginning to confirm these antidepressant min C may be introduced into one or more receiving qualities of SAMe. chambers of a primary capsule in Solid form and a thera Vitamin E, also named alpha-tocopherol, is a well-known peutically effective amount of vitamin E, beta carotene and Scavenger of free-radicals in the body. Free-radical scaven fish oil may be introduced into one or more receiving 40 gers are sometimes referred to as antioxidants. This scav chambers of a secondary capsule in the form of a liquid. enging process is important for detoxifying the body of Since the encapsulation process and multi-compartment, chemicals which are known to promote apoptosis, or pro multi-phase capsule of the present invention are configured grammed cell death. Apoptosis is a scientific description of to apply to an anticipated treatment regime or medicinal cellular destruction. Although it is a popular anti-oxidant, design of a single dosage capsule, it will be readily appre 45 Vitamin E is poorly soluble in water and thus can be ciated that the introduction of one or more active ingredients administered only as a liquid-oil formulation or in an oil into the receiving chambers of the primary and secondary formulation enclosed in a soft elastic capsule. Vitamin E is capsules, respectively, is anticipated Such that the various typically measured in international units (IU) of alpha ingredients may be introduced in different receiving cham tocopherol. bers to accommodate different treatment modalities. It is 50 In one presently preferred embodiment of the present intended, therefore, that the examples provided herein be invention, therapeutically effective amounts of Fluoxetine, viewed as exemplary of the principles of the present inven SAMe and Vitamin E (active ingredients) may be introduced tion, and not as restrictive to a particular structure or method into receiving chambers of a multi-compartment capsule for implementing those principles. wherein Fluoxetine and SAMe comprises a physical state 55 (e.g., Solid, liquid, gas or dispersion) different from the EXAMPLE VI physical state of Vitamin E. As shown in FIGS. 3 and 4, a therapeutically effective amount of Fluoxetine and SAMe Fluoxetine (Solid), S-Adenosylmethione (SAMe) may be introduced into receiving chamber 218a and a (Solid) & Vitamin E (Liquid) therapeutically effective amount of Vitamin E may be intro 60 duced into receiving chamber 218b of a multi-compartment As appreciated by those skilled in the art, depression is a capsule 210 of the present invention. Consistent with the mental state characterized by excessive sadness. Depression foregoing, multi-compartment, multi-phase capsules and is one of several forms of mood disorders. Activity in those encapsulation technology are herein contemplated to pro affected with depression may be agitated and restless or slow duce a delivery vehicle for delivering mood enhancing, and retarded. Those affected may also show pessimistic or 65 anti-depressant and anti-oxidant compounds to the body in despairing behavior and may have disturbances in sleep, a single dosage. A capsular format of the present invention appetite and concentration. Depression is often a co-morbid may include the following composition: US 9,539,216 B2 57 58 having Fluoxetine and SAMe introduced into the receiving Receiving Chamber (218a): chambers of the secondary capsule and Vitamin E may be Fluoxetine 20 mg introduced into the receiving chamber of the primary cap 20-60 mg/day sule. It is intended, therefore, that the examples provided S-adenosylmethione 1000 mg herein be viewed as exemplary of the principles of the 200-1600 mg/day present invention, and not as restrictive to a particular Receiving Chamber (218b): structure or method for implementing those principles. Vitamin E 200 IU 200-400 IU/day) EXAMPLE VII 10 The incorporation of time-release coatings to varying the Rofecoxib (Solid) & Vitamin E (Liquid) release rates of the active ingredients (e.g., Fluoxetine/ As appreciated by those skilled in the art, arthritis is an SAMe and Vitamin E) in the primary and secondary cap inflammatory condition typically affecting the synovia and Sules, respectively, of the multi-compartment capsule may 15 cartilage of joints. It has been estimated that as many as one be used to target key time intervals or events when the body in three persons may experience symptoms associated with may be most able to utilize the named active ingredients. arthritis during their lifetime. Thus, the incorporation of time-release coatings in the In addition to arthritis, various other chronic, debilitating encapsulation process when forming a multi-compartment conditions may afflict the aged. Many of these conditions capsule may be specifically designed to fit the needs and result from the natural process of aging in humans. The desires of numerous different users having similar condi natural aging process is partially due to the accumulation tions that are being targeted for treatment. and effects of toxic free-radical chemicals. Free-radicals According to one presently preferred embodiment of the result from several homeostatic biochemical processes. It is, present invention, a therapeutically effective amount of accordingly, desirable to develop pharmaceutical, biotech Fluoxetine and SAMe may be introduced into at least a 25 nical, nutraceutical or dietary Supplement products which portion of the receiving chamber 218a in the form of a solid may alleviate multiple chronic, debilitating conditions. It is and a therapeutically effective amount of Vitamin E may be also desirable to package and administer Such products in introduced into at least a portion of the receiving chamber the most economic and convenient possible fashion. 218b of the primary capsule 211 in the form of a liquid. Anti-inflammatory agents may have many diverse thera In an alternative presently preferred embodiment of the 30 peutic roles in the human body. Inflammation is the process present invention, therapeutically effective amounts of Flu undertaken by the body as it responds to an injury. A typical oxetine and SAMe and Vitamin E (active ingredients) may inflammatory response involves blood vessel dilation, be introduced into receiving chambers of a multi-compart increased blood flow to the site of injury, and influx of white ment capsule wherein Fluoxetine and SAMe comprises a blood cells to process and remove dead tissue. Inflammation physical state (e.g., Solid, liquid, gas or dispersion) different 35 can lead to pain and Swelling at the site of injury. Medica from the physical state of Vitamin E. As shown in FIG. 2, a ments used in modulating the inflammatory response may be therapeutically effective amount of Fluoxetine and SAMe, in divided into steroid and non-steroidal labels. The latter is the form of a solid, may be introduced into receiving more commonly identified as non-steroidal anti-inflamma chamber 118 and 138 and a therapeutically effective amount tory drugs (NSAIDs). of Vitamin E, in the form of a liquid, may be introduced into 40 Rofecoxib belongs to a class of NSAID compounds given receiving chamber 128 of a multi-compartment capsule 110 the functional name cyclo-oxygenase-2 (“COX-2) inhibi of the present invention. The material forming the primary tors. This class may include, for example: rofecoxib (VI capsule shell 111 may be formulated in a manner allowing OXX(R), celecoxib (CELEBREX(R), Valdecoxib (BEX for immediate dissolution and release of the of the contents TRAR), and meloxicam (MOBICR). As appreciated, the of receiving chamber 118. The material forming the second 45 foregoing list is provided herein as exemplary and should ary capsule shell 120 may be formulated in a manner not be considered exclusive or exhaustive. allowing for either an immediate dissolution or a time Rofecoxib is presently believed to inhibit the action of delayed dissolution and release of the contents of receiving COX-2, an enzyme involved in the production of prosta chamber 128. The material forming the tertiary capsule shell glandins in the human body. Prostaglandins serve many 138 may be formulated in a manner allowing for time 50 diverse roles, one of which is to stimulate an inflammation delayed dissolution and release of the contents of receiving mechanism in immune responses. Recently, Rofecoxib was chamber 138. In this presently preferred embodiment of the labeled for use in the treatment of osteoarthritis, rheumatoid present invention, a total daily dosage of Fluoxetine and arthritis, acute pain, and primary dysmenorrhea. SAMe may be delivered as two separate dosages within a Vitamin E, also named alpha-tocopherol, is a well-known single oral dosage form. One presently preferred embodi 55 Scavenger of free-radicals in the body. Free-radical scaven ment of the present invention thus makes for a more con gers are sometimes referred to as antioxidants. This scav venient dosage form. enging process is important for detoxifying the body of Since the encapsulation process and multi-compartment, chemicals which are known to promote apoptosis, or pro multi-phase capsule of the present invention are configured grammed cell death. Apoptosis is a scientific description of to apply to an anticipated treatment regime or medicinal 60 cellular destruction. Although it is a popular anti-oxidant, design of a single dosage capsule, it will be readily appre Vitamin E is poorly soluble in water and thus can be ciated that the introduction of one or more active ingredients administered only as a liquid-oil formulation or in an oil into the receiving chambers of the primary and secondary formulation enclosed in a soft elastic capsule. capsules, respectively, is anticipated Such that the various In one