WO2012096655A1 - Compositions pour le traitement d'infections virales chroniques - Google Patents

Compositions pour le traitement d'infections virales chroniques Download PDF

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Publication number
WO2012096655A1
WO2012096655A1 PCT/US2011/020876 US2011020876W WO2012096655A1 WO 2012096655 A1 WO2012096655 A1 WO 2012096655A1 US 2011020876 W US2011020876 W US 2011020876W WO 2012096655 A1 WO2012096655 A1 WO 2012096655A1
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Prior art keywords
zinc
copper
composition
vitamin
group
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PCT/US2011/020876
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English (en)
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Sam Poon Ang
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Sam Poon Ang
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Priority claimed from US13/004,756 external-priority patent/US20120082720A1/en
Publication of WO2012096655A1 publication Critical patent/WO2012096655A1/fr

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    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23D—EDIBLE OILS OR FATS, e.g. MARGARINES, SHORTENINGS, COOKING OILS
    • A23D9/00—Other edible oils or fats, e.g. shortenings, cooking oils
    • A23D9/007—Other edible oils or fats, e.g. shortenings, cooking oils characterised by ingredients other than fatty acid triglycerides
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23D—EDIBLE OILS OR FATS, e.g. MARGARINES, SHORTENINGS, COOKING OILS
    • A23D7/00—Edible oil or fat compositions containing an aqueous phase, e.g. margarines
    • A23D7/005—Edible oil or fat compositions containing an aqueous phase, e.g. margarines characterised by ingredients other than fatty acid triglycerides
    • A23D7/0053—Compositions other than spreads
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/045—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
    • A61K31/047—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates having two or more hydroxy groups, e.g. sorbitol
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/35—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/06—Fungi, e.g. yeasts
    • A61K36/07—Basidiomycota, e.g. Cryptococcus
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Definitions

  • the present invention relates generally to enhancing immune system function, and specifically to dietary compositions that enhance immune response, including methods of use thereof, for treating chronic viral infections.
  • the immune response is often partly responsible for the pathogenic effects.
  • those agents which are associated with an aggressive TH 2 -type response and may be characterized by high IgE levels e.g., parasitic infections
  • damage is caused by a failure to completely eliminate the agent via an immune response.
  • mycobaterial infections such as tuberculosis and leprosy, that result in persistent intracellular infection, where a THi-type response aids in containing the infection but also causes granuloma formation and tissue necrosis.
  • hepatitis B and hepatitis C infections are commonly followed by persistent viral carriage and hepatic injury, resulting in death from hepatitis (i.e., cirrhosis or liver failure) or hepatoma (i.e., malignant hepatoma or hepatocellular carcinoma).
  • hepatitis i.e., cirrhosis or liver failure
  • hepatoma i.e., malignant hepatoma or hepatocellular carcinoma
  • HIV infections very rarely are viral clearance and/or protection against subsequent re-infection observed.
  • the immune response fails primarily because of the relative "tolerance” of the immune system to the agent.
  • One example would be the herpes virus. As the virus is passed, it becomes latent in nerve tissue and may cause resultant lesions, which are frequently recurrent. This tolerance or “invisibility” seems to be caused by the viral protein ICP-47, which binds to TAP complex and inhibits peptide transport into the endoplasmic reticulum in infected cells. Thus, viral peptides are not presented to the immune system by MHC class I molecules.
  • HBV hepatitis B virus
  • HCV hepatitis C virus
  • Acute HBV or HCV infection can lead to acute liver failure in rare instances ( ⁇ 1%).
  • chronic infection can lead to cirrhosis in about 20% to 30% of individuals, and eventually to end-stage liver disease or HCC.
  • Many individuals are unaware that they are infected until they develop signs or symptoms of cirrhosis or liver disease.
  • Chronic HBV infection is responsible for 3,000 deaths per year in the United States, and chronic HCV infection is responsible for 12,000 deaths per year. Chronic infection can thus have dire consequences: debilitating symptoms, impaired quality of life, disability, costly health care expenditures, and death.
  • a dietary and/or therapeutic supplement composition including, in admixture, alkylglycerols, artemisinin or derivatives thereof, agaricus bisporous or an extract thereof, and chlorophyllin or an analog or derivative thereof.
  • the supplement composition is formed by adding alkylglycerols to a composition including artemisinin or derivatives thereof, agaricus bisporous or an extract thereof, and chlorophyllin or an analog or derivative thereof in situ or situs.
  • the composition including artemisinin or derivatives thereof, agaricus bisporous or an extract thereof, and chlorophyllin or an analog or derivative thereof further includes one or more ingredients including idebenone or CoQIO, melatonin or a derivative thereof, milk thistle or a derivative thereof, at least 2 separate mineral salts, at least 2 separate fat soluble vitamins, and combinations thereof.
  • the mineral salts are zinc and copper salts.
  • the copper salts include copper ascorbate, copper bisglycinate chelate, copper chelate, copper chelate polyvinylpyridine, copper citrate, copper copper citrate on dicalcium phosphate (DCP), copper gluconate, copper glycinate, copper histidinate, copper Krebs trit on dicalcium phosphate, copper lysinate, copper orotate, copper oxide, copper picolinate, copper sebacate, copper sebicate, and copper sulfate and the zinc salts include zinc ascorbate complex (15%), bacitracin zinc, zinc acetate, zinc arginate, zinc aspartate, zinc bisglycinate, zinc caprylate, zinc chelate, zinc citrate, zinc gluconate, zinc gluconate trihydrate, zinc glutamate, zinc glycinate, zinc heptahydrate, zinc histidinate, zinc Krebs, zinc malate, zinc methionate, zinc orotate, zinc oxide, zinc picolinate,
  • DCP dicalc
  • the fat soluble vitamins are vitamin D and vitamin A, including that vitamin D may be vitamin D2 (ergocalciferol), vitamin D3 (cholicalciferol), doxercalciferol, and paricalcitol and vitamin A may be retinyl acetate, retinyl palmitate, retinol palmitate, retinoic acid, beta carotene, and alpha carotene.
  • the composition having idebenone or CoQIO, melatonin or a derivative thereof, milk thistle or a derivative thereof includes zinc gluconate, copper gluconate, vitamin D, and vitamin A.
  • the composition includes CoQ IO or a derivatives or an analog thereof, melatonin or a derivative thereof, milk thistle or a derivative or analog thereof, zinc gluconate, copper gluconate, vitamin D, and vitamin A.
  • the composition includes idebenone or a derivatives thereof, melatonin or a derivative thereof, milk thistle or a derivative or analog thereof, zinc gluconate, copper gluconate, vitamin D, and vitamin A.
  • the admixture includes about 600 to 1200 mg of alkylglycerols, about 600 to 1500 mg of artemisinin or derivatives thereof, about 600 to 1000 mg of agaricus bisporous or an extract thereof, and about 100 to about 600 mg of chlorophyllin or an analog or derivative thereof.
