# US 10,479,687 B2 · Sodium thiosulfate-containing pharmaceutical compositions

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- Number: US 10,479,687 B2
- Document ID: US10479687B2
- Status: Granted
- Kind: B2
- Application number: 16/208,667
- Filed: 2018-12-04
- Published: 2019-04-04
- Granted: 2019-11-19
- Earliest claimed: 2009-07-08
- Assignees: Hope Medical Enterprises, Inc.
- Applicants: Hope Medical Enterprises, Inc.
- Inventors: Craig Sherman; Catherine Marie Smith; Kevin Robert Wirtz; Erich Schulze
- Web page: https://patentgrep.com/patent/US10479687B2

## CPC

- C01B 17/64: Thiosulfates; Dithionites; Polythionates
- A61K 9/0014: {Skin, i.e. galenical aspects of topical compositions (non-active ingredients are additionally classified in A61K47/00; A61K9/0009, A61K9/0021, A61K9/7015, A61K9/7023 take precedence; cosmetic preparations A61K8/00, A61Q; preparations for wound dressings or bandages A61L26/00)}
- 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 31/404: Indoles, e.g. pindolol
- A61K 31/4418: having a carbocyclic group directly attached to the heterocyclic ring, e.g. cyproheptadine
- A61K 31/519: ortho- or peri-condensed with heterocyclic rings
- A61K 31/573: substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
- A61K 31/60: Salicylic acid; Derivatives thereof
- A61K 31/727: Heparin; Heparan
- A61K 33/00: Medicinal preparations containing inorganic active ingredients
- A61K 33/04: Sulfur, selenium or tellurium; Compounds thereof
- A61K 33/14: Alkali metal chlorides; Alkaline earth metal chlorides
- A61K 33/22: Boron compounds
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61P 3/14: for calcium homeostasis (vitamin D A61P3/02; parathyroid hormones A61P5/18; calcitonin A61P5/22; osteoporosis A61P19/10; bone metastasis A61P35/04)
- A61P 9/00: Drugs for disorders of the cardiovascular system
- A61P 9/10: for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
- A61P 13/12: of the kidneys
- A61P 17/00: Drugs for dermatological disorders
- A61P 17/02: for treating wounds, ulcers, burns, scars, keloids, or the like
- A61P 17/06: Antipsoriatics
- A61P 17/12: Keratolytics, e.g. wart or anti-corn preparations
- A61P 19/06: Antigout agents, e.g. antihyperuricemic or uricosuric agents
- A61P 27/16: Otologicals
- A61P 29/00: Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
- A61P 31/04: Antibacterial agents
- A61P 31/10: Antimycotics
- A61P 31/12: Antivirals
- A61P 39/02: Antidotes
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- C01P 2006/80: Compositional purity
- Y10T 436/23: Carbon containing
- C01B: NON-METALLIC ELEMENTS; COMPOUNDS THEREOF; {METALLOIDS OR COMPOUNDS THEREOF NOT COVERED BY SUBCLASS C01C}
- 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
- C01P: INDEXING SCHEME RELATING TO STRUCTURAL AND PHYSICAL ASPECTS OF SOLID INORGANIC COMPOUNDS
- Y10T: TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION

## Abstract

Provided herein are pharmaceutically acceptable sodium thiosulfate and pharmaceutical compositions thereof. Also provided herein are methods for determining the total non-purgeable organic carbon in a sodium thiosulfate-containing sample. Further provided herein are methods for producing pharmaceutically acceptable sodium thiosulfate. Still further provided herein are methods of treatment comprising the administration of pharmaceutically acceptable sodium thiosulfate.

## Claims

### Claim 1

A pharmaceutical composition comprising sodium thiosulfate pentahydrate and one or more pharmaceutically acceptable carriers or excipients, wherein the sodium thiosulfate pentahydrate contains no greater than 8 ppm of non-purgeable organic carbon, contains no greater than 0.05 ppm of mercury, contains no greater than 2 ppm of aluminum, contains no greater than 0.003% by weight of selenium, contains no less than 98% by weight and no greater than about 102% by weight of sodium thiosulfate on an anhydrous basis measured by ion chromatography, has a water content between 32% and 37% by weight, has a heavy metal content of no greater than 10 ppm, contains no greater than 200 ppm of chloride, contains no greater than 0.001% by weight of sulfide, contains no greater than 0.002% by weight of iron, contains no greater than 0.01% by weight of calcium, contains no greater than 0.005% by weight of potassium, contains no greater than 0.1% of sulfite, contains no greater than 0.5% of sulfate, contains no greater than 3 ppm of arsenic, contains no greater than 0.001% by weight of lead, has total aerobic count of microbial load of no greater than 100 CFU/g, has total yeast and mold count of no greater than 20 CFU/g, contains no greater than 0.02 EU/mg of bacterial endotoxins, contains no greater than 0.002% by weight of nitrogen compounds, contains no greater than 0.005% by weight of insoluble matter, contains no greater than 0.01% by weight of residual anti-caking agent, and contains no greater than ICH Q3C (R3) limits of organic volatile impurities, wherein a 10% aqueous solution of the solid sodium thiosulfate pentahydrate at 25° C. is colorless and has a pH between 6.0 and 8.0, and wherein the solid sodium thiosulfate pentahydrate is odorless crystals,
wherein the pharmaceutical composition is an enteric-coated capsule or is formulated for rectal administration.

### Claim 2 (depends on 1)

The pharmaceutical composition of claim 1, wherein the enteric-coating of said enteric-coated capsule comprises a fatty acid, a fat, a phenyl salicylate, a wax, a shellac, an ammoniated shellac, a cellulose acetate phthalate, or a combination thereof.

### Claim 3 (depends on 1)

The pharmaceutical composition of claim 1, wherein the pharmaceutical composition formulated for rectal administration is an enema formulation.

### Claim 4 (depends on 1)

The pharmaceutical composition of claim 1, wherein the pharmaceutical composition formulated for rectal administration is a suppository formulation.

### Claim 5 (depends on 4)

The pharmaceutical composition of claim 4, wherein the suppository formulation comprises a stiffening agent.

### Claim 6 (depends on 4)

The pharmaceutical composition of claim 4, wherein the suppository formulation comprises cocoa butter, glycerin-gelatin, carbowax, spermaceti, paraffin, white or yellow wax, a mixture of mono-, di- and triglycerides of fatty acids, a hydrogel, polyvinyl alcohol, hydroxyethyl methacrylate, polyacrylic acid, glycerinated gelatin, or a combination thereof.

### Claim 7 (depends on 1)

The pharmaceutical composition of claim 1, wherein the sodium thiosulfate pentahydrate has a positive identification test for sodium.

### Claim 8 (depends on 1)

The pharmaceutical composition of claim 1, wherein the sodium thiosulfate pentahydrate has a positive identification test for thiosulfate.

### Claim 9 (depends on 1)

The pharmaceutical composition of claim 1, wherein the composition is formulated as a single dosage form.