口腔粘膜付着性ロラゼパムフィルムの開発I―薬剤の口腔粘膜吸収を目的とした速効性・利便性を有する新規フィルム製剤の調製と評価―

抄録

As-needed use of Lorazepam (LOR) by patients with psychiatric maladies is described as effective when they show an unexpected restlessness. In this study, we attempted to prepare a sublingual film containing LOR (LOR-film) to improve both the instantaneous effect of LOR and the convenience of drug administration. Polyglutamic acid (γ-PGA), hydroxypropyl starch (HPS) and its resolvent were adopted as the main ingredients in the film, and various amount of glycerol (Gly) and/or glycerin fatty acid ester (GE) were added as plasticizer or surfactant. While the increase in the amount of Gly added increased the adhesion property and plasticity of the film, there had been a tendency to decrease the disintegration time and handling ability. As for the release of LOR from LOR-film, a tendency to delay was recognized with an increase in the amount of Gly. On the other hand, an increase in the amount of GE accelerated the release of LOR at the initial portion. Disintegration time of LOR-films in the oral cavity was prolonged with an increase in an increase of the amount of Gly. These results indicate that the release of LOR from LOR-film is controllable by the amount of Gly or GE.