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Topical Drug Bioavailability, Bioequivalence, and Penetration pp 181–215Cite as

Development of Pilosebaceous Unit-Targeted Drug Products

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Abstract

The present chapter outlines the rationale, advances, methods, and product development processes of pilosebaceous unit (PSU)-targeted topical drug products. Since the anatomic structure of the pilosebaceous unit provides a possible pathway for targeted drug delivery into hair follicles and sebaceous glands, significant progress has been made in the area of PSU-targeted drug delivery over past 20 years. Discovery of new chemical entities (NCEs) targeting the PSU is being explored in part because the physical/chemical properties of NCEs are not ameniable for transepidermal penetration. As a formulation approach, micro-/nanoparticulate systems, micro-/nanovesicular systems, and excipients enhancing follicular delivery have been widely investigated for PSU-targeted drug delivery. Several dermal products with these micro-/nanostructures are commercialized for possible enhancement of follicular delivery. Product development process pathways are illustrated using a stage-dependent approach. Considering the complexity, rate of success, cost, and time, product development strategy for NCEs are significantly different from that for an existing drug molecule. The methods for the characterization, testing, quality control of dermal products, and in vitro and in vivo models for nonclinical development are also summarized in the present chapter. Despite substantial advances in the science and technology, it is still challenging to develop commercial prescription (Rx) products based on PSU-targeted mechanisms.

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Author information

Authors and Affiliations

  1. Pharmaceutical Development, Research & Development, Allergan, Irvine, CA, USA

    Guang Wei Lu, Kevin S Warner & Fangjing Wang

Authors
  1. Guang Wei Lu
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  2. Kevin S Warner
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  3. Fangjing Wang
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Corresponding author

Correspondence to Guang Wei Lu .

Editor information

Editors and Affiliations

  1. Pharmaceutical Consultant, North Potomac, Maryland, USA

    Vinod P. Shah

  2. University of California, San Francisco School of Medicine, Department of Dermatology, San Francisco, California, USA

    Howard I. Maibach

  3. The Defence Science and Technology Laboratory, Biomedical Sciences Department, Salisbury, United Kingdom

    John Jenner

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Lu, G., Warner, K., Wang, F. (2014). Development of Pilosebaceous Unit-Targeted Drug Products. In: Shah, V., Maibach, H., Jenner, J. (eds) Topical Drug Bioavailability, Bioequivalence, and Penetration. Springer, New York, NY. https://doi.org/10.1007/978-1-4939-1289-6_12

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