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快速溶解口腔薄膜给药系统简介:综述

An introduction to fast dissolving oral thin film drug delivery systems: a review.

机构信息

Vivekanand Education Society's College of Pharmacy, Hashu Advani Memorial Complex, behind Collector Colony, Chembur (E), Mumbai-400 074, India.

出版信息

Curr Drug Deliv. 2013 Dec;10(6):667-84. doi: 10.2174/156720181006131125150249.

Abstract

Many pharmaceutical companies are switching their products from tablets to fast dissolving oral thin films (OTFs). Films have all the advantages of tablets (precise dosage, easy administration) and those of liquid dosage forms (easy swallowing, rapid bioavailability). Statistics have shown that four out of five patients prefer orally disintegrating dosage forms over conventional solid oral dosages forms. Pediatric, geriatric, bedridden, emetic patients and those with Central Nervous System disorders, have difficulty in swallowing or chewing solid dosage forms. Many of these patients are non-compliant in administering solid dosage forms due to fear of choking. OTFs when placed on the tip or the floor of the tongue are instantly wet by saliva. As a result, OTFs rapidly hydrate and then disintegrate and/or dissolve to release the medication for local and/or systemic absorption. This technology provides a good platform for patent non- infringing product development and for increasing the patent life-cycle of the existing products. The application of fast dissolving oral thin films is not only limited to buccal fast dissolving system, but also expands to other applications like gastroretentive, sublingual delivery systems. This review highlights the composition including the details of various types of polymers both natural and synthetic, the different types of manufacturing techniques, packaging materials and evaluation tests for the OTFs.

摘要

许多制药公司正在将其产品从片剂转换为快速溶解的口腔薄膜(OTF)。薄膜具有片剂的所有优点(精确剂量,易于管理)和液体剂型的优点(易于吞咽,快速生物利用度)。统计数据表明,五分之四的患者更喜欢口服崩解剂型而不是传统的固体口服剂型。儿科、老年、卧床不起、呕吐患者以及患有中枢神经系统疾病的患者,在吞咽或咀嚼固体剂型方面存在困难。由于担心窒息,许多这些患者在服用固体剂型时不遵守规定。OTF 放在舌头的尖端或底部会立即被唾液润湿。结果,OTF 迅速水合,然后崩解和/或溶解以释放药物用于局部和/或全身吸收。这项技术为非专利侵权产品的开发提供了一个良好的平台,并延长了现有产品的专利生命周期。快速溶解口腔薄膜的应用不仅限于颊部快速溶解系统,还扩展到其他应用,如胃滞留、舌下给药系统。这篇综述强调了组成,包括各种类型的天然和合成聚合物的详细信息、不同类型的制造技术、包装材料和 OTF 的评估测试。

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