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(12) Patent Application Publication (10) Pub. No.: US 2007/0292501 A1 Udel (43) Pub

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(12) Patent Application Publication (10) Pub. No.: US 2007/0292501 A1 Udel (43) Pub US 200702925O1A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2007/0292501 A1 Udel (43) Pub. Date: Dec. 20, 2007 (54) CHEWABLE SOFT GELATIN CAPSULES Related U.S. Application Data (76) Inventor: Ronald G. Udell, Beverly Hills, CA (60) Provisional application No. 60/810,917, filed on Jun. (US) 5, 2006. Correspondence Address: Publication Classification DORSEY & WHITNEY LLP INTELLECTUAL PROPERTY DEPARTMENT (51) Int. Cl. SUTE 15OO A6IR 9/64 (2006.01) SO SOUTH SIXTH STREET (52) U.S. Cl. .............................................................. 424/456 MINNEAPOLIS, MN 55402-1498 (US) (57) ABSTRACT (21) Appl. No.: 11/757,789 The present invention is directed to compositions and meth ods of delivery of fill materials containing active agents, optionally dissolved or Suspended in a Suitable carrier, (22) Filed: Jun. 4, 2007 encapsulated in a chewable soft gelatin capsule. US 2007/02925O1 A1 Dec. 20, 2007 CHEWABLE SOFT GELATIN CAPSULES 0013 In still another aspect, the present invention also includes packaged formulations of the soft gelatin chewable CROSS-REFERENCE TO RELATED capsules. APPLICATION(S) 0014. The present invention provides the advantage of a 0001) This application claims the benefit of U.S. Provi chewable soft gelatin capsule for individuals who might not sional Application No. 60/810,917, filed Jun. 5, 2006, otherwise easily take a pill or tablet. This is especially true entitled “Chewable Soft Gelatin Capsule” by Michael Fan for the elderly and small children where swallowing can be tuzzi, the entire contents of which is incorporated herein by problematic. Likewise, animals, such as dogs, cats and reference. horses, often do not readily take “hard' pills and tablets. The present invention solves these issues by use of a chewable FIELD OF THE INVENTION capsule while delivering the beneficial active agent to the Subject. 0002 The present invention relates to delivery of a fill material encapsulated within a chewable soft gelatin cap 0015. In one aspect, the shell is hydrogenated starch Sule. hydrolysate free. This is advantageous for those subjects that are allergic to starch based products. BACKGROUND OF THE INVENTION 0016. In another aspect, the shell contains less than 4% 0003 Encapsulation of active agents, such as pharma by weight of hydrogenated Starch hydrolysate. Again, utili ceuticals, vitamins, antioxidants, and the like, can be accom Zation of a very minimal amount of a hydrogenated Starch plished with hard gelatin capsules or soft gelatin capsules. hydrolysate is advantageous for those Subjects that are Soft gelatin compositions used to prepare the shell of the allergic to starch based products. capsule are not conducive to chewing to release the active 0017 While multiple embodiments are disclosed, still agent. Most of the Soft gelatin shells provide a gummy, other embodiments of the present invention will become unpleasant tasting, intractable mass in the mouth when apparent to those skilled in the art from the following chewed. detailed description, which shows and describes illustrative 0004 Sometimes the individual or mammal has a difficult embodiments of the invention. As will be realized, the time swallowing traditional pills that are either hard or soft, invention is capable of modifications in various obvious due to age, gag refleX, diminished throat muscle strength due aspects, all without departing from the spirit and scope of the to stroke, and other ailments. Sometimes the pill is not present invention. Accordingly, the drawings and detailed palatable to the Subject due to size, taste, or other factors. description are to be regarded as illustrative in nature and not restrictive. 0005 There are instances where the subject is in imme diate need of rapid application of the active agent, such as DETAILED DESCRIPTION an angina attack. The shell of the Soft gelatin capsule must dissolve rapidly upon chewing so as to release the active 0018. The present invention provides chewable soft gela agent. tin capsules that contain an encapsulated fill material of an active agent and, optionally, a suitable carrier. In one aspect, 0006 Therefore, there is a need in the art for an improved the chewable soft gelatin shell includes at least gelatin, a methodology to deliver active agents to an individual or plasticizer other than xylitol, xylitol and water. The carrier mammal. Such as a dog, in need thereof. is especially optional where the active agent is a liquid that BRIEF SUMMARY OF THE INVENTION does not dissolve the chewable soft gelatin shell. 