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

Claim 16:
17. A method of increasing shelf life of an immediate release baclofen stick pack composition comprising baclofen or a pharmaceutically acceptable salt thereof, the method comprising reducing formation of 4-(4-chlorophenyl)-2-pyrrolidone (4-CPP) impurity to an amount of less than 0.2 wt %,
wherein the formation of the 4-CPP impurity is reduced by intimately mixing the baclofen or a pharmaceutically acceptable salt thereof and a stabilizer in a stabilizer to baclofen weight ratio of from about 1.5:1 to about 20:1;
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 stick pack composition for 6 months at 40° C. and 75% relative humidity (RH).