College of Pharmacy, University of Texas at Austin, Austin, TX 78712, USA.
Eur J Pharm Biopharm. 2011 Feb;77(2):187-99. doi: 10.1016/j.ejpb.2010.11.023. Epub 2010 Dec 3.
The buccal route of administration has a number of advantages including bypassing the gastrointestinal tract and the hepatic first pass effect. Mucoadhesive films are retentive dosage forms and release drug directly into a biological substrate. Furthermore, films have improved patient compliance due to their small size and reduced thickness, compared for example to lozenges and tablets. The development of mucoadhesive buccal films has increased dramatically over the past decade because it is a promising delivery alternative to various therapeutic classes including peptides, vaccines, and nanoparticles. The "film casting process" involves casting of aqueous solutions and/or organic solvents to yield films suitable for this administration route. Over the last decade, hot-melt extrusion has been explored as an alternative manufacturing process and has yielded promising results. Characterization of critical properties such as the mucoadhesive strength, drug content uniformity, and permeation rate represent the major research areas in the design of buccal films. This review will consider the literature that describes the manufacture and characterization of mucoadhesive buccal films.
经口腔给药途径有许多优点，包括绕过胃肠道和肝脏首过效应。黏膜黏附膜是一种保持剂型，可将药物直接释放到生物基质中。此外，与含片和片剂相比，由于其体积小、厚度薄，因此改善了患者的顺应性。在过去的十年中，黏膜黏附口腔膜的发展有了显著的提高，因为它是一种很有前途的递药方式，适用于多种治疗类别，包括肽类、疫苗和纳米颗粒。“膜铸造工艺”涉及到水溶剂和/或有机溶剂的铸造，以生产适合这种给药途径的薄膜。在过去的十年中，热熔挤出已被探索作为一种替代制造工艺，并取得了有希望的结果。对关键性质的表征，如黏膜黏附强度、药物含量均匀性和渗透速率，是口腔膜设计的主要研究领域。本文综述了描述黏膜黏附口腔膜的制造和表征的文献。
