Claims for Patent: 9,579,345

Summary for Patent: 9,579,345

Title:	Sodium thiosulfate-containing pharmaceutical compositions
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.
Inventor(s):	Sherman; Craig (Scottsdale, AZ), Smith; Catherine Marie (Grafton, WI), Wirtz; Kevin Robert (Belgium, WI), Schulze; Erich (Mission Viejo, CA)
Assignee:	Hope Medical Enterprises, Inc. (Scottsdale, AZ)
Application Number:	15/137,082
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,579,345
Patent Claims:	1. A method for treating vascular calcification, calciphylaxis or platinum-induced ototoxicity, comprising administering to a subject having vascular calcification, calciphylaxis or platinum-induced ototoxicity, a therapeutically effective amount of pharmaceutical grade sodium thiosulfate pentahydrate, wherein the pharmaceutical grade sodium thiosulfate pentahydrate contains no greater than about 10 ppm of non-purgeable organic carbon, contains no greater than about 0.05 ppm of mercury, contains no greater than about 2 ppm of aluminum, contains no greater than about 0.003% by weight of selenium, contains no less than about 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 about 10 ppm, contains no greater than about 200 ppm of chloride, contains no greater than about 0.001% by weight of sulfide, contains no greater than about 0.002% by weight of iron, contains no greater than about 0.01% by weight of calcium, contains no greater than about 0.005% by weight of potassium, contains no greater than about 0.1% of sulfite, contains no greater than about 0.5% of sulfate, contains no greater than about 3 ppm of arsenic, contains no greater than about 0.001% by weight of lead, has total aerobic count of microbial load of no greater than about 100 CFU/g, has total yeast and mold count of no greater than about 20 CFU/g, contains no greater than about 0.02 EU/mg of bacterial endotoxins, contains no greater than about 0.002% by weight of nitrogen compounds, contains no greater than about 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 pharmaceutical grade sodium thiosulfate pentahydrate at 25.degree. C. is colorless and has a pH between about 6.0 and about 8.0, and wherein the pharmaceutical grade sodium thiosulfate pentahydrate is odorless crystals, wherein the administration is topical, oral or parenteral. 2. The method of claim 1, wherein vascular calcification is treated. 3. The method of claim 2, further comprising the administration of a diuretic, a renin inhibitor, a neutral endopeptidase inhibitor (NEP), a vasopeptidase inhibitor (dual NEP-ACE inhibitor), a HMG CoA reductase inhibitor, a bile acid sequestrant, an anti-atherosclerotic agent, a calcium channel inhibitor, a potassium channel activator, an alpha-adrenergic agent, a beta-adrenergic agent, an antiarrhythmic agent, an ACAT inhibitor, a MTP inhibitor, a vasodilator, a platelet activating factor (PAF) antagonist, an anti-platelet agent, a P2Y(AC) antagonist, aspirin, or an anticoagulant. 4. The method of claim 3, wherein the diuretic is chlorothiazide, hydrochlorothiazide, flumethiazide, hydroflumethiazide, bendroflumethiazide, methylchlorothiazide, trichloromethiazide, polythiazide, benzothiazide, ethacrynic acid, ticrynafed, chlorothalidone, furosemide, muzolimine, bumetanide, triamterene, amiloride or spironoloactone. 5. The method of claim 3, wherein the vasopeptidase inhibitor is omapatrilat or gemopatrilat. 6. The method of claim 3, wherein the HMG CoA reductase inhibitor is pravastatin, lovastatin, atorvastatin, simvastatin, NK-104 (itavastatin), and ZD-4522 (rosuvastatin). 7. The method of claim 3, wherein the bile acid sequestrant is questran or niacin. 8. The method of claim 3, wherein the calcium channel blocker is amlodipine besylate. 9. The method of claim 3, wherein the beta-adrenergic agent is carvedilol or metoprolol. 10. The method of claim 3, wherein the vasodilator is a phosphodiesterase inhibitor, or sodium nitrite. 11. The method of claim 10, wherein the phosphodiesterase inhibitor is cilostazol, sildenafil, tadalafil, or vardenafil. 12. The method of claim 3, wherein the anti-platelet agent is abciximab, eptifibatide, or tirofiban. 13. The method of claim 3, wherein the P2Y(AC) antagonist is clopidogrel, itclopidine or CS-747. 14. The method of claim 3, wherein the anticoagulant is wafarin, a low molecular weight heparin, a Factor VIIa inhibitor, or a Factor Xa inhibitor. 15. The method of claim 14, wherein the low molecular weight heparin is enoxaparin. 16. The method of claim 2, wherein the administration is intradermal, dermal or transdermal. 17. The method of claim 2, wherein the administration is intravenous or subcutaneous. 18. The method of claim 1, wherein calciphylaxis is treated. 19. The method of claim 18, further comprising the administration of a hormonal agent, a diuretic or an anti-diabetic agent. 20. The method of claim 19, wherein the diuretic is chlorothiazide, hydrochlorothiazide, flumethiazide, hydroflumethiazide, bendroflumethiazide, methylchlorothiazide, trichloromethiazide, polythiazide, benzothiazide, ethacrynic acid, ticrynafed, chlorothalidone, furosemide, muzolimine, bumetanide, triamterene, amiloride or spironoloactone. 