腸溶性錠剤の崩壊試験法に関する研究

概要

論文の詳細を見る
In the J.P.IX disintegration test for enteric-coated tablets, the tablets are tested for 120 min in the first fluid (pH 1.2) prior to the test in the second fluid (pH 7.5). In clinical medicine, tablets are often administered to patients under fasting conditions and to partial or total gastrectomy patients. It is well known that the gastric emptying rate in these conditions is faster than in normal condition. Therefore, to clarify the effects of a shortened test period in the first fluid on entericcoated tablets disintegration time and coefficient of variation (C.V.), three different test periods (120,30 and 0 min) were used. These tests were conducted on 17 enteric-coated tablets on the market. Two lots of these preparations failed to disintegrated completely under all of the test conditions. The disintegration time of these tablets in the second fluid obtained with the first fluid was generally faster compared to that obtained without the fluid. When the tablets were tested with the first fluid for 30 or 120 min, disintegration time was approximately constant. Moreover, in some preparations the disintegration time obtained without disks was markedly increased and they failed to disintegrate completely. The effect of test period in the first fluid on the C.V. in disintegration time was not negligible and the C.V. was changed irregularly by alterations of the test period. Usually, but not always, it was found that adherence of the test tablets to disks or test equipment tends to increase disintegration time and C.V.
社団法人日本薬学会の論文
1979-03-25

腸溶性錠剤の崩壊試験法に関する研究

スポンサーリンク

概要

著者

関連論文

スポンサーリンク