sign in sign up
<<
Home , Biapenem, Panipenem, Pheneticillin

US 2014O186467A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2014/0186467 A1 DIGGS et al. (43) Pub. Date: Jul. 3, 2014

(54) COMPOSITION AND USE FOR Publication Classification ERADICATION OF HIV, TREATMENT OF AIDS AND OTHERDISEASES INCLUDING (51) Int. Cl. TUBERCULOSS IN A HUMAN A633/26 (2006.01) A 6LX3L/295 (2006.01) (71) Applicant: BNEERS CORP. Fort Washington, MD A647/44 (2006.01) (US) A613 L/43 (2006.01) (52) U.S. Cl. (72) Inventors: Comfort Wynee DIGGS, Monrovia CPC ...... A61 K33/26 (2013.01); A61K 31/43 (LR): Christian SOMUAH, Arlington, (2013.01); A61 K3I/295 (2013.01); A61 K VA (US); Isaac DoworJOEMAH, II, 47/44 (2013.01) Washington, DC (US) USPC ...... 424/648: 514/199 (73) Assignee: BNEERS CORP. Fort Washington, MD (US) (57) ABSTRACT (21) Appl. No.: 14/197,629 A composition comprising at least one , at least one (22) Filed: Mar. 5, 2014 iron Source, and at least one oil, method of making, and method of use thereof are described. Although suitable for Related U.S. Application Data many forms and uses, the composition is, in some embodi ments, Suitable as a pharmaceutical composition, and, in (63) Continuation-in-part of application No. PCT/US2013/ Some embodiments, as an antiviral composition capable of 056790, filed on Aug. 27, 2013. restoring T cell count and eradicating HIV virus from patients (60) Provisional application No. 61/695,447, filed on Aug. suffering from HIV/AIDS and other diseases including 31, 2012. Tuberculosis. US 2014/0186467 A1 Jul. 3, 2014

COMPOSITION AND USE FOR 0012 Inventors named herein discovered a composition ERADICATION OF HIV, TREATMENT OF comprising, in part, natural ingredients extracted from plant AIDS AND OTHERDISEASES INCLUDING materials, which ingredients when administered, made it pos TUBERCULOSIS IN A HUMAN sible to increase T cell counts by over 300% and eradicate HIV virus, cure AIDS and other diseases such as tuberculosis. 0001. The present application is a continuation in part of The component parts were isolated, purified, and identified. PCT/US 13/56790, filed Aug. 27, 2013, which application The purified and isolated active components, apart from any claims the priority benefits of U.S. Provisional application no. 61/695,447, filed Aug. 31, 2012, each application of which is extracting material, are described below. incorporated by reference herein in its entirety. 0013 In some embodiments, a composition, comprises at 0002 The present description regards a composition, in least one penicillin; at least one iron source; and at least one particular a pharmaceutical composition comprising at least oil (“core composition'). one penicillin, at least one iron source, and oil. Although 0014. In some embodiments, the at least one penicillin is Suitable for many forms and uses, the composition is, in some present in an amount ranging from 33.0 to 99.5% weight embodiments, suitable as a pharmaceutical composition, and, percent of the total weight of the at least one penicillin, at least in Some embodiments, as an antiviral composition capable of one iron source, and at least one oil (i.e., the core composi treating HIV and Tuberculosis in a human. tion). In some embodiments, the same weight percentage is 0003 HIV infection is a condition caused by the human from 45 to 90% weight percent or from 60 to 85% weight immunodeficiency virus (HIV). The condition gradually percent. destroys the immune system, which makes it harder for the 0015. In some embodiments, at least one iron source is body to fight infections. present in an amount ranging from 0.5 to 65.5% weight per 0004 Humans, including those infected with HIV, have T cent of the total weight of the core composition. In some cells, which are a type of white blood cells (lymphocytes) embodiments, the same weight percentage is from 8.0 to 55% making up part of the immune system. T cells help a body weight percent or from 14.0 to 40.0% weight percent. fight diseases or harmful Substances. T cells are also called 0016. In some embodiments, the at least one oil is present “CD4 cells” or “helper cells.” in an amount ranging from 0.00001 to 9.0% weight percent of 0005 Lower than normal T cell levels may be due to the total weight of the core composition. In some embodi various ailments. For example, common ailments associated ments, the same weight percentage is from 0.0002 to 7.0% with T cell counts below 200 cells/mm include AIDS, AIDS weight percent or from 0.006 to 6.0% weight percent or from dementia, and wasting syndrome caused by HIV itself. Simi 0.01 to 1.0% weight percent. larly, a common ailment associated with T cell counts below 200 cells/mm include AIDS. 0017. The composition comprises at least one penicillin. In some embodiments, the at least one penicillin is chosen 0006. The present inventors know that when a human from , , Benza infected with HIV has a weakened immune system (<500 thine benzylpenicillin, Benzathine phenoxymethylpenicillin, cells/mm), an HIV antiviral medicine is sometimes admin Penicillin G, Penicillin G procaine, Penicillin V. Carfecillin, istered to the infected human. The present inventors also , , , , Carin know that in some cases, even before the human infected with dacillin, , , , Mezlocil HIV has a weakened immune system, an HIV antiviral medi lin, , , , , Het cine is administered to the infected human. acillin, , , , , 0007. In some