Craig Sherman, Scottsdale, AZ (US); Catherine Marie Smith, Grafton, WI (US); Kevin Robert Wirtz, Belgium, WI (US); and Erich Schulze, Mission Viejo, CA (US)
Assigned to Hope Medical Enterprises, Inc., Scottsdale, AZ (US)
Filed by Hope Medical Enterprises, Inc., Scottsdale, AZ (US)
Filed on Sep. 8, 2021, as Appl. No. 17/469,006.
Application 17/469,006 is a continuation of application No. 16/905,959, filed on Jun. 19, 2020, granted, now 11,142,456.
Application 16/905,959 is a continuation of application No. 16/248,026, filed on Jan. 15, 2019, granted, now 10,723,623, issued on Jul. 28, 2020.
Application 16/248,026 is a continuation of application No. 16/208,667, filed on Dec. 4, 2018, granted, now 10,479,687, issued on Nov. 19, 2019.
Application 16/208,667 is a continuation of application No. 15/916,950, filed on Mar. 9, 2018, granted, now 10,479,686, issued on Nov. 19, 2019.
Application 15/916,950 is a continuation of application No. 15/409,659, filed on Jan. 19, 2017, granted, now 9,944,524, issued on Apr. 17, 2018.
Application 15/409,659 is a continuation of application No. 15/137,082, filed on Apr. 25, 2016, granted, now 9,579,345, issued on Feb. 28, 2017.
Application 15/137,082 is a continuation of application No. 14/310,133, filed on Jun. 20, 2014, granted, now 9,345,724, issued on May 24, 2016.
Application 14/310,133 is a continuation of application No. 14/222,766, filed on Mar. 24, 2014, granted, now 9,144,580, issued on Sep. 29, 2015.
Application 14/222,766 is a continuation of application No. 13/927,241, filed on Jun. 26, 2013, granted, now 8,715,746, issued on May 6, 2014.
Application 13/927,241 is a continuation of application No. 12/831,331, filed on Jul. 7, 2010, granted, now 8,496,973, issued on Jul. 30, 2013.
Claims priority of provisional application 61/223,993, filed on Jul. 8, 2009.
Prior Publication US 2022/0063999 A1, Mar. 3, 2022
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 pharmaceutical composition comprising a therapeutically effective amount of pharmaceutical grade sodium thiosulfate pentahydrate, wherein the pharmaceutical grade sodium thiosulfate pentahydrate contains no greater than about 8 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° C. is colorless and has a pH between about 6.0 and about 8.0, wherein the pharmaceutical grade sodium thiosulfate pentahydrate is odorless crystals, and wherein the pharmaceutical composition further comprises one or more of an isotonic agent, a buffering agent or a pH adjusting agent.