  • the composition further includes at least one pharmaceutically acceptable excipient.
  • the composition including artemisinin or derivatives thereof, agaricus bisporous or an extract thereof, and chlorophyllin or an analog or derivative thereof is formulated in an enteric coated capsule.
  • the composition including artemisinin or derivatives thereof, of agaricus bisporous or an extract thereof, and chlorophyllin or an analog or derivative thereof is formulated in an enteric coated tablet.
  • the composition includes about 600 to 1200 mg of alkylglycerols, about 600 to 1500 mg of artemisinin or derivatives thereof, about 600 to 1000 mg of agaricus bisporous or an extract thereof, about 100 to about 600 mg of chlorophyllin or an analog or derivative thereof, about 50 to 500 mg of idebenone, about 5 to about 50 mg of melatonin, about 300 to 1000 mg of milk thistle, about 14 to 50 mg of zinc gluconate, about 1 to 6 mg of copper gluconate, about 5 to 15 ⁇ g of vitamin D3, and about 500 to 3500 ⁇ g of retinyl acetate.
  • the composition includes about 600 to 1200 mg of alkylglycerols, about 600 to 1500 mg of artemisinin or derivatives thereof, about 600 to 1000 mg of agaricus bisporous or an extract thereof, about 100 to about 600 mg of chlorophyllin or an analog or derivative thereof, about 50 to 500 mg of CoQIO, about 5 to about 50 mg of melatonin, about 300 to 1000 mg of milk thistle, about 14 to 50 mg of zinc gluconate, about 1 to 6 mg of copper gluconate, about 5 to 15 ⁇ g of vitamin D3, and about 500 to 3500 ⁇ g of retinyl acetate.
  • the alkylglycerol is contained in shark liver oil.
  • at least one alkylglycerol has the structure of formula:
  • R 1 and R 2 are the same or different and each includes hydrogen and aliphatic acyl groups of at most 24 carbon atoms
  • one of R 3 and R 4 is hydrogen and the other includes straight, branched, saturated and unsaturated alkoxy groups of at most 7 carbon atoms
  • R 5 includes straight chain and branched alkyl and alkenyl groups of 4 to 21 carbon atoms.
  • the composition may contain an antiviral including abacavir, acyclovir, acyclovir, adefovir, amantadine, amprenavir, ampligen, arbidol, atazanavir, atripla, boceprevir, cidofovir, combivir, darunavir, delavirdine, didanosine, efavirenz, emtricitabine, entecavir, entry inhibitors, famciclovir, fos amprenavir, foscarnet, fosfonet, fusion inhibitor, ganciclovir, imunovir, indinavir, inosine, integrase inhibitor, interferon type III, interferon type I, lamivudine, lopinavir, maraviroc, moroxydine, methisazone, nelfinavir, nevirapine, nucleoside analogs, oseltamivir, peginter
  • composition of the present invention may be used in conjunction with non-orally administered antivirals including antivirals administered via injections (e.g., but not limited to enfuvirtide, fomivirsen, interferon gamma, nexavir, penciclovir, and peramivir), topically/dermatologically administered (e.g., but not limited to, docosanol, edoxudine, ibacitabine, imiquimod, and loviride), orally inhaled (e.g., but not limited to, zanamivir) and ophthalmically administered (e.g., but not limited to, idoxuridine and trifluridine).
  • antivirals administered via injections e.g., but not limited to enfuvirtide, fomivirsen, interferon gamma, nexavir, penciclovir, and peramivir
  • topically/dermatologically administered e.g., but not limited to
  • kits including a first container containing an alkylglycerol containing composition, where the alkylglycerol has the structure of formula:
  • R 1 and R 2 are the same or different and each includes hydrogen and aliphatic acyl groups of at most 24 carbon atoms, one of R 3 and R 4 is hydrogen and the other includes straight, branched, saturated and unsaturated alkoxy groups of at most 7 carbon atoms, and R 5 includes straight chain and branched alkyl and alkenyl groups of 4 to 21 carbon atoms; a second container including artemisinin or a derivative thereof, agaricus bisporous or extract thereof, and chlorophyllin or a derivative or an analog thereof containing composition; instructions comprising procedures for mixing the compositions of the first and second container; and a label.
  • the instructions further include procedures for administering an admixture containing the compositions of the first and second container to a subject in need thereof.
  • the second container contains one or more ingredients including idebenone or a derivative thereof or CoQIO or an analog or derivative thereof, melatonin or a derivative thereof, milk thistle or an analog or derivative thereof, at least 2 separate mineral salts, at least 2 separate fat soluble vitamins, and combinations thereof.
  • the mineral salts are zinc and copper salts.
  • the copper salts include copper ascorbate, copper bisglycinate chelate, copper chelate, copper chelate polyvinylpyridine, copper citrate, copper copper citrate on DCP, copper gluconate, copper glycinate, copper histidinate, copper Krebs trit on dicalcium phosphate, copper lysinate, copper orotate, copper oxide, copper picolinate, copper sebacate, copper sebicate, and copper sulfate and the zinc salts include zinc ascorbate complex (15%), bacitracin zinc, zinc acetate, zinc arginate, zinc aspartate, zinc bisglycinate, zinc caprylate, zinc chelate, zinc citrate, zinc gluconate, zinc gluconate trihydrate, zinc glutamate, zinc glycinate, zinc heptahydrate, zinc histidinate, zinc Krebs, zinc malate, zinc methionate
  • the fat soluble vitamins are vitamin D and vitamin A.
  • vitamin D includes vitamin D2 (ergocalciferol), vitamin D3 (cholicalciferol),
  • doxercalciferol, and paricalcitol and vitamin A includes retinyl acetate, retinoic acid, retinyl palmitate, retinol palmitate, beta carotene, and alpha carotene.
  • the admixture includes about 50 to 500 mg of idebenone or CoQIO, about 5 to about 50 mg of melatonin, about 300 to 1000 mg of milk thistle, about 14 to 50 mg of zinc gluconate, about 1 to 6 mg of copper gluconate, about 5 to 15 ⁇ g of vitamin D3, and about 500 to 3500 ⁇ g of retinyl acetate.
  • the admixture includes about 600 to 1200 mg of alkylglycerols, about 600 to 1500 mg of artemisinin, about 600 to 1000 mg of agaricus bisporous or extract thereof, and about 100 to about 600 mg of chlorophyllin.
  • a method of supplementing the diet of a subject including a step of administering to the subject the dietary supplement is disclosed which includes, in admixture, alkylglycerols, artemisinin or derivatives thereof, agaricus bisporous or an extract thereof, and chlorophyllin or an analog or derivative thereof.
  • the subject is infected with a virus.
  • administration of the dietary supplement reduces viral load.
