One-dose packages are useful for managing complicated medication regimens for older patients. We experienced a case of Bayaspirin® tablet 100 mg (BA) and Micardis® tablet 40 mg (Mic 40) that were fused in a one-dose package at the time of medicine reconciliation. To our knowledge, there are no previous reports assessing the quality of these tablets caused by this physical incompatibility. Therefore, we aimed to examine this phenomenon and its impact on the drug compositions, as well as to identify the mechanisms.
BA and Mic 40 in one-dose packages were stored at 30℃/75％ relative humidity (RH) or 93％RH condition for 1 week. The stability evaluations were performed on appearance change, hardness, content, and dissolution rate. The active ingredients in each tablet were investigated to determine the mechanisms.
Mic 40 showed changes in appearance and hardness, while BA showed a changed appearance, and reduced content and dissolution rate. The enteric coatings of BA and the additive in Mic 40 had an influence on the mechanism of incompatibility.
Mic 40 contains meglumine, which is hygroscopic and deliquescent. Therefore, meglumine absorbs moisture and becomes a basic solution. Methacrylic acid copolymer LD dissolved in this basic solution results in adhesion with Mic 40 and leads to a decrease in both the content and the dissolution rate in BA. This is the first study to analyze the physical incompatibilities of enteric-coated aspirin tablets with non-coated telmisartan tablets in one-dose packages and provides useful information for clinical practice.