一般論文
難溶性薬物を含有する湿式法による口腔内速崩壊錠―調製と崩壊機構の解明
キーワード:
rapidly disintegrating tablet,
wet compression method,
sugar,
binary system,
water penetration
2003 年 63 巻 1 号 p. 1-11
詳細
2003 年 63 巻 1 号 p. 1-11
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. In this research, rapidly disintegrating tablets containing a model drug with relatively low solubility were prepared by the wet compression method. Then, the optimal formulation for tablets having a tensile strength greater than 5 kg/cm2 and disintegration time shorter than 15s was examined, and the mechanisms involved in the disintegration of these tablets were clarified. Using a binary system composed of highly soluble trehalose (Tre) and low solubility lactose (Lac) as excipients, optimal formulations for rapidly disintegrating tablets were investigated by changing Tre/Lac mixing ratios. It became clear that the incorporation of 10-20% Tre made tablets rigid without causing a significant delay in disintegration time, and the tablets had a high water penetration rate because of the large pore size. When Tre content was more than 50%, however, a remarkable delay in disintegration time was observed because of the decrease in both water penetration rate and water uptake ability of the disintegrant.