  • the virus is selected from the group consisting of Hepatitis B, Hepatitis C, Epstein Barr Virus, HIV, Cytomegalovirus, Herpes Simplex Virus 1, Herpes Simplex Virus 2, Human Papillomavirus, Adenovirus, Kaposi's Sarcoma-Associated Herpesvirus,
  • the composition may contain an antiviral including abacavir, acyclovir, acyclovir, adefovir, amantadine, amprenavir, ampligen, arbidol, atazanavir, atripla, boceprevir, cidofovir, combivir, darunavir, delavirdine, didanosine, efavirenz, emtricitabine, entecavir, entry inhibitors, famciclovir, fos amprenavir, foscarnet, fosfonet, fusion inhibitor, ganciclovir, imunovir, indinavir, inosine, integrase inhibitor, interferon type III, interferon type I, lamivudine, lopinavir, maraviroc, moroxydine, methisazone, nelfinavir, nevirapine, nucleoside analogs, oseltamivir, peginter
  • composition of the present invention may be used in conjunction with non-orally administered antivirals including antiviral administered via injections (e.g., but not limited to enfuvirtide, fomivirsen, interferon gamma, nexavir, penciclovir, and peramivir), topically/dermatologically administered (e.g., but not limited to, docosanol, edoxudine, ibacitabine, imiquimod, and loviride), orally inhaled (e.g., but not limited to, zanamivir) and ophthalmically administered (e.g., but not limited to, idoxuridine and trifluridine).
  • antiviral administered via injections e.g., but not limited to enfuvirtide, fomivirsen, interferon gamma, nexavir, penciclovir, and peramivir
  • topically/dermatologically administered e.g., but not limited to
  • the use of a dietary supplement is disclosed, where the supplement consists essentially of, in admixture: an alkylglycerol, where the alkylglycerol has the structure of formula: where Rl and R2 are the same or different and each may include hydrogen and aliphatic acyl groups of at most 24 carbon atoms, one of R3 and R4 is hydrogen and the other includes straight, branched, saturated and unsaturated alkoxy groups of at most 7 carbon atoms, and R5 includes a straight chain and branched alkyl and alkenyl groups of 4 to 21 carbon atoms; artemisinin or a derivative thereof; agaricus bisporous or an extract thereof; and chlorophyllin or an analog or derivative thereof, optionally in association with one or more pharmaceutically acceptable carriers, excipients, and/or diluents for the manufacture of a medicament for the treatment or prevention of disorders associated with chronic infections in a subject, and where the medicament may also comprise one or more additional
  • Figure 1 illustrates the activation of the immune system by antigen.
  • supply includes, but is not limited to, an herb, enzyme, vitamin, animal oil, naturally occurring hormone, medicinal plant, animal extract, or diet-oriented compound or medicament such as those traditionally used in the treatment of a disease or a medical condition.
  • in situ or “in situs” means restricted to a site within the body of a subject.
  • analog means a compound having a structure similar to that of another one, but differing from it with respect to a certain component. It can differ in one or more atoms, functional groups, or substructures, which are replaced with other atoms, groups, or substructures. In a related aspect, such structures possess at least the same or similar therapeutic efficacy (e.g., reduces viral load).
  • derivative means a compound derived or obtained from another and containing essential elements of the parent substance. In a related aspect, such a derivative possesses at least the same or similar therapeutic efficacy (e.g., reduces viral load) as the parent.
  • therapeutic means to provide treatment for a disease or medical condition.
  • the composition as described herein improves at least one parameter associated with a disease or medical condition (e.g., chronic infection).
  • the dietary supplement as disclosed reduces viral load (e.g., by about 40% to 50%, about 50% to 60%, about 60% to 70%, about 70% to 80%, about 80% to 90%, about 90% to 100% or reduces viral load to the detection limit of PCR and/or immunoassay) or clears detectable virus from the subject when administered.
  • reduction in viral load may be assayed by any technique known in the art (e.g., immunologically or by nucleic acid-based assay, e.g., PCR).
  • therapeutic efficacy is achieved by giving the dietary supplement in 3 daily doses. As disclosed in the present invention, the amount of drug dosed three times per day must add-up to the total amount (e.g., weigh or units) as recited. For example, 600 to 1000 mg of artemisinin per day is administered using three divided doses, not 600 mg to 1000 mg per each of the 3 doses.
  • therapeutic efficacy is achieved in at least about 20 days, about 30 days, about 60 days, about 80 days, about 90 days, or about 120 days. Alternatively, therapeutic efficacy may be achieved in 6 months to a year.
  • admixture means an additional ingredient that is added by mixing one component or composition with a separate component or composition.
  • the alkylglycerols of the present invention may be mixed separately with 10 other components as recited herein (e.g., artemisinin, agaricus bisporous or extract thereof, chlorophyllin, idebenone, melatonin, milk thistle, at least 2 separate mineral salts, at least 2 separate fat soluble vitamins, and/or combinations thereof).
  • subject means a human or an animal that is exposed to experimental, therapeutic other observational procedures.
  • infectious agent means any power, principle or substance by which something is accomplished, or which is capable of producing a chemical, physical or biological effect such as a disease.
  • agents include, but are not limited to, Hepatitis B, Hepatitis C, Epstein Barr Virus, HIV,
  • Cytomegalovirus Herpes Simplex Virus 1, Herpes Simplex Virus 2, Human Papillomavirus, Adenovirus, Kaposi's Sarcoma-Associated Herpesvirus, Hepatitis B, Torquetenovirus, JC Virus, and BK Virus.
  • Other such agents may include bacterial organisms.
  • the present invention discloses a specific mix of supplements, which are free of serious side effects, to turn on "switches" of the immune system.
  • the admixture as presently disclosed is able to reverse Hepatitis C virus infections in 30 days and Hepatitis B virus infections in 23 days. Because all human immune systems behave in a relatively predictable fashion, except in rare cases of in-born T cell defects, the protocol should be 100% effective, regardless of any type or genotype of virus or subject (e.g., should be effective in those individuals with multiple gene morphology related to glutathione-S-transferase alleles; see, e.g., Kandemir et al, Hepatogastroenterology (2008) 55(86-87): 1729-1733). Further, the infectious agent is not likely to mutate against the treatment due to somatic hyper-mutation of the antibodies.
  • the formulation of the present application provides a way to induce the immune system with the right mixture of nutrition so that the host/subject in need thereof can produce potent antibodies against chronic virus infections such as Hepatitis B, Hepatitis C, Herpes Virus, Epstein Barr Virus, and the like.
  • the formulation of the present invention may be used to treat chronic bacterial infections such as chronic bacterial prostatitis, Lyme disease, leprosy, and the like.
  • the human immune system relies on antigen processing cells (APCs) to recognize invading microbial such as virus and bacteria in order to develop antibodies to destroy them (see, e.g., Figure 1).
