Method of treatment of glutathione deficient mammals

Abstract

Glutathione (GSH) is a tripeptide of extreme importance as a catalyst, reductan, and reactant. It can be depleted intracellulary either by forming a direct complex with an electrophilic agent (accomplished investigationally by agents such as bromobenzene or diethyl maleate), by way of inhibition of synthesis, or by subjecting cells to oxidant stress. Most cells, except for epithelia cells, do not have a direct transport capacity for intact GSH. Non-epithelial cells must either transport precursor substrates for GSH synthesis or salvage amino acids from circulating GSH for reuse in intracellular resynthesis. Dietary cysteine is a rate limiting substrate for the synthesis of glutathione and also inhibits GSH efflux. Although GSH is synthesized from precursors in virtually all cells, the liver is the main source of plasma GSH. Protection and support of liver function is paramount to elevating GSH levels. The disclosure is also of a unique combination of nutritional supplements including n-acetyl cysteine, vitamin C, l-glucosamine, n-acetyl d-glucosamine, quercitin, sylimarin, Alpha lipoic acid and high protein, low fat whey that are combined to support various bodily systems involved in glutathione synthesis, reutilization and storage; all intended to elevate glutathione concentration in the mammalian cell.

1. A composition of matter, which comprises in admixture;
 N-acetylcysteine; N-acetyl-d-glucosamine vitamin C whereby the amount of vitamin C is in an amount of at least 1000 mg. or greater to facilitate the absorption of N-acetylcysteine across the cellular membrane; and    a pharmaceutically acceptable carrier for oral administration.    
     
     
       2. The composition of  claim 1  further comprising one or more of the following substances from the group consisting of alpha-lipoic acid, sylmarin, quercitin, l-glutamine, a probiotic, and dietary protein. 
     
     
       3. The composition of  claim 1  further comprising alpha-lipoic acid, sylmarin, quercitin, l-glutamine, and a probiotic. 
     
     
       4. The composition of  claim 3  further comprising dietary protein. 
     
     
       5. The composition of  claim 1  further comprising flavorants. 
     
     
       6. The systematic administration of a pharmaceutically effective amount of the composition according to  claim 1  to a mammal suffering from low glutathione levels, to stimulate the natural production of glutathione in the biologically active cells of the mammal. 
     
     
       7. The systemic administration of a pharmaceutically effective amount of the composition according to  claim 2  to a mammal suffering from hepatitis, to stimulate the natural production of glutathione in the biologically active cells of the mammal. 
     
     
       8. The systemic administration of a pharmaceutically effective amount of the composition according to  claim 2  to a mammal suffering from HIV, to stimulate the natural production of glutathione in the biologically active cells of the mammal. 
     
     
       9. The systemic administration of a pharmaceutically effective amount of the composition according to  claim 2  to a mammal suffering from allergies, to stimulate the natural production of glutathione in the biologically active cells of the mammal and to promote the shift of the T-cell balance from TH2 to TH1 and decrease levels of IgE. 
     
     
       10. The systemic administration of a pharmaceutically effective amount of the composition according to  claim 2  to a mammal to decrease serum cholesterol and triglycerides. 
     
     
       11. The systemic administration of a pharmaceutically effective amount of the composition according to  claim 2  to a mammal suffering from one or more of the following illnesses from the group consisting of chronic viral infections: HIV, hepatitis C, chronic fatigue, immuno deficiency syndrome, immune deficiencies, cancer, B-cell malignancies, including lymphomas, chronic leukemia, myeloma Waldenstrom's and MGUS to improve immune defense productions and thereby mitigate the progression of the illnesses to thereby limit fatigue. 
     
     
       12. The systemic administration of a pharmaceutically effective amount of the composition according to  claim 2  to a mammal to decrease fatigue. 
     
     
       13. The systemic administration of a pharmaceutically effective amount of the composition according to  claim 2  to a mammal to decrease the biologic effects of stress. 
     
     
       14. The systemic administration of a pharmaceutically effective amount of the composition according to  claim 2  to a mammal to increase energy and improve physical performance. 
     
