# US 10,786,577 B2 · Pharmaceutical composition comprising glutatione disulfide and glutathione disulfide S-oxide

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- Number: US 10,786,577 B2
- Document ID: US10786577B2
- Status: Granted
- Kind: B2
- Application number: 16/603,042
- Filed: 2018-07-17
- Published: 2020-04-23
- Granted: 2020-09-29
- Earliest claimed: 2017-11-17
- Assignees: Obschestvo S Organichennoy Otvetstvennostju “Iva Farm”
- Applicants: Obschestvo S Ogranichennoy Otvetstvennostju “Iva Farm”
- Inventors: Mark Borisovich Balazovskij; Viktor Georgievich Antonov; Oleg Aleksandrovich Ignatenko
- Web page: https://patentgrep.com/patent/US10786577B2

## CPC

- A61K 47/64: Drug-peptide, drug-protein or drug-polyamino acid conjugates, i.e. the modifying agent being a peptide, protein or polyamino acid which is covalently bonded or complexed to a therapeutically active agent (peptidic linkers A61K47/65)
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- A61K 9/0019: {Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner (non-active ingredients are additionally classified in A61K47/00)}
- A61K 9/19: lyophilised {, i.e. freeze-dried, solutions or dispersions (lyophilised products with subsequent particle size reduction A61K9/14; granules or pellets made by lyphilisation A61K9/1682; solid oral dosage forms made by lyophilisation A61K9/2095; lyophilisation additives A61K47/00)}
- A61K 31/155: Amidines ([IMAGE cpc-sch-A61K-1029.gif]), e.g. guanidine (H2N—C(=NH)—NH2), isourea (N=C(OH)—NH2), isothiourea (—N=C(SH)—NH2)
- A61K 31/4709: Non-condensed quinolines and containing further heterocyclic rings
- A61K 33/243: Platinum; Compounds thereof
- A61K 38/063: {Glutathione}
- A61K 38/212: {IFN-alpha}
- A61K 39/00117: {Mucins, e.g. MUC-1}
- A61K 39/12: Viral antigens
- A61K 39/205: Rhabdoviridae, e.g. rabies virus
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61K 47/26: Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
- A61P 31/04: Antibacterial agents
- A61P 31/14: for RNA viruses
- A61K 33/24: Heavy metals; Compounds thereof
- A61K 2039/55505: {Inorganic adjuvants}
- C12N 2760/20134: Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
- C12N 2760/20231: Uses of virus other than therapeutic or vaccine, e.g. disinfectant
- Y02A 50/30: Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)
- Y02A: TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE

## Abstract

Pharmaceutical composition comprising glutathione disulphide or pharmaceutically acceptable organic or inorganic salt thereof and glutathione disulfide S-oxide of the following structure: or pharmaceutically acceptable organic or inorganic salt thereof for eliminating dose-related toxicity and enhancing the therapeutic activity of a pharmacologically active compound in the treatment of infectious and non-infectious diseases is provided. Typically, the composition comprises glutathione disulfide S-oxide in an amount of 0.01-10% by weight of the total composition, and additionally a metal (Me) in the form of coordination compound(s) containing Me-S-glutathione bond, said metal is selected from the platinum group, typically it is platinum. The amount of d-metal coordination compound administered to a patient can be 10−3 to 10−15 mol/kg of body weight. The composition can be used in combination with pharmacologically active compound, which is an anticoagulant, factor Xa inhibitor, antimicrobial or antiviral agents to increase their therapeutic activity and eliminate dose-related toxicity.

## Claims

### Claim 1

A pharmaceutical composition for treating dose-related toxicity and enhancing the therapeutic activity of a pharmacologically active compound in the treatment of infectious and non-infectious diseases, comprising glutathione disulfide or pharmaceutically acceptable organic or inorganic salt thereof and glutathione disulfide S-oxide of the following structure:
or pharmaceutically acceptable organic or inorganic salt thereof,
wherein said composition further comprises a d-metal (Me) selected from the platinum group, and
wherein the amount of d-metal in the composition ranges from 1×10−10 moles to 1×10−3 moles per 1 kg of the composition.

### Claim 2 (depends on 1)

The pharmaceutical composition of claim 1, wherein the amount of glutathione disulfide S-oxide is 0.01-10% by weight of the total composition.

### Claim 3 (depends on 1)

The pharmaceutical composition of claim 1, wherein the metal is platinum.

### Claim 4 (depends on 1)

The pharmaceutical composition of claim 1, wherein the amount of d-metal in the composition is 1×10−5 moles per 1 kg of the composition.

### Claim 5 (depends on 1)

A pharmacological combination for treating dose-dependent toxicity and enhancing the therapeutic activity of a pharmacologically active compound in the treatment of infectious and non-infectious diseases, comprising the composition of claim 1 and pharmacologically active compound selected from the group of anticoagulant, factor Xa inhibitor, antimicrobial or antiviral agent, calcium channel inhibitor.

### Claim 6 (depends on 5)

The pharmacological combination of claim 5, wherein non-infectious disease is thromboses, where the pharmacologically active compound is anticoagulant, factor Xa inhibitor amidine hydrochloride.

### Claim 7 (depends on 5)

The pharmacological combination of claim 5, wherein said infectious disease is caused by Gram-negative and Gram-positive bacteria, selected from the group consisting of Escherichia coli, Pseudomonas aeruginosa, Acinetobacter baumannii, Listeria monocytogenes EGD, Staphylococcus aureus, MRSA—methicillin-resistant Staphylococcus aureus, and wherein the pharmacologically active compound is antimicrobial agent moxifloxacin.

### Claim 8 (depends on 5)

The pharmacological combination of claim 5, wherein the infectious disease is a viral disease, where the pharmacologically active compound is antiviral agent.

### Claim 9 (depends on 8)

The pharmacological combination of claim 8, wherein the viral disease is rabies, wherein the pharmacologically active compound is antigenic material of anti-rabies vaccine.

### Claim 10 (depends on 1)

A medicament for treating dose-related toxicity and enhancing the therapeutic activity of a pharmacologically active compound in the treatment of infectious and non-infectious diseases, comprising at least one pharmaceutical composition according to claim 1 in a therapeutically effective amount together with pharmaceutically acceptable excipients.

### Claim 11 (depends on 5)

A medicament for treating dose-related toxicity and enhancing the therapeutic activity of a pharmacologically active compound in the treatment of infectious and non-infectious diseases, comprising at least one pharmacological combination according to claim 5 in a therapeutically effective amount together with pharmaceutically acceptable excipients.

### Claim 12 (depends on 10)

The medicament for treating dose-related toxicity and enhancing the therapeutic activity of a pharmacologically active compound in the treatment of infectious and non-infectious diseases, according to claim 10, wherein said medicament can be manufactured for external, inhalational, enteral or parenteral administration.

### Claim 13 (depends on 1)

A method of treating a second phase of xenobiotic detoxification by administering the pharmaceutical composition of claim 1.

### Claim 14 (depends on 1)

A method of treating a viral diseases associated with interferon alpha activity by administering the pharmaceutical composition of claim 1.