口溶膜类新药的开发与评价探讨  

Discussion on the development and evaluation of new drugs of oral soluble film

作　　者：王璐 胡延臣 王亚敏 WANG Lu;HU Yanchen;WANG Yamin(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3期302-307,312,共7页Journal of Pharmaceutical Research

摘　　要：膜剂系指原料药物与适宜的成膜材料经加工制成的膜状制剂,口溶膜系指在口腔可迅速溶化的膜剂。口溶膜具有剂量准确、携带方便、可提高特定适应证人群患者依从性等特点。本文结合注册法规要求及近年来国内外口溶膜药物的开发和审评审批情况,对口溶膜新药的开发立项、处方工艺、质量研究和控制等方面的评价进行了探讨。研究建议企业在立项开发时应全面评估,合理选择申报策略和路径。处方工艺开发时,根据剂型特点关注影响产品质量的关键因素,并有针对性地进行质量研究和控制。希望通过本文能够指导现阶段口溶膜类新药产品的开发和评价,助力有临床需求的、高质量的口溶膜类新药的获批上市。Films refer to the film-like preparation made by processing the raw material and the appropriate film-forming material.Oral soluble film refers to the film that dissolves rapidly in the mouth.The characteristics of the oral soluble film include accurate dose,easy to carry,and improving the compliance of patients with specific indications.Based on the requirements of registration regulations and approval of oral soluble films at home and abroad in recent years,the evaluation of oral soluble films were put forward in terms of development,formulation,manufacturing process and quality research and control.The application strategy and path should be rationally selected after comprehensive evaluation.During formulation and process development,focus on the key factors affecting product quality according to the characteristics of dosage forms,and conduct targeted quality research and control.These discussions are expected to guide the development and evaluation of oral soluble films,and promote the approval and marketing of high-quality oral soluble film new drugs with clinical needs.

关 键 词：口溶膜 口腔速溶膜 新药 处方工艺 质量控制 开发与评价 

分 类 号：R95[医药卫生—药学]