presently preferred embodiment of the present ingredients may be introduced in different receiving cham 65 invention, therapeutically effective amounts of Rofecoxib bers to accommodate different treatment modalities. For and Vitamin E (active ingredients) may be introduced into example, a multi-compartment capsule may be formulated receiving chambers of a multi-compartment capsule wherein US 9,539,216 B2 59 60 Rofecoxib comprises a physical state (e.g., Solid, liquid, gas Since the encapsulation process and multi-compartment, or dispersion) different from the physical state of Vitamin E. multi-phase capsule of the present invention are configured As shown in FIGS. 3 and 4, a therapeutically effective to apply to an anticipated treatment regime or medicinal amount of Rofecoxib may be introduced into receiving design of a single dosage capsule, it will be readily appre chamber 218a and a therapeutically effective amount of 5 ciated that the introduction of one or more active ingredients Vitamin E may be introduced into receiving chamber 218b into receiving chambers defined within a capsule is antici of a multi-compartment capsule 210 of the present inven pated Such that the various ingredients may be introduced in tion. Consistent with the foregoing, multi-compartment, different receiving chambers to accommodate different treat multi-phase capsules and encapsulation technology are ment modalities. It is intended, therefore, that the examples herein contemplated to produce a delivery vehicle for deliv 10 provided herein be viewed as exemplary of the principles of ering anti-inflammatory and anti-oxidant compounds to the the present invention, and not as restrictive to a particular body in a single dosage. A capsular format of the present structure or method for implementing those principles. invention may include the following composition: EXAMPLE VIII 15 Receiving Chamber (218a): Diphenhydramine Hydrochloride (Solid) & Vitamin E (Liquid) Rofecoxib 25 mg 12.5-25 mg/day Receiving Chamber (218b): As appreciated by those skilled in the art, allergic reac tions are conditions wherein the immune system is stimu Vitamin E 200 IU lated to identify, segregate and dispose of exogenous chemi 200-400 IU/day) cals which cannot be recognized by the body. Allergic reactions are often associated with the release of histamine, The incorporation of time-release coatings to varying the a chemical compound which produces changes in the per release rates of the active ingredients (e.g., Rofecoxib and 25 meability of blood vessels and the accumulation of other Vitamin E) of the multi-compartment capsule 210 may be immune system cells. In some circumstances, it may be used to target key time intervals or events when the body desirable to modulate the amount of allergic response that is may be most able to utilize the named active ingredients. capable of being generated by the immune system. Thus, the incorporation of time-release coatings in the Diphenhydramine belongs to a class of compounds which encapsulation process when forming a multi-compartment 30 are given the functional name: histamine-1 (H. Sub.1) recep capsule may be specifically designed to fit the needs and tor antagonists. These compounds are more generally desires of numerous different users having similar condi labeled as antihistamines. These antagonists are further tions that are being targeted for treatment. divided according to their chemical structures. Diphenhy According to one presently preferred embodiment of the dramine is an ethanolamine (aminoalkyl ether) derivative. present invention, a therapeutically effective amount of 35 Other chemical divisions may include, for example: ethyl Rofecoxib may be introduced into at least a portion of the enediamine, propylamine, phenothiazine, piperazine. The receiving chamber 218a in the form of a solid and a ethanolamine division may include, for example: diphenhy therapeutically effective amount of Vitamin E may be intro dramine, clemastine, dimenhydrinate, and doxylamine. As duced into at least a portion of the receiving chamber 218b appreciated, the foregoing list is provided herein as exem of the primary capsule 211 in the form of a liquid. 40 plary and should not be considered exclusive or exhaustive. In an alternative presently preferred embodiment of the Antihistamines block the interaction of the neurotrans present invention, therapeutically effective amounts of Rofe mitter, histamine, with H receptors located in Smooth coxib and Vitamin E (active ingredients) may be introduced muscle linings of the gastrointestinal tract, bronchial tract into receiving chambers of a multi-compartment capsule and large blood vessels. This blocking action may lead to wherein Rofecoxib comprises a physical state (e.g., Solid, 45 marked relaxation in Smooth muscle tone and is facilitative liquid, gas or dispersion) different from the physical state of of numerous physiological processes including respiration. Vitamin E. As shown in FIG. 2, a therapeutically effective The Hantagonists may also be divided according to their amount of Rofecoxib, in the form of a solid, may be selectivity for central and peripheral HI receptors. A second introduced into receiving chamber 118 and 138 and a generation of H has emerged in recent years. These agents therapeutically effective amount of Vitamin E, in the form of 50 have a greater selectivity for peripheral H receptors. Sec a liquid, may be introduced into receiving chamber 128 of ond-generation H receptor antagonists may include, for a multi-compartment capsule 110 of the present invention. example: azelastine (ASTELLNR), cetirizine (ZYRTECR), The material forming the primary capsule shell 111 may be desloratadine (CLARINEX(R), fexofenadine (ALLEGRAR) formulated in a manner allowing for immediate dissolution and loratadine (CLARITINn(R). and release of the of the contents of receiving chamber 118. 55 Vitamin E, also named alpha-tocopherol, is a well-known The material forming the secondary capsule shell 120 may Scavenger of free-radicals in the body. Free-radical scaven be formulated in a manner allowing for either an immediate gers are sometimes referred to as antioxidants. This scav dissolution or a time-delayed dissolution and release of the enging process is important for detoxifying the body of contents of receiving chamber 128. The material forming the chemicals which are known to promote apoptosis, or pro tertiary capsule shell 138 may be formulated in a manner 60 grammed cell death. Apoptosis is a scientific description of allowing for time-delayed dissolution and release of the cellular destruction. Although it is a popular anti-oxidant, contents of receiving chamber 138. In this presently pre Vitamin E is poorly soluble in water and thus can be ferred embodiment of the present invention, a total daily administered only as a liquid-oil formulation or in an oil dosage of Rofecoxib may be delivered as two separate formulation enclosed in a soft elastic capsule. dosages within a single oral dosage form. One presently 65 In one presently preferred embodiment of the present preferred embodiment of the present invention thus makes invention, therapeutically effective amounts of Diphenhy for a more convenient dosage form. dramine and Vitamin E (active ingredients) may be intro US 9,539,216 B2 61 62 duced into receiving chambers of a multi-compartment increased blood flow to the site of injury, and influx of white capsule wherein at least two of the active ingredients have blood cells to process and remove dead tissue. Inflammation physical States (e.g., Solid, liquid, gas or dispersion) that can lead to pain and Swelling at the site of injury. Medica differ. Consistent with the foregoing, multi-compartment, ments used in modulating the inflammatory response may be multi-phase capsules and encapsulation technology are divided into steroid and non-steroidal labels. The latter is herein contemplated to produce a delivery vehicle for deliv more commonly identified as non-steroidal anti-inflamma ering anti-allergic and anti-oxidant compounds to the body tory drugs (NSAIDs). in a single dosage. A capsular format of the present invention Celecoxib belongs to a class of NSAID compounds given may include the following composition: the functional name cyclo-oxygenase-2 (“COX-2) inhibi 10 tors. This class may include, for example: rofecoxib (VI OXX(R), celecoxib (CELEBREX(R), Valdecoxib (BEX Primary Capsule: TRAR), etodolac (LODINE(R) and meloxicam (MOBICR). Diphenhydramine HCI 50 mg As appreciated, the foregoing list is provided herein as 25-100 mg/day 15 exemplary and should not be considered exclusive or Secondary Capsule: exhaustive. Vitamin E 200 IU Celecoxib is believed to inhibit the action of COX-2, an 200-400 IU/day) enzyme involved in the production of prostaglandins in the human body. Prostaglandins serve many diverse roles, one The incorporation of time-release coatings to varying the of which is to stimulate an inflammation mechanism in release rates of the active ingredients (e.g., Diphenhy immune responses. Recently, Celecoxib was labeled by the dramine and Vitamin E) in the primary and secondary United States Food and Drug Administration (FDA) for use capsules, respectively, of the multi-compartment capsule in the treatment of osteoarthritis, rheumatoid arthritis, acute may be used to target key time intervals or events when the pain, and primary dysmenorrhea. body my be most able to utilize the named active ingredi 25 Ibuprofen is another NSAID and is believed to function as ents. Thus, the incorporation of time-release coatings in the a non-selective inhibitor of cyclo-oxygenase. Ibuprofen has encapsulation process when forming a multi-compartment been labeled by the FDA for use in the treatment of capsule may be specifically designed to fit the needs and osteoarthritis, rheumatoid arthritis, relief of mild to moder desires of numerous different users having similar condi ate pain and primary dysmenorrhea. Ibuprofen belongs to a tions that are being targeted for treatment. 