化学药品口颊膜剂的开发与评价探讨  

Discussion on the development and evaluation of buccal films

作　　者：王璐 胡延臣 WANG Lu;HU Yanchen(Center for Drug Evaluation,National Medical Products Administration,Beijing 100076,China)

机构地区：[1]国家药品监督管理局药品审评中心,北京100076

出　　处：《药学研究》2024年第9期871-875,共5页Journal of Pharmaceutical Research

摘　　要：口颊膜系指粘贴于口腔,经黏膜吸收后起全身作用的膜剂。口颊膜作为口腔黏膜给药的代表性剂型之一,具有起效快、避免药物胃肠道降解和肝脏首过效应、提高患者依从性等优势。结合近年来国内外口颊膜药物的开发和上市情况,对口颊膜处方工艺、质量研究和控制等方面进行了探讨。希望能够助力现阶段对此类产品的开发和评价,助推有临床价值的高质量口颊膜产品获批上市。Buccal films refer to adhesive in the oral cavity,through the mucosal absorption after the systemic action of the film.As one of the representative dosage forms of oral mucosal administration,buccal films have the advantages of rapid onset,avoiding gastrointestinal degradation and first-pass effect of drugs in the liver,and improving patient compliance.Based on the development and approval of buccal films in recent years,the evaluation of buccal films are put forward in terms of formulation,manufacturing process and quality research and control.These discussions are expected to guide the development and evaluation of buccal films,and promote the approval and marketing of high-quality buccal films with clinical needs.

关 键 词：口颊膜 处方工艺 质量控制 开发与评价 

分 类 号：R943[医药卫生—药剂学]