The Role of Microstructure in Topical Drug Product Development

  • Nigel Langley
  • Bozena Michniak-Kohn
  • David W. Osborne

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

Table of contents

  1. Front Matter
    Pages i-xiv
  2. Critical Quality Attributes

    1. Front Matter
      Pages 1-1
    2. Amit Rawat, Simerdeep Singh Gupta, Haripriya Kalluri, Michael Lowenborg, Kuljit Bhatia, Kevin Warner
      Pages 3-45
    3. Lakshmi Raghavan, Marc Brown, Bozena Michniak-Kohn, Stephanie Ng, Srinivasa Sammeta
      Pages 47-87
    4. David W. Osborne, Kevin Dahl, Harshil Parikh
      Pages 89-106
  3. Role of API and Excipients

    1. Front Matter
      Pages 107-107
    2. Ke Wu, Thean Yeoh, Yi-Ling Hsieh, David W. Osborne
      Pages 109-154
    3. Amy Ethier, Padam Bansal, James Baxter, Nigel Langley, Norman Richardson, Amitkumar Mavjibhai Patel
      Pages 155-193
  4. Back Matter
    Pages 195-199

About this book


Following the Semi-solid Microstructure Workshop sponsored by BASF and hosted by the Rutgers Center for Dermal Research, a pharmaceutical product development working group was formed. The group, known as the Q3 Working Group, selected the following five areas of focus:  Particle/Globule Size and Distribution,      Viscosity/Rheology/Spreadability,  In Vitro Testing,  State of API,   State of Excipients. A committee was appointed for each of these five areas. The committees were tasked to review the literature, identify best practices, list experimental details required for an independent lab to duplicate the test, and propose scientific studies that may meaningfully advance this specific area of focus.  Each committee has a chair (or co-chairs) that are the lead author(s) of the chapter. The Q3 Working Group members serve as the critical reviewers of each chapter, making suggestions that improve the quality of the document and that make each of the five chapters uniform in scope and content.
Pharmaceutical development scientists that formulate topical products (creams, lotions, gels suspensions, foams, etc) and all the allied raw material suppliers, packaging suppliers, contract laboratories including CROs, CMOs and regulators need access to this book.  Overall, the topic of semisolid microstructure is of equal importance to the generic pharmaceutical companies (filing Abbreviated New Drug Applications or ANDAs) and pharmaceutical companies filing New Drug Applications (NDAs).  In addition to products applied to the skin, hair, and nails, The Role of Microstructure in Topical Drug Product Development crosses over and is essential reading to developers of oral suspensions, ophthalmic ointments and gels, otic suspension, vaginal semisolids and retention enemas.



semi-solid microstructure excipients particle size topical dosage forms PEG IVRT and IVPT MDRS SEM CPP particle characterization globule size viscosity rheology in vitro testing state of API suspended API optical microscopy of emulsions Thixotropy Viscometry Rheometry

Editors and affiliations

  • Nigel Langley
    • 1
  • Bozena Michniak-Kohn
    • 2
  • David W. Osborne
    • 3
  1. 1.Pharma SolutionsBASF CorporationsTarrytownUSA
  2. 2.RutgersThe State University of New JerseyPiscatawayUSA
  3. 3.Product DevelopmentArcutisWestlake VillageUSA

Bibliographic information