30 class of compounds called phenyl-a-methylacetic acids, A therapeutically effective amount of Diphenhydramine which are derived from salicylic acid. Non-selective cyclo may be introduced into at least a portion of the internal oxygenase inhibitors may include, for example: ibuprofen periphery of the receiving chambers of a primary capsule in (MOTRINR), naproxen (NAPROSYNR), diclofenac the form of a solid and a therapeutically effective amount of (VOLTARENR), flurbiprofen (ANSAIDR), indomethacin Vitamin E may be introduced into at least a portion of a 35 (INDOCINR), ketoprofen (ORUDIS(R), ketorolac (TO secondary capsule in the form of a liquid, if desired. Since RADOL(R), nabumetone (RELAFENR), oxaprozm (DAY the encapsulation process and multi-compartment, multi PROR), piroxicam (FELDENER) and sulindac phase capsule of the present invention are configured to (CLINORILR). As appreciated, the foregoing list is pro apply to an anticipated treatment regime or medicinal design vided herein as exemplary and should not be considered of a single dosage capsule, it will be readily appreciated that 40 exclusive or exhaustive. the introduction of one or more active ingredients into the In one presently preferred embodiment of the present receiving chambers of the primary and secondary capsules, invention, therapeutically effective amounts of Celecoxib respectively, is anticipated Such that the various ingredients and Ibuprofen (active ingredients) may be introduced into may be introduced in different receiving chambers to accom receiving chambers of a multi-compartment capsule wherein modate different treatment modalities. For example, a multi 45 Celecoxib comprises a physical state (e.g., Solid, liquid, gas compartment capsule may be formulated having Diphenhy or dispersion) different from the physical state of Ibuprofen. dramine introduced into the receiving chambers of the As shown in FIGS. 3 and 4, a therapeutically effective secondary capsule and Vitamin E may be introduced into the amount of Celecoxib may be introduced into receiving receiving chamber of the primary capsule. It is intended, chamber 218a and a therapeutically effective amount of therefore, that the examples provided herein be viewed as 50 Ibuprofen may be introduced into receiving chamber 218b exemplary of the principles of the present invention, and not of a multi-compartment capsule 210 of the present inven as restrictive to a particular structure or method for imple tion. Consistent with the foregoing, multi-compartment, menting those principles. multi-phase capsules and encapsulation technology are herein contemplated to produce a delivery vehicle for deliv EXAMPLE IX 55 ering anti-arthritic and anti-oxidant compounds to the body in a single dosage. A capsular format of the present invention Celecoxib (Solid) & Ibuprofen (Liquid) may include the following composition: As appreciated by those skilled in the art, arthritis is an Receiving Chamber (218a): inflammatory condition typically affecting the synovia and 60 cartilage of joints. It has been estimated that as many as one Celecoxib 200 mg in three persons may experience symptoms associated with 200-400 mg/day arthritis during their lifetime. Receiving Chamber (218b): Anti-inflammatory agents may have many diverse thera Ibuprofen 800 mg peutic roles in the human body. Inflammation is the process 65 2400-3200 mg/day undertaken by the body as it responds to an injury. A typical inflammatory response involves blood vessel dilation, US 9,539,216 B2 63 64 The incorporation of time-release coatings to varying the plary ingredients that can be used with the present invention, release rates of the active ingredients (e.g., Celecoxib and including the broader Subclasses and classes to which they Ibuprofen) of the multi-compartment capsule 210 may be belong. used to target key time intervals or events when the body may be most able to utilize the named active ingredients. Botanicals Thus, the incorporation of tirme-release coatings in the encapsulation process when forming a multi-compartment Green Trea capsule may be specifically designed to fit the needs and Griffonia Simplicifolia desires of numerous different users having similar condi Guarana 10 Guggul tions that are being targeted for treatment. Gymnema Sylvestre According to one presently preferred embodiment of the Hawthorne present invention, a therapeutically effective amount of Henna Celecoxib may be introduced into at least a portion of the Herbal Extracts, receiving chamber 218a in the form of a solid and a 15 Standardized therapeutically effective amount of Ibuprofen may be intro Herbal Teas duced into at least a portion of the receiving chamber 218b Hops of the primary capsule 211 in the form of a liquid. Horehound In an alternative presently preferred embodiment of the Horse Chestnut present invention, therapeutically effective amounts of Cele Horsetail coxib and Ibuprofen (active ingredients) may be introduced Hysop into receiving chambers of a multi-compartment capsule Ipriflavone wherein Celecoxib comprises a physical State (e.g., Solid, Jojoba Oil liquid, gas or dispersion) different from the physical state of Juniper Berries Ibuprofen. As shown in FIG. 2, a therapeutically effective 25 Kava Kava amount of Celecoxib, in the form of a solid, may be Kelp Extract introduced into receiving chamber 128 and a therapeutically Kola Nut effective amount of Ibuprofen, in the form of a liquid, may Kombucha be introduced into receiving chambers 118 and 138 of a Kudzu multi-compartment capsule 110 of the present invention. 30 Larch Lavender The material forming the primary capsule shell 111 may Lemon Balm be formulated in a manner allowing for immediate dissolu Licorice Extract tion and release of the of the contents of receiving chamber Liden Flowers 118. The material forming the secondary capsule shell 120 35 Lobelia may be formulated in a manner allowing for either an Maca immediate dissolution or a time-delayed dissolution and Maitake Mushroom release of the contents of receiving chamber 128. The Marshmallow material forming the tertiary capsule shell 138 may be Milk Thistle formulated in a manner allowing for time-delayed dissolu 40 Molasses tion and release of the contents of receiving chamber 138. In Mushrooms this presently preferred embodiment of the present inven Neem tion, a total daily dosage of Ibuprofen may be delivered as Nettle two separate dosages within a single oral dosage form. One Noni presently preferred embodiment of the present invention 45 Nopal thus makes for a more convenient dosage form. Oatstraw Since the encapsulation process and multi-compartment, Octacosanol multi-phase capsule of the present invention are configured Olive Extract to apply to an anticipated treatment regime or medicinal Orange Peel Extract design of a single dosage capsule, it will be readily appre 50 Oregano Oil ciated that the introduction of one or more active ingredients Oregon Mountain Grape into receiving chambers defined within a capsule is antici Organic Sweeteners pated Such that the various ingredients may be introduced in Parsley different receiving chambers to accommodate different treat Passion Flower ment modalities. It is intended, therefore, that the examples 55 Pau d'Arco provided herein be viewed as exemplary of the principles of Pennyroyal the present invention, and not as restrictive to a particular Peppermint structure or method for implementing those principles. Pfaffia Paniculata Pine Bark Extract EXAMPLES X 60 Piper Longum Pygeum Africanum Some embodiments of the present invention will use of or Quercitin more of the below ingredients in a multi-compartment Raspberry Powder capsule, combinable as would be recognized in view of the Red Clover teachings of the present application in combination with the 65 Reishi Mushroom knowledge available to one of ordinary skill in the art. It is Resveratrol Extract noted that the following non-limiting lists illustrate exem Rhubarb Root US 9,539,216 B2 65 66 Rice Products Bitter Melon Extract 8:1 Rose Hips Black Cohosh Extract 2.5% Rosemary Extract Black Cohosh Root Powder Sage Black Pepper Extract 4:1 Sarsaparilla Black Soy Bean Extract 10.1 Saw Palmetto Bone Powder Schizandra Boswellia Serrata Extract 65% Seaweed extracts Broccoli Sprout Extract 10:1 Senna Buchu Leaf Powder Shatavari 10 Buplerum (Chai Hu) Extract 5:1 Shiitake Mushroom Burdock Root Extract 4:1 Silymarin Cabbage Extract 4:1 Skullcap Caffeine (Natural) 86-87% Slippery Elm Caffeine 99% Soy Isoflavones 15 Calcium Citrate Granular 21 A Soybean Products Calcium-Pyruvate 99% Spirulina Carrot Root Extract 4:1 St. John's Wort Cassia Nonane Extract 4:1 Stevia Catnip Extract 4:1 Summa Cat's Claw (Inner Bark) Powder Tea Tree Oil Cauliflower Extract 4:1 Terminalia Ajruna Celandine (Greater) Extract 4:1 Tribulus Terrestris Celery Seed Extract Triphala Cetyl Myristoleate 11% Tumeric 25 Cetyl Myristoleate 20% Uva Ursi Chaenomeles Extract 4:1 Valerian Extract Chamomile Flower Extract 10:1 Vegetable Extracts Chamomile Flower Extract 4:1 Vitex Chaste Tree Berry Extract 4:1 Wheat Germ 30 Chitin Chitosan 80% White Willow Bark Chitosan 90% Wild Cherry bark Chondroitin Sulfate 90% Wild Yam Chrysin 99% Witch Hazel Cinnamon Powder Wormwood Yarrow 35 Cistanches Extract 5:1 Yellow Dock Citrus Aurantium Extract 6% Yerba Sante Citrus Bioflavonoid Complex 13% Yohimbine Citrus Peel Extract 5:1 Yucca Clove Extract 5:1 40 Clove Powder