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The Role of Microstructure in Topical Drug Product Development pp 109–154Cite as

Quality Assessment of API in Semisolid Topical Drug Products

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Part of the book series: AAPS Advances in the Pharmaceutical Sciences Series ((AAPS,volume 36))

Abstract

This chapter highlights the significance of microstructure of active pharmaceutical ingredients (APIs) in the quality and performance of topical semisolid drug products. Due to the central role of API in drug product, comprehensive characterization of API’s physicochemical properties and understanding of how these properties relate to critical quality attributes of the drug product are necessary to establish Q3 sameness. In this work, scientific principles, analytical techniques, and best practices are introduced to help define and understand the relationship between APIs and microstructure of the formulations. A quality target product profile (QTPP) for products with API in various dispersed states is proposed. Key preformulation and formulation considerations are also provided to address the impact of formulation and manufacturing parameters on the arrangement of matter of the API in the drug products.

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Author information

Authors and Affiliations

  1. Pharmaceutical Development, Allergan plc, Irvine, CA, USA

    Ke Wu & Yi-Ling Hsieh

  2. Drug Product Design, Pharmaceutical Sciences, Pfizer Inc., Groton, CT, USA

    Thean Yeoh

  3. R & D, Arcutis, Westlake Village, CA, USA

    David W. Osborne

Authors
  1. Ke Wu
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  2. Thean Yeoh
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  3. Yi-Ling Hsieh
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  4. David W. Osborne
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Corresponding author

Correspondence to Ke Wu .

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Editors and Affiliations

  1. Pharma Solutions, BASF Corporations, Tarrytown, NY, USA

    Nigel Langley

  2. Rutgers, The State University of New Jersey, Piscataway, NJ, USA

    Bozena Michniak-Kohn

  3. Product Development, Arcutis, Westlake Village, CA, USA

    David W. Osborne

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Wu, K., Yeoh, T., Hsieh, YL., Osborne, D.W. (2019). Quality Assessment of API in Semisolid Topical Drug Products. In: Langley, N., Michniak-Kohn, B., Osborne, D. (eds) The Role of Microstructure in Topical Drug Product Development. AAPS Advances in the Pharmaceutical Sciences Series, vol 36. Springer, Cham. https://doi.org/10.1007/978-3-030-17355-5_4

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