Lindert Sandra, Breitkreutz Jörg
a Institute of Pharmaceutics and Biopharmaceutics , Heinrich Heine University Düsseldorf , Düsseldorf , Germany.
Expert Opin Drug Deliv. 2017 Nov;14(11):1265-1279. doi: 10.1080/17425247.2017.1276899. Epub 2017 Jan 17.
The oral mucosa has recently become increasingly important as an alternative administration route for tailor-made, controlled drug delivery. Oromucosal multilayer films, assigned to the monograph oromucosal preparations in the Ph.Eur. may be a promising dosage form to overcome the requirements related to this drug delivery site. Areas covered: We provide an overview of multilayer films as drug delivery tools, and discuss manufacturing processes and characterization methods. We focus on the suitability of characterization methods for particular requirements of multilayer films. A classification was performed covering indication areas and APIs incorporated in multilayer film systems for oromucosal use in order to provide a summary of data published in this field. Expert opinion: The shift in drug development to high molecular weight drugs will influence the field of pharmaceutical development and delivery technologies. For a high number of indication areas, such as hormonal disorders, cardiovascular diseases or local treatment of infections, the flexible layer design of oromucosal multilayer films provides a promising option for tailor-made, controlled delivery of APIs to or through defined surfaces in the oral cavity. However, there is a lack of discriminating or standardized testing methods to assess the quality of multilayer films in a reliable way.
作为定制化、可控药物递送的一种替代给药途径，口腔黏膜近来愈发重要。欧洲药典专论中归类为口腔黏膜制剂的口腔黏膜多层膜，可能是一种有前景的剂型，可满足与该药物递送部位相关的要求。涵盖领域：我们概述了多层膜作为药物递送工具的情况，并讨论了其制造工艺和表征方法。我们重点关注表征方法对于多层膜特定要求的适用性。进行了一项分类，涵盖用于口腔黏膜的多层膜系统中的适应症领域和所包含的活性药物成分（API），以便总结该领域已发表的数据。专家观点：药物研发向高分子量药物的转变将影响药物研发和递送技术领域。对于大量适应症领域，如激素紊乱、心血管疾病或感染的局部治疗，口腔黏膜多层膜的灵活层设计为将活性药物成分定制化、可控地递送至口腔内特定表面或透过该表面提供了一个有前景的选择。然而，缺乏可靠地评估多层膜质量的鉴别性或标准化测试方法。