Extracts Coca Extract 4:1 Codonopsis Pilosula Extract 5:1 2O-ECD 7-9% Colostrum 4-Androstenedione 99% Common Peony Extract 8:1 Acetyl L-Carnitine HC1.99% 45 Cordyceps Extract 7% Adenophora Tetraohylla Ext 5:1 Cornsilk Extract 4:1 Alisma Extract 10:1 Cornsilk Powder Alpha Lipoic Acid 99% Corydalis Extract 10:1 Angelica Root Extract Cranberry Extract 4:1 Arbutin 99% 50 Cranberry Powder Artemisia Extract 4:1 Curcumin Extract 95% Artichoke Extract 5%, Globe Cuscuta Extract 5:1 Asparagus Extract 4:1 Damiana Extract 4:1 Asparagus Powder Damiana Leaves Powder Astragulus Extract 10:1 55 Dandelion Powder Astragulus Extract 4:1 Dandelion Root Extract 6:1 Astragulus Extract 5:1 Danshen Extract 80% Astragulus Root Extract 0.5% D-Calcium Pantothenate Astragulus Root Powder Devil’s Claw Extract 2.5% Atractylodes Extract 10:1 60 Devil’s Claw Extract 4:1 Avena Sativa Extract 10.1 Devil’s Claw Root Powder Avena Sativa Extract 4:1 DHEA 99% Barbed Skullcap Extract 10:1 Diosgenin 95% Barberry Extract 10% DL-Phenyl Alanine Bee Pollen Powder 65 DMAE Bitartrate Beta-Sisterol 35% Doug Quai Extract 10:1 Bilberry Extract 10:1 Doug Quai Extract 4:1 US 9,539,216 B2 67 68 Doug Quai Root Powder Grape Seed Extract 95% D-Ribose Grape Seed Powder Echinacea Angustifolia Extract 4:1 Grape Skin Extract 20:1 Echinacea Leaf Powder Grape Skin Extract 4:1 Echinacea Purpurea Extract 10:1 Grass-Leaved Sweetflai Extract Echinacea Purpurea Extract 4% Green Lip Mussel Extract Echinacea Purpurea Extract 4:1 Green Tea Extract 30% Echinacea Purpurea Root Powder Green Tea Extract 4:1 Elder Flower Extract 4:1 Green Tea Extract 95% Elderberry Extract 20:1 10 Guarana Seed Extract 10% Elderberry Extract 4:1 Guarana Seed Extract 22% Epimedium Extract 10% Guarana Seed Extract 25% Epimedium Extract 10:1 Guggul Extract 10% Epimedium Extract 4:1 Guggul Extract 2.5% Epimedium Extract 5% 15 Gugulipid Extract 10% Epimedium Powder Gymnema Sylvestre Extract 25% Eucommia (Du Thong) Extract 5:1 Gymnema Sylvestre Powder Fennel Seed Extract 4:1 Hawthorne Berry Extract 4:1 Fennel Seed Powder Hawthorne Berry Powder Fenugreek Extract 4:1 Hawthorne Leaf Extract 2% Fenugreek Extract 6:1 Hearbacious Peony Extract 5:1 Feverfew Extract 5:1 Hesperidin Extract 98% Fisetin Honeysuckle Herb Extract 4:1 Fish Oil Powder Hops Flower Extract 4:1 Forbidden Palace Flower Extract 5:1 25 Horehound Extract 10:1 Forskolin 8% Horehound Extract 4:1 Fo-Ti Extract 12:1 Horehound Herb Powder Fo-Ti Extract 8:1 Horse Chestnut Extract 20% Fo-Ti Powder Horse Chestnut Extract 4:1 Gardenia Extract 8:1 30 Horse Chestnut Powder Garlic Extract. 4:1 Horsetail Extract 7% Garlic Powder Horsetail Powder. Gentian Root Extract 6:1 Houttuynia Cordata Extract 5:1 Ginger Extract 4:1 Hydrangea Extract 8:1 Ginger Root Extract 5% 35 Hydroxy Apatite Ginger Root Powder Hyssop Extract 4:1 Ginkgo Biloba Extract 8:1 Indole-3-Carbinol 99% Ginkgo Extract 24/6% Isodon Glaucocalyx Extract 10:1 Ginkgo Extract 24/6%<5 Japanese Knotweed Extract Ginkgo Extract 24/7% 40 Jiaogulan EXtract 4:1 Ginkgo Leaf Extract 4:1 Jin Qian Cao Extract 4:1 Ginkgo Leaf Powder Jingjie Extract 4:1 Ginseng (Korean) Powder Jujube Fruits Extract 4:1 Ginseng (Panax) Extract 5% Kava Kava Extract 30% Ginseng (Panax) Extract 8% 45 Kava Kava Powder Ginseng (Panax) Extract 80% Kelp Extract 4:1 Glucomannans Konjac Powder Kelp Powder Glucosamine HCl 95% Granulation Kidney Bean Extract 10:1 Glucosamine HC1 99% Kidney Bean Pole 4:1 Gluesosamine Sulfate Potassium 50 Kidney Bean Pole 8:1 Glucsosamine Sulfate Sodium 95% Kidney Bean Powder Granulation Kola Nut Extract 10% Glucsosamine Sulfate Sodium 99% Kudzu Extract 4:1 Goldenrod Extract 4:1 Kudzu Extract 6:1 Goldenrod Powder 55 Lettuce Extract 4:1 Goldenseal Root Extract 14% L-Glutamine Goldenseal Root Powder L-Glycine Gotu Kola Extract 16% Licorice Extract 10% Gotu Kola Extract 4:1 Licorice Extract 5:1 Gotu Kola Extract 8:1 60 Licorice Powder Gotu Kola Powder Lotus Leaf Powder Grape Fruit Powder L-Tyrosine Grape Seed Lycium Fruit Extract 4:1 Grape Seed Extract 10:1 Lycium Fruit Extract 5:1 Grape Seed Extract 20:1 65 Ma Huang Extract 6% Grape Seed Extract 4:1 Ma Huang Extract 8% Grape Seed Extract 5:1 Maca Extract 0.6% US 9,539,216 B2 69 70 Maca Extract 4:1 Red Pepper Extract 4:1 Maca Root Powder Red Yeast Rice Magnesium Stearate Red Yeast Rice Extract 10:1 Magnolia Bark Powder Red Yeast Rice Powder Magnolia Officinal Extract 4:1 Rehmannia Root Extract 4:1 Maitike Mushroom Extract 4:1 Reishi Mushroom Extract 4:1 Marigold Extract (Lutein 5%) Rhodiola Rosea Extract 4:1 Methozyisoflavone 99% Rhododendron Extract 4:1 Methylsulfonylmethane 99% Rhododendron Powder Milk Thistle Extract 4:1 10 Rhubarb Extract 4:1 Milk Thistle Seed Extract 80% Rhubarb Root Powder silymarin Riboflavin (B2) Morinda Extract 5:1 Rice Powder Motherwort Extract 4:1 Rosemary Extract 20% Motherwort Powder 15 Rumex Madaid Extract 4:1 Mucuna Pruriens Extract (11.5% L-Dopa) Salvia Extract 10:1 Muira Puama Extract 12:1 Salvia Extract 4:1 Muira Puama Extract 4:1 SAMe Muira Puama Powder Saw Palmetto Extract 25% Mushroom Extract 10:1 (feishi) Saw Palmetto Extract 25% Mustard Seed Extract 8:1 Saw Palmetto Extract 25% Myrobalan Extract 4:1 Saw Palmetto Extract 4:1 Myrrha Gum Extract 2.5% Saw Palmetto Extract 45-50% N-Acetyl-D-Glucosamine Saw Palmetto Oil 85-95% N-Acetyl-L-Cysteine 25 Saw Palmetto Powder Nettle Extract 7% Schizandra Extract 10:1 Nettle Leaf Extract 4:1 Schizandra Extract 4:1 Nettle Leaf Powder Scopolia Acutangula Powder Noni Powder Sea Cucumber Powder Olive Leaf Extract 18% 30 Senna Leaf Powder Olive Powder Sesame (Black) Seed Powder Orange Peel Extract 4:1 Shark Cartilage Powder Orange Peel Powder Shitake Mushroom Extract Oroxylum Indicum Extract 4:1 Siberian Ginseng Extract 0.8% Oroxylum Indicum Powder 35 Siberian Ginseng Extract 4:1 Oyster Meat Powder Siberian Ginseng Powder Oyster Shell Powder Skullcap Extract 4:1 Papaya Fruit Extract 4:1 Skullcap Extract 4:1 Parsley Extract 10:1 Slippery Elm Powder Parsley Extract 4:1 40 Sodium-Pyruvate 99% Parsley Leaf Extract 4:1 Songaria Cynomorium Extract 4:1 Parsley Powder Songaricum Powder Passion Flower Extract 4:1 Spirulina Powder Passion Flower Powder St. John's Wort Extract 03% Pau D'Arco Powder 45 St. John's Wort Extract 4:1 Peppermint Extract 4:1 St. John's Wort Powder Peppermint Powder Stanol 50% Perilla Seed Extract 4:1 Stephania Extract 4:1 Periwinkle Extract 4:1 Stevia Extract 4:1 Pharbitidis Extract 4:1 50 Sulfate N-- Phosphatidyl Serine 20% Suma Root Extract 4:1 Pine Bark Extract 4:1 Suma Root Powder Plantago Asiatica Leaf Extract 5:1 Taurine Powder Polygala Tenoifolia Extract 4:1 Thorowax Extract 4:1 Polygonum Extract Polygonum Extract 4:1 55 Tomato Extract Pregnenolone 99% Tomato Extract (0.2% Lycopene) Propolis Extract 3% (trans)-Resveratrol 20-25% Pseudoginseng Extract Tribulus Extract 10:1 Psyllium extract 4:1 Tribulus Extract 40% Pumpkin Seed Extract 4:1 60 Tribulus Powder Purple Willow Bark Extract 4:1 Trifal Extract 4:1 Purslane Herb Extract 4:1 Turmeric Extract 4:1 Pygeum Extract 4:1 Turmeric Root Powder Quercetin Radish Extract 4:1 Uva Ursi Extract 4:1 Radix Isatidis Extract 4:1 65 Uva Ursi Powder Radix Polygoni Extract 4:1 Valerian Root Extract 0.8% Red Clover Extract 4:1 Valerian Root Extract 4:1 US 9,539,216 B2 71 Valerian Root Powder Glandular Products Vinca Major Seed Extract 10:1 Glucosamine HCL White Wax Extract 4:1 Glucosamine Sulfate White Willow Bark 15% (total salicins) HMB (Hydroxyl Methyl Butyrate) White Willow Bark 20% 5 Immunoglobulin (Immune System Support) White Willow Bark 25% Lactic Acid White Willow Bark Extract 4:1 L-Carnitine White Willow Bark Powder Liver Products Wild Yam Extract 10:1 Malic Acid Wild Yam Extract 16% 10 Maltose-anhydrous Wild Yam Extract 4:1 Mannose (d-mannose) Wild Yam Extract 6% MSM Wild Yam Powder Other Carnitine Products Williams Elder Extract 4:1 Phytosterols Wolfberry Fruit Extract 10:1 15 Wolfiporia Extract 8:1 Picolinic Acid Yellow Dock Root Extract 4:1 Pyruvate Yerba Mate Extract (2% caffeine) Red Yeast Extract Yerba Mate Extract 4:1 SAMe Yohimbe Bark Extract 15:1 2O Selenium Yeast Yohimbe Bark Extract 2% Shark Cartilage Yohimbe Bark Extract 3% Theobromine Yohimbe Bark Powder Vanadyl Sulfate Yucca Extract 4:1 Velvet Deer Antler 25 Yeast Enzymes Herbal Oils Alpha Galactosidase Amylase Aloe Vera Bromelain 30 Artichoke Oil Cellulose Artichoke Oil Papain Black Currant Seed Oil 14% GLA Peptidase Black Currant Seed Oil 15% GLA Protease Borage Oil 20% GLA Proteolytic Enzymes 35 Borage Oil 22% GLA Superoxide Dismutase Boswellia Serrata Oil CLA Trypsin Conjugated Linolic Acid 75% min. Evening Primrose Oil 10% GLA Phospholipids Evening Primrose Oil 9% GLA 40 Flax Seed Oil 50% ALA Lecithin Garlic Oil Phosphatidyl Choline Grape Seed Oil Phosphatidy Serine Guggul Lipid Oil Olive Leak Extract Specialty Nutraceuticals 45 Oregano Oil Perilla Oil 60% ALA 5-Hydroxytryptophan Pumpkin Seed Oil Acetyl L-Carnitine Pygeum Oil Alpha Lipoic Acid Rosehip Oil Alpha-Ketoglutarates 50 Rosemary Oil Bee Products Saw Palmetto Oil Betaine Hydrochloride Sterols Bovine Cartilage Tocotrienol Palm Oil Caffeine Walnut Oil Cetyl Myristoleate 55 Wheat Germ. Oil Charcoal Sesame Seed Oil Chitosan Dill Seed Oil Choline Clove Bud Oil Chondroitin Sulfate Ginger Root Oil Coenzyme Q10 60 Cinnamon Leaf Oil Collagen Fennel Seed Oil Colostrum Curcuna Longa Oil Creatine Cummin Seed Oil Cyanocobalamin (Vitamin B12) Celery Seed Oil DMAE 65 Coriander Seed Oil Fumaric Acid Red Rasberry Seed Oil Germanium Sesquioxide Cranberry Seed Oil US 9,539,216 B2 73 74 Blackberry Seed Oil Melatonin Nor-Androstenedione Marine Oils Prognenolone Progesterone Cod Liver Oil (1000A/100 D) Cod Liver Oil (2500 A/250 5 19 Nor-4-Androstendiol D) 19 Nor-4-Androstenedione Fish Oil 30% EPA/20% DHAFish