化学药品舌下片药学研究关注点探讨OA

Sublingual tablets are intended to be placed beneath the tongue,where they rapidly disintegrate or dissolve and allow the drug to be absorbed through the sublingual mucosa for systemic action.As a specialized tablet dosage form,sublingual tablets offer several advantages,including easy of administration,rapid onset of action following sublingual dissolution,avoidance of first-pass metabolism,and improved bioavailability.Based on regulatory review experience,relevant pharmacopoeial requirements,and currently marketed products,this article discusses key considerations in the pharmaceutical development of sublingual tablets,including formulation and manufacturing process,quality research and control,stability,and packaging.It aims to provide references for the development of sublingual tablets and to facilitate the availability of more high-quality sublingual tablets.