Physical properties of lansoprazole orally disintegrating tablets

Abstract

Here we examined the physical properties of one branded and five generic lansoprazole orally disintegrating tablets (formulations A and B, C, D, E, and F, respectively), including their hydrophilia and tablet strength and the strength required to push the tablets out of a press through package. The wetting time of formulation F (38 ± 4 s) was approximately 1.5–2.7 fold of that of formulations A, B, C, D, and E (25 ± 2, 14 ± 1, 14 ± 1, 16 ± 1, and 22 ± 1 s, respectively). Formulations B, C, D, E, and F had hardness (>3 kgf) and friability (<1%) that could endure impact and vibration of the manufacturing process and transporting. However, formulation A did not have enough tablet strength. The press through package pushing out strength of formulation C (34.4 ± 3.0 N) was approximately 1.2–1.7 fold of that of formulations A, B, D, E, and F (20.1 ± 1.8, 29.7 ± 1.3, 28.0 ± 1.8, 22.3 ± 2.3, and 24.2 ± 2.1 N, respectively). These findings indicate that the physical properties of lansoprazole orally disintegrating tablets, such as their hydrophilia, tablet strength, and press through package pushing out strength, differ between formulations. This study provides useful information for selecting lansoprazole orally disintegrating tablets individually suitable for each patient.