口腔内速崩壊錠の開発

抄録

Recently tablets that can rapidly disintegrate in the oral cavity have attracted attention as a novel dosage form that can be taken easily and safely even by infants and elderly people. The aim of the present research was, by ordinary equipment, to develop rapidly disintegrating tablets that have satisfactory physical hardness. In this report, rapidly disintegrating tablets were prepared using direct compression methods. Tablet properties, such as porosity, hardness, swelling ability, wetting time, disintegration time, etc., were evaluated, and the formulations and preparation conditions were optimized by different kinds of additives, the content of additives, compression pressure, etc. Furthermore, disintegration mechanisms of the tablets were clarified. It was possible to prepare an oral rapidly disintegrating tablet with the targeted physical properties for the present study, i. e., hardness of more than 30 N, a disintegration time of less than 30 seconds and friability of less than 0.5%, by direct compression at 0.4 t compression pressure by using 3% of crospovidone as a disintegrant, 0.3% of magnesium stearate as a lubricant and 10% of crystalline lactose as a core particle. The rapid disintegration of tablets was mainly due to the porous structures and wetting.