embodiments, a composition, comprises at Meticillin, , , , Apalcillin, least one penicillin; at least one iron source; and oil. Although Aspoxicillin, , Clemizole penicillin, , Suitable for many forms and uses, the composition is, in some Lenampicillin, , and and pharmaceuti embodiments, Suitable as composition capable of treating cally acceptable salts thereof. HIV in a human having a weakened immune system (<500 cells/mm) or the compositionis, in Some embodiments, suit 0018. In some embodiments, the at least one penicillin is able as composition capable of treating HIV in a human chosen from Benzylpenicillin, Penicillin G benzathine, Peni having a normal immune system (>500 cells/mm) In some cillin G potassium, Penicillin G procaine, Penicillin G embodiments, a human having a weakened immune system sodium, and Penicillin V. below 200 cells/mm and AIDS 0019. In some embodiments, the at least one penicillin is 0008. Additional results of the described embodiments chosen from Penicillin G procaine. will be set forth in part in the description which follows, and 0020. The at least one penicillin is present in the compo in part will be obvious from the description, or may be learned sition in an amount effective for decreasing viral load of HIV by practice of the embodiments disclosed herein. The results when administered with the at least one source of iron and the of practicing the embodiments will be realized and attained at least one oil. The effective dose depends on the age, weight, by means of the elements and combinations particularly and administered form of composition. In some embodi pointed out in the appended claims. ments, the at least one penicillin is present in an amount 0009. It is to be understood that both the foregoing general ranging from 100 to 25,000 mg daily dose. In some embodi description and the following detailed description are exem ments, the at least one penicillin is present in an amount plary and explanatory only and are not restrictive of the inven ranging from 400 to 18,000 mg daily dose or from 800 to tion, as claimed. 5,000 mg daily dose or from 1,500 to 4,000 mg daily dose. In 0010. The accompanying description serves to explain the Some embodiments, the at least one penicillin is present in an principles of the invention. amount ranging from 500 to 1,300 mg daily dose. In some 0.011 Reference will now be made in detail to the exem embodiments, the amount is from 20 to 50 mg/kg daily dose plary embodiments and examples. or from 25 to 40 mg/kg daily dose. US 2014/0186467 A1 Jul. 3, 2014

0021. In some embodiments, daily doses of the at least one TABLE 2 penicillinare shown below in Table 1 for representative mem bers of the at least one penicillin. Representative daily doses of the iron source. Low High TABLE 1. Low High daily daily daily daily Percent elemental elemental dose dose elemental Fe dose Fe dose Representative daily doses of penicillin Iron Source (mg) (mg) Fe (mg) (mg) Low daily High daily ferrous furmate 325 1OOO 33% 107 330 Penicillin (mg) (mg) ferrous sulfate 500 1OOO 20% 100 2OO ferrous gluconate 12SO 1750 12% 150 210 polysaccharide- 150 3OO 100% 150 3OO amoxicillin 1OOO 1750 iron ampicillin 2OOO 4000 heme-iron 175 350 100% 175 350 bacampicillin 2OOO 4000 polypeptide ferric ammonium 1OOO 2OOO 18% 18O 360 carbenicillin 2OOO 4000 citrate cloxacillin 1OOO 2OOO Ferrous 1OOO 2OOO 20% 200 400 dicloxacillin 500 1OOO biglycinate flucloxacillin 1OOO 2OOO 3OOO 4000 18OOO 24OOO 0025. Any oil which is pharmaceutically acceptable is nafcillin 1SOO 6OOO usable as the at least one oil. In some embodiments, the at oxacillin 3OOO 6OOO least one oil is a vegetable oil. In some embodiments, the at penicillin 500 12SO least one oil is an animal oil. In some embodiments, the at G/penicillin G least one oil is chosen from oleoresins (solvent-free) and procaine natural extractives (including distillates). benzathine 750 1SOO 0026. In some embodiments, the at least one oil is chosen penicillin G from oil derived from palm, soybean, rapeseed, canola, Sun Kpenicillin 3750 18OOO flower seed, peanut, cottonseed, palm kernel, coconut, olive, Gi Na. safflower oil, corn, grape seed, hazelnut, linseed, flax seed, penicillin G rice bran, castor bean, and sesame oil. In some embodiments, penicillin V 500 2OOO the oil is chosen from olive, corn, peanut, nut, Soy, rapeseed, piperacillin 18OOO 24OOO cottonseed, vitamin E, fish, or tallow-derived oils, and min pivampicillin 1 OSO 2100 eral oils. In some embodiments, the oil is chosen from almond pivmecillinam 400 800 oil, apricot kernel oil PEG-6 esters, canola oil, castor oil, cedar leaf oil, cinnamon oil, clove oil, coconut oil, coriander icarcillin 16OOO 18OOO oil, corn oil, corn oil PEG-6 esters, cottonseed oil, eucalyptus oil, fractioned coconut oil, lemon oil, light mineral oil, lime oil, nutmeg oil, olive oil, orange oil, polyoxyl castor oils, 0022. The at least one source of iron is chosen from phar poppy seed oil, sesame oil, and soybean oil. In some embodi maceutically acceptable forms of elemental, ferrous, and fer ments, the oil is chosen from hydrogenated oils, e.g., hydro ric moieties. In some embodiments, the at least one iron genated castor oil, hydrogenated palm oil, and hydrogenated Source is chosen from ferrous fumarate, ferrous Sulfate, and soybean oil. Exemplary embodiments of the at least one oil ferrous gluconate. In some embodiments, the at