  • APCs antigen processing cells
  • B cells B cells
  • macrophages macrophages
  • DCs dendritic cells
  • Both B cells and macrophages are permanent cells, meaning that most of the time, the human immune system depends on them as the main APCs to detect invading viruses and bacteria.
  • both B cells and macrophages are very poor quality APCs.
  • Dendritic cells were first described by Paul Langerhans in the late nineteenth century. It wasn't until 1973, however, that the term "dendritic cells” was coined by Ralph M. Steinman and Zanvil A. Cohn. Some of the basic functions of DCs were first reported by Ralph Steinman in 1980, but today not enough has been learned about these cells that only appear in the body under certain conditions and for only about 3 days at a time. DCs are the most powerful APCs because they are the only cells that are able to induce primary immune responses, thus permitting establishment of immunological memory. In fact, it is estimated that a DC to T cell ratio of 1 to 100 is all the body needs to initiate vigorous and optimal immune responses.
  • DCs select the rare specific T cells from the assembled repertoire that recognize the specific peptide information the DCs are carrying. However, only one in 10,000-100,000 of the T cells in that repertoire are able to respond to this information. In comparison with B cells and macrophages, DCs are 10,000 to 100,000 times more precise in selecting the most suitable T cell to initiate the antibody response. In other words, when compare with B cells and macrophages, DCs are 10,000 to 100,000 more precise in recognizing the invaders.
  • MHC (major histocompatibility complex) Class II molecules are found only on macrophages, dendritic cells and B cells. MHC Class II molecules interact exclusively with CD4+ ("helper") T cells (again, see Figure 1). The helper T cells then help to trigger an appropriate immune response which may include localized inflammation and swelling due to recruitment of phagocytes or may lead to a full-force antibody immune response due to activation of B cells.
  • Mature DCs are the only cell group that expresses MHC Class II at all times. MHC products and MHC peptide complexes are 10 to 100 folds higher on DCs than B cells and macrophages. Thus, DCs are 10 to 100 times more efficient in activating a potent/effective antibody response than B cells and macrophage cells. In fact, it is now recognized that immunity through vaccination will not take place without DCs.
  • DCs for immunotherapy are temporary cells, meaning the body needs specific conditions to trigger the release of the DCs. While not being bound by theory, it may be that those who fail to develop immunity against invading agents must also have failed to produce sufficient DCs, and therefore, their immune system is unable to recognize the infectious agent effectively.
  • the stimulation of DCs may represent a vital first step in the development of potent antibodies against any invading agent, viral or microbial.
  • the immune system needs more help than a simple boost in DCs in order to produce potent antibodies against invading virus and bacteria.
  • the human immune system contains four "switches.” While not being bound by theory, if all four switches are turned on in cascading sequence, the immune system will develop potent antibodies against any infectious agent, including Hepatitis B, Hepatitis C, HIV, Herpes, HPV virus and Epstein Barr virus and the like. This suggests that the immune system needs a very specific set of enhancers (e.g., nutrients) to produce potent antibodies in order to defend itself against infectious agents.
  • enhancers e.g., nutrients
  • a dietary and/or therapeutic supplement composition for the treatment of infectious agents including, in admixture, alkylglycerols, a
  • the supplement composition is formed by adding alkylglycerols to a composition comprising a sesquiterpene lactone, agaricus bisporous or an extract thereof, and chlorophyllin in situ or situs, where the sesquiterpene lactone may be artemisinin.
  • the liver oil from the rat fish and other elasmobranch fish is particularly rich in alkylglycerols. In natural sources alkylglycerols are always found ether-linked with fatty acids.
  • the ratfish (Chimera monstrosa), like the dog fish and the shark, is a member of the elasmobranch class of fish which are characterized by their distinctive lamellate gills.
  • the oil from the liver of the fish has been used for centuries to treat lymphodenopathy.
  • the substances in the oil that have accounted for these medicinal properties are the alkylglycerols.
  • Alkylglycerols are lipids with a glycerol backbone, to which fatty acid derivatives are coupled by means of an ether bond instead of the ester bond that characterizes most mono-, di- and triglycerols and related phospholipids (see, e.g., U.S. Pat. No. 6, 121,245, herein incorporated by reference).
  • the glycerol esters are widely distributed in animal tissues, although the liver of the elasmobranch fish remains the richest natural source.
  • the naturally occurring alkylglycerols are in most cases esterified with fatty acids of 16-18 C-atoms, sometimes unstaturated.
  • such alkylglycerols comprise compounds represented by the formula:
  • R 1 and R 2 are the same or different and each is selected from the group consisting of hydrogen and aliphatic acyl groups of at most 24 carbon atoms
  • one of R 3 and R 4 is hydrogen and the other is selected from the group consisting of straight, branched, saturated and unsaturated alkoxy groups of at most 7 carbon atoms
  • R 5 is selected from the group consisting of straight chain and branched alkyl and alkenyl groups of 4 to 21 carbon atoms.
  • Shark oil may be obtained commercially (see, e.g., ALKYROL, Eurohealth, Inc., Parkside, PA). Common fatty alcohols found in shark liver oil are chimyl alcohol, batyl alcohol and selachyl alcohol. Main ingredients of commercial sources may contain squalamine, 20% alkylglycerols, squalene, omega-3 oils, free fatty acids, vitamin E, Fe, Zn, and Cu. Synthetic alkylglycerols have been generated and shown to possess adjuvant properties (see, e.g., Acevado et al, Vaccine (2006) 24(Supp. 2):532-533; see, also, U.S. Pat. No.
  • the alkylglycerols may be natural or synthetic.
  • the alkyglycerols are naturally occurring.
  • the alkyglycerols are derived from shark oil.
  • Alkylglycerols are potent macrophage stimulating agents. Administration of small amounts of alkylglycerols to mice greatly enhances macrophage activation for Fc mediated ingestion activity at the 5th day post treatment (Yamamoto et al., Can Res (1998) 48:6044-649).
  • the present invention discloses the use of alkylglycerols in combination with other ingredients as recited herein as an effective admixture for treating viral infection.
  • the alkylglycerols may be administered at about 100 to 200 mg, about 300 to 600 mg, about 600 to 1200 mg, about 1200 to 1500 mg and about 1500 to 2000 mg of alkylglycerols.
  • Artemisinin also known as qinghaosu, and its derivatives are a group of drugs that possess the most rapid action of all current drugs against falciparium malaria.
  • artemisinin-combination therapies ACTs
  • ACTs artemisinin-combination therapies
  • the starting compound, artemisinin a sesquiterpene lactone
  • Artemisia annua an herb described in Chinese traditional medicine, though it is usually chemically modified and combined with other medications.
  • Use of the drug by itself as a monotherapy is explicitly discouraged by the WHO as there have been signs that malarial parasites are developing resistance to the drug.
