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Glutathione formulation and method of use

一种谷胱甘肽、制剂的技术，应用在抗毒剂、三肽成分、抗病毒剂等方向，能够解决GSH分解代谢GSH浓度增加等问题

Active Publication Date: 2018-06-08
MOLECULAR DEFENSES CORP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Administration of amino acid precursors of GSH had no or little effect on plasma GSH values, suggesting that GSH catabolism and resynthesis cannot explain the increased GSH concentrations seen

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0360] The generation of embodiment 1 GSH-ascorbic acid mixture

[0361] A preferred GSH formulation according to the invention provides capsules for oral use containing 500 mg of reduced L-GSH (Kyowa Hakko ), 250 mg USP grade crystalline ascorbic acid, and not more than 0.9 mg magnesium stearate, NF grade, in a type OO gelatin capsule. The powder can also be packaged in sachets, for example containing 500mg to 5g, more preferably 1-3g per sachet. Preferred packets preferably form an oxygen impermeable barrier such that GSH remains in a substantially reduced state for at least about 2.5 years under standard conditions of temperature and pressure. For example, metalized (eg aluminized) heat-sealable polymeric film packaging may be suitable.

[0362] GSH was mixed with ascorbic acid in a rotary mixer under a dry nitrogen flush. Prior to preparation, GSH should be stored under conditions of controlled temperature 68-75°F (19-24°C) and humidity of about less than 20% relative ...

Embodiment 2

[0366] Embodiment 2 treatment plan

[0367]A preferred regimen for the treatment of humans with GSH according to the invention is to administer encapsulated stabilized GSH according to Example 1 in two divided doses of 1 to 10 grams per day between meals (on an empty stomach). The study detailed in Appendix B administered GSH to HIV-infected, otherwise healthy men aged 18-65 with CD4+ cell counts above 500 and no other medications. As detailed in Figure 1, clinical responses were observed in PBM intracellular GSH levels. Thus, a 3-fold increase in GSH was measured 1 hour after administration of 1 gram of encapsulated stabilized GSH in two 500 mg capsules. It is worth noting that due to the large amount of GSH produced by the human body, the role of external GSH may sometimes be obscured or even appear contradictory in individual cases. However, as shown in Figure 3, statistical analysis revealed a dose-response effect of GSH administration to the subject population. Figure ...

Embodiment 3

[0368] Example 3 IND

[0369] In a compressed phase I / II clinical trial (FDAIND #45012), the composition according to Example 1 administered according to the regimen of Example 2 was shown to rapidly and safely increase HIV infection in a well-defined GSH deficiency state Intracellular GSH levels 2-3 times. Thus, by employing the composition according to Example 1 administered according to the regimen of Example 2, an oral drug has been shown to treat the critical loss of GSH known to drive a range of major disorders. The GSH metabolism, especially the pharmacokinetics, of the subjects in the phase II study was considered to be relatively normal. Thus, the same regimen can be used to treat other conditions, including CHF, diabetes, early stroke or other ischemic events, toxic injury, viral infection or disease, or other conditions where free radical responses are uncontrolled, abnormal, or lead to pathology.

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PUM

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Abstract

The use of glutathione to treat or prophylax viral, bacterial, chemical, and nuclear agents, or to treat or prophylax radiation injury to humans due to release of radioactive elements. The preferred formulation is an oral dosage form, with reduced glutathione stabilized by ascorbic acid, packaged to under controlled humidity and temperature conditions to ensure creation of charge transfer complexes that ensure consistent packaging, insignificant oxidation during packaging and subsequent normal storage, and high oral bioavailability for humans.

Description

technical field [0001] The present invention relates to the use of glutathione for the treatment and / or prevention of various conditions. Background technique [0002] The ubiquitous tripeptide L-glutathione (GSH) (γ-glutamyl-cysteinyl-glycine) is a well-known biological antioxidant and is actually considered the major intracellular antioxidant in higher organisms. oxidizing agent. When oxidized, it forms a dimer (GSSG), which can be recycled in organs with glutathione reductase. Glutathione can be transported across membranes by a sodium-dependent glutamate pump. Tanuguchi, N. et al., eds., Glutathione Centennial, Academic Press, New York (1989). Glutathione is widely distributed in nature, including yeast cells, plant life and animals. It is made in the same way in the human body by two different enzymes, which is relevant for understanding the properties of glutathione (12). [0003] GSH is "bent" by two enzymes in the same way in thousands of life forms, and has lon...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/06A61K47/22A61K31/195A61K45/06
CPCA61K9/0019A61K9/0056A61K47/22A61K9/0095A61K38/063A61K9/4858A61P25/16A61P25/28A61P31/18A61P39/00A61P39/02A61P39/06A61P43/00A61P9/00A61K9/145A61K9/4833A61K9/0053
Inventor 哈里·B·德莫普洛斯凯文·戴维斯
Owner MOLECULAR DEFENSES CORP
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