least one iron are commercially available. Source is chosen from iron carbonyl, iron polysaccharide, 0027. The at least one oil is present in the composition in ironprotein Succinylate, and heme iron polypeptides. In some an amount effective for decreasing viral load of HIV/AIDS embodiments, the at least one iron source is chosen from iron when administered with the at least one penicillin and at least dextran, iron Sucrose, iron carboxymaltose, ferrous glycine one iron Source. In some embodiments, the at least one oil is Sulfate, and ferroglycine Sulfate. present in an amount ranging from 0.0005 to 50 mg daily dose. In some embodiments, the same amount is from 0.001 0023 The at least one iron source is present in the com to 25 mg daily dose or from 0.003 to 15 mg daily dose or from position in an amount effective for decreasing viral load of 0.005 tolmg daily dose. In some embodiments, daily doses of HIV when administered with the at least one penicillin and at the at least one oil are shown below in Table 3 for represen least one oil. Elemental iron is the amount of iron form that is tative members of the at least one oil. available for absorption. In some embodiments, the at least one iron Source is present in an amount effective to deliver a TABLE 2 daily dose ranging from 100 to 750 mg of elemental iron. In Representative daily doses of the oil. Some embodiments, the at least one iron Source is present in an amount effective to deliver a daily dose ranging from 150 Oil Low amount (mg) High amount (mg) to 600 mg of elemental iron. In some embodiments, the at Sunflower O.OOOS 25 Sesame O.OO3 1 least one iron source is present in an amount effective to Fish O.OOS 15 deliver a daily dose from 12 to 18 mg/kg of elemental iron. Soybean O.OO1 50 hydrogenated palm O.OOOS O.OO3 0024. In some embodiments, daily doses of the at least one Castor bean O.OOOS 50 iron source are shown below in Table 2 for representative members of the at least one iron Source. US 2014/0186467 A1 Jul. 3, 2014

0028. In some embodiments, the composition comprises ents chosen form a pharmaceutically acceptable vehicle, any combination of one ingredient from Table 1, one ingre Sodium, maltase, caffeine, and other pharmaceutically dient from Table 2, and one ingredient from Table 3. In some acceptable excipients. embodiments, the amounts vary due to the dosing regimen. 0039. In some embodiments, the pharmaceutical compo For example, if there are an integer “n” doses per day, then the sition has a form and component ingredients dependent upon amounts would vary by (1/n) times those amounts shown in the route of administration chosen and the patient chosen. Tables 1-3. For example, typical values of n range from 1, 2. 0040. In some embodiments, the pharmaceutical compo ... 6. If n=3, then the values of the amounts for each ingredient sition is made in a conventional manner using one or more in Tables 1-3 is divided by 3. physiologically acceptable carriers comprising excipients 0029. In some embodiments, the composition is in a phar which facilitate processing of core composition into prepara maceutically acceptable vehicle, i.e., a carrier or inert tions which are pharmaceutically useable. medium used as a solvent (or diluent) in which the core 0041. In some embodiments, the dosage form is chosen composition is formulated and/or administered. from tablets, troches, dispersions, Suspensions, Solutions, 0030. In some embodiments, the composition further capsules, patches, syrups, elixirs, gels, powders, magmas, comprises caffeine or a salt thereof. In some embodiments, lozenges, ointments, creams, pastes, plasters, lotions, discs, the caffeine is in the form of a salt, such as caffeine citrate. In Suppositories, nasal sprays, oral sprays, aerosols, and the like. Some embodiments, the Sodium chloride is present in the 0042. In some embodiments, the pharmaceutical compo composition in an amount ranging from 10 to 200 mg daily sition is in a form Suitable for injection. In some embodi dose. In some embodiments, the amount is from 20 to 150 mg ments, forms suitable for injection are chosen from aqueous daily dose or from 60 to 100 mg daily dose. Solutions, such as those in physiologically compatible buffers 0031. In some embodiments, the composition further Such buffers, optionally, having a stabilizing amount of Sur comprises maltase. Maltase, according to the MeSH Head factant or co-solvent, or physiological Saline buffer. ings, is part of the alpha-Glucosidases, i.e., enzymes that 0043. In some embodiments, the pharmaceutical compo catalyze the exohydrolysis of 1,4-alpha-glucosidic linkages sition is in a form suitable for oral administration. In some with a release of alpha-glucose. Maltase has a CAS Type 1 embodiments, the pharmaceutical composition is made by Name of alpha-D-Glucoside glucohydrolases and an Enzyme combining the core composition with at least one pharmaceu Commission EC Registry Number of EC 3.2.1.20. Maltase is tically acceptable vehicle. Such pharmaceutically acceptable commercially available. vehicles facilitate forming tablets, pills, lozenges, dragees, 0032. In some embodiments, the maltase is in the form of capsules, liquids, gels, Syrups, slurries, Suspensions and the a lyophilized powder having greater than 125 or greater than like, for oral ingestion by a patient. In some embodiments, the 50 units/mg protein. Other forms are