oil Concentrated 19 Nor-5-Androstenediol Fish Oil DeodorizedMarine Lipid Oil 18/12 19 Nor-5-Androstendione Marine Lipid Oil 30/20Marine Lipid Oil 36/24 3-Indolebutyric Acid Salmon Oil 18% EPA/12% DHA 10 4 Androstendiol Squalene Oil (Shark) 4 Androstendione 6 Furfurylaminopurene Other Oils 6-Benzylaminopurine Alpha Lipoic Acid 15 Minerals Cetyl Myristoleate CM Coenzyme Q10 Boron Lecithin Calcium Medium Chain Triglycerides MCT Chelated Minerals 20 Chloride Vitamins Chromium Coated Minerals Ascorbic Acid (Vitamin C) Cobalt B Vitamins Copper Biotin 25 Dolomite Fat Soluble Vitamins Iodine Folic Acid Iron HCA (Hydroxycitric Acid) Magnesium Inositol Manganese Mineral Ascorbates 30 Mineral Premixes Mixed Tocopherols Mineral Products Niacin (Vitamin B3) Molybdenum Orotic Acid Other Minerals PABA (Para-Aminobenzoic Acid) Phosphorus Pantothenates 35 Potassium Pantothenic Acid (Vitamin B5) Selenium Pyridoxine Hydrochloride (Vitamin B6) Sodiuml Riboflavin (Vitamin B2) Specialty Minerals Synthetic Vitamins Trace Minerals Thiamine (Vitamin B1) 40 Vanadium Tocotrienols Zinc Vitamin A Malik Acid Vitamin D Pyruvate Vitamin E Vitamin F 45 Probiotics Vitamin K Vitamin Oils Acidophilus Vitamin Premixes Bifido Bacteria Vitamin-Mineral Premixes Lactobacillus Water Soluble Vitamins 50 Proteins/Amino Acids Carotenoids Amino Acids Apocarotenal Betaine Astaxanthin 55 Casein Beta-Carotene Functional Soy Canthaxanthin Glutamic Acid Carotenoids L-Alanine Lutein/Lutein Esters L-Arginine Lycopene 60 L-Cysteine Zeaxanthin L-Glutamine L-Glycine Hormones L-Histidine L-Isoeueince 7-Keto-DHEA 65 L-Leucine Androstenedione L-Lysine DHEA L-Methionine US 9,539,216 B2 75 76 L-Ornithine Acetylcholinesterase Inhibitors Acetylcholinesterase Inhibi L-Phenylalaline tors (“Reversible') L-Proline edrophonium (TENSILONR) L-Taurine neostigmine (PROSTIGMINR) L-Threonine 5 physostigmine (ANTILIRIUM(R) L-Tryptophan Acetylcholinesterase Inhibitors ("Irreversible') L-Tyrosine (diisopropylflurophosphate DFP) L-Valine echothiophate (PHOSPHOLINE(R) N-Acetly-L-Cysteine isofluorophate (FLOROPRYL(R) 10 Muscarinic Antagonists Atropine Protein ipratropium (ATROVENTR) Soluble Soy pirenzepine Soy Protein Isolates Scopolamine Textured Soy 2-PAM: Acetylcholinesterase Reactivator Pralidoxime Whey Protein Isolates 15 (Protopam) {2-PAM: peripheral acetycholinesterase Specialty Nutrients reactivator for certain phosphoryl-enzyme complexes ATP Ganglionic Blockers Forskolin hexamethonium Sterol Esters mecamylamine (INVERSINE(R) Stanol Esters 20 trimethaphan Probiotics Catecholamines Lactoferin dobutamine (DOBUTREX(R) Lutein Esters dopamine (INTROPINR) Zeaxanthin epinephrine Immunoglobulins 25 isoproterenol (ISUPREL(R) Ipriflavone norepinephrine (LEVOPHEDR) Isoflavones Direct Adrenoceptor Agonist Medicaments Fructo-Oligo-Saccharides albuterol (VENTOLINR, PROVERITIL(R) Inulin clonidine (CATAPRES(R) Huperzine A 30 methoxamine (VASOXYL(R) Melatonin oxymetazohne (AFRINR) Medicinal Mushrooms phenylephrine (NEO-SYNEPHRINE(R) Bile Products ritodrine (YUTOPAR(R) Peptone Products salmeterol (SEREVENTR) Glandular Products 35 terbutaline (BRETHINE(R) Pancreatic Products Indirect-Acting Sympathomimetic Medicaments Thyroid Products amphetamine Ribose cocaine Probiotics ephedrine, Pseudoephedrine tyramine Oleo Resins 40 Alpha-Adrenoceptor Antagonists Medicaments Dill Seed Oleo Resin doxazosin (Cardura CARDURA(R) Black Pepper Oleoresin labetalol (TRANDATER, NORMODYNE(R) Capsicum Oleoresin phenoxybenzamine (DIBENZYLINE(R) phentolamine (REGITINE(R) EXAMPLES XI 45 prazosin (MINIPRESS(R) terazosin (HYTRINR) The present invention further contemplates the use of any tolazoline (PRISCOLINE(R) active ingredients or medicaments known in the art. In this trimaZosin regard, it is well within the purview of the skilled artisan to yohimbine (YOCONR) select a particular combination of active ingredients or 50 B-Adrenoceptor antagonist Medicaments medicaments. The following non-limiting lists illustrate atenolol (TENORMIN(R) exemplary active ingredients or medicaments and the butoxamine broader Subclasses and classes to which they belong for use esmolol (BREVIBLOC(R) in this invention. labetalol (TRANDATER, NORMODYNE(R) Medicaments Acting on the Autononic Nervous System 55 metoprolol (LOPRESSORR) Adrenergic Medicaments nadolol (CORGARDR) Cholinergic Medicaments pindolol (VISKENR) Direct Muscarinic Agonists Choline Esters propranolol (INDERAL(R) acetylcholine timolol (BLOCADRENR) bethanechol (URECHOLINE(R) 60 Adrenergic Neuron Blocking Medicaments carbachol gutanethidine (ISMELINR) reserpinme methacholine (PROVOCHOLINE(R) Cardiovascular System Disorders Alkaloids Cardiovascular testing and diagnosis muscarine Hypertension (HTN) pilocarpine (PILOCAR(R) 65 Heart Failure Direct Nicotinic Agonist Ischemic Heart Disease nicotine Myocardial Infarction US 9,539,216 B2 77 78 Arrhythmias propranlol (INDERAL(R) Isolated Diastolic Heart Failure and Cardiomyopathies terazosin (HYTRINR) Cardiac Transplantation timolol (TIMOPTICR) Venous Thromboembolism Calcium Channel Antagonists Stroke 5 amlodipine (NORVASC(R) Hyperlipidemia diltiazem (CARDIZEMR) Peripheral vascular disease felodipine (Plendil) Diuretics isradipine (DYNACIRC(R) carbonic-anhydrase inhibitors nicardipine (CARDENE(R) loop diuretics 10 nifedipine (PROCARDIAR) osmotic diuretics nimodipine (NIMOTOPR) potassium sparing diuretics nisoldipine (SULAR(R) thiazide diuretics verapamil (ISOPTINR, CATANR) Antiarrhythmic Medicaments Angiotensin Converting Enzyme (ACE) Inhibitor Sodium Channel blocking agents 15 benazepril (LOTENSINR) isopyramide (NORPACE(R) bepridil (VASCOR(R) flecainide (TAMBOCOR(R) captopril (CAPOTENR) ibutilide enalapril (VASOTEC(R) lidocaine (XYLOCAINE(R) fosinopril (MONOPRIL(R) mexiletine (MEXITIL(R) lisinopril (PRINIVIL(R), ZESTRIL(R) moricizine (ETHMOZINE.(R) moexipril (UNIVASC(R) procainamide (PRONESTYL(R), PROCANR) quinapril (ACCUPRIL(R) propafenone (RYTHMOL(R) ramipril (ALTACE(R) quinidine Angiotensin II Receptor Antagonists tocainide (TONOCARDR) 25 losartan (COZAAR(R) Calcium Channel blocking agents valasartan (DIOVANR) bepridil (VASOCORR) Diuretics diltiazem (CARDIZEMR) amiloride (MIDAMOR(R) verapamil (ISOPTINR, CALANR) bumetanide (BUMEX(R) Adrenergic receptor antagonists 30 chlorothalidone (HYGROTONR) propranlol (INDERAL(R) ethacrynic acid (EDECRINR) Other medicaments furosemide (LASIX(R) adenosine (ADENOCARDR) hydrochlorothiazide (DIURIL(R) amiodarone (CORDARONE(R) indapamide (LOZOL(R) bretylium (BRETYLOL(R) 35 metolazone (ZAROXOLYNR) disopyramide (NORPACE(R) torsemide (DEMADEX(R) esmolol (BREVIBLOC(R) triamterene sotalol (BETAPACE(R) Other Agents Hypolipidemic medicaments hydralazine (APRESOLINE(R) HMG CoA Reductase Inhibitors 40 minoxidil (ROGAINE(R) atorvastatin (LIPITOR(R) nitroprusside (NIPRIDE(R) cerivistatin (BAYCOLOR) prazosin (MINIPRES(R) lovastatin (MEVACORR) reserpine pravastatin (PRAVOCHOL(R) sotalol (BREVIBLOC(R) simvastatin (ZOCOR(R) 45 spironolactone (ALDACTONE(R) Bile-acid sequestrants terazosin (HYTRINR) cholestyramine (QUESTRANR) Antianginal medicaments colestipol (COLESTID(R) Organic nitrates Fibric acids Calcium Channel Antagonists clofilbrate 50 Adrenergic Receptor Antagonists fenofibrate (TRICOR(R) amyl nitrite gemfibrozil (LOPID(R) erythrityl tetranitrate niacin, nicotinic acid isosorbide dinitrate (ISORDIL(R) probucol (LORELCOR) nitroglycerin Antihypertensive mendicants 55 pentaerythritol tetranitrate Adrenergic receptor antagonists Congestive Heart Failure Medicaments acebutalol (SECTRAL(R(R) phosphodiesterase (PDE) inhibitors atenolol (TENORMINR) aminone (INOCORR) betaxolol (BETOPTIC(R) milrinone (PRIMACOR(R) bisoprolol (ZEBETAR) 60 carvedilol (COREGR) carteolol (CARTROL(R) cardiac glycosides clonidine (CATAPRES(R) digitoxin labetalcl (NORMODYNER) digoxin metoprolol (TOPROL(R) diuretics penbutalol (LEVATOLOR) 65 ACE Inhibitors pindolol (VISKENR) Dobutamine prazosin (MINIPRES(R) dopamine US 9,539,216 B2 79 80 Respiratory System Disorders cannabinoids Asthma Prokinetic gastric stimulants (gastric motility stimulants) Chronic Obstructive Lung Disease (COLD)/Chronic cisapride (PROPULSID(R) Obstructive Pulmonary metoclopramide (REGLANR) Disease (COPD) Laxatives Acute Respiratory Distress Syndrome (ARDS) Saline laxatives Drug-Induced Pulmonary Disease magnesium salts Cystic Fibrosis Sodium salts Corticosteroids irritant/stimulant medicaments beclomethasone 10 CaSCaa betamethasone Setti cortisone phenolphthalein dexamethasone bisacodyl fluticasone (FLOVENTR/FLONASE(R) casanthranol hydrocortisone 15 castor oil methylprednisolone bulk producing medicaments prednisolone methylcellulose prednisone psyllium triamcinolone polycarbophil sympathomimetics lubricant albuterol (PROVENTILR/VENTOLINR) mineral oil salmeterol (SEREVENTR) Surfactants muscarinic antagonists docusate ipratropium (COMBIVENTR) miscellaneous leukotriene pathway inhibitors 25 glycerin montelukast (SINGULAIR(R) lactulose Anti-diarrheal medicaments Zafirtukast (ACCOLATE(R) diphenoxylate mast cell stabilizers atropine cromolyn (INTAL(R) diphenoxin methylxanthines 30 loperamide theophyline bismuth aminophylline lactobacillus Dnase (Pulmozyme) Ulcerative Colitis Medicaments Gastrointestinal System Disorders mesalamine Gastro-esophageal Reflux Disease (GERD) 35 olsalazine Peptic Ulcer Disease Renal System Disorders Inflammatory Bowel Disease Acute Renal Failure Nausea and Vomiting Progressive Renal Failure/Chronic Renal Failure Diarrhea, Constipation, Irritable Bowel Disease (IBD) Neurologic System Disorders Portal Hypertension and Cirrhosis 40 Multiple Sclerosis and inflammatory polyneuropathies Drug-Induced Liver Disease Epilepsy Pancreatitis Parkinson's disease and Movement Disorders Viral Hepatitis Pain management Liver Transplantation Headache