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Hot Topics in Dissolution Testing

机译:溶出度测试的热门话题

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Dissolution is an ever-evolving test with the development of novel dosage forms and increased quality expectations from regulators. There are many "hot topics" in dissolution testing, but probably the most pressing is the need for clinically relevant dissolution specifications and the methodology needed to achieve this goal. Other hot topics are in vitro release methods for the many special dosage forms; USP initiatives and general chapters on items such as semi solid dosage forms, gelatin capsules, two-tier testing with enzyme addition to media, chewable tablets, validation and method development; and the Apparatus 1 and 2 performance verification test.
机译:随着新型剂型的发展以及调节剂对质量的期望提高,溶出度是一个不断发展的测试。溶出度测试中有许多“热门话题”,但最紧迫的可能是需要临床相关的溶出度规范和实现此目标所需的方法。其他热门话题是许多特殊剂型的体外释放方法。 USP计划和一般章节涉及诸如半固体剂型,明胶胶囊,在培养基中添加酶的两层测试,可咀嚼片剂,验证和方法开发等项目;以及设备1和2的性能验证测试。

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