possible. pharmaceutical composition is made using a solid excipient, 0033. In some embodiments, the maltase is present in the optionally grinding the resulting mixture, and processing the composition in an amount ranging from 1 to 100 mg daily mixture of granules, after adding other excipients if desired, dose. In some embodiments, the amount is from 5 to 50 mg to obtain tablets or dragee cores. In some embodiments, daily dose or from 10 to 25 mg daily dose. excipients are chosen from fillers such as Sugars, including 0034. In some embodiments, the composition further lactose, Sucrose, mannitol, and Sorbitol; cellulose prepara comprises pharmaceutically acceptable sodium. In some tions such as, for example, maize starch, wheat starch, rice embodiments, the sodium is in the form of sodium chloride. starch, and potato starch; and other materials such as gelatins, In some embodiments, the Sodium chloride is present in the gum tragacanth, methyl cellulose, hydroxypropylmethyl-cel composition in an amount ranging from 1,500 to 3,000 mg lulose, Sodium carboxymethylcellulose, and polyvinyl-pyr daily dose. In some embodiments, the amount is from 1,250 rolidone (PVP). In some embodiment, the pharmaceutical to 2,750 mg daily dose or from 1,500 to 2,300 mg daily dose. composition comprises a disintegrating agent, such as those 0035. In some embodiments, the composition comprises a chosen from cross-linked polyvinyl pyrrolidone, agar, and pharmaceutically acceptable excipient. Pharmaceutically alginic acid. In some embodiments, the pharmaceutical com acceptable excipients include Substances added to a core position comprises a salt, Such as Sodium alginate. composition in order to provide Suitable consistency to the 0044. In some embodiments, the pharmaceutical compo dosage form. Pharmaceutically acceptable excipients include sition is in the form of a dragee. Dragee cores are provided binders, matrix, base or diluent in pills, tablets, creams, with Suitable coatings. In some embodiments, concentrated salves, and the like. In some embodiments, the pharmaceuti Sugar Solutions are used which optionally comprise gum ara cally acceptable excipient is inert. bic, talc, polyvinyl pyrrolidone, carbopol gel, polyethylene 0036 Techniques for formulation and administration of glycol, and/or titanium dioxide, lacquer Solutions, and Suit drugs and pharmaceutical compositions are found in "Rem able organic solvents or solvent mixtures. Dyestuffs or pig ington: The Science and Practice of Pharmacy. Lippincott ments, in some embodiments, are added to the tablets or Williams & Wilkins, 21 ed. (2005). dragee coatings for identification or to characterize different 0037. In some embodiments, the pharmaceutical compo combinations of active compound doses. sition is made by processes well known in the art, e.g., by 0045. In some embodiments, the pharmaceutical compo means of conventional mixing, dissolving, granulating, dra sition is in the form of a capsule. Such as those chosen from gee-making, levigating, emulsifying, encapsulating, entrap oral push-fit capsules comprising gelatin; and soft, sealed ping, lyophilizing processes or spray drying. capsules comprising gelatinanda plasticizer, Such as glycerol 0038. In some embodiments, the pharmaceutical compo or Sorbitol. In some embodiments, the push-fit capsules com sition is made by bringing in association the at least one prise the core composition in admixture with a filler, Such as penicillin, at least one source of iron, at least one oil with a lactose, a binder, Such as starch, and/or a lubricant, such as pharmaceutical vehicle. In some embodiments, the pharma talc or magnesium Stearate and, optionally, one or more sta ceutical composition further comprises one or more ingredi bilizers. In some embodiments, the soft-capsules comprise US 2014/0186467 A1 Jul. 3, 2014

the core composition dissolved or Suspended in one or more 0055. In some embodiments, a sweetener is present in the Suitable liquids, such as fatty oils, liquid paraffin, liquid poly composition in an amount Sufficient to affect Sweetness. ethylene glycols, cremophor, capmul, medium or long chain Exemplary Sweeteners include, e.g., Sucrose (Sugar), glucose, mono- di- or triglycerides; and optionally one or more stabi fructose, Sorbitol, mannitol, corn syrup, high fructose corn lizers. syrup, Saccharin, aspartame. Sucralose, acesulfame potas 0046. In some embodiments, the pharmaceutical compo sium (acesulfame-K), and neotame. sition is in a form suitable for parenteral administration, e.g., 0056. In some embodiments, a color additive is present in by bolus injection or continuous infusion. In some embodi the composition in amount Sufficient to offset color loss due to ments, formulations suitable for injection are in unit dosage exposure to light, air, temperature extremes, moisture and form, e.g., in ampoules or in multi-dose containers, and storage conditions; to correct natural variations in color; to optionally further comprising at least one preservative. In enhance colors that occur naturally, or to provide color. Some embodiments, the pharmaceutical composition is in a Exemplary color additives include, e.g., FD&C Blue Nos. 1 form chosen from Suspensions, Solutions, or emulsions in oily and 2, FD&C Green No. 3, FD&C Red Nos. 3 and 40, FD&C or aqueous pharmaceutical vehicles, and optionally further Yellow Nos. 5 and 6, Orange B, Citrus Red No. 