FDA关于溶出测试的指南 - 药群论坛

In August 2015, the FDA published thedraft of a guideline on dissolution testing for immediate release solid oraldosage forms. It is planned that after its finalisation, a part of thisguideline will replace the current guideline from August 1997.

在2015年8月，FDA公布了即释固体口服制剂的溶出度测试指南草案。FDA计划在其定稿后，此指南的一部分将替代自1997年8月开始实施的现行指南。

The Biopharmaceutics ClassificationSystem (BCS) distinguishes 4 different classes of APIs depending ontheir solubility and permeability.

生物药品分类系统（BCS）根据其溶解度和渗透性将原料药分为4类。

On the basis of this classification, adecision can be taken for determining when bioavailability or bioequivalencestudies are required, or when a successful in vitro-in vivo correlation (IVIVC)is likely.

在此分类基础上，可以决定什么时候需要进行生物利用度或生物等效性研究，什么时候体内体外试验（IVIVC）能成功对应。

The BCS proposes that, for certainmedicinal products which contain a high soluble API, dissolution testing can bestandardised. Due to their high solubility, medicinal products in the BCSclasses 1 and 3 have a relatively low risk with regard to the impact on dissolution,provided that the in vitro performance meets or exceeds the recommendationsgiven.

BCS提议对于特定的药品，如果含有可溶的原料药，其溶出度测试可以标准化。由于在BCS一类和三类的药品具有较高的溶解度，如果体外表现符合或超出所给出的建议，则其对溶出的影响风险相对较低。

If these conditions are met, the newguideline will provide concrete provisions regarding the methods which can bestandardised: USP apparatus 1 (basket method) or 2 (paddle method)with fixed parameters for stirring rate, medium and temperature. Forthis, the permitted limits for the specifications are laid down. In addition,the possibility is granted that, under certain conditions, disintegrationtesting can be used as alternative method.

如果符合这些条件，则新指南会提供一个具体的方法标准化条款：USP仪器1（转篮法）或2（桨法），配有固定的搅拌速度参数，介质和温度。对此，界定了质量标准所允许的限度。另外，在固定条件下，可以保证崩解试验可以用作替代方法。