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最近的制剂进展和口服崩解片的制备。

Recent Formulation Advances and Preparation of Orally Disintegrating Tablets.

机构信息

School of Pharmacy, College of Medicine and Health Sciences, Mizan-Tepi University, Ethiopia.

出版信息

Int J Pharm Compd. 2022 Sep-Oct;26(5):370-377.

Abstract

The cost of research and development for a single new treatment that reaches the market is enormous and rising, with estimates ranging from $1 billion to $2 billion. Because of the high cost of development and the need to quickly access multiple technologies, it is more cost-effective (clinically and financially) to optimize existing drugs for potency, selectivity, drug metabolism, and dosing convenience before they reach the market. This has resulted in the development of orally disintegrating tablets. Orally disintegrating tablets are patient-oriented pharmaceutical preparations which aim to enhance the safety and efficacy of the drug molecule by formulating a dosage form which disintegrates or dissolves in a few seconds after placement in the mouth. This dosage form has gained popularity among the general public because it is easily administered to geriatrics patients, pediatric patients, patients with poor physiological abilities (e.g., patients suffering from mental disorders), and patients with physical abilities (e.g., patients suffering from dysphagia), traveling patients that may not have ready access to water, and to patients that are in a situation where swallowing conventional solid oral-dosage forms presents difficulties. These tablets can be prepared in many ways like direct compression, freeze drying, sublimation, molding, and spray drying by using single or combinations of superdisintegrants or subliming agents.

摘要

一种新的治疗方法的研发成本非常高,而且还在不断上升,据估计,其成本在 10 亿至 20 亿美元之间。由于开发成本高昂,并且需要快速获取多种技术,因此在药物进入市场之前,优化现有药物的效力、选择性、药物代谢和给药便利性,从经济和临床角度来看更具成本效益。这导致了口腔崩解片的发展。口腔崩解片是一种面向患者的药物制剂,旨在通过将剂型设计成在放入口中几秒钟内崩解或溶解,从而提高药物分子的安全性和疗效。这种剂型在普通大众中很受欢迎,因为它易于管理给老年患者、儿科患者、生理功能较差的患者(例如患有精神障碍的患者)、身体能力较差的患者(例如患有吞咽困难的患者)、可能无法随时获得水的旅行患者,以及吞咽常规固体口服剂型有困难的患者。这些片剂可以通过直接压缩、冷冻干燥、升华、成型和喷雾干燥等多种方法制备,使用单一或组合的超级崩解剂或升华剂。

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