2, annatto comprise one or more excipients such as Suspending agents, extract, beta-carotene, grape skin extract, cochineal extractor Stabilizing agents, and dispersing agents. carmine, paprika oleoresin, caramel color, fruit and vegetable 0047. In some embodiments, the pharmaceutical compo juices, and saffron. sition comprises an excipient chosen from Sodium carboxym 0057. In some embodiment, a flavor is present in the com ethyl cellulose, sorbitol, and dextran. positioninanamount Sufficient to add a specific flavor. Exem 0048. In some embodiments, the pharmaceutical compo plary flavors and/or spices include, e.g., natural flavoring, sition is in the form of a powder. In some embodiments, the artificial flavor, and spices. powder is constituted with a suitable pharmaceutical vehicle, 0058. In some embodiments, a nutrient is present in the e.g., sterile, pyrogen-free water, before administering. composition in an amount Sufficient to add nutrients that are 0049. In some embodiments, the pharmaceutical compo lacking in the diet (fortification). Exemplary nutrients sition is in the form of a depot. In some embodiments, the include, e.g., thiamine hydrochloride, riboflavin (Vitamin depot is administered by implantation (for example, Subcu B2), niacin, niacinamide, folate or folic acid, beta carotene, taneously or intramuscularly) or by intramuscular injection. potassium iodide, iron or ferrous Sulfate, alpha tocopherols, 0050. In some embodiments, the pharmaceutical compo ascorbic acid, Vitamin D, amino acids (L-tryptophan, sition comprises a pharmaceutical Vehicle chosen from a L-lysine, L-leucine, L-methionine). co-solvent system comprising benzyl alcohol, a nonpolar Sur 0059. In some embodiments, a pH control agent and/oran factant, a water-miscible organic polymer and an aqueous acidulant is/are present in the composition in an amount Suf phase such as the VPD co-solvent system. VPD is a solution ficient to control acidity and alkalinity and/or to prevent spoil of 3% W/v benzyl alcohol, 8% W/v of the nonpolar surfactant age. Exemplary pH control agents and/or acidulants include, Polysorbate 80, and 65% W/v polyethylene glycol 300, made e.g., lactic acid, citric acid, ammonium hydroxide, and up to Volume in absolute ethanol. In some embodiments, the Sodium carbonate. proportions of Such a co-solvent system are varied without 0060. In some embodiments, the composition is in the destroying its solubility and toxicity characteristics. Further form of a tablet or capsule. In some embodiments, a tablet more, the identity of the co-solvent components, in some comprises a mixture of core ingredients and one or more embodiments, is varied: for example, in Some embodiments, excipients, usually in powder form, pressed or compacted other low-toxicity nonpolar surfactants are substituted for from a powder into a solid dose. The excipients, in some Polysorbate 80. embodiments, are chosen from color additives, flavors and 0051. In some embodiments, the pharmaceutical compo spices, flavor enhancers, preservatives, binders, fillers, and sition comprises Suitable solid or gel phase pharmaceutical lubricants. The color additives, flavors and spices, flavor vehicles and/or excipients. Examples of such vehicles or enhancers, and preservatives were noted above. excipients include, but are not limited to, calcium carbonate, 0061. In some embodiments, a binder is present in the calcium phosphate, various Sugars, starches, cellulose deriva composition in an amount Sufficient to produce uniform tex tives, gelatin, and polymers such as polyethylene glycols. ture, improve “mouth-feel” or binding of the tablet or capsule 0052. In some embodiments, the composition further ingredients. Exemplary binders include, e.g., gelatin, pectin, comprises at least one excipient present in an amount Suffi guar gum, carrageenan, Xanthan gum, and whey. cient to perform its function. In some embodiments, the at 0062. In some embodiments, a filler is present in the com least one excipient is added by mixing the at least one excipi position in an amount Sufficient to bulk up the tablet or cap ent with the core composition. Sule Exemplary binders include, e.g., Sugars, such as lactose, 0053. In some embodiments, the at least one excipient is Sucrose, mannitol, calcium carbonate, and calcium phos chosen from preservatives, Sweeteners, color additives, fla phate. Vors, nutrients, and pH control agents and/or acidulants. 0063. In some embodiments, a lubricant is present in the 0054. In some embodiments, a preservative is present in composition in an amount Sufficient to prevent clumping of the composition in an amount Sufficient to prevent spoilage the ingredients of the tablet or capsule Exemplary lubricants from bacteria, molds, fungi, or yeast (antimicrobials); to slow include, e.g., talc, silica, Stearic acid, and magnesium Stear or prevent changes in color, flavor, or texture and delay ran ate. cidity (antioxidants); or to maintain freshness. Exemplary 0064. In some embodiments, the pharmaceutical compo preservatives include, e.g., ascorbic acid, citric acid, sodium sition is administered via a route chosen from oral, intraoral, benzoate, calcium propionate, sodium erythorbate, sodium rectal, transmucosal, intestinal routs; intramuscular, epicuta nitrite, calcium sorbate, potassium sorbate, BHA, BHT, neous, parenteral, Subcutaneous, transdermal, intramedul EDTA, and tocopherols (Vitamin E). lary, intrathecal, direct intraventricular, intravenous, intravit US 2014/0186467 A1 Jul. 3, 2014

