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In Vitro Release Tests as a Critical Quality Attribute in Topical Product Development

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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

Critical quality attributes (CQAs) play an important role in demonstrating Q1, Q2, and Q3 equivalence of topical products between the test and reference products. In vitro testing is one of the CQAs that is predominantly used in the correlation of Q3 microstructure to product performance. Two types of in vitro tests are typically employed to understand the microstructure, namely, in vitro release tests (IVRT) and in vitro permeation tests (IVPT). IVRT provides information on the release of the drug from a formulation and IVPT provides information on the permeation of the drug through the skin. Both can be influenced by the type of dosage form that includes gels, creams, ointments, and lotions. Each of the dosage forms has a different matrix that varies in complexity and affects the IVRT/IVPT differently. Different microstructure parameters influence release rates and some of these include: viscosity and rheological properties, globule and particle sizes, pH, phase homogeneity, polymorphism, etc. Excipients have an influence on microstructure properties: for example, the type and grade of the excipient, different solvents, co-solvents, penetration enhancers, preservatives, coloring agents, and fragrances. Microstructure properties are also greatly influenced by the critical processing parameters (CPPs). Examples are mixing time, cooling/heating, mixer type, mixing temperature, speed and duration, and hold times at various process stops. IVRT plays a very important role in evaluating any post-approval change in process that can impact product quality and performance. FDA has issued the SUPAC-SS guidance to identify the different levels of process changes and how IVRT should be conducted to evaluate the impact. The various process level changes and what methodology should be adopted are discussed. In summary, this chapter provides an introduction to in vitro release and permeation testing and how this test can be a tool in evaluating Q3 microstructure.

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Authors and Affiliations

  1. Solaris Pharma Corporation, Bridgewater, NJ, USA

    Lakshmi Raghavan

  2. MedPharm Ltd., Surrey, UK

    Marc Brown

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

    Bozena Michniak-Kohn

  4. Acrux DDS Pty Ltd., West Melbourne, VIC, Australia

    Stephanie Ng

  5. Teva Pharmaceuticals, Salt Lake City, UT, USA

    Srinivasa Sammeta

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  1. Lakshmi Raghavan
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  4. Stephanie Ng
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  5. Srinivasa Sammeta
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Correspondence to Lakshmi Raghavan .

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  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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Raghavan, L., Brown, M., Michniak-Kohn, B., Ng, S., Sammeta, S. (2019). In Vitro Release Tests as a Critical Quality Attribute in Topical Product Development. 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_2

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