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含有环糊精的固体剂型开发中的实际考量

Practical considerations in development of solid dosage forms that contain cyclodextrin.

作者信息

Miller Lee A, Carrier Rebecca L, Ahmed Imran

机构信息

Pfizer, Inc., Ann Arbor, Michigan 48105, USA.

出版信息

J Pharm Sci. 2007 Jul;96(7):1691-707. doi: 10.1002/jps.20831.

Abstract

The following is a review of the literature that addresses the use of cyclodextrin in solid dosage forms. Care was taken to exclude physical and chemical characteristics of cyclodextrin, which have been discussed in the literature. A flow diagram is provided to outline the decision-making steps that are involved in the development process. Both preparation of physical mixtures and inclusion complexes are considered. Analytical techniques to determine the presence of inclusion complexes, the effect of other excipients on complex formation, the effect of size limitation of solid dosages forms, powder processing, and storage of solid dosage forms are discussed.

摘要

以下是一篇关于环糊精在固体剂型中应用的文献综述。已注意排除文献中已讨论过的环糊精的物理和化学特性。提供了一个流程图来概述开发过程中涉及的决策步骤。物理混合物和包合物的制备均在考虑范围内。讨论了用于确定包合物存在的分析技术、其他辅料对包合物形成的影响、固体剂型尺寸限制的影响、粉末加工以及固体剂型的储存。

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