US 11,753,301 B2
Sodium thiosulfate-containing pharmaceutical compositions
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 Feb. 13, 2023, as Appl. No. 18/108,803.
Application 18/108,803 is a continuation of application No. 17/469,006, filed on Sep. 8, 2021.
Application 17/469,006 is a continuation of application No. 16/905,959, filed on Jun. 19, 2020, granted, now 11,142,456, issued on Oct. 12, 2021.
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 2023/0183067 A1, Jun. 15, 2023
This patent is subject to a terminal disclaimer.
Int. Cl. C01B 17/64 (2006.01); A61K 33/14 (2006.01); A61K 33/22 (2006.01); A61K 33/04 (2006.01); A61K 31/404 (2006.01); A61K 31/519 (2006.01); A61K 31/573 (2006.01); A61K 31/60 (2006.01); A61K 45/06 (2006.01); A61K 33/00 (2006.01); A61K 9/00 (2006.01); A61K 31/4418 (2006.01); A61K 31/727 (2006.01)
CPC C01B 17/64 (2013.01) [A61K 9/0014 (2013.01); A61K 9/0019 (2013.01); A61K 31/404 (2013.01); A61K 31/4418 (2013.01); A61K 31/519 (2013.01); A61K 31/573 (2013.01); A61K 31/60 (2013.01); A61K 31/727 (2013.01); A61K 33/00 (2013.01); A61K 33/04 (2013.01); A61K 33/14 (2013.01); A61K 33/22 (2013.01); A61K 45/06 (2013.01); C01P 2006/80 (2013.01); Y10T 436/23 (2015.01)] 24 Claims
 
1. Pharmaceutical grade sodium thiosulfate which 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 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% by weight of sulfite, contains no greater than about 0.5% by weight 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 sodium thiosulfate at 25° C. is colorless and has a pH between about 6.0 and about 8.0.