院内製剤アミノフィリン錠の試作(2) : In VitroとIn Vivoの評価

概要

論文の詳細を見る
Aminophylline (AP) is an important drug on bioavailability. Therefore, if a hospital changed half of a single available 100mg-AP tablet to 50mg-AP tablet, significant changes to bioavailability are undersirable. So two kinds of tablets, each containing 50mg of AP were prepared on the basis of their dissolution rates: tablet No. I containing HPC 4% and tablet No. II containing a mixture of HPC 2% with PVP 3% and evaluated both in vitro and in vivo. These experimental tablets met all the requirements restricted by the JP XI. For the in vivo evaluation, Neophylline^<[○!R]> tablets were cut in half and used as a standard preparation. AUC values were calculated by the trapezoidal method. The AUC percentage of the experimental tablets to the standard preparation was found to be 95.54% for the No.I tablet and 91.90% for the No.II tablet. Thus, both of these AP tablets were bioequivalent to half of a single Neophylline^<[○!R]> tablet. These results suggest that if AP tablet was changed from half of Neophylline^<[○!R]> tablet to 50mg AP manufactured in hospital, its bioavailability is not affected. Therefore, 50mg-AP tablets we developed could be clinically applicable for pediatric patients.
日本医療薬学会の論文
1988-10-20