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Glutathione

a technology of glutathione and reactive intermediates, applied in the field of glutathione, can solve the problems of tissue-disrupting excesses of reactive intermediates, and achieve the effect of reducing the content of glutathion

Inactive Publication Date: 2016-12-22
DEMOPOULOS HARRY B
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The patent text discusses the negative effects of overexpressed IL-4 in acute viral infections and how insufficient intracellular glutathione concentrations can lead to the up-regulation of IL-4. This can result in the up-regulation of lipoxygenases and down-regulation of protective enzymes that disassemble lipid hydroperoxides. The text also mentions that glutathione therapy can help down-regulate IL-4 and correct the GSH insufficiencies that may lead to Th2 cytokines. The technical effect of the patent text is to provide a potential preventive and therapeutic measure to reduce the toxic effects associated with smallpox infections.

Problems solved by technology

Otherwise these cause tissue-disrupting excesses of reactive intermediates from lipid hydroperoxides (alkoxy radicals, LO., and hydroxyls, .OH).

Method used

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  • Glutathione

Examples

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Effect test

example 1

[0726]Reduced L-glutathione, a naturally-occurring water-soluble tripeptide (gamma-glutamyl-cysteinyl-glycine) is the most prevalent intracellular thiol in most biological systems. A preferred formulation of glutathione according to the present invention provides capsules for oral use containing 500 mg reduced L-glutathione, 250 mg USP grade crystalline ascorbic acid, and not more than 0.9 mg magnesium stearate, NF grade in an 00-type gelatin capsule. The powder may also be packaged in packets, for example containing 500 mg to 5 gm, and more preferably 1-3 grams per packet. The preferred packet preferably forms an oxygen impermeable barrier, to maintain the glutathione in a substantially reduced state for at least about 2.5 years under standard temperature and pressure conditions. For example, a metallized (e.g., aluminized), heat sealable polymer film packet may be suitable.

example 2

[0727]The preferred regimen for treatment of humans with glutathione according to the present invention is the administration of between 1 and 10 grams per day, in two divided doses, between meals (on an empty stomach), of encapsulated, stabilized glutathione according to Example 1. The study detailed in Appendix B administered the glutathione to HIV infected, otherwise healthy males between 18 and 65, with CD4+ cell counts above 500, not on any other medications. Clinical responses were seen in the PBM intracellular glutathione levels. Thus, at 1 hour after administration of a 1-gram bolus of encapsulated stabilized glutathione in two 500 mg capsules, a three-fold increase in glutathione was measured. It is noted that, since the human body produces large quantities of glutathione, the effects of external glutathione in individual cases may sometimes be masked or even appear paradoxical. However, a statistical analysis shows a dose response effect of the administration of glutathion...

example 3

[0728]24 HIV positive people received glutathione in a clinical trial. The first dose of one gram was taken at 0 time, or 10:00 a.m., and the second dose at 3 hours, or 1:00p.m. A baseline was measured two weeks earlier, on the same patient. A temporary intravenous catheter was in place for 7 hours to permit frequent blood sampling at the numerous time points. The statistical analysis of the entire patient population shows statistically significant elevations and a significant dose response relationship. In a compressed Phase I / II clinical trial (FDA IND#45012), in a well-defined GSH deficiency state, HIV infection, the composition according to Example 1 administered according to the protocol of Example 2 was demonstrated to rapidly and safely raises intracellular GSH levels two to three fold. Thus, by employing the composition according to Example 1 administered according to the protocol of Example 2, an oral pharmaceutical has been shown to treat the critical losses of GSH that ar...

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Abstract

The use of glutathione to treat or prophylax smallpox infection, to treat or prophylax chemical warfare agents, or to treat or prophylax radiation injury to humans due to release of radioactive elements is proposed. The preferred formulation is an oral dosage form, with reduced glutathione stabilized by ascorbic acid in at least equimolar concentration. The formulation may be in unit dosage form or in bulk.

Description

CROSS REFERENCE TO RELATED APPLICATIONS[0001]The present application claims benefit of priority under 35 U.S.C. §119(e) from U.S. Provisional Patent Application No. 62 / 182,229, filed Jun. 19, 2015, the entirety of which are each expressly incorporated herein by reference.FIELD OF THE INVENTION[0002]The present invention relates to the use of glutathione for treatment and / or prophylaxis of various conditions.BACKGROUND OF THE INVENTION[0003]The ubiquitous tripeptide L-glutathione (GSH) (gamma-glutamyl-cysteinyl-glycine), is a well known biological antioxidant, and in fact is believed to be the primary intracellular antioxidant for higher organisms. When oxidized, it forms a dimer (GSSG), which may be recycled in organs having glutathione reductase. Glutathione may be transported through membranes by the sodium-dependent glutamate pump. Tanuguchi, N., et al. Eds., Glutathione Centennial, Academic Press, New York (1989), expressly incorporated herein by reference.[0004]Glutathione (L-g...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K38/06A61K9/00
CPCA61K9/0053A61K38/063A61K9/0019A61K9/0056A61K47/22A61K9/0095A61K9/4858A61P25/16A61P25/28A61P31/18A61P39/00A61P39/02A61P39/06A61P43/00A61P9/00A61K9/145A61K9/4833
Inventor DEMOPOULOS, HARRY B.
Owner DEMOPOULOS HARRY B
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