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The Role of Microstructure in Topical Drug Product Development (eBook)

Artikelnummer: 978-3-030-17355-5
Einband: PDF
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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 thatimprove 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.

 


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 thatimprove 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.

 


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VerlagSpringer International Publishing
EinbandPDF
Erscheinungsjahr2019
Seitenangabe199 S.
AusgabekennzeichenEnglisch
AbbildungenXIV, 199 p. 102 illus., 57 illus. in color.
Masse8'394 KB
PlattformPDF
ReiheAAPS Advances in the Pharmaceutical Sciences Series
AutorLangley, Nigel (Hrsg.) / Michniak-Kohn, Bozena (Hrsg.) / Osborne, David W. (Hrsg.)

Alle Bände der Reihe "AAPS Advances in the Pharmaceutical Sciences Series"

Über den Autor Nigel (Hrsg.) Langley

Nigel Langley is the Global Technical Director of Gaylord Chemical Company LLC, which provides technical support to the pharmaceutical industry and helps solve drug formulation challenges. Prior to joining Gaylord Chemical, Nigel has held various senior technical and marketing positions with BASF and Croda International PLC. Nigel has also worked in Japan and England with Croda. He gained his Chemistry (Hons) degree and PhD (liquid crystals) from the University of Hull (UK) and an MBA from Leeds University (UK). He also took a 2- year Postdoctoral research position at Leeds University (UK) in natural product synthesis. He has over 100 scientific publications and has co- edited 2 books. Nigel is an adjunct professor at the University of Mississippi and a Fellow of the Royal Society of Chemistry (UK). In 2018 he was awarded the Industry Research Achievement Award in Excipient Technology by the IPEC Foundation. He has been a member of the Executive Committee at IPEC- Americas since 2010 and is currently Chair. Nigel is on the Medicine Maker's Power List for 2020, 2021 & 2022.

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