Intrathecal baclofen pharmaceutical dosage forms with fewer degradation products

摘要

The present invention relates generally to a sterile, particulate-free, stable intrathecal baclofen solution with less than 0.5% 4-(4-chlorophenyl)-2-pyrrolidone, a degradation product. These solutions are stable under a variety of storage conditions and for extended periods of time. Also disclosed are methods for preparing such compositions.

主权项

1. An aqueous, terminally sterilized pharmaceutical composition suitable for intrathecal delivery, wherein the composition comprises baclofen at a concentration of between about 0.5 mg/mL to about 4.0 mg/mL, and wherein the composition contains 0.5% (by weight of baclofen) or less 4-(4-chlorophenyl)-2-pyrrolidone.