real, intraperitoneal, intranasal, intramuscular, intradural, ments, the composition is administered two to three times a intrarespiratory, nasal inhalation or intraocular injections. In day for a period of time ranging from two to eight weeks or six Some embodiments, routes of administration are chosen from to eight weeks. oral routes and parenteral routes. 0077. In some embodiments, administering is for a period 0065. The amount of the core composition (and any carrier of time sufficient to remove at least 50% of the detectable or other ingredient) administered will be dependent on the amounts of HIV in the patient. The detectable amount is subject being treated, the severity of the disorder or condition, determined by measuring the detectable amount of HIV the rate of administration, the disposition of the pharmaceu present before treatment (HIV) and during treatment tical composition, and the discretion of the prescribing phy (HIV) and thereafter calculating the decrease according to Sician. formula (1). 0066. In some embodiments, the dosage levels (of the core composition) below the lower limit of the above range is (HIV/HIVinitial 1)x100% (1) Sufficient, while in other cases a larger dosage is Sufficient. 0078. In some embodiments, administering is for a period 0067. In some embodiments, larger doses (of the pharma of time sufficient to remove at least 60% of the detectable ceutical composition) are typically divided into several amounts of HIV in the patient. In some embodiments, admin Smaller doses for administration periodically throughout the istering is for a period of time sufficient to remove at least day. 70% of the detectable amounts of HIV in the patient. In some 0068. In some embodiments, the composition is adminis embodiments, administering is for a period of time sufficient tered to a subject. The Subject is an animal, e.g., a human to remove at least 80% of the detectable amounts of HIV in infected with HIV. In some embodiments, the human has the patient. In some embodiments, administering is for a AIDS. period of time sufficient to remove at least 90% of the detect 0069. Two types of HIV have been characterized: HIV-1 able amounts of HIV in the patient. In some embodiments, and HIV-2. Unless otherwise indicated, the term HIV refers to administering is for a period of time Sufficient to remove at both HIV-1 and HIV-2. least 95% of the detectable amounts of HIV in the patient. In 0070. In some embodiments, the human is infected with Some embodiments, administering is for a period of time HIV-1. In some embodiments, the human is infected with sufficient to remove at least 99% of the detectable amounts of HIV-2. HIV in the patient. In some embodiments, administering is 0071. In some embodiments, the human infected with for a period of time sufficient to remove at least 99.9% of the HIV has a T cell count below 500 cells/mm. In some embodi detectable amounts of HIV in the patient. In some embodi ments, the human infected with HIV has a T cell count greater ments, administering is for a period of time Sufficient to than or equal to 500 cells/mm. In some embodiments, the remove at least 100% of the detectable amounts of HIV in the human infected with HIV has a T cell count below 200 cells/ patient. In other words, in some embodiments, administering mm or AIDS. the composition described herein makes it possible to not 0072. In some embodiments, the human infected with only minimize but also eliminate or eradicate the detectable HIV has one or more symptoms associated with AIDS (e.g., amount of HIV/AIDS in the patient. diarrhea, fatigue, fever, frequent vaginal yeast infections, 007.9 The present inventors have concluded that the com headache, mouth Sores, including yeast infection (thrush), position described herein has antiviral activity against HIV or muscle stiffness or aching, flashes of different types, includ activity against AIDS and other diseases including Tubercu ing seborrheic dermatitis and psoriasis, Sore throat, Swollen losis. The present inventors have concluded that the compo lymph glands). In some embodiments, the human infected sition described herein makes it possible to cure AIDS. The with HIV is asymptomatic of conditions associated with present inventors have concluded that the composition AIDS. described herein makes it possible to cure HIV. 0073. In some embodiments, the composition is adminis tered to a human in need of enhancing of T cells and decreas EXAMPLE 1. ing HIV viral load. In some embodiments, the human is infected with HIV. In some embodiments, the human has 0080 A scaled up set of amounts sufficient to result in a AIDS. In some embodiments, administering the composition dosage form having 125 mg of penicillin G and 325 mg makes it possible to eradicate the viral load in the human ferrous fumarate are mixed while adding 0.001 mg of veg having HIV infection and Tuberculosis disease. etable oil. The resultant composition is suitable for mixing 0.074. In some embodiments, the human infected with with an excipient like microcrystalline cellulose to form tab HIV has AIDS dementia, wasting syndrome caused by HIV lets; calcium carbonate or magnesium carbonate to form a itself. chewable tablets; or mannitol, sorbitol, fructose, and/or mal 0075. In some embodiments, the composition