Stability and compatibility of intrathecal admixtures containing baclofen and high concentrations of morphine

Autor: Manjula Sitaram, Michael Tsui, H Barry Rawicki, Skip Lam, Balvant R. Sitaram
Rok vydání: 1997
Předmět:
Zdroj: International Journal of Pharmaceutics. 153:13-24
ISSN: 0378-5173
DOI: 10.1016/s0378-5173(97)04926-0
Popis: We have found that the simultaneous intrathecal infusion of low concentrations of baclofen and morphine are of significant benefit in the treatment of both severe pain and spasticity. To extend the range of drug concentrations for clinical use, the stability and physical compatibility of baclofen and morphine sulphate admixtures containing high concentrations of baclofen and morphine sulphate have been examined. The studies reported demonstrate that baclofen and morphine in the admixtures examined were stable for at least 30 days when stored at 37°C. 4-(4-chlorophenyl)-2-pyrrolidone, a degradation product of baclofen was detected in all admixtures examined. Its concentration remained less than 1% of that of baclofen throughout the period of storage. Morphine-N-oxide, a potential degradation product of morphine, could not be detected in any of the admixtures examined. While the use of a highly sensitive and selective liquid chromatographic technique with on-line fluorescence detection revealed the presence of pseudomorphine and its time-dependent increase on storage, its concentration also constituted less than 1% of the parent drug.
Databáze: OpenAIRE