High-throughput determination of OROS® drug release rate profile using micro parallel liquid chromatography

A high throughput method with the use of micro parallel liquid chromatography (μPLC) technique was first applied for the determination of drug release profiles in OROS® tablets. Currently, high-performance liquid chromatography (HPLC) is a preferred analytical tool to analyze samples released from OROS® tablets. However, it usually takes more than 20 h to analyze a large number of release rate samples and generate a release-rate profile. In this study, with the use of a 24-column Brio cartridge, the μPLC enabled simultaneous analysis of 24 release-rate samples. The total analysis time including the generation of the release-rate profile was greatly reduced to 3 h. Two different OROS® formulations were used to compare the drug release testing using both μPLC and conventional HPLC. The drug release profiles generated using μPLC were comparable with those obtained by HPLC. In addition, the reproducibility and sensitivity of μPLC analysis were examined. Overall, significant reductions in analysis time and solvent consumption were the major advantages of using μPLC in profiling the drug release rate for a controlled-release dosage.