	US 12,102,624 B2
	Pantoprazole compositions and methods
Brijeshkumar B. Pandya, Sacramento, CA (US); Govind R. Jagadale, Sacramento, CA (US); Dasaradhi Lakkaraju, Sacramento, CA (US); Bala Tripura Sundari Chodavarapu, Davis, CA (US); Anand Shukla, Denver, CO (US); and Jwalant Shukla, Sacramento, CA (US)
Assigned to Nivagen Pharmaceuticals, Inc., Sacramento, CA (US)
Filed by NIVAGEN PHARMACEUTICALS, INC., Sacramento, CA (US)
Filed on Aug. 26, 2021, as Appl. No. 17/446,063.
Claims priority of provisional application 63/070,510, filed on Aug. 26, 2020.
Prior Publication US 2022/0062253 A1, Mar. 3, 2022
Int. Cl. A61K 31/4439 (2006.01); A61J 1/10 (2006.01); A61K 9/16 (2006.01)

CPC A61K 31/4439 (2013.01) [A61J 1/10 (2013.01); A61K 9/1611 (2013.01); A61K 9/1694 (2013.01)]

20 Claims

1. A spray-dried storage stable pantoprazole composition comprising:

pantoprazole; and

an excipient matrix comprising sodium chloride (NaCl), wherein the sodium chloride and the pantoprazole are present at a weight ratio of between 50:1 and 5:1;

wherein the pantoprazole is substantially uniformly dispersed in the excipient matrix; and

wherein the pantoprazole composition is storage stable such that, after storage at 25° C. and 40% relative humidity for 12 weeks, the composition contains equal or less than 0.20% by weight of a pantoprazole sulfone degradant (Impurity-A) and equal or less than 0.20% by weight of a pantoprazole Methyl degradant (Impurity-D&F).