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The type of dosage form, composition, and critical quality attributes determine the rate and extent of drug absorption from a topical product. Some of the CQAs that influence the product performance include the pH of the formulation, phase distribution of the API, particle size, globule size, polymorphic form, rheological properties, water activity, density, and work of adhesion. The main goal of this chapter is to discuss in detail the role of different quality attributes on the performance of topical products.

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Topical Formulations and Critical Quality Attributes

  • 章节

  • 发表日期：

    2025年

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  • H. N. Shivakumar,
  • Avichal Kumar,
  • Ashana Puri,
  • S. Narasimha Murthy

摘要

The type of dosage form, composition, and critical quality attributes determine the rate and extent of drug absorption from a topical product. Some of the CQAs that influence the product performance include the pH of the formulation, phase distribution of the API, particle size, globule size, polymorphic form, rheological properties, water activity, density, and work of adhesion. The main goal of this chapter is to discuss in detail the role of different quality attributes on the performance of topical products.