• Lian-Jie Ren, Juan Liu, Jun-Wei Ma, Jia-Chen Yan, and Li-Fang Yin.
• Center for Drug Evaluation, China Food and Drug Administration, Beijing 100038, China.
• Zhongguo Zhong Yao Za Zhi. 2017 Oct 1; 42 (19): 3696-3702.

AbstractOral film is a new type of oral preparation. Due to portability, simple preparation process and good clinical compliance, oral films have become the focus of novel drug delivery system in recent years. Meanwhile, oral films have been gradually used in the development of Chinese medicine preparations. According to the application and approval situation of different types of oral films both at home and abroad in recent years, their research and development status was analyzed, including the basic concept, formulation, manufacturing process and quality control, as well as related progress and development prospects of oral films applied in traditional Chinese medicine. Some suggestions on the technical evaluation of oral films were put forward by considering specific requirements from regulatory agencies. This paper could provide some references for the development and evaluation of oral films. Due to the complexity of the drug substances and the particularity of the drug product, the development and application of oral films in traditional Chinese medicine are still faced with opportunity and challenges.Copyright© by the Chinese Pharmaceutical Association.

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