  • Combination therapies that include artemisinin are the preferred treatment for malaria and are both effective and well tolerated in patients.
  • the drug is also increasingly being used in vivax malaria as well as being a topic of research in cancer treatment.
  • the present invention discloses the use of artemisinin in combination with alkylglycerols and other ingredients as recited herein as an effective admixture for treating viral infection, including, but not limited to derivatives and analogs of artemisinin such as dihydroartemisinin or DHQHS, artemether, arteether, sodium artesunate, artelinic acid, sodium artelinate, artenimol, or other C-10 carbon-substitutional derivatives of the trioxane artemisinin (see, e.g., U.S. Pat. No. 6,586,464, herein incorporated by reference).
  • the artemisinin, or a derivative thereof may be administered at about 100 to 600 mg, about to 600 to 1500 mg, or about 1500 to 2000 mg of artemisinin.
  • Agaricus bisporus known variously as the common mushroom, button mushroom, white mushroom, table mushroom, cremini, Champignon mushroom, crimini mushroom, Swiss brown mushrooms, Roman brown mushrooms, Italian brown, Italian mushroom, or cultivated mushroom— is an edible basidiomycete mushroom native to grasslands in Europe and North America. Agaricus bisporus is cultivated in more than 70 countries and is one of the most commonly and widely consumed mushrooms in the world.
  • These mushrooms can contain high amounts of vitamin D especially when UV- irradiated.
  • Agaricus bisporus also contains sodium, potassium, and phosphorous, conjugated linoleic acid, and antioxidants.
  • the table mushroom has been shown to possess possible immune system enhancing properties.
  • An in vitro study demonstrated the mushroom enhanced dendritic cell function (see, e.g., Ren et al, J Nutr (2008) 128(3):544-550).
  • the present invention discloses the use of Agaricus bisporus in combination with alkylglycerols, artemisinin, and other ingredients as recited herein as an effective admixture for treating viral infection.
  • the Agaricus bisporus (or extract thereof) may be administered at about 100 to 600 mg, about to 600 to 1000 mg, or about 1000 to 2000 mg of
  • Chlorophyllin refers to any one of a group of closely related water soluble salts that are semi synthetic derivatives of chlorophyll, differing in the identity of the cations associated with the anion. Its most common form is a sodium/copper derivative used as a food additive and in alternative medicine, and includes, but is not limited to, copper chlorin e6, copper chlorin e4, copper chlorin e4 ethyl ester, and related cyclic tetrapyrrole chlorins (see, e.g., Fahey et al, Carcinogenesis (2005) 26(7): 1247-1255, herein incorporated by reference).
  • Chlorophyllin is the active ingredient in a number of internally -taken preparations intended to reduce odors associated with incontinence, colostomies and similar procedures, as well as body odor in general. It is also available as a topical preparation, purportedly useful for both treatment and odor control of wounds, injuries, and other skin conditions. Chlorophyllin is extracted from green plants, nettle, spinach or grass.
  • the present invention discloses the use of chlorophyllin in combination with alkylglycerols, artemisinin, Agaricus bisporus and other ingredients as recited herein as an effective admixture for treating viral infection.
  • chlorophyllin may be administered at about 100 mg, about 200 mg, about 300 mg, about 400 mg, about 500 mg or about 600 mg of chlorophyllin.
  • a composition including alkylglycerols in admixture with a sesquiterpene lactone (e.g., artemisinin or derivatives thereof), agaricus bisporous (or an extract thereof), and chlorophyllin (including related cyclic tetrapyrrole chlorines and derivatives thereof).
  • a sesquiterpene lactone e.g., artemisinin or derivatives thereof
  • agaricus bisporous or an extract thereof
  • chlorophyllin including related cyclic tetrapyrrole chlorines and derivatives thereof.
  • the admixture essentially includes about 600 to 1200 mg of
  • alkylglycerols about 600 to 1500 mg of artemisinin or derivatives and analogs thereof, about 600 to 1000 mg of agaricus bisporous or extract thereof, and about 100 to about 600 mg of chlorophyllin, including related cyclic tetrapyrrole chlorins and derivatives thereof.
  • the admixture may contain idebenone (or derivatives thereof) or CoQIO (or analogs or derivatives thereof), melatonin or derivatives thereof, milk thistle or analogs or derivatives thereof, at least 2 separate mineral salts, at least 2 separate fat soluble vitamins, and/or combinations thereof.
  • the mineral salts are gluconic acid salts of zinc and copper.
  • the fat soluble vitamins are vitamin D and vitamin A.
  • Idebenone e.g., trade names CATENA and SOVRIMA
  • CATENA trade names CATENA and SOVRIMA
  • SOVRIMA is an experimental drug, initially developed for the treatment of Alzheimer's disease and other cognitive defects. This has been met with limited success. Recently it has started to be investigated for the treatment of neuromuscular diseases, including Friedreich's ataxia and Duchenne muscular dystrophy.
  • idebenone is an organic compound of the quinone family. It is also promoted commercially as a synthetic analog of coenzyme Q 10 (CoQIO), including that dietary supplements containing idebenone may be used as a potent version of CoQ IO.
  • CoQIO coenzyme Q 10
  • Derivatives include, but are not limited to, hydrophilic esters (e.g., sulfonic acid esters and other substituted idebenones; see U.S. Pat. No. 6,756,045, herein incorporated by reference).
  • idebenone is present in the composition of the present invention at a concentration of greater than about 50 and less than about 500 mg.
  • the idebenone or derivative thereof is present at about 50 to about 100 mg, about 100 to about 150 mg, about 150 to about 200 mg, about 200 to about 250 mg, about 250 to about 300 mg, about 300 to about 350 mg, about 350 to about 400 mg, about 400 to about 450 mg, or about 450 to about 500 mg.
  • idebenone is present at about 300 mg.
  • idebenone and CoQlO may be substituted for each other in a composition comprising alkylglycerols, artemisinin, agaricus bisporous or extract thereof, chlorophyllin, melatonin, milk thistle, at least 2 separate mineral salts, at least 2 separate fat soluble vitamins or derivatives thereof.
  • derivatives of CoQlO may be used (see, e.g., U.S. Pat. No.
  • CoQlO is present in the composition of the present invention at a concentration of greater than about 50 and less than about 500 mg.
  • the CoQlO, or derivative thereof is present at about 50 to about 100 mg, about 100 to about 150 mg, about 150 to about 200 mg, about 200 to about 250 mg, about 250 to about 300 mg, about 300 to about 350 mg, about 350 to about 400 mg, about 400 to about 450 mg, or about 450 to about 500 mg.
  • CoQlO is present at about 300 mg.