     
       15. Administration according to  claim 6  wherein a pharmaceutically effective amount is 0.1 mg/kg to about 50 mg/kg of body weight of the mammal, daily. 
     
     
       16. Administration according to  claim 6  wherein a pharmaceutically effective amount is 0.5 mg/kg to about 25 mg/kg of body weight of the mammal daily. 
     
     
       17. The systemic administration of a pharmaceutically effective amount of the composition according to  claim 2  to a mammal suffering from low glutathione levels, to stimulate the natural production of glutathione in the biologically active cells of the mammal. 
     
     
       18. The systemic administration of a pharmaceutically effective amount of the composition according to  claim 3  to a mammal suffering from low glutathione levels, to stimulate the natural production of glutathione in the biologically active cells of the mammal. 
     
     
       19. The systemic administration of a pharmaceutically effective amount of the composition according to  claim 1  to a mammal suffering from low glutathione levels, to stimulate the natural production of glutathione in the biologically active cells of the mammal and reduce symptoms of diseases caused by excess unneutralized free radicals. 
     
     
       20. The systemic administration of a pharmaceutically effective amount of the composition according to  claim 2  to a mammal suffering from low glutathione levels, to stimulate the natural production of glutathione in the biologically active cells of the mammal and reduce symptoms of diseases caused by excess unneutralized free radicals. 
     
     
       21. The systemic administration of a pharmaceutically effective amount of the composition according to  claim 3  to a mammal suffering from low glutathione levels, to stimulate the natural production of glutathione in the biologically active cells of the mammal and reduce symptoms of diseases caused by excess unneutralized free radicals. 
     
     
       22. The systemic administration of a pharmaceutically effective amount of the composition according to  claim 19 , wherein the disease is a member of the group consisting of pulmonary oxygen toxicity, adult respiratory distress syndrome, broncopulmonery dysplasia, sepis syndrome, Parkinson's disease, encephalitis, endotoxemia, anoxia induced neuronal damage, ischemic reperfusion injury, inflammatory diseases, systemic lupus erythematosis, myocardial infarction, stroke, traumatic hemorrhage, spinal cord trauma, Crohn's disease, rheumatoid arthritis, diabetes, cataract formation, uvetis, emphysema, gastric ulcers, oxygen toxicity, neoplasia, undesired cell apoptosis, radiation sickness. 
     
     
       23. The systemic administration of a pharmaceutically effective amount of the composition according to  claim 20 , wherein the disease is a member of the group consisting of pulmonary oxygen toxicity, adult respiratory distress syndrome, broncopulmonery dysplasia, sepis syndrome, Parkinson's disease, encephalitis, endotoxemia, anoxia induced neuronal damage, ischemic reperfusion injury, inflammatory diseases, systemic lupus erythematosis, myocardial infarction, stroke, traumatic hemorrhage, spinal cord trauma, Crohn's disease, rheumatoid arthritis, diabetes, cataract formation, uvetis, emphysema, gastric ulcers, oxygen toxicity, neoplasia, undesired cell apoptosis, radiation sickness. 
     
     
       24. The systemic administration of a pharmaceutically effective amount of the composition according to  claim 21 , wherein the disease is a member of the group consisting of pulmonary oxygen toxicity, adult respiratory distress syndrome, broncopulmonery dysplasia, sepis syndrome, Parkinson's disease, encephalitis, endotoxemia, anoxia induced neuronal damage, ischemic reperfusion injury, inflammatory diseases, systemic lupus erythematosis, myocardial infarction, stroke, traumatic hemorrhage, spinal cord trauma, Crohn's disease, rheumatoid arthritis, diabetes, cataract formation, uvetis, emphysema, gastric ulcers, oxygen toxicity, neoplasia, undesired cell apoptosis, radiation sickness. 
     
     
       25. The systemic administration of a pharmaceutically effective amount of the composition according to  claim 1  to a mammal, to promote the natural production of glutathione in the biologically active cells of the mammal which accelerates the detoxification of ethanol and alleviates symptoms associated with excessive ethanol imbibation. 
     
