Patent ID: 11857683
Assignee: SUN PHARMA ADVANCED RESEARCH COMPANY LTD.
Field: Pharmaceuticals (Chemistry)
Classification: CPC A | IPC A

Claim 20:
21. A pharmaceutical composition of phenobarbital sodium having an ethanol content in the range from about 12000 ppm to about 25000 ppm, wherein the pharmaceutical composition is made by reconstituting the lyophilized pharmaceutical composition of phenobarbital sodium;
wherein the amount of total impurities present following 12 hours of storage at 20-25° C. or following 36 hours of storage at 2-8° C. does not exceed 0.2%;
wherein phenobarbital sodium is present in a concentration from 10-200 mg/ml; and
wherein the pharmaceutical composition is free of benzyl alcohol and propylene glycol.