0007. The present invention pertains to chewable soft 0019. The phrase “sufficient quantity of a carrier suitable gelatin capsules containing a fill material that includes an to solubilize an active agent' is therefore intended to mean active agent. The chewable soft gelatin shell includes at least that that amount of a carrier that will dissolve or suspend the gelatin, a plasticizer other than Xylitol, Xylitol and water. The active agent under a given set of conditions, generally, those fill material encapsulated within the chewable soft gelatin at ambient temperature. This determination should be under shell, includes an active agent, and optionally, an acceptable stood by one skilled in the art and can be determined by carrier. methods known in the art, such as by solubility studies. 0020. One type of suitable carrier is a monoterpene. The 0008. In one embodiment the chewable soft gelatin cap term "monoterpene' as used herein, refers to a compound Sule consists essentially of gelatin, a plasticizer other than having a 10-carbon skeleton with non-linear branches. A Xylitol, i.e., glycerin, Xylitol and water. monoterpene refers to a compound with two isoprene units 0009. In another embodiment, the chewable soft gelatin connected in a head-to-end manner. The term "monoter shell does not include a starch acetate. pene' is also intended to include “monoterpenoid’, which refers to a monoterpene-like Substance and may be used 0010. In still another embodiment, the chewable soft loosely herein to refer collectively to monoterpenoid deriva gelatin shell does not include two types of gelatin. tives as well as monoterpenoid analogs. Monoterpenoids can 0011. In one aspect, the shell can further include maltitol, therefore include monoterpenes, alcohols, ketones, alde wherein the maltitol is present at a weight percentage of the hydes, ethers, acids, hydrocarbons without an oxygen func total weight of the shell of less than about 4 weight percent. tional group, and so forth. 0012. In another aspect, the shell and/or fill material can 0021. It is common practice to refer to certain phenolic include a coloring agent and/or a flavoring agent. compounds, such as eugenol, thymol and carvacrol, as US 2007/02925O1 A1 Dec. 20, 2007 monoterpenoids because their function is essentially the 0029. The chewable soft gelatin formulations of the same as a monoterpenoid. However, these compounds are invention are considered dietary Supplements useful to pro not technically “monoterpenoids” (or “monoterpenes') vide an effective amount of an active agent to the individuals because they are not synthesized by the same isoprene or animals in need thereof. biosynthesis pathway, but rather by production of phenols 0030) The term “effective amount” is intended to mean from tyrosine. However, common practice will be followed that amount useful to achieve a desired effect. For example, herein. Suitable examples of monoterpenes include, but are an effective amount of a vitamin would be the recommended not limited to, limonene, pinene, cintronellol, terpinene, daily requirement. As another example, an effective amount nerol, menthane, carveol. S-linalool, Safrol, cinnamic acid, of an antibiotic would be that amount required to help apiol, geraniol, thymol, citral, carvone, camphor, etc. and diminish or eradicate the bacterial infection in the subject. derivatives thereof. For information about the structure and Of course, this treatment may take several days and multiple synthesis of terpenes, including terpenes of the invention, doses of the active agent within the chewable soft gelatin see Kirk-Othmer Encyclopedia of Chemical Technology, capsule during each day's treatment. Mark, et al., eds., 22:709-7623d Ed (1983), the teachings of which are incorporated herein in their entirety. 0031. Alternatively, the formulations of the invention are also considered to be nutraceuticals. The term “nutraceuti 0022. In particular, suitable limonene derivatives include cal is recognized in the art and is intended to describe perillyl alcohol, perillic acid, cis-dihydroperillic acid, trans specific chemical compounds found in foods that may dihydroperillic acid, methyl esters of perillic acid, methyl prevent disease. Many of the active agents set forth through esters of dihydroperillic acid, limonene-2-diol, uroterpenol, out the specification are considered to be neutraceuticals. and combinations thereof. 0032. The formulations, the fill materials, of the inven 0023. Other suitable carriers useful in the fill material tion include one or more active agents that can be supple include but are not limited to, for example, fatty acids, esters ments to an individual’s diet. Suitable active agents can and salts thereof, that can be derived from any source, include vitamins and biologically-acceptable minerals. Non including, without limitation, natural or synthetic oils, fats, limiting examples of vitamins include vitamin A, B vita waxes or combinations thereof. Moreover, the fatty
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