Description: The Role of Microstructure in Topical Drug Product Development Please note: this item is printed on demand and will take extra time before it can be dispatched to you (up to 20 working days). Author(s): Nigel Langley, Bozena Michniak-Kohn, David W. Osborne Format: Hardback Publisher: Springer Nature Switzerland AG, Switzerland Imprint: Springer Nature Switzerland AG ISBN-13: 9783030173548, 978-3030173548 Synopsis 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 [url] 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.
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Book Title: The Role of Microstructure in Topical Drug Product Development
Number of Pages: 199 Pages
Language: English
Publication Name: The Role of Microstructure in Topical Drug Product Development
Publisher: Springer Nature Switzerland A&G
Publication Year: 2019
Subject: Pharmacy
Item Height: 235 mm
Item Weight: 494 g
Type: Textbook
Author: Nigel Langley, David W. Osborne, Bozena Michniak-Kohn
Subject Area: Chemical Engineering
Series: Aaps Advances in the Pharmaceutical Sciences Series
Item Width: 155 mm
Format: Hardcover