Histamine-2 receptor antagonists 45 Amyotrophic Lateral Sclerosis famotidine (PEPCIDR) Anti-epileptic medicaments nizatidine (AXID(R) carbamazepine (TEGRETOL(R) pantoprazole (PROTONIX(R) divalproex sodium (DEPAKOTE(R) rabeprazole (ACIPHEX(R) felbamate (Felbatol FELBATOLR) ranitidine (ZANTAC(R) 50 gabapentin (NEURONTINR) Proton Pump Inhibitors (PPIs) lamotrigine (LAMICTAL(R) esomeprazole (NEXIUM(R) oxcarbazepine (TRILEPTAL(R) lansoprazole (PREVACIDR) phenyloin (DILANTINR) omeprazole (PRILOSECR) topiramate (TOPAMAX(R) Anti-nausea/anti-vertigo medicaments 55 Zonisamide (ZONEGRANR) anticholinergics Antimigraine medicaments antihistamines (Histamine-1 receptor antagonists) Serotonin 5HT1 d receptor agonists dopamine antagonists almotriptan (AXERTR) prokinetic gastric stimulant frovatriptan (FROVAR) serotonin 5HT3 receptor antagonists 60 naratriptan (AMERGEC)) dolasetron (ANZMETR) rizatriptan (RIZALTR) granisetron (KYTRIL(R) Sumatriptan (IMITREX(R) ondansetron (ZOFRANR) Zolmitriptan (ZOMIG(R) other medicaments ergot alkaloids hydroxyzine (ATARAX(R), VISTARIL(R) 65 dihydroergotamine (DHE(R) corticosteroids isometheptine/dichlorophenazone (MIDRINR) benzodiazepines caffeine US 9,539,216 B2 81 82 pizotifen (SANOMIGRANR) dantrolene (DANTRIUM(R) Sedative-hypnotic Medicaments diazepam (VALIUM(R) benzodiazepines metaxalone (SKELAXINR) alprazolam (XANAX(R) methocarbamol (ROBAXINR) clonazepam (KLORIOPINR) orphenadrine (NOR-FLEX(R) clorazepate (TRANXENER) tizanidine (ZANAFLEX(R) diazepam (VALIUM(R) Psychiatric System Disorders flumazenil (ROMAZICONR)-antagonist Childhood psychiatric disorders lorazepam (ATIVANR) Attention Deficit Hyperactivity Disorder (ADHD)/Atten midazolam (VERSEDR) 10 tion Deficit Disorder (ADD) triazolam (HALCIONR) Eating disorders barbiturates/Anesthetics pentobarbital (Nembutal) Alzheimer's disease and Dementia Disorders Phenobarbital (Lumninal LUMINAL(R) Substance abuse and Addictive Disorders alcohol, thiopental (PENTOTHAL(R) tobacco and caffeine abuse non-depressant anxiolytic 15 Schizophrenia buspirone (BUSPAR(R) Depressive disorders Treatment of alcoholism Bipolar disorders disulfiram (ANTABUSER) Anxiety disorders Pain Management Medicaments Obsessive-Compulsive disorders Opioids Sleep disorders Opioid Peptides Psychostimulant Medicaments beta-endorphin amphetamine mixed salts (ADDERALL(R) dynorphin dextroamphetamine (DEXEDRINE(R) enkephalins methylphenidate (RITALINR, CONCERTAR) Agonists 25 Antipsychotic Medicaments (dopamine antagonists) codeine Phenothiazine type etorphine chlorpromazine (THORAZINE(R) fentanyl (SUBLIMAZE(R) fluphenazine (PROLIXINR) hydrocodeine Thioxanthene type hydromorphone 30 thiothixene (NAVANE(R) meperidine (DEMEROL(R) Butyrophenone type methadone (DOLOPHINE(R) haloperidol (HALDOL(R) morphine Dibenzodiazepine type Oxycodone clozapine (CLOZARIL(R) propoxyphene 35 Thienobenzodiazepine type Agonist-antagonists olanzapine (ZYPREXAR) buprenorphine quetiapine (SEROQUEL(R) Partial Agonist Antidepressant Medicaments dezocine (DALGANR) Tricyclic antidepressants (TCA's) nalbuphine (NUBAINR) 40 amitriptyline (EVAVIL(R, ENDEPR) pentazocine (TALWAINR) clomipramine (ANAFRANIL(R)), also a SSRI Antagonist desipramine (Norpramin NORPRAMINR) naloxone (NARCANR) doxepin (SINEQUANR) Non-opiate imnipramine (TOFRANIL(R)) acetaminophen (TYLENOL(R) 45 maprotiline (LUDIOMILR) tramadol (ULTRAMR) nortriptyline (AVENTYL(R), PAMELOR(R) Anti-Parkinsonism Medicaments protriptyline (VIVACTIL(R) levodopa Monoamine oxidase inhibitors (MAO-I's) carbidopa clorgyline (specific for MAO type A) bromocriptine (PARLODEL(R) 50 isocarboxazid (MARPLANR) pergolide (PERMAX(R) phenelzine (NARDIL(R) amantadine (SYMMETREL(R) tranylcypromine (PARNATE(R) selegiline (DEPRENYL(R) Second Generation Medicaments (not including SSRIs) anticholinergic agents amoxapine (ASENDINR) dopamine Agonists 55 bupropion (WELLBUTRINR) pramipexole (MIRAPEX(R) netazodone (SERZONE(R) ropinirole (REQUIPR) trazodone (DESYREL(R) COMT inhibitors Serotonin-Specific Reuptake Inhibitors (SSRIs) entacapone (COMTANR) citalopram (CELEXAR) tolcapone (TASMAR(R) 60 clomipramine (ANAFRANIL(R) Anti-Spasticity Medicaments escitalopram (LEXAPROR) baclofen (LIORESAL(R) fluoxetine (PROZAC(R) botulinum toxin type A (BOTOX(R) fluvoxamine (LUVOX(R) carisoprodol (SOMAR), RELAR) paroxetine (PAXIL(R) chlorphenesin (Maolate MAOLATE(R) 65 sertraline (ZOLOFTR) chlorZoxazone (PARAFLEX(R) Other cyclobenzaprine (FLEXERIL(R) lithium US 9,539,216 B2 83 84 mirtazapine (TEMERONR) sermorelin (GHRH) (GEREFR) venlafaxine (EFFEXOR(R) somatrem (PROTROPINR) Anti-anxiety agents somatropin (HUMATROPE(R), NUTROPINR) barbiturates thyrotropin (TSH) (THYTROPAR(R) benzodiazepines urofollitropin (METRODINR) buspirone (BUSPAR(R) vasopressin (Pitressin Synthetic) chloral hydrate Gynecologic System and Obstetric Conditions doxepin Pregnancy and Lactation hydroxy Zine Infertility sedative-hypnotics 10 Contraception serotonin reuptake inhibitors Menstruation-related disorders Anti-demential Medicaments Endometriosis cholinesterase inhibitors Hormone Replacement Therapy (HRT) donepezil (ARICEPTR) Conjugated estrogens (PREMARINR) galantamine (REMINYL(R) 15 desogestrel rivastigmine (EXELONR) di-norgestrel tacrine (COGNEX(R) ethinyl diacetate Endocrinologic System Disorders ethinyl estradiol Diabetes mellitus levonorgestrel Thyroid disorders medroxyprogesterone Adrenal Gland disorders norethindrone norgestimate Pituitary Gland disorders progesterone ACTH Urologic System Disorders Adrenal androgens Erectile Dysfunction Adrenocortical Function Antagonists 25 Benign Prostatic Hypertrophy Mineralocorticoid antagonists Urinary Incontinence Anti-Diabetic Medicaments apomorphine Insulin alprostadit Sulfonylureas phosphodiesterase (PDE-5) inhibitors acetohexamide (DYMELOR(R) 30 sildenafil (VIAGRAR) chlorpropamide (DIABINESE(R) tadalafil (CIALIS(R) glimepiride (AMARYL(R) 0812 vardenafil (LEVITRAR) glipizide (GLUCOTROL(R) tolterodine (DETROL(R) glyburide (MICRONASER, DIABETAR) tamulosin (FLOMAX(R) tolazaride (TOLINASE(R) 35 yohimbine tolbutamide (ORINASE(R) Immunologic System Disorders Biguanides Systemic Lupus Erythematosus and other Collagen-vas metformin (GLUCOPHAGE(R) cular diseases Alpha-glucosidase Inhibitors Allergic and pseudo-allergic drug reactions acarbose (PRECOSE(R) 40 Bone and Joint System Disorders miglitol (GLYSETR) Osteoporosis and Osteomalacia Thiazolidinedione Derivatives Rheumatoid Arthritis 0822 pioglitazone (ACTOS(R) Osteoarthritis 0823) rosiglitazone (AVANDIAR) Gout and hyperuricemia 0824 troglitazone (REZULINR) 45 Medicaments used in the Control of Inflammation Thyroid Disorder Medicaments Non-steroidal anti-inflammatory drugs (NSAIDs) Levothyroxine aspirin Liothyronine diclofcenac (CATAFLAMIR, VOLTARENR) Liotrix diflusnisal (DOLOBIDR) Hypothalamic and Pituitary Gland Medicaments 50 etodolac (LODINE(R) bromocriptine (PARLODEL(R) fenoprofen (NALFONR) chorionic gonadotropin (hCG(R) flubiprofen (ANSAID(R) corticotropin generic (ACTHR) ibuprofen (MOTRINR, ADVIL(R), NUPRINR) cosyntropin (CORTROSYNR) indomethacin (INDOCINR) desmopressin (DDAVPR) 55 ketoprofen (ORUDIS(R) gonadorelin acetate (GnRH) (LUTREPULSE(R) ketcrolac (TORADOL(R) gonadorelin hydrochloride (GnRH) (FACTREL(R) mecofenamate0899) nabumetone (RELAFENR) goserelin acetate (ZOLADEXOR) naproxen (NAPROSYNR) 0901) oxaprozin (DAY growth hormone PROR) histrelin (SUPPRELINR) 60 phenylbutaZone leuprolide (LUPRONR) piroxicam (FELDENE(R) menotropins (hMG) (PERGONAL(R), HUMEGONR) Salicytate natarelin (SYNAREL(R) sulindac (CLINORIL(R) octreotide (SANDOSTATINR) tolmetin (TOLECTINR) oxytocin (PITOCINITR, SYNTOCINONR) 65 Cyclocygenase-2 inhibitors (COX-2) pergolide (PERMAX(R) celecoxib (CELEBREX(R) protirelin (THYPINONER), RELEFACT TRHR) rofecoxib (VIOXX(R) US 9,539,216 B2 85 86 Arthritis and Gout Medicaments Urinary Tract Infections and Prostatis allopurinol Sexually Transmitted Diseases anti-malarial compounds Bone and Joint Infections chloroquine Sepsis and Septic Shock colchicine 5 Superficial Fungal Infections enbrel Invasive Fungal Infections Glucocorticoids Infections in Immunocompromised Patients Gold Antimicrobial prophylaxis in Surgery methotrexate Vaccines, toxoids, and other immunobiologics NSAIDS 10 Human Immunodeficiency Virus Infection Penicillamine Medicaments Used in Infectious Diseases Other Medicaments Cell Wall Synthesis Inhibitors alendronate (FOSAMAX(R) Penicillins raloxifene (EVISTAR) amoxicillin (AMOXIL POLYMOX(R) Disorders of the Eyes, Ears, Nose, and Throat Systems 15 ampicillin (PRINCIPENR), OMNIPENR) Glaucoma benzathine Penicillin G Allergic rhinitis benzyl Penicillin (PENICILLINGC)) Histamine-1 receptor antagonists carbenicillin (GEOCILLINR) brompheniramine (DIMETANE(R) cloxacillin (CLOXAPENR) cetirizine (ZYRTECR) 2O dicloxacillin (DYNAPENR) chlorpheniramine (CHLOR-TRIMETONR) methicillin (STAPHCILLINR) clemastine (TAVISTR) mezlocillin cyproheptadine (PERIACTINR) nafcillin (NAFCIL(R), UNIPENR) dimenhydrinate (DRAMAMINE(R) oxacillin diphenhydramine (BENDARYL(R) 25 phenoxymethyl Penicillin (PENICILLIN VC)) doxylamine (SOMINEXR, UNISOMR) piperacillin (PIPRACHR) fexofenadine (ALLEGRAR) ticarcillin (TICAR(R) loratidine (CLARITINR) Cephalosporins Sympathomimetic medicaments 1st generation: pseudoephedrine (Sudated) 30 cefazolin (ANCEFR, DEFZOL(R) Dermatologic System Disorders cephalexin (KEFLEX(R) Acne cephatothin (KEFLINR) Psoriasis 2nd generation: Rosacea and pigmentation disorders cefaclor (CECLORR) Hematologic System Disorders 35 cefoxitin (MEFOXINR) Hematopoeisis cefpodoxime (VANTINR) Anemias cefuroxime (ZINACEFR, CEFTINR) Coagulation disorders loracarbef (LORABIDR) Sickle-cell anemia 3rd generation: Drug-induced hematologic disorders 40 cefoperaZone Coagulation disorders Medicaments cefotaxime (CLAFORANR) aspirin