Evaluation of the Sensitivity of USP Prednisone Tablets to Dissolved Gas in the Dissolution Medium Using USP Apparatus 2

Abstract

This study evaluated the sensitivity of USP Prednisone tablets (Reference Standard Lot P0E203) to dissolved gas in the medium in USP Apparatus 2. This lot will be introduced into commerce over the summer of 2006 as a replacement for current Lot O0C056. The effect of deaeration techniques and water purification methods on dissolution was also studied. Dissolution tests were performed in water containing nine different concentrations of dissolved gas. The oxygen and total dissolved gas pressure was monitored using a dissolved gas and oxygen meter. Other experimental variables such as the equipment,shaft position,and vessel position were kept constant throughout the study. The same analyst performed all studies. The study tablets were highly sensitive to dissolved gas in USP Apparatus 2. An increase in both the amount of prednisone dissolved and the variability of results was observed when the dissolved oxygen concentration exceeded 6 mg/L. The corresponding sum of the partial pressure of gases other than oxygen and the percent saturation were 510 mm Hg and 68%,respectively.