Patent ID: 11931328
Assignee: AMNEAL PHARMACEUTICALS, LLC
Field: Pharmaceuticals (Chemistry)
Classification: CPC A | IPC A

Claim 0:
1. An immediate release pharmaceutical composition comprising granules comprising an active ingredient selected from 4-amino-3-(4-chlorophenyl) butanoic acid) (“baclofen”) and a pharmaceutically acceptable salt thereof; a stabilizer; and 4-(4-chlorophenyl)-2-pyrrolidone (4-CPP) impurity in an amount of less than 0.2 wt % of the active ingredient,
wherein the stabilizer is poly(butyl methacrylate-co-(2-dimethylaminoethyl) methacrylate-co-methyl methacrylate),
wherein the impurity does not increase to more than 0.2 wt % after storage under accelerated storage conditions, and
wherein the accelerated storage conditions comprise storage of the composition for 6 months at 40° C. and 75% relative humidity (RH).