Heinrich Heine University, Institute of Pharmaceutics and Biopharmaceutics, Universitätsstr. 1, 40225 Düsseldorf, Germany.
Expert Opin Drug Deliv. 2011 Mar;8(3):299-316. doi: 10.1517/17425247.2011.553217. Epub 2011 Feb 2.
Orodispersible films for oral delivery are gaining popularity. Whereas breath-fresheners and over-the-counter products have already become quite common in the US, the first prescription drug films were introduced into the EU and US markets only very recently. Already considered as a unique Rx (prescription drug) dosage form by the FDA (oral soluble film), such products are not substitutable by conventional oral dosage forms. The official term defined by the European Medicines Agency is orodispersible film (ODF).
This review gives an overview on the benefits of ODFs, typical excipients and products already available on the market. ODFs are defined and differentiated from other films and dosage forms. Possible manufacturing methods are described. As ODFs are not yet listed in one of the pharmacopoeias, possible methods for characterization and quality control are discussed. Required characteristics, advantages and disadvantages are elaborated. Biopharmaceutical considerations are provided because such films can also be used to enhance bioavailability of a drug.
The magnitude of variants of ODF technology and the advantages over conventional dosage forms promise more applications and more marketed products with ODFs in the near future. Therefore, the authorities have to publish a monograph for ODFs as soon as possible to standardize characterization methods and quality specifications.
口腔崩解膜作为一种口服给药制剂，正日益受到关注。虽然口气清新剂和非处方产品在美国已经相当普遍，但最近才刚刚有第一批处方药物口腔崩解膜被引入欧盟和美国市场。这些产品已被 FDA（口服可溶性膜）视为独特的 Rx（处方药）剂型，不可被传统的口服剂型替代。欧洲药品管理局（EMA）给出的官方术语为口腔崩解膜（ODF）。
本篇综述概述了 ODF 的优势、典型辅料和已上市的产品。对 ODF 进行了定义和区分，使其与其他膜剂和剂型区分开来。还介绍了可能的制造方法。由于 ODF 尚未在任何药典中列出，因此讨论了可能的表征和质量控制方法。阐述了所需的特性、优点和缺点。提供了生物药剂学方面的考虑因素，因为此类薄膜还可用于提高药物的生物利用度。
ODF 技术的多样性及其相对于传统剂型的优势预示着在不久的将来，会有更多的应用和更多的 ODF 上市产品。因此，当局应尽快发布 ODF 专论，以标准化表征方法和质量规范。