21. The method of claim 19, wherein the anti-diabetic agent is a biguanide, a glucosidase inhibitor, insulin, a meglitinide, a sulfonylurea, a thiozolidinediones, a PPAR-gamma agnonist, metformin, acarbose, repaglinide, flimepiride, glyburide, glipizide, troglitazone, rosiglitazone or pioglitazone. 22. The method of claim 18, wherein the administration is intradermal, dermal or transdermal. 23. The method of claim 18, wherein the administration is intravenous or subcutaneous. 24. The method of claim 18, wherein the administration is topical, oral or parenteral. 25. The method of claim 1, wherein platinum-induced ototoxicity is treated. 26. The method of claim 25, wherein the administration is intradermal, dermal or transdermal. 27. The method of claim 25, wherein the administration is intravenous or subcutaneous. 28. A method for treating atherosclerosis, comprising administering to a subject having atherosclerosis, a therapeutically effective amount of pharmaceutical grade sodium thiosulfate pentahydrate, wherein the pharmaceutical grade sodium thiosulfate pentahydrate contains no greater than about 10 ppm of non-purgeable organic carbon, contains no greater than about 0.05 ppm of mercury, contains no greater than about 2 ppm of aluminum, contains no greater than about 0.003% by weight of selenium, contains no less than about 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 about 10 ppm, contains no greater than about 200 ppm of chloride, contains no greater than about 0.001% by weight of sulfide, contains no greater than about 0.002% by weight of iron, contains no greater than about 0.01% by weight of calcium, contains no greater than about 0.005% by weight of potassium, contains no greater than about 0.1% of sulfite, contains no greater than about 0.5% of sulfate, contains no greater than about 3 ppm of arsenic, contains no greater than about 0.001% by weight of lead, has total aerobic count of microbial load of no greater than about 100 CFU/g, has total yeast and mold count of no greater than about 20 CFU/g, contains no greater than about 0.02 EU/mg of bacterial endotoxins, contains no greater than about 0.002% by weight of nitrogen compounds, contains no greater than about 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 pharmaceutical grade sodium thiosulfate pentahydrate at 25.degree. C. is colorless and has a pH between about 6.0 and about 8.0, and wherein the pharmaceutical grade sodium thiosulfate pentahydrate is odorless crystals. 29. The method of claim 28, further comprising the administration of a diuretic, a renin inhibitor, a neutral endopeptidase inhibitor (NEP), a vasopeptidase inhibitor (dual NEP-ACE inhibitor), a HMG CoA reductase inhibitor, a bile sequestrant, an anti-atherosclerotic agent, a calcium channel inhibitor, a potassium channel activator, an alpha-adrenergic agent, a beta-adrenergic agent, an antiarrhythmic agent, an ACAT inhibitor, a MTP inhibitor, a vasodilator, a platelet activating factor (PAF) antagonist, an anti-platelet agent, a P2Y(AC) antagonist, aspirin, or an anticoagulant. 30. The method of claim 29, wherein the diuretic is chlorothiazide, hydrochlorothiazide, flumethiazide, hydroflumethiazide, bendroflumethiazide, methylchlorothiazide, trichloromethiazide, polythiazide, benzothiazide, ethacrynic acid, ticrynafed, chlorothalidone, furosemide, muzolimine, bumetanide, triamterene, amiloride or spironoloactone. 31. The method of claim 29, wherein the vasopeptidase inhibitor is omapatrilat or gemopatrilat. 32. The method of claim 29, wherein the HMG CoA reductase inhibitor is pravastatin, lovastatin, atorvastatin, simvastatin, NK-104 (itavastatin), and ZD-4522 (rosuvastatin). 33. The method of claim 29, wherein the bile acid sequestrant is questran or niacin. 34. The method of claim 29, wherein the calcium channel blocker is amlodipine besylate. 35. The method of claim 29, wherein the beta-adrenergic agent is carvedilol or metoprolol. 36. The method of claim 29, wherein the vasodilator is a phosphodiesterase inhibitor, or sodium nitrite. 37. The method of claim 36, wherein the phosphodiesterase inhibitor is cilostazol, sildenafil, tadalafil, or vardenafil. 38. The method of claim 29, wherein the anti-platelet agent is abciximab, eptifibatide, or tirofiban. 39. The method of claim 29, wherein the P2Y(AC) antagonist is clopidogrel, itclopidine or CS-747. 40. The method of claim 29, wherein the anticoagulant is wafarin, a low molecular weight heparin, a Factor VIIa inhibitor, or a Factor Xa inhibitor. 41. The method of claim 40, wherein the low molecular weight heparin is enoxaparin. 42. The method of claim 28, wherein the administration is topical, oral or parenteral. 43. The method of claim 42, wherein the administration is intradermal, dermal or transdermal. 44. The method of claim 42, wherein the administration is intravenous or subcutaneous.

Details for Patent 9,579,345

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Janssen Biotech, Inc.	REOPRO	abciximab	Injection	103575	12/22/1994		2029-07-08