  • Melatonin also known chemically as N-acetyl-5-methoxytryptamine, is a naturally occurring compound found in animals, plants, and microbes. In animals, circulating levels of the hormone melatonin vary in a daily cycle, thereby allowing the entrainment of the circadian rhythms of several biological functions. Many biological effects of melatonin are produced through activation of melatonin receptors, while others are due to its role as an antioxidant, with a particular role in the protection of nuclear and mitochondrial DNA. In mammals, melatonin is secreted into the blood by the pineal gland in the brain.
  • Derivatives of melatonin include, but are not limited to, 5-methoxytryptamine, 5- methoxytryptophan, 5-methoxytryptophol, 5 -methoxyindole-3 -acetic acid and 6- hydroxymelatonin.
  • melatonin is present in the composition of the present invention at a concentration of greater than about 5 and less than about 50 mg.
  • the melatonin, or a derivative thereof is present at about 5 to about 10 mg, about 10 to about 15 mg, about 15 to about 20 mg, about 20 to about 25 mg, about 25 to about 30 mg, about 30 to about 35 mg, about 35 to about 40 mg, about 40 to about 45 mg, or about 45 to about 50 mg. In a related aspect, melatonin is present at about 30 mg.
  • Milk thistle (Sifybum marianum) is a flowering plant of the daisy family (Asteraceae). They are native to the Mediterranean regions of Europe, North Africa and the Middle East. The name “milk thistle” derives from two features of the leaves: they are mottled with splashes of white and they contain a milky sap.
  • the seeds of the milk thistle have been used for over 2000 years to treat chronic liver disease and protect the liver against toxins. Increasing research is being undertaken on the physiological effects, therapeutic properties and possible medical uses of milk thistle.
  • the active ingredient (silymarin) is made of flavonolignans (most commonly silybin).
  • silybin analogs may also be used, including but not limited to, 3',4'-ethylenedioxyflavonoids, 23-O-pivaloylsilybin, hesperetin (HESP), naringenin (NAN) and naringin (NAR).
  • milk thistle is present in the composition of the present invention at a concentration of greater than about 300 and less than about 1000 mg.
  • the milk thistle or analog or derivative thereof is present at about 300 to about 400 mg, about 400 to about 500 mg, about 500 to about 600 mg, about 600 to about 700 mg, about 700 to about 800 mg, about 800 to about 900 mg, and about 900 to about 1000 mg.
  • milk thistle is present at about 700 mg.
  • the mineral salts of the present invention contain copper or zinc.
  • the copper salts include, but are not limited to, copper amino acid chelate, copper ascorbate, copper bisglycinate chelate, copper chelate, copper chelate polyvinylpyridine, copper citrate, copper copper citrate on dicalcium phosphate, copper gluconate, copper glycinate, copper histidinate, copper Krebs trit on dicalcium phosphate, copper lysinate, copper orotate, copper oxide, copper picolinate, copper sebacate, copper sebicate, copper sulfate, and combinations thereof.
  • the compositions comprise natural sources of copper, including but not limited to, derivatives and extracts from seafood, nuts, legumes, and organ meats.
  • the copper salts are present in the admixture at a concentration of greater than about 1 mg and less than about 6 mg. In a related aspect, the concentration of copper salts is about 2 to about 3 mg, about 3 to about 4 mg, about 4 to about 5 mg, about 5 to about 6 mg.
  • the mineral salt is copper gluconate, where the copper gluconate is present at about 3 mg.
  • the zinc salts include, but are not limited to, zinc ascorbate complex (15%), bacitracin zinc, zinc amino acid chelate, zinc acetate, zinc arginate, zinc aspartate, zinc bisglycinate, zinc caprylate, zinc chelate, zinc citrate, zinc gluconate, zinc gluconate trihydrate, zinc glutamate, zinc glycinate, zinc heptahydrate, zinc histidinate, zinc Krebs, zinc malate, zinc methionate (monomethionine), zinc orotate, zinc oxide, zinc picolinate, zinc sulfate, zinc sulfate heptahydrate, zinc taurate, zinc yeast, and combinations thereof.
  • zinc ascorbate complex 15%), bacitracin zinc, zinc amino acid chelate, zinc acetate, zinc arginate, zinc aspartate, zinc bisglycinate, zinc caprylate, zinc chelate, zinc citrate, zinc gluconate, zinc gluconate trihydrate, zinc glutamate, zinc
  • the compositions comprise natural sources of zinc, including but not limited to, derivatives and extracts from meats, seafood and grains.
  • the zinc salts are present in the admixture at a concentration of greater than about 14 mg and less than about 50 mg. In a related aspect, the concentration of zinc salts is about 14 to about 20 mg, about 25 to about 30 mg, about 35 to about 40 mg, or about 45 to about 50 mg.
  • the mineral salt is zinc gluconate, where the zinc gluconate is present at about 30 mg.
  • the fat soluble vitamins include, but are not limited to vitamin A and vitamin D.
  • vitamin A includes, but is not limited to, retinyl acetate, retinoic acid, retinyl palmitate, retinol palmitate, beta carotene, and alpha carotene.
  • the compositions comprise natural sources of vitamin A, including but not limited to, derivatives and extracts from deep green and orange vegetables and fruits, and dairy products.
  • vitamin A is present in the admixture at a concentration of greater than about 2400 IU and less than about 10000 IU.
  • the concentration of vitamin A is about 2400 to about 3000 IU, about 3000 to about 5000 IU, about 5000 to about 7000 IU, about 7000 to about 9000 IU, or about 9000 to about 10000 IU.
  • IU for vitamin A may be converted to mg as follows: multiplying IU by 0.0003 mg/1 IU.
  • vitamin A is retinyl acetate, where retinyl acetate is present at about 1500 ⁇ g.
  • vitamin D includes, but is not limited to, vitamin D2 (ergocalciferol), vitamin D3 (cholicalciferol), doxercalciferol, and paricalcitol.
  • the compositions comprise natural sources of vitamin D, including but not limited to, derivatives and extracts from dairy products and egg yolk.
  • vitamin D is present in the admixture at a concentration of greater than about 300 IU and less than about 1000 IU.
  • the concentration of vitamin D is about 300 to about 400 IU, about 400 to about 500 IU, about 500 to about 600 IU, about 600 to about 700 IU, about 700 to about 800 IU, about 800 to about 900 IU or about 900 to about 1000 IU.
  • IU for vitamin D may be converted to mg by multiplying IU by 0.000025 mg/1 IU.
  • vitamin D is vitamin D3, where vitamin D3 is present at about 10 ⁇ g.
  • the admixture of the present invention includes about 300 mg of idebenone, about 30 mg of melatonin, about 700 mg of milk thistle, about 30 mg of zinc gluconate, about 3 mg of copper gluconate, about 10 ⁇ g of vitamin D3, and about 1500 ⁇ g of retinyl acetate.
