US 12,186,337 B2
Sodium nitrite-containing pharmaceutical compositions
Craig Sherman, Scottsdale, AZ (US); Anthony James Lepine, Greendale, WI (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 Jan. 18, 2023, as Appl. No. 18/098,361.
Application 18/098,361 is a division of application No. 17/126,329, filed on Dec. 18, 2020, granted, now 11,583,550.
Application 14/042,783 is a division of application No. 12/703,448, filed on Feb. 10, 2010, granted, now 8,568,793.
Application 17/126,329 is a continuation of application No. 16/842,939, filed on Apr. 8, 2020, granted, now 10,898,513.
Application 16/842,939 is a continuation of application No. 16/578,671, filed on Sep. 23, 2019, granted, now 10,874,691.
Application 16/578,671 is a continuation of application No. 15/973,659, filed on May 8, 2018, granted, now 10,456,417.
Application 15/973,659 is a continuation of application No. 15/599,617, filed on May 19, 2017, granted, now 10,251,910.
Application 15/599,617 is a continuation of application No. 15/249,746, filed on Aug. 29, 2016, granted, now 9,687,505.
Application 15/249,746 is a continuation of application No. 14/547,255, filed on Nov. 19, 2014, granted, now 9,597,354.
Application 14/547,255 is a continuation of application No. 14/042,783, filed on Oct. 1, 2013, granted, now 8,920,852.
Claims priority of provisional application 61/224,021, filed on Jul. 8, 2009.
Claims priority of provisional application 61/151,820, filed on Feb. 11, 2009.
Prior Publication US 2023/0256006 A1, Aug. 17, 2023
Int. Cl. A61K 33/00 (2006.01); A61K 9/00 (2006.01); A61K 9/08 (2006.01); A61K 31/17 (2006.01); A61K 31/4418 (2006.01); A61K 31/4709 (2006.01); A61K 31/519 (2006.01); A61P 9/00 (2006.01); A61P 11/00 (2006.01); A61P 17/00 (2006.01); A61P 43/00 (2006.01); C01B 21/50 (2006.01)
CPC A61K 33/00 (2013.01) [A61K 9/0019 (2013.01); A61K 9/08 (2013.01); A61K 31/17 (2013.01); A61K 31/4418 (2013.01); A61K 31/4709 (2013.01); A61K 31/519 (2013.01); A61P 9/00 (2018.01); A61P 11/00 (2018.01); A61P 17/00 (2018.01); A61P 43/00 (2018.01); C01B 21/50 (2013.01); Y02A 50/30 (2018.01); Y10T 436/204998 (2015.01)] 24 Claims
 
1. A method for treating a dermatological disease or a condition associated with the skin, comprising administering to a subject having the dermatological disease or condition associated with the skin a therapeutically effective amount of sodium nitrite which contains no greater than about 0.02% by weight of sodium carbonate, contains no greater than about 10 ppm of an anti-caking agent, has a loss on drying of no greater than about 0.25% by weight, wherein the water content is no greater than about 0.5% by weight, wherein the heavy metal content is no greater than about 10 ppm, contains no greater than about 0.4% by weight of sodium nitrate, contains no greater than about 0.005% by weight of insoluble matter, contains no greater than about 0.005% by weight of chloride, contains no greater than about 0.01% by weight of sulfate, contains no greater than about 0.001% 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 0.05 ppm of mercury, contains no greater than about 2 ppm of aluminum, contains no greater than about 3 ppm of arsenic, contains no greater than about 0.003% by weight of selenium, contains no greater than about 5000 ppm of ethanol, contains no greater than about 3000 ppm methanol, wherein the total non-volatile organic carbon content is no greater than about 10 ppm, and contains no greater than about 0.25 EU/mg of bacterial endotoxins.