Hydrophilia, Tablet Strength, and Pushing Out by Pressing Through the Package of Acarbose and Rebamipide Orally Disintegrating Tablets

摘要

Here we used a brand-name and two generic acarbose orally disintegrating (OD) tablets and three generic rebamipide OD tablets (formulations A, B, and C in both groups) and examined hydrophilia, tablet strength, and pushing out by press through package (PTP) to evaluate the quality of each formulation. In the case of acarbose OD tablets, the wetting time of formulation C (52 ± 4 sec) was approximately 1.6 fold of those of formulations A and B (31 ± 1 sec and 32 ± 3 sec, respectively) and PTP pushing out strength of formulation C (46.3 ± 1.6 N) was approximately 1.5-1.9 fold of those of formulations A and B (24.5 ± 1.6 N and 30.0 ± 1.3 N, respectively). In the case of rebamipide OD tablets, no major differences in wetting time and PTP pushing out strength between formulations A, B, and C were observed. In both acarbose and rebamipide OD tablets, each formulation had hardness ( >3 kgf) and friability (< 1%) that could endure vibration and impact in the manufacturing process and transporting. These findings indicated that the quality of acarbose OD tablets was different between the formulations in hydrophilia and pushing out by PTP, and the quality of rebamipide OD tablets was equivalent between formulations. This study provides useful information for selecting acarbose and rebamipide OD tablets suitable for the individual patient.