  • the composition may contain an antiviral acyclovir, adefovir, amantadine, amprenavir, ampligen, arbidol, atazanavir, atripla, boceprevir, cidofovir, combivir, darunavir, delavirdine, didanosine, efavirenz, emtricitabine, entecavir, entry inhibitors, famciclovir, fosamprenavir, foscarnet, fosfonet, fusion inhibitor, ganciclovir, imunovir, indinavir, inosine, integrase inhibitor, interferon type III, interferon type I, lamivudine, lopinavir, maraviroc, moroxydine, methisazone, nelfinavir, nevirapine, nucleoside analogs, oseltamivir, peginterferon alfa-2a, peramivir, plec
  • composition of the present invention may be used in conjunction with non-orally administered antivirals including antivirals administered via injections (e.g., but not limited to enfuvirtide, fomivirsen, interferon gamma, nexavir, penciclovir, and peramivir), topically/dermatologically administered (e.g., but not limited to, docosanol, edoxudine, ibacitabine, imiquimod, and loviride), orally inhaled (e.g., but not limited to, zanamivir) and ophthalmically administered (e.g., but not limited to, idoxuridine and trifluridine).
  • antivirals administered via injections e.g., but not limited to enfuvirtide, fomivirsen, interferon gamma, nexavir, penciclovir, and peramivir
  • topically/dermatologically administered e.g., but not limited to
  • the amount of antiviral administered is about 1 to about 10 mg, about 10 to about 50 mg, about 50 to about 100 mg, about 100 to about 150 mg, or about 150 to about 200 mg.
  • the dosage may be determined by dose/kg body weight.
  • the antivirals include compositions from natural sources such as oils, juices, and other extracts.
  • natural antivirals include, but are not limited to, Melissa, tea tree oil, thyme, eucalyptus, lemon and other citrus oils, geranium, clove, rosemary, juniper, niaoulli, cinnamon, anise, Clary sage, bergamot, lemongrass, oregano, tannic acid, rose, sandalwood, myrtle, cypress, Siberian ginseng, Baikal or Chinese Skullcap, Elderberry/European Elder, echinacea, mullein, licorice, garlic, vitamin C, green tea, St Johns wort, vitamin E, apple juice, resveratrol, cranberry juice, cat's claw, curcumin, astragalus root, forsythia, grape seed extract, honeysuckle, isatidis, and leptotaenia.
  • the admixture may be combined with at least one antibiotic including, but not limited to, aminoglycosides, ansamycins, carbacephan, carbapenems, cephalosporins, glycopeptides, lucosamides, lipopeptides, macrolides, monobactams, nitrofurans, penicillins, antibiotic polypeptides (e.g., bacitracin, colistin, polymyxin B and the like), quinolones, sulfonamides, tetracyclines, chloramphenicol, and combinations thereof.
  • antibiotics may be administered orally or by intravenous route depending on the antibiotic used, as would be apparent to one of skill in the art.
  • the antibiotic is present or may be administered at about 250 mg to about 500 mg, about 500 mg to about 1000 mg, about 1000 mg to about 1500 mg, about 1500 mg to about 2000 mg, or about 2000 mg to about 3 g.
  • the dosage may be determined by dose/kg body weight.
  • compositions may be incorporated into a tablet, aqueous or oil suspension, dispersible powder or granule, microbead, emulsion, hard or soft capsule, syrup or elixir.
  • the components of the composition may also be administered separately, for example, alkylglycerols are separately mixed with a composition including a sesquiterpene lactone, agaricus bisporous or an extract thereof, and chlorophyllin.
  • Compositions may be prepared according to any method known in the art for the manufacture of pharmaceutically acceptable compositions and such compositions may contain one or more of the following agents: sweeteners, flavoring agents, coloring agents and preservatives.
  • Tablets containing the active ingredients in admixture with non-toxic pharmaceutically acceptable excipients suitable for tablet manufacture are acceptable.
  • pharmaceutically and/or pharmacologically acceptable refer to molecular entities and/or compositions that do not produce an adverse, allergic and/or other untoward reaction when administered to a subject as appropriate.
  • pharmaceutically acceptable means that the agent should be acceptable in the sense of being compatible with the other ingredients of the formulation.
  • excipients include inert diluents such as calcium carbonate, sodium carbonate, lactose, calcium phosphate or sodium phosphate; granulating and disintegrating agents, such as corn starch and alginic acid; binding agents such as starch, gelatin or acacia; and lubricating agents such as magnesium stearate, stearic acid or talc. Tablets may be uncoated or may be coated with known techniques to delay disintegration and absorption in the gastrointestinal tract and thereby provide a sustained action over a longer period of time. For example, a time delay material such as glyceryl monostearate or glyceryl stearate alone or with a wax may be employed.
  • inert diluents such as calcium carbonate, sodium carbonate, lactose, calcium phosphate or sodium phosphate
  • granulating and disintegrating agents such as corn starch and alginic acid
  • binding agents such as starch, gelatin or acacia
  • Another embodiment of the present invention is a pharmaceutical composition comprising an enteric-coated form of the compositions.
  • Any pharmaceutical formulation well known in the art can be coated with an enteric coating.
  • the formulation is a tablet, capsule or microbead.
  • the enteric coating may prevent dissolution of the tablet, capsule or microbead in the acidic environment of the stomach. Instead, this coating dissolves in the small intestine at a more neutral pH.
  • enteric coated compositions are described by Bauer et al., Coated
  • Formulations for oral use may also be presented as hard gelatin capsules wherein the active ingredient(s) is mixed with an inert solid diluent, for example calcium carbonate, calcium phosphate or kaolin, or as soft gelatin capsules wherein the active ingredient(s) is mixed with water or an oil medium, such as peanut oil, liquid paraffin or olive oil.
  • an inert solid diluent for example calcium carbonate, calcium phosphate or kaolin
  • water or an oil medium such as peanut oil, liquid paraffin or olive oil.
  • Aqueous compositions may be used in the present invention and comprise an effective amount of a therapeutic chemical compound or pharmaceutically acceptable salts thereof dissolved and/or dispersed in a pharmaceutically acceptable carrier and/or aqueous medium.
  • pharmaceutically acceptable carrier includes any and/or all solvents, dispersion media, coatings, antibacterial and/or antifungal agents, isotonic and/or absorption delaying agents and/or the like. The use of such media and/or agents for pharmaceutical active substances is well known in the art. Except insofar as any conventional media and/or agent is incompatible with the active ingredient, its use in the therapeutic compositions is contemplated. Supplementary active ingredients can also be incorporated into the compositions.
  • preparations may meet sterility, pyrogenicity, general safety and/or purity standards as required by FDA Office of Biologies standards.
  • the biological material may be extensively dialyzed to remove undesired small molecular weight molecules and/or lyophilized for more ready formulation into a desired vehicle, where appropriate.
  • aqueous compositions that contain an effective amount of a therapeutic agent as an active component and/or ingredient will be known to those of skill in the art in light of the present disclosure.
