錠剤の重量偏差試験法に関する研究

概要

論文の詳細を見る
Recent advances in pharmaceutical technology and instruments have made it possible to manufacture more uniform preparations. However, the Japanese pharmacopoeia have not kept in step with these developments. For example, the weight variation test for uncoated tablets has not been revised since publication of the 7th edition in 1961. Fifty four brands of commercial, uncoated and coated tablets were selected at random and subjected to the weight variation test of the J.P.IX. For comparison purposes, four uncoated tablets, formulated in our laboratory, were included in this study. All uncoated tablets complied with the requirements of the J. P. IX. Variations in tablet weight, presented as standard deviation and/or range, increased with the average weight increase of the tablets. However, the variations were found to be considerably less than the requirements. This suggests that the requirements should be updated since they do not adapt to present status of tablet formulations. More than 80% of the coated tablets complied with the requirements which are applied only to uncoated tablets in the J.P.IX. It was apparent that the variations in coated tablets were not as small as those of uncoated tablets ; however, the fact that more than 80% of the coated tablets complied with the J. P. requirements suggests that some requirement should be established for the coated preparations.
社団法人日本薬学会の論文
1979-12-25