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喷雾成膜系统作为有前景的局部给药系统:综述

Spray Film-Forming systems as promising topical Systems: A review.

作者信息

Bakhrushina Elena O, Shumkova Marina M, Sergienko Felix S, Novozhilova Elizaveta V, Demina Natalia B

机构信息

I.M. Sechenov First Moscow State Medical University (Sechenov University), Moscow 119991, Russia.

出版信息

Saudi Pharm J. 2023 Jan;31(1):154-169. doi: 10.1016/j.jsps.2022.11.014. Epub 2022 Nov 23.

Abstract

Spray film-forming systems (SFFSs) provide great potential for the treatment of various types of wounds. Such systems afford to prolong the action of active substances, to prevent cross-contamination, and to ensure accelerated wound healing. Spray films are known since the mid-20th century, and nowadays they are widely used to treat minor skin injuries, but numerous clinical cases describe their successful use in the treatment of burns, wounds, bedsores, etc. The current level of polymer development and composite synthesis has greatly expanded the possibilities of creating compositions of spray film-forming systems. Scattered information and lack of standardization of such delivery systems creates difficulties for pharmaceutical development. This review highlights most of the existing requirements and suggestions from studies to standardize the characteristics of SFFSs and classify them based on scientific sources and regulatory documentation, as well as the position of such systems in the pharmaceutical market. The search and evaluation of known characterization methods and their modifications, as well as the approval of their list (separately for development and for standardization) can potentially increase the research interest in the problem of spray film-forming systems development and contribute to the registration of new drugs and medical devices in this promising dosage form, including with its own pharmacological effect.

摘要

喷雾成膜系统(SFFSs)在各类伤口治疗方面具有巨大潜力。这类系统能够延长活性物质的作用时间,防止交叉污染,并确保加速伤口愈合。喷雾膜自20世纪中叶就已为人所知,如今广泛用于治疗轻微皮肤损伤,但众多临床案例表明它们在治疗烧伤、伤口、褥疮等方面也取得了成功。当前聚合物开发和复合材料合成的水平极大地拓展了创建喷雾成膜系统组合物的可能性。此类给药系统信息分散且缺乏标准化,给药物研发带来了困难。本综述着重介绍了研究中为规范SFFSs特性并依据科学来源、监管文件对其进行分类而提出的大多数现有要求和建议,以及这类系统在医药市场中的地位。对已知表征方法及其改进方法的搜索与评估,以及确定其清单(分别针对研发和标准化),有望提高对喷雾成膜系统开发问题的研究兴趣,并有助于将这种有前景的剂型中的新药和医疗器械注册上市,包括具有自身药理作用的产品。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/18df/9845128/94aa923a5266/ga1.jpg

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