  • such compositions can be prepared as liquid solutions and/or suspensions; solid forms suitable for using to prepare solutions and/or suspensions upon the addition of a liquid prior to administration can also be prepared; and/or the preparations can also be emulsified.
  • the pharmaceutical forms suitable for use include sterile aqueous solutions and/or dispersions; formulations including sesame oil, peanut oil and/or aqueous propylene glycol; and/or sterile powders for the extemporaneous preparation of sterile solutions and/or dispersions. It must be stable under the conditions of manufacture and/or storage and/or must be preserved against the contaminating action of microorganisms, such as bacteria and/or fungi.
  • Solutions of the active compounds as free base and/or pharmacologically acceptable salts can be prepared in water suitably mixed with a surfactant, such as hydroxypropylcellulose.
  • Dispersions can also be prepared in glycerol, liquid polyethylene glycols, and/or mixtures thereof and/or in oils. Under ordinary conditions of storage and/or use, these preparations contain a preservative to prevent the growth of microorganisms.
  • Therapeutic agents of the present invention can be formulated into a composition in a neutral and/or salt form.
  • Pharmaceutically acceptable salts include the acid addition salts and/or which are formed with inorganic acids such as, for example, hydrochloric and/or phosphoric acids, and/or such organic acids as acetic, oxalic, tartaric, mandelic, and/or the like. Salts formed with the free carboxyl groups can also be derived from inorganic bases such as, for example, sodium, potassium, ammonium, calcium, and/or ferric hydroxides, and/or such organic bases as isopropylamine, trimethylamine, histidine, procaine and/or the like.
  • the carrier can also be a solvent and/or dispersion medium containing, for example, water, ethanol, polyol (for example, glycerol, propylene glycol, and/or liquid polyethylene glycol, and/or the like), suitable mixtures thereof, and/or vegetable oils.
  • the proper fluidity can be maintained, for example, by the use of a coating, such as lecithin, by the maintenance of the required particle size in the case of dispersion and/or by the use of surfactants.
  • the prevention of the action of microorganisms can be brought about by various antibacterial and/or antifungal agents, for example, parabens, chlorobutanol, phenol, sorbic acid, thimerosal, and/or the like.
  • isotonic agents for example, sugars and/or sodium chloride.
  • Prolonged absorption of the compositions can be brought about by the use in the compositions of agents delaying absorption, for example, aluminum monostearate and/or gelatin.
  • Sterile solutions are prepared by incorporating the active compounds in the required amount in the appropriate solvent with several of the other ingredients enumerated above, as required, followed by filtered sterilization.
  • dispersions are prepared by incorporating the various sterilized active ingredients into a sterile vehicle which contains the basic dispersion medium and/or the required other ingredients from those enumerated above.
  • the preferred methods of preparation are vacuum- drying and/or freeze-drying techniques which yield a powder of the active ingredient plus any additional desired ingredient from a previously sterile-filtered solution thereof.
  • solutions Upon formulation, solutions will be administered in a manner compatible with the dosage formulation and/or in such amount as is therapeutically effective.
  • the formulations are easily administered in a variety of dosage forms, such as the type of solutions described above.
  • kits of the present invention are kits comprising a therapeutic agent such those components as disclosed.
  • Such kits will generally contain, in suitable container means, a pharmaceutically acceptable formulation of a therapeutic agent(s).
  • the kit may have a single container means, and/or it may have distinct container means for each compound.
  • the kit may also contain instruction for administration/mixing the components therein.
  • the instructions may be a pamphlet, CD, or other computer readable medium. Further, the instructions may provide information about a website which may contain downloadable content.
  • Example 1 Preparation of the dietary supplement. [00103] The formulation consists of the 11 ingredients in two parts:
  • Part one consists of 600 mg to 1200 mg of alkylglycerols in 3 dividing doses daily.
  • Alkylglycerols are extracted from shark liver oil, and should not be mixed with the rest of the 10 ingredients.
  • the alkylglycerols are delivered in the form of shark liver oil (softgel), where each 1000 mg of shark oil contains 200 mg of alkylglycerols.
  • Part two consists of the following 10 ingredients in an enteric coated capsule or tablet to ensure that their potency is not affected by stomach acid. a. Artemisinin 600 mg to 1500 mg in 3 dividing doses daily
  • Alkylglycerols, artemisinin, agaricus bisporus and chlorophyllin form the core ingredients. Without any one of these four ingredients, the entire formulation is not likely to work effectively. Idebenone, melatonin, milk thistle, Zinc gluconate, Copper gluconate, vitamin D3 and retinyl acetate together enhance the efficacy of the formulation. Since each person's immune system is unique in some respect, these 7 ingredients allow patients with compromised, depressed or over-regulated immune systems to respond better to the formulation.
  • Example 2 Clinical examples of the efficacy of the formulation.
  • composition was formulated as above and administered as recited, unless otherwise indicated.
  • Viral load was determined by PCR and checked again by immunological methods.
  • the Hepatitis C virus count dropped below 615 IU/mL in about 30 days. Before treatment, the virus count was 109,570 IU/mL.
  • HBsAg Positive a Chronic B carrier
  • HBsAg Negative a non carrier
  • the Hepatitis C virus count dropped from 92, 152 IU/mL to 4, 192 IU/mL in 120 days. (Dropped by 96% in 120 days.)

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Abstract

Cette invention concerne des compositions diététiques et des méthodes d'utilisation de ces compositions pour le traitement d'infections virales chroniques, notamment par l'hépatite B et l'hépatite C.
PCT/US2011/020876 2011-01-11 2011-01-11 Compositions pour le traitement d'infections virales chroniques WO2012096655A1 (fr)

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PL422220A1 (pl) * 2017-07-14 2019-01-28 Aflofarm Farm Polska Spolka Z Ograniczona Odpowiedzialnoscia Kompozycja farmaceutyczna w postaci wodnego roztworu, korzystnie syropu, zawierająca pranobeks inozyny oraz glukonianu cynku oraz jej sposób otrzymywania
US11135162B2 (en) 2017-07-14 2021-10-05 Aflofarm Farmacja Polska Sp. Z O. O. Pharmaceutical composition in the form of an aqueous solution, 1A syrup, containing inosine pranobex and zinc gluconate and a method of preparation thereof
RU2779129C1 (ru) * 2019-02-04 2022-09-01 Афлофарм Фармацья Польска Сп З О О Твердая дозированная лекарственная форма, содержащая глюконат цинка и инозина пранобекс, способ ее получения и применения
CN111202723A (zh) * 2020-02-15 2020-05-29 江苏艾立康药业股份有限公司 一种达芦那韦吸入干粉药物组合物及其制备方法
CN111202724A (zh) * 2020-02-16 2020-05-29 江苏艾立康药业股份有限公司 一种阿比朵尔吸入干粉药物组合物及其制备方法

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