is adminis tose to form a chewable tablet. Alternatively, the resultant tered orally, parenterally, topically, rectally, nasally, buccally, composition is capable of forming an aqueous Suspension vaginally, or via an implanted reservoir in dosage formula with or without a dispersing agent like soybean oil or PEG tions. The term parenteral as used herein includes Subcutane 400. The resultant formulation is suitable to be administered, ous, intravenous, intramuscular, intraperitoneal, intrathecal, e.g., from 3 to 6 times a day. intraventricular, intrasternal or intracranial injection and infusion techniques. Example 2 0076. In some embodiments, the composition is adminis tered from one to six times a day for a period of time ranging I0081 300 g of penicillin G procaine and 600 g ferrous from one week to one year. In some embodiments, the com sulfate are mixed while adding 1 mg of castor oil. The result position is administered one to four times a day for a period of ant composition (A) is suitable for forming the various dosage time ranging from two weeks to six months. In some embodi forms outlined in example 1. US 2014/0186467 A1 Jul. 3, 2014

0082 Alternatively, to the resultant composition (A), 30 g tinued for a period of time ranging from one week to one year. of caffeine are mixed and the modified resultant composition Administration, in Some embodiments, is to those in need of (B) is suitable for forming the various dosage forms outlined lesion relief, digestive assistance, and colon relaxation. in example 1. 0083. The resultant formulation (A) or (B) is suitable to be Example 7 administered, e.g., from 1 to 2 times a day. Administration, in some embodiments, is to those in need of bowel relaxation. Use 0096. In a manner similar to that used in Example 1 a Example 3 dosage form having 150 mg of penicillin G procaine, 250 mg 0084. A scaled up set of amounts sufficient to result in a of elemental iron, 0.1 mg of castor oil and 0.1 soybean oil is dosage form having 500mg of penicillin V potassium salt and made into a Suspension. 1000 mg ferrous sulfate are mixed while adding 1 mg of palm 0097. The formulation is administered orally in an amount oil. of one dose once a day to a human Suffering from wasting 0085. The resultant composition (C) is suitable for form syndrome caused by HIV. Administering according to this ing the various dosage forms outlined in example 1. regimen is continued for a period of time ranging from one I0086 Alternatively, to the resultant composition (C), 10 week to one month. mg perdose of maltase (125 units/mglyophilized powder) are mixed and the modified resultant composition (D) is suitable Example 8 for forming the various dosage forms outlined in example 1. I0087. The resultant formulation (C) or (D) is suitable to be 0098. A composition comprising natural ingredients administered, e.g., from 2 to 4 times a day. Administration, in extracted from plant materials was administered to patients Some embodiments, is to those in need of digestive assistance. having AIDS and Tuberculosis, made it possible to increaseT cell counts by over 300% and eradicate detectable amounts of Example 4 the HIV virus. The component parts were isolated from the extracting material, purified, and identified. The component 0088. In a manner similar to that used in Example 1, a parts were screened for their activity. dosage form having 1,000 mg of penicillin V Sodium salt, 1000 mg ferrous sulfate, 0.001 mg of castor oil, and 750 mg Example 9 of sodium chloride is made. 0089. The formulation is administered in an amount of one 0099 Based on these examples and information known to dose twice a day to a human patient infected with HIV. The each inventors, it is concluded that the composition described human patient is infected with HIV and has a T cell count herein has antiviral activity against HIV and/or Tuberculosis. below 500 cells/mm. Based on these examples, it is concluded that administering 0090 Administration, in some embodiments, is to a the composition described herein makes it possible to mini human patient infected with HIV and having a T cell count mize, if not eradicate, the detectable amount of HIV and/or greater than or equal to 500 cells/mm. Tuberculosis in the patient. Based on these examples, it is concluded that administering the composition described Example 5 herein makes it possible to cure HIVAIDS and/or Tuberculo 0091. In a manner similar to that used in Example 1, a sis in the patient. Based on these examples and information dosage form having 700 mg of penicillin G procaine, 350 mg known to each inventors, the present inventors have con of elemental iron, 0.0005 mg of soybean oil, 600 mg of cluded that the composition described herein makes it pos sodium chloride, 25 mg of caffeine citrate, and 10 mg of sible to cure AIDS. Based on these examples and information maltase (about 50 units/mglyophilized powder) is made. known to each inventors, the present inventors have con 0092. The formulation is administered in an amount of one cluded that the composition described herein makes it pos dose twice a day to a human suffering from tuberculosis, HIV. sible to cure HIV. and AIDS. The human patient is infected with HIV and has a 0100 Other embodiments of the invention will be appar T cell countbelow 500 cells/mm Administering according to ent to those skilled in the art from consideration of the speci this regimen is continued for a period of time ranging from fication and practice of the invention disclosed herein. It is one week to one year. Administration, in Some embodiments, intended that the specification and examples be considered as is to those in need of lesion relief digestive assistance, and exemplary only, with a true scope and spirit of the invention colon relaxation. being indicated by the following claims. 