cefotetan clopidogrel (PLAVIX(R) ceftazidime (FORTAX(R, TAXIDIMER, TAZI fibrinolytic inhibitors CEFR) fibrinolytics 45 ceftriaxone (ROCEPHINR) glycoprotein (GP) IIb/IIIa antagonists/monoclonal ve?tizoxime (CEFIZOX(R) antibodies 4th generation: abciximab (REOPROR) cefepime eptifibatide (INTEGRELINR) Other beta-Lactams aztreonam (AZACTANR) tiofibran (AGGRASTATR) 50 clavulanic acid heparin imipenem (PRIMAXINR) low-molecular weight heparins meropenem (MERREM IVC) Plasma fractions-blood factors Sulbactam ticlopidine (TICLID(R) Other Cell-Wall Synthesis Inhibitors bacitracin vitamin K 55 cycloserine warfarin (COUMADINR) fosfomycin (MONUROL(R) Infectious System Diseases vancomycin (VANCOCINR) Central Nervous System (CNS) infections Agents Which Affect Cell Membranes Lower Respiratory Tract Infections Polymixins Upper Respiratory Tract Infections 60 Colistimethate Skin and Soft Tissue Infections Potymyxin B Infective Endocarditis Protein Synthesis Inhibitors Tuberculosis Amino glycosides Gastrointestinal Infections and Enterotoxigenic poison- amikacin (AMIKINR) ings 65 gentamicin (GARAMYCINR) Intra-abdominal Infections kanamycin (KANTREX(R) Parasitic diseases neomycin US 9,539,216 B2 87 88 netilmicin (NETROMYCINR) pentamidine isethionate streptomycin pyrimethamine-Sulfonamide tobramycin trimethoprim (generic) sulfamethoxazole (GANTA Tetracyclines NOL(R) demeclocycline (DECLOMYCINR) 5 Antihelminthic Medicaments doxycycline mebendazole doxycyclimine (VIBRAMYCINR, DORYX(R) praziquantel (BILTRICIDE(R) tetracycline (ACHROMYCINR) pyrantel pamoate Macrollides thiabendazole (MINTEZOL(R) azithromycin (ZITHROMAX(R) 10 Antiviral Medicaments clarithromycin (BIAXINR) acyclovir (ZOVIRAX(R) erythromycin esters erythromycin didanosine (DDIR) Other Protein Synthesis Inhibitors foscarnet (FOSCAVIR(R) Chloramphenicol (CHLOROMYCETINR) ganciclovir (DHPG(R), CYTOVENER) Clindamycin (CLEOCINR) 15 ribarvirin Spectinomycin (TROBICINR) rimantadine Inhibitors of Folate-Dependent Pathways stavudine (d4T)) co-trimoxazole valacyclovir (VALTREX(R) silver Sulfadiazine vidarabine (VIRA-AR) sodium Sulfacetamide 2O Zalcitabine (DDCR) sulfamethoxazile (GANTANOL(R) zidovudine (AZIDOTHYMIDINE(R), AZTR) sulfasalazine (AZULFIDINE(R) Protease inhibitors (SALICYLAZOSULFAPYRIDINE(R) indinavir (CRIXIVANR) sulfisoxazole (GANTRISINR) ritonavir (NORVIR(R) Sulfonamides 25 saquinavir (FORTOVASE(R) Dihydrofolate Reductase Inhibitor Oncologic and Immunological Disorders trimethoprim Breast Cancer DNA Gyrase Inhibitors Lung Cancer ciprofloxacin (CIPROR) Colorectal Cancer gatifloxacin (TEQUINR) 30 Prostate Cancer levofloxacin (LEVAQUINR) Malignant Lymphomas lomefloxacin (MAXAQUINR) Ovarian Cancer nalidixic acid Acute Leukemias ofloxacin (FLOXINR) Chronic Leukemias Urinary Tract Antiseptics 35 Melanoma and other Skin Cancers nitrolurantoin Hematopoeitic Stem Cell Transplantation Antimyobacterial Agents Anti-neoplastic Medicaments First-line anti-TB medicaments Alkylating Agents ethambutol busulfan (MYLERANR) isoniazid (INI-IR) 40 carboplatin (PARAPLATINR) pyrazinamide carmustine (BNCUR, BiCNUR) rifampin (RIMACTANE(R) cisplatin (PLATINOL(R) streptomycin cyclophosphamide (CYTOXANR) Second-line anti-TB medicaments ifofamide (IFEX(R) capreomycin A 45 lomustine (CCNUR), CeeNUR) cycloserine mechlorethamine (MUSTARGENR) dapsone meiphalan (ALKERANR) ethionamide bazine (MATULANE(R) para-aminosalicylic acid thiotepa AntiFungal Agents 50 Antimetabolites amphotericin B (FUNGIZONER), AMPHOTEC(R) folic acid Antagonist clotrimazole (MYCELEX(R) methotrexate fluconazole (DIFLUCANR) Purine Antagonists 6-mercaptopurine flucytosine 6-thioguanine 1155 griseofulvin 55 Pyrimidine Antagonists itraconazole (SPORANOX(R) cytarabine (ARA-C(R) ketoconazole (NIZORAL(R) fluorouracil (5-FUR) miconazole (MONISTATR) Hormonal Agents Hormones nystatin (MYCOSTATINR) diethylstilbestrol (DES(R) Antiparasitic Agents 60 estrogens Antimalarials prednisone (DELTASONE(R) chloroquine (ARALENR) Modulation of Hormone Release & Action Aminoglute mefloquine (LARIAM(R) thimide primaquine leuprolide acetate pyrimethamine-sulfadoxine (FANSIDAR(R) 65 tamoxifen (NOLVADEX(R) Anti protozoals Plant Alkaloids metronidazole (FLAGYL(R) Vinca Alkaloids US 9,539,216 B2 89 90 vinblastine (VELBANR) Nasal Decongestants vincristine (Oncovin ONCOVINR) ephedrine Podophyllotoxins phenylephrine Etoposide (VP-16(R) phenylpropanolamine Other 5 pseudoephedrine docetaxel (TAXOTERE(R) Antihistamines (Histamine-1 receptor antagonists) paclitaxel (TAXOL(R) Antitussive agents Antibiotics benzonatate bleomycin (BLENOXANE(R) codeine dactinomycin (COSMEGENR) 10 dextromethorphan daunorubicin (DAUNOXOME(R) Expectorants doxorubicin (ADRIAMYCINR) guaifenesin mitomycin (MUTAMYCINR) iodinated glycerol Other Anti-neoplastic Medicaments terpin hydrate amsacrine (AMSAR) 15 Xanthines azathioprine (IMURANR) aminophyline capecitabine (XELODAR) caffeine chlorambucil (LEUKERANR) dyphylline cyclosporine (SANDIMMUNER), NEORAL(R) theophylline gemcitabine (GEMZAR(R) 20 Pain relievers hydroxyurea (HYDREAR) narcotic agonists mitotane (SODRENR) NSAIDS mitoxantrone (NOVANTRONE(R) acetaminophen pamidronate (AREDIAR) Dietary Supplements Immunosuppressant Medicaments 25 Arnica 15-desoxyspergualin Bilberry corticosteroids Black Cohosh cyclosporine Cat's claw Interferons Chamomile Interleukins 30 Echinacea mycophenolate mofetil Evening Primrose Oil sirolimus (RAPAMYCINR) Fenugreek tacrolimus Flaxseed thalidomide Feverfew Nutritional Disorders 35 Garlic Malnutrition, vitamin and mineral deficiencies Ginger root Enteral Nutrition Ginkobiloba Obesity Ginseng orlistat (XENICAL(R) Goldenrod appetite Suppressants 40 Hawthorn sympathomimetic stimulants Kava-Kava amphetamine stimulants Licorice Mineral Supplementation Milk thistle calcium ion iodine Psyllium iron 45 Rauwolfia magnesium ion Senna phosphorous Soybean potassium ion St. John's wort Selenium Saw palmetto Sodium ion 50 Turmeric Valerian Zinc Therapeutic Proteins and Biotechnology Medicaments Fat-soluble vitamins Additional Agents: NORVACSR), NEURONTINR, Vitamin A PAXIL(R), AUGMENTINR, PROPECIAR, LAMISIL(R), vitamin D LESCOLR, bisphosphonate. vitamin E 55 Other Drugs vitamin K abacavir sulfate Water-soluble vitamins acetazolamide vitamin C acetylsalicylic acid thiamine (vitamin B1) albendazole riboflavin (vitamin B2) 60 allopurinol niacin (vitamin B3) amiloride hydrochloride pyridoxine (vitamin B6) amitriptyline hydrochloride artemether folate atropine Sulfate cyanocobalamin (vitamin B12) benznidazole Medicaments Used to Alleviate Symptoms of Allergic Rhi- 65 biperiden hydrochloride nitis, Upper Respiratory Symptoms, Cough, Mild Aches and chloroquine phosphate Pains chlorpheniramine maleate US 9,539,216 B2 91 92 chlorpromazine hydrochloride naproxen Sodium cimetidine nelfinavir ciprofloxacin hydrochoride nevirapine clofazimine niclosamide clomiphene citrate nicotinamide clomipramine hydrochloride nifurtimox cloxacillin Sodium nitrofurantoin codeine phosphate nortriptyline hydrochloride dapsone oxybutynin chloride didanosine 10 oxycodone hydrochloride diethylcarbamazine citrate paracetamol digoxin paroxetine hydrochloride diloxanide furoate penicillin V potassium DL-methionine phenyloin Sodium Doxycycline 15 pioglitaZone hydrochloride Efavirenz prednisolone ergometrine maleate primaquine phosphate ergotamine tartrate pravastatin Sodium erythromycin ethyl Succinate prednisolone ethambutol hydrochloride promethazine hydrochloride ethosuximide promethazine fumarate ferrous sulfate propylthiouracil alendronate Sodium pyrantel embonate amlodipine besylate pyridostigmine bromide amphetamine (mixed salts) 25 raloxifene hydrochloride atorvastatin calcium ranitidine hydrochloride benazepril hydrochloride rifampicin bisoprolol fumarate risedronate sodium bupropion hydrochloride risperidone carbidopa 30 rosiglitaZone maleate cefprozil salbutamol sulfate cetirizine hydrochloride saquinavir mesylate citalopram hydrobromide sertraline hydrochloride clindamycin hydrochloride sildenafil citrate clonidine hydrochloride 35 Sulfadiazine clopidogrel bisulfate Sumatriptan Succinate cyclobenzaprine hydrochloride tamoxifen citrate desloratadine tamsulosin hydrochloride digoxin temazepam diltiazem hydrochloride 40 terazosin hydrochloride doxazosin mesylate timolol maleate doxycycline tolterodine tartrate enalapril maleate tramadol hydrochloride fexofenadine hydrochloride trazodone hydrochloride fluoxetine hydrochloride 45 triclabendazole folic acid valacyclovir hydrochloride fosinopril Sodium Valdecoxib hydrocodone bitartrate valproic acid hydrocodone Valsartan hydroxyzine hydrochloride 50 venlafaxine hydrochloride indinavir Verapamil hydrochloride irbesartan warfarin Sodium isosorbide mononitrate Zolpidem tartrate lamivudine levothyroxine sodium 55 EXAMPLES XII lopinavir loratadine As can be seen above, various embodiments of the present losartan potassium invention can be utilized in specific medical applications. By meclizine hydrochloride way of example only and not by way of limitation, the medroxyprogesterone acetate 60 present invention can be practiced to prepare delivery meperidine devices for use in chemotherapy to address/treat, by way of metformin hydrochloride example and not by limitation, the following aspects of methylphenidate hydrochloride chemotherapy: psychological, timing (to coincide with methylprednisolone tumor growth for example) route of administration, nausea, metoclopramide hydrochloride) 65 Vomiting (CINV), compliance, and cost (e.g. reduce hospital minocycline hydrochloride management of patients, reduce the number of “repeat' drug montelukast Sodium doses due to patient vomiting, etc.). Still further, the just US 9,539,216 B2 93 94 mentioned aspects are not limited to chemotherapy, as the Category: Antioxidant