Discussion of development and validation of dissolution methods for solid oral dosage forms
10.16438/j.0513-4870.2017-0985
- VernacularTitle:口服固体制剂溶出方法建立和验证的技术探讨
- Author:
Yue-qing ZHAO
1
;
Shi-hai ZHOU
1
;
Wen-jie LIU
1
;
Ze-neng CHENG
1
Author Information
1. Xiangya School of Pharmaceutical Science, Central South University, Changsha 410000, China
- Publication Type:REVIEWS
- Keywords:
orally administrated formulation;
dissolution procedure;
development and validation;
in vitro and in vivo correlation
- From:
Acta Pharmaceutica Sinica
2018;53(2):202-209
- CountryChina
- Language:Chinese
-
Abstract:
It is generally assumed that study of in vitro dissolution can reveal the in vivo behavior and bioavailability of a drug. The dissolution test indisputably plays a vital role in the research and development of pharmaceutical preparations as well as routine quality control of approved drugs. In order to develop an ideal dissolution method, the physicochemical properties of drug and the characteristics of its dosage form should be considered, and a proper dissolution condition be established to simulate the in vivo dissolution behavior of drugs. The new dissolution method should have the required characteristics of accuracy and durability, but also could distinguish pharmaceutic preparations with different quality. In recent years, there have been more and more reports on the establishment and verification of dissolution methods for oral solid dosage forms. However, there is very few review articles on the topic. According to the latest guidelines by domestic and foreign drug organizations, this review paper is prepared to summarize the most important skills and progress in the development of dissolution methods for oral solid preparations. The aim is to provide a reference for the development and validation of new dissolution methods.
