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口腔崩解片的综合评述。

Comprehensive review on oral disintegrating films.

机构信息

Department of Pharmaceutics, Vaagdevi College of Pharmacy, Warangal, India.

出版信息

Curr Drug Deliv. 2013 Feb;10(1):96-108. doi: 10.2174/1567201811310010016.

Abstract

Fast-dissolving drug-delivery systems were first developed in the late 1970s as an alternative to tablets, capsules, and syrups for pediatric and geriatric patients who experience difficulties swallowing traditional oral solid dosage forms. In response to this need, a variety of orally disintegrating tablet (ODT) formats were commercialized, which disintegrate within 1 min when placed in the mouth without drinking water or chewing. Oral drug delivery technology has improved from conventional dosage forms to modified release dosage forms to ODT to the recent oral disintegrating films (ODF). Oral disintegrating film or strip that employs a water dissolving polymer which allows the dosage form to quickly hydrate by saliva, adhere to mucosa, and disintegrate within a few seconds, dissolve and releases medication for oromucosal absorption when placed on the tongue or oral cavity. Oral strip technology provides an alternate route for drugs with first pass metabolism. This review give details of materials used in ODF, manufacturing aspects, technologies, evaluation tests and marketed products.

摘要

速溶给药系统于 20 世纪 70 年代末首次开发,作为儿童和老年患者的片剂、胶囊和糖浆的替代物,这些患者在吞咽传统口服固体制剂时存在困难。为了满足这一需求,各种口崩片(ODT)剂型被商业化,这些剂型在口中放置 1 分钟内无需饮水或咀嚼即可崩解。口服药物递送技术已从传统剂型发展到缓释剂型,再到口崩片,再到最近的口腔崩解膜(ODF)。口腔崩解膜或条带采用水溶性聚合物,允许剂型通过唾液快速水合,粘附在粘膜上,并在几秒钟内崩解,当放置在舌头上或口腔中时,溶解并释放药物用于口腔粘膜吸收。口腔条带技术为首过代谢的药物提供了另一种给药途径。本综述详细介绍了 ODF 中使用的材料、制造方面、技术、评价试验和市售产品。

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