0093. Administration, in some embodiments, is to a What is claimed is: human patient infected with HIV and having a T cell count 1. A method of curing HIV/AIDS and other diseases greater than or equal to 500 cells/mm. including Tuberculosis in a human patient in need thereof, comprising, administering, to a human patient infected with Example 6 HIV/AIDS and/or Tuberculosis, a pharmaceutical composi 0094. In a manner similar to that used in Example 1, a tion capable of restoring T cell count and eradicating HIV dosage form having 350 mg of penicillin G benzatine, 400 mg virus from patients affected by HIV/AIDS and other diseases of elemental iron, 0.005 mg of castor oil, 600 mg of sodium including Tuberculosis, comprising: chloride, 25 mg of caffeine citrate, and 10 mg of maltase at least one penicillin; (about 50 units/mglyophilized powder) is made. at least one iron Source; and 0095. The formulation is administered via injection in an at least one oil. amount of one dose once a day to a human Suffering from 2. The method of claim 1, wherein the human patient has a tuberculosis. Administering according to this regimen is con T cell count below 500 cells/mm. US 2014/0186467 A1 Jul. 3, 2014

3. The method of claim 1, wherein the human patient has a 15. A method of treating HIV and Tuberculosis in a human T cell count greater than or equal to 500 cells/mm. patient in need thereof, comprising, administering, to a 4. The method of claim 1, wherein the human patient has an human patient infected with HIV and or Tuberculosis and ailment chosen from AIDS, AIDS dementia, wasting syn having a T cell count greater than or equal to 500 cells/mm. drome caused by HIV itself. an effective amount of a composition, comprising: 5. The method of claim 1, wherein the human patient is at least one penicillin; asymptomatic of conditions associated with AIDS. at least one iron Source; and 6. The method of claim 1, wherein the composition further at least one oil comprises caffeine. wherein the administering is for a period of time sufficient to 7. The method of claim 1, wherein the composition further remove at least 95% of the detectable amounts of HIV and/or comprises maltase. Tuberculosis in the human patient. 8. The method of claim 1, wherein the composition further 16. The method of claim 15, wherein the administering is comprises sodium. for a period of time sufficient to eradicate detectable amounts 9. The method of claim 1, wherein the composition further of HIV, cure AIDS and/or cure Tuberculosis in the human comprises a pharmaceutically acceptable vehicle. patient. 10. The method of claim 1, wherein the at least one peni 17. The method of claim 15, wherein the at least one cillin is chosen from Benzylpenicillin, Phenoxymethylpeni penicillin is chosen from Benzylpenicillin, Penicillin G ben cillin, BenZathine benzylpenicillin, Benzathine phenoxym Zathine, Penicillin G potassium, Penicillin G procaine, Peni ethylpenicillin, Penicillin G, Penicillin G procaine, Penicillin cillin G sodium, and Penicillin V. V. Carfecillin, Ampicillin, Pivampicillin, Carbenicillin, 18. A method of treating HIV and Tuberculosis in a human Amoxicillin, , Bacampicillin, Pivmecillinam, patient in need thereof, comprising, administering, to a Azlocillin, Mezlocillin, Piperacillin, Ticarcillin, Talampicil human patient infected with HIV and/or Tuberculosis and lin, Sulbenicillin, , Propicillin, Pheneticillin, having a T cell count below 500 cells/mm, an effective Dicloxacillin, Cloxacillin, Meticillin, Oxacillin, Flucloxacil amount of a composition, comprising: lin, Biapenem, Apalcillin, Aspoxicillin, Ciclacillin, Clemi at least one penicillin; Zole penicillin, Imipenem, Lenampicillin, Nafcillin, and at least one iron Source; and Panipenem and pharmaceutically acceptable salts thereof. at least one oil 11. The method of claim 1, wherein the at least one peni cillin is chosen from Benzylpenicillin, Penicillin G benza wherein the administering is for a period of time sufficient to thine, Penicillin G potassium, Penicillin G procaine, Penicil remove at least 95% of the detectable amounts of HIV and/or lin G sodium, and Penicillin V. Tuberculosis in the human patient. 12. The method of claim 1, wherein the at least one peni 19. The method of claim 18, wherein the administering is cillin is Penicillin G procaine. for a period of time sufficient to remove detectable amounts of 13. The method of claim 1, administering is for a period of HIV and or Tuberculosis in the human patient. time sufficient to remove at least 90% of the detectable 20. The method of claim 18, wherein the at least one amounts of HIV and/or Tuberculosis in the patient. penicillin is chosen from Benzylpenicillin, Penicillin G ben 14. The method of claim 1, wherein the administering is for Zathine, Penicillin G potassium, Penicillin G procaine, Peni a period of time sufficient to remove detectable amounts of cillin G sodium, and Penicillin V. HIV and or Tuberculosis in the patient. k k k k k