Quality Evaluation of Pharmaceutical Preparations( II ) -Dissolution of Prednisolone Tablets-

의약품(醫藥品)의 품질평가(品質評價)에 관(關)한 연구(硏究) (제 2 보)(第 2 報) -프레드니솔론 정제(錠劑)의 용출(溶出)에 관한 연구(硏究)-

The dissolution profiles of the seven branded prednisolone tablets were determined by means of available compendium. Those tablets were stored at $40^{\circ}C,\;50^{\circ}C\;and\;60^{\circ}C$ for 15, 30 and 60 days respectively. Under the stress conditions, the dissolution efficiency showed significant changes. It is considered that the determination of shelf life of drug from these aging effects is possible because the dissolution data followed a logarithmic distribution. There were no substantial differences of dissolution between two prednisolone formulations with different particle size not larger than $100\;{\mu}m$. The effect of two starches (corn and potato) on the rate of dissolution of prednisolone from dosage form was also investigated. All marketed tablets met the requirement of the established compendium.