     
       26. The composition of  claim 1  further comprising a probiotic, said probiotic for promoting the breakdown and absorption of nutrients, the elimination of toxins and to inhibit the growth of harmful bacteria in the gastrointestinal tract, thereby facilitating the absorption of N-acetylcysteine into the gastrointestinal tract. 
     
     
       27. The probiotic of  claim 1 , wherein said probiotic is a composition of “healthy bacteria” containing one or more of said healthy bacteria selected from the group comprising bifidobacterium longum, bifidobacterium infantis, lactobacillus acidophilus, lactobacillus casei, lactobacillus rhamnosus, saccharomyces boulardi, propionibacteria and enterococci. 
     
     
       28. The composition of  claim 2  further comprising 1-glutamine, said component being an essential dietary component to promote the support of gastrointestinal growth and function, thus facilitating the absorption of N-acetylcysteine through the gastrointestinal tract. 
     
     
       29. The composition of  claim 4  wherein N-acetyl-d-glucosamine promotes the biosynthesis of mucosal glycoproteins which make up the glycocalyx, a layer of the gut mucosa which acts to protect the tissue of the gastrointestinal tract while providing a selectively absorptive surface, thus facilitating the absorption of N-acetylcysteine into the gastrointestinal tracts. 
     
     
       30. A composition of matter which comprises in admixture: N- acetylcysteine, N - acetyl - d - glucosamine, vitamin C, present in an amount by weight of  1  to  20  parts N - acetylcysteine,  0 . 5  to  2  parts N - acetyl - d - glucosamine and  5  to  50  parts vitamin C;      whereby the amount of vitamin C is in an amount of at least  1000  mg or greater to facilitate the absorption of N - acetylcysteine across a cellular membrane; and        a pharmaceutically acceptable carrier for oral administration.     
     
     
       31. A composition of matter which comprises in admixture:  3  parts N- acetylcysteine,  1  part N - acetyl - d - glucosamine and  2  parts vitamin C;      whereby the amount of vitamin C is in an amount of at least  1000  mg or greater to facilitate the absorption of N - acetylcysteine across the cellular membrane; and        a pharmaceutically acceptable carrier for oral administration.     
     
     
       32. A composition of matter of  claim 30 , which comprises in admixture;
   further comprising one or more substances selected from the group consisting of alpha - lipoic acid, sylmarin, quercitin, L - glutamine, a probiotic, and dietary protein.     
     
     
       33. The composition of  claim 31 , further comprising alpha- lipoic acid, sylmarin, quercitin, L - glutamine, and a probiotic.   
     
     
       34. The composition of  claim 33 , further comprising dietary protein. 
     
     
       35. The composition of  claim 30 , further comprising flavorants. 
     
     
       36. A method of stimulating natural production of glutathione in cells of a mammal which comprises systemic administration of a pharmaceutically effective amount of a composition of  claim 30 . 
     
     
       37. The method of  claim 36 , wherein the mammal is suffering from hepatitis. 
     
     
       38. The method of  claim 36 , wherein the mammal is suffering from HIV. 
     
     
       39. A method of stimulating natural production of glutathione in cells of the mammal and to promote shift of T- cell balance from TH 2  to TH 1  and decrease levels of IgE which comprises systemic administration of a pharmaceutically effective amount of a composition of    claim 32   .   
     
     
       40. A method of decreasing serum cholesterol and triglycerides in a mammal which comprises systemic administration of a pharmaceutically effective amount of a composition of  claim 32 . 
     
     
       41. A method of improving immune defense productions and thereby mitigating progression of illnesses to thereby limit fatigue to a mammal suffering from one or more of the following illnesses selected from the group consisting of chronic viral infections: HIV, hepatitis C, chronic fatigue, immuno deficiency syndrome, immune deficiencies, cancer, B- cell malignancies, lymphomas, chronic leukemia, myeloma Waldenstrom's and MGUS,      which comprises systemic administration of a pharmaceutically effective amount of the composition according to    claim 32    to a mammal.     
     
     
       42. The method of decreasing fatigue in a mammal which comprises systemic administration of the composition of  claim 32  to a mammal. 
     
