	US 11,857,683 B2
	Stabilization of phenobarbital sodium for injection
Malay Shah, Vadodara (IN); Bhushan Borole, Jalgaon (IN); Ravi Patel, Anand (IN); and Ajay Jaysingh Khopade, Vadodara (IN)
Assigned to SUN PHARMA ADVANCED RESEARCH COMPANY LIMITED, Mumbai (IN)
Filed by SUN PHARMA ADVANCED RESEARCH COMPANY LIMITED, Maharashtra (IN)
Filed on Apr. 7, 2022, as Appl. No. 17/715,491.
Claims priority of provisional application 63/319,918, filed on Mar. 15, 2022.
Claims priority of application No. 202121030559 (IN), filed on Jul. 7, 2021.
Prior Publication US 2023/0031957 A1, Feb. 2, 2023
Int. Cl. A61K 9/19 (2006.01); A61P 25/08 (2006.01); A61K 9/08 (2006.01); A61K 31/515 (2006.01); A61K 47/10 (2017.01)

CPC A61K 9/19 (2013.01) [A61K 9/08 (2013.01); A61K 31/515 (2013.01); A61K 47/10 (2013.01); A61P 25/08 (2018.01)]

25 Claims

1. A lyophilized pharmaceutical composition of phenobarbital or salts thereof having an ethanol content in the range from 12000 ppm to 50000 ppm, wherein an amount of total impurities in the lyophilized pharmaceutical composition does not exceed 0.2% following 36 months of storage at 20-25° C., wherein the lyophilized pharmaceutical composition is free of benzyl alcohol and propylene glycol.