present invention can be practiced to address common Primary Capsule: aspects between chemotherapy and other treatments. d alpha Tocopherol Further by way of examples, capsules containing Zofran Beta Carotene (ondansertron), Temodar (temozolomide) can be made. Tocotrineol Still further, the present invention can be used in cardio Grape Seed Oil vascular treatments, for example hypertension, heart failure, Secondary Capsule: and heart rhythm disorders. Also, the present invention can Selenium be used in immunology (e.g. transplant rejections, auto Vitamin C Ester immune disorders, etc.). The present invention can be used 10 Category: Brain Support to treat neurological disorders (such as Parkinson's disease, Primary Capsule: dementia, stroke, epilepsy, and migraine headache, etc.), d alpha Tocopherol psychiatric disorders (Schizophrenia, bipolar disease, DHA depression, anxiety, ADHD/ADD. Addictions, etc.), infec Omega 3 tious diseases (fungal, bacterial, viral (HIV), etc.), and in 15 Lecithin anesthesiology (induction anesthesia, local anesthesia). Fur Choline thermore, the present invention has application in endocri Secondary Capsule: nology (cholesterol, diabetes, hormone replacement therapy, Coenzyme Q 10 thyroid dysfunction, oral contraception, obesity, etc.), der Ginkgo Biloba matology (onychomycosis, acne, rosaceae, psoriasis, etc.), B12 rheumatology (arthritis, gout, osteoporosis/Osteomalacia), Category: Mood Support respiratory fields (asthma, emphysema, cystic fibrosis, etc.), Primary Capsule: gastro-intestinal fields (gastroesophageal reflux disease, D alpha Tocopherol ulcer prophylaxis, crohn's disease, inflammatory bowel dis Lecithin ease, etc.), chronic real failure (vitamin and mineral replace 25 DHA ment, blood pressure regulation, diabetes, depression, etc.), Omega 3 genito-urinary (enlarged prostate/BPH, overactive bladder, Secondary Capsule: erectile dysfunction, feminine yeast infections, etc.) and SAME hematology-oncology (thromboembolous, hermatopoeisis, L Tyrosine neoplastic disease, nausea/vomiting). 30 Category: Cardio Support Primary Capsule: EXAMPLES XIII d alpha Trocopherol Tocotrienol The present invention can be utilized with a variety of Flax Oil Omega 6 excipients. Categories of excipients include, but are not 35 Fish Oil Omega 3 limited to, Binders, Disintegrants Fillers (diluents), Lubri Secondary Capsule: cants, Glidants (flow enhancers), Compression aids, Colors, Calcium Sweeteners, Preservatives, Suspensing/dispersing agents, Magnesium Film formers/coatings, Flavors, and Printing inks. Still fur Coenzyme Q 10 ther by way of example and not by limitation, the present 40 Category: Diet Support invention can be utilized with the following excipients: Primary Capsule: Conjugated Linolic Acid Flax Seed Oil Magnesium Stearate Titanium Dioxide Secondary Capsule: Lactose Stearic Acid Microcrystalline Cellulose Sodium Starch Glycolate 45 Chromium Starch (corn) Gelatin Zinc Silicon Dioxide Talc L. Carnitine Sucrose Croscarmellose Calcium Stearate Hydroxy Propyl Cellulose Category: Immune Support Povidone Ethylcellulose Primary Capsule: Pretzelatinized Starch Calcium Phosphate (dibasic) 50 Garlic Oil Hydroxy Propyl Methylcellulose Crospovidone Olive Leaf Oil OPA products (coatings & inks) Shellac (and Glaze) d alpha Tocopherol Secondary Capsule: Zinc EXAMPLES XIV 55 Echinacea Category: Laxative Support Examples of the Supporting nutraceutical formulations are Primary Capsule: to illustrate examples where specific categories of the natu Aloe Vera ral products industry can be utilized with the present inven Flax Seed Oil tion. There are many more categories than the ones that are 60 Secondary Capsule: listed and therefore this is for simply for the purpose to show Senna Leaf that the technology is broad and could be utilized for many Psyllium specific categories. The specific mg of each product is not Category: Prostate Support included due to the amounts of each material is typically Primary Capsule: based upon the formulators opinions, however there are 65 Saw Palmetto Oil some (RDA) recommended daily allowances that could be Pygeum Oil used to determine the formulation. Flaxseed Oil US 9,539,216 B2 95 96 Pumpkin Seed Oil between an air bubble and one or more active ingredients Secondary Capsule: introduced into the capsule and, accordingly, improving Selenium stability of the capsular ingredient(s). Zinc The present invention may be embodied in other specific Boswellia Serrata forms without departing from its spirit or essential charac Category: Inflammation Support teristics. The described embodiments are to be considered in Primary Capsule: all respects only as illustrative, and not restrictive. The scope Boswellia Serrata Oil of the invention is, therefore, indicated by the appended Guggul Oil claims, rather than by the foregoing description. All changes Omega 3 Oil 10 Ginger Oil which come within the meaning and range of equivalency of Secondary Capsule: the claims are to be embraced within their scope. Curcumin Holy Basil What is claimed is: Category: Sports Nutrition/Muscle Support 15 1. A multi-compartment capsule, comprising: a first Primary Capsule: receiving chamber comprising at least one ingredient having Conjugated linolic Acid a first physical state, and a second receiving chamber MCT O1 comprising at least one ingredient having a second physical Secondary Capsule: State, Zinc wherein the first physical state of the ingredient of the first Chromium receiving chamber is different from the second physical Tribulus Terestris state of the ingredient of the second receiving chamber, 19 Nor-5-Androstendione and Category: Menopause Support wherein in one of the receiving chambers the ingredient is Primary Capsule: 25 a cannabinoid and in the other receiving chamber the Evening Primrose Oil ingredient comprises pharmaceuticals, nutraceuticals, Red Raspberry Oil botanicals, extracts, antioxidants, herbal oils, vitamins, Secondary Capsule: minerals, enzymes, brain Support components, diet Licorice Root Support components or mood Support components, or Black Cohosh 30 Soy Isoflavones mixtures thereof. Category: Cholesterol Support 2. The multi-compartment capsule of claim 1, wherein the Primary Capsule: antioxidants comprise: d-alpha tocopherol, beta carotene, Sterol Esters tocotrienol, grape seed oil, selenium, Vitamin C, or mixtures Guggul Oil 35 thereof. d alpha Tocopherol 3. The multi-compartment capsule of claim 1, wherein the Tocotrienol brain Support components comprise: d-alpha tocopherol, Secondary Capsule: Omega 3 fatty acids, lecithin, choline, coenzyme Q 10, Garlic Extract Ginkgo biloba, vitamin B 12, or mixtures thereof. Zinc 40 4. The multi-compartment capsule of claim 1, wherein the From the above discussion, it will be appreciated that the mood support components comprise: d-alpha tocopherol, present invention provides novel integrated capsule delivery lecithin, Omega 3 fatty acids, S-Adenosylmethione (SAM apparatus and methods for delivering diverse physical states e), I-tyrosine, or mixtures thereof. (e.g., Solid, liquid, gas or dispersion) of a single active 5. The multi-compartment capsule of claim 1, wherein the ingredient or medicament (e.g., pharmaceutical, biotechni 45 diet Support components comprise: conjugated linoleic acid, cal, nutraceutical, Vitamin, dietary Supplement, mineral or flax seed oil, chromium, zinc, I-carnitine, or mixtures combination thereof), or a plurality of active ingredients or thereof. medicaments, in a single dosage capsular form, wherein at 6. The multi-compartment capsule of claim 1, wherein the least two of the active ingredients or medicaments if differ botanicals comprise: bilberry, black cohosh, cinnamon, dan ent receiving chambers have physical states that differ. In 50 delion, Evening primrose oil, forskolin, turmeric, green tea, preferred design, the encapsulation processes and multi ginger oil, ginseng, fennel seed, fenugreek, curcumin, compartment capsular technology of the present invention guarana, garlic, glucosamine, gotu kola, grape seed, Holy may include various desirable properties such as, for Basil, mahuang, hesperidin, licorice root, red raspberry oil, example, controlling time-release of key active ingredients red rice yeast, spirulina, saw palmetto, St. John's Wort, or medicaments, prolonging shelf-life of the active ingredi 55 yohimbe, yohimbine, Valerian, kava kava, chamomile, quer ents or medicaments, improving palatability, reducing over cetin, oregano, sage, saw palmetto, lavender, or mixtures all production costs and reducing the number of capsules thereof. consumed by a patient or consumer as nutritional or thera 7. The multi-compartment capsule of claim 1 wherein the peutic agents. minerals comprise: Selenium, magnesium, calcium, chro The present invention provides novel integrated capsule 60 mium, iron, or zinc. delivery apparatus and methods for delivering a single 8. The multi-compartment capsule of claim 1, further dosage, multi-compartment capsule comprising a capsular comprising a third receiving chamber for incorporating at base and cap configuration, wherein the size and shape of the least one ingredient that is different from the ingredients in cap, relative to its sealing relationship with the base, gen the first and second receiving chambers. erally eliminates or Substantially reduces any potential dead 65 9. The multi-compartment capsule of claim 3, wherein the space Volume within the internal periphery, of the capsule, Omega 3 fatty acids consist of docosahexaenoic acid thereby functionally negating the opportunity for reaction (DHA). US 9,539,216 B2 97 98 10. The multi-compartment capsule of claim 4, wherein the Omega 3 fatty acids consist of docosahexaenoic acid (DHA).