Flynn G L, Shah V P, Tenjarla S N, Corbo M, DeMagistris D, Feldman T G, Franz T J, Miran D R, Pearce D M, Sequeira J A, Swarbrick J, Wang J C, Yacobi A, Zatz J L
University of Michigan, College of Pharmacy, Ann Arbor, USA.
Pharm Res. 1999 Sep;16(9):1325-30. doi: 10.1023/a:1018997520950.
The FDA recently issued a guidance covering practices of scaleup and post approval changes with semisolids (SUPAC-SS). This guidance outlines the steps that must be taken by a company to maintain certification of its semisolid dermatological products after quantitative changes have been made in their compositions and/or after changes have been made in the sourcing of their key ingredients, in their processing, in their batch sizes, and/or after their site of manufacture has been relocated. A key element within the guidance is a release test to be used to determine if the diffusional release of a drug found in a formulation is the same after changes have been made to the formulation as it was prior to implementing the changes. The AAPS-FDA sponsored workshop was set up to explore this qualifying test. The stated aims of the workshop were: a) to illustrate the methodology and techniques of in vitro release testing, b) to show the sensitivity of in vitro release with respect to manufacturing variables and to variations in components and composition (of specific formulations), c) to recognize in vitro release testing as a useful procedure for SUPAC documentation, d) to highlight and evaluate other applications of in vitro release testing, e) to explore the degree to which in vitro release testing and bioavailability may be related, and f) to evaluate the role of in vitro release testing of topical dosage forms as a tool to improve product quality.
美国食品药品监督管理局（FDA）最近发布了一份指南，涵盖半固体制剂的放大生产及批准后变更的相关操作（SUPAC - SS）。该指南概述了公司在其半固体皮肤科产品的成分发生定量变化后，和/或在其关键成分的来源、加工、批量大小发生变化后，和/或在其生产地点搬迁后，为维持产品认证必须采取的步骤。该指南中的一个关键要素是一项放行测试，用于确定在制剂发生变更后，制剂中药物的扩散释放是否与变更实施前相同。美国药学协会（AAPS）与FDA联合主办了此次研讨会，以探讨这项合格测试。研讨会设定的目标如下：a）阐述体外释放测试的方法和技术；b）展示体外释放在制造变量以及特定制剂的成分和组成变化方面的敏感性；c）认可体外释放测试是SUPAC文件编制的有用程序；d）强调并评估体外释放测试的其他应用；e）探讨体外释放测试与生物利用度的相关程度；f）评估局部剂型的体外释放测试作为提高产品质量工具的作用。
