アスピリン腸溶錠の崩壊性に関する製品間における比較検討

抄録

Enteric-coated aspirin tablets are marketed as generic drugs in Japan. However, data on the results of the pharmaceutical tests of enteric-coated aspirin tablets are insufficient. Therefore, we performed a disintegration test according to the Japanese Pharmacopoeia (sixteenth edition) and tablet hardness test on five brands of enteric-coated aspirin tablets. In the disintegration test, four out of five brands were in accordance with the regulation criteria of disintegration media No. 1 (pH1.2). However, one brand was unsuitable; it disintegrated in purified water and buffer solution (pH3.5) as well as in disintegration media No. 1. In addition, in the tablet hardness test, this brand was found to have the lowest values compared with the other four brands. In contrast, all brands of tablets disintegrated in disintegration media No. 2 (pH6.8) within the regulation criteria. If enteric-coated aspirin tablets disintegrate in the stomach, gastrointestinal injury may occur. All the studied brands used methacrylic acid copolymer LD as the enteric-coating agent. Thus, it may be assumed that the production method of tablets and ratio of additives may affect disintegration, even if the same enteric-coating agent is used. We suggest that pharmaceutical companies should further promote the use of generic drugs by producing products that pass various pharmaceutical tests.