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The Role of Excipients in the Microstructure of Topical Semisolid Drug Products

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The Role of Microstructure in Topical Drug Product Development

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

Abstract

The most common pharmaceutical dosage forms for topical delivery of drugs are creams, ointments, and gels, all of which are semisolid in consistency. Attributes that are critical to the effective performance of pharmaceutical semisolids include viscosity, API status, and bioavailability and shelf-life stability. Recent investigations have demonstrated that these critical attributes are driven by the microscale organization of matter (or microstructure) in the semisolid formulation. The microstructure is, in turn, affected by the selection of excipients, amount of excipients, quality of excipients, as well as the processing methods utilized to manufacture the semisolid product. This chapter explores the role of excipients in the microstructure of creams, ointments, and gels, as well as the impact of microstructure on their critical quality attributes and performance.

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Author information

Authors and Affiliations

  1. BASF Pharma Solutions, Tarrytown, NY, USA

    Amy Ethier, Nigel Langley & Norman Richardson

  2. Amneal Pharmaceuticals, Piscataway, NJ, USA

    Padam Bansal & Amitkumar Mavjibhai Patel

  3. Lubrizol, Cleveland, OH, USA

    James Baxter

Authors
  1. Amy Ethier
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  2. Padam Bansal
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  3. James Baxter
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  4. Nigel Langley
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  5. Norman Richardson
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  6. Amitkumar Mavjibhai Patel
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Corresponding author

Correspondence to Norman Richardson .

Editor information

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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Ethier, A., Bansal, P., Baxter, J., Langley, N., Richardson, N., Patel, A.M. (2019). The Role of Excipients in the Microstructure of Topical Semisolid 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_5

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