     
       43. A method of decreasing the biological effects of stress which comprises systemic administration of a pharmaceutically effective amount of the composition according to  claim 32  to a mammal. 
     
     
       44. A method of increasing energy and improving physical performance which comprises systemic administration of a pharmaceutically effective amount of the composition according to  claim 32  to a mammal. 
     
     
       45. The method of  claim 36 , wherein the pharmaceutically effective amount is  0 . 1  mg/kg to about  50  mg/kg of body weight of the mammal, daily. 
     
     
       46. The method of  claim 36 , wherein the pharmaceutically effective amount is  0 . 5  mg/kg to about  25  mg/kg of body weight of the mammal, daily. 
     
     
       47. The method of  claim 36 , wherein the composition further comprising one or more of the following substances selected from the group consisting of alpha- lipoic acid, sylmarin, quercitin, L - glutamine, a probiotic, and dietary protein.   
     
     
       48. The method of  claim 47 , wherein the composition further comprising one or more of the following substances selected from the group consisting of alpha- lipoic acid, sylmarin, quercitin, L - glutamine, and a probiotic.   
     
     
       49. A method of stimulating the natural production of glutathione in the cells of the mammal and reduce symptoms of diseases caused by excess unneutralized free radicals which comprises the systemic administration of a pharmaceutically effective amount of the composition of  claim 32 . 
     
     
       50. The method of  claim 49 , wherein the composition further comprising one or more of the following substances selected from the group consisting of alpha- lipoic acid, sylmarin, quercitin, L - glutamine, a probiotic, and dietary protein.   
     
     
       51. The method of  claim 50 , wherein the composition further comprising one or more of the following substances selected from the group consisting of alpha- lipoic acid, sylmarin, quercitin, L - glutamine, and a probiotic.   
     
     
       52. The method of  claim 49 , wherein the disease is selected from the group consisting of pulmonary oxygen toxicity, adult respiratory distress syndrome, bronchopulmonery dysplasia, sepsis syndrome, Parkinson's disease, encephalitis, endotoxemia, anoxia induced neuronal damage, ischemic reperfusion injury, inflammatory diseases, systemic lupus erythematosis, myocardial infarction, stroke, traumatic hemorrhage, spinal cord trauma, Crohn's disease, rheumatoid arthritis, diabetes, cataract formation, uvetis, emphysema, gastric ulcers, oxygen toxicity, neoplasia, undesired cell apoptosis, and radiation sickness. 
     
     
       53. The method of  claim 50 , wherein the disease is selected from the group consisting of pulmonary oxygen toxicity, adult respiratory distress syndrome, bronchopulmonery dysplasia, sepsis syndrome, Parkinson's disease, encephalitis, endotoxemia, anoxia induced neuronal damage, ischemic reperfusion injury, inflammatory diseases, systemic lupus erythematosis, myocardial infarction, stroke, traumatic hemorrhage, spinal cord trauma, Crohn's disease, rheumatoid arthritis, diabetes, cataract formation, uvetis, emphysema, gastric ulcers, oxygen toxicity, neoplasia, undesired cell apoptosis, and radiation sickness. 
     
     
       54. The method of  claim 51 , wherein the disease is selected from the group consisting of pulmonary oxygen toxicity, adult respiratory distress syndrome, bronchopulmonery dysplasia, sepsis syndrome, Parkinson's disease, encephalitis, endotoxemia, anoxia induced neuronal damage, ischemic reperfusion injury, inflammatory diseases, systemic lupus erythematosis, myocardial infarction, stroke, traumatic hemorrhage, spinal cord trauma, Crohn's disease, rheumatoid arthritis, diabetes, cataract formation, uvetis, emphysema, gastric ulcers, oxygen toxicity, neoplasia, undesired cell apoptosis, and radiation sickness. 
     
     
       55. The method of  claim 36 , wherein the method of stimulating natural production of glutathione in cells of a mammal results in detoxification of ethanol and alleviation of symptoms associated with excessive ethanol imbibation. 
     
     
       56. The composition of  claim 32  wherein the one or more substances is L- glutamine.