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

Claim 24:
25. 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° C.-25° C.,
wherein, said lyophilized pharmaceutical composition upon reconstitution with water for injection or an aqueous saline or an aqueous dextrose solution provides a stable reconstituted composition up to 12 hours of storage at 20° C.-25° C. or 36 hours of storage at 2° C.-8° C.;
wherein, an amount of total impurities in the reconstituted composition does not exceed 0.2% following 12 hours of storage at 20° C.-25° C. or 36 hours of storage at 2° C.-8° C.;
wherein said lyophilized pharmaceutical composition and said reconstituted composition are free of benzyl alcohol and propylene glycol;
optionally wherein said lyophilized pharmaceutical composition and said reconstituted composition comprise HCl; and
wherein said reconstituted composition is suitable for the treatment of neonatal seizure in newborn infants of 2 weeks of age or younger in need thereof.