University of Ljubljana, Faculty of Pharmacy, Askerceva cesta 7, SI-1000 Ljubljana, Slovenia.
Expert Opin Drug Deliv. 2010 Aug;7(8):967-76. doi: 10.1517/17425247.2010.495982.
Knowledge of gastric emptying (GE) of solid drug delivery systems (DDS) is meaningful for the development of new DDS as it enables the design of in vitro dissolution experiments with conditions close to those in vivo in order to predict drug plasma concentration profiles with high reliability.
Gastric emptying of non-disintegrating pellets, tablets and mini-tablets in the fasted state is described on the basis of various studies performed in the last 30 years, which have evaluated the emptying process mostly by gamma scintigraphy. Different influences on GE and mathematical models describing GE kinetics of single and multiunit dosage forms are represented. A discussion on the implementation of these data in the development of drug dissolution testing procedures is given.
Readers will gain an insight into the kinetics and mechanisms of GE processes. Some suggestions on the use of the obtained knowledge in biopharmaceutical testing of DDS are also given.
Gastric emptying of non-disintegrating solid DDS is a very important process, which might influence drug dissolution, bioavailability and the plasma concentration profile. It is reasonable to consider this process in biopharmaceutical testing of these DDS.
对固体药物传递系统（DDS）的胃排空（GE）的了解对于新 DDS 的开发具有重要意义，因为它能够设计与体内条件接近的体外溶解实验，从而以高可靠性预测药物血浆浓度曲线。
根据过去 30 年来进行的各种研究，描述了空腹状态下非崩解丸剂、片剂和迷你片剂的胃排空情况，这些研究主要通过伽马闪烁成像术评估排空过程。代表了对 GE 的不同影响和描述单剂量和多剂量剂型 GE 动力学的数学模型。讨论了将这些数据应用于药物溶解测试程序开发的情况。
读者将深入了解 GE 过程的动力学和机制。还对在 DDS 的生物制药测试中利用所获得的知识提出了一些建议。
非崩解固体 DDS 的胃排空是一个非常重要的过程，可能会影响药物溶解、生物利用度和血浆浓度曲线。在这些 DDS 的生物制药测试中考虑这一过程是合理的。
