新型口腔崩解用冻干片剂的研究进展

Orally disintegrating tablets based on lyophillization technology:research advances

基于冷冻干燥工艺成型的口腔崩解片(简称口腔崩解冻干片)是药品市场中一类新型的口服固体制剂。该类制剂在口腔中仅通过微量存在的唾液在数秒内即可快速崩散溶解,因此服药无需用水,便捷、起效快、生物利用度高,尤其适合于儿童、老年人及吞咽困难的特殊病患者。本文对口腔崩解冻干片的处方特点、冻干原理、辅料选择、速溶机制及崩解时间的测定方法等进行了综述。

The orally disintegrating tablets（ODT）are the kinds of novel oral dosage forms which begin to gain popularity and acceptance since they can disintegrate/dissolve quickly in the oral cavity upon contact with saliva,resulting in solutions or suspensions form of the administered medicine. The ODTs are perfect alternative for pediatric and geriatric patients with difficulty in swallowing,and uncooperative patients because of their convenience of self-administration and compactness. This communication reviews the applications and technologies involved in formulation feature,lyophillization process,excipients selection,fast dissolving mechanism,and determination of disintegration time.