The Role of Microstructure in Topical Drug Product Development

Nigel Langley, Bozena Michniak-Kohn, David W. Osborne (Herausgeber)

Buch | Hardcover

XIV, 199 Seiten

2019 | 1st ed. 2019
Springer International Publishing (Verlag)
978-3-030-17354-8 (ISBN)

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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 that improve the quality of the document and that make eachof 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.

Nigel Langley, Director Technical Service and Scientific Affairs - BASF Pharma Solutions, provides technical support to the pharmaceutical industry and helps solve drug development challenges with BASF's platform solutions. Prior to joining BASF, Dr. Langley worked for Croda Inc. as Technical Director Health Care, responsible for product and application development for both dietary supplements and Pharmaceutical excipients. He 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). Nigel has been a member of the Executive Committee at IPEC Americas since 2010 and is currently VC membership. He is also helping to lead the Novel excipient initiative in collaboration with the IQ Pharma Consortium. Nigel has 30 years' experience within the Pharmaceutical excipient industry.

Part I - Critical Quality Attributes: 1. Rheological Characterization in the Development of Topical Drug Products.- 2. In Vitro Release & Permeation Tests as Critical Quality Attributes in Topical Product Development.- 3. Determination of Particle Size and Microstructure in Topical Pharmaceuticals.- Part II - Role of API and Excipients: 4. Quality Assessment of API in Semisolid Topical Drug Products.- 5. The Role of Excipients in the Microstructure of Topical Semi-solid Drug Products.

Erscheinungsdatum	25.08.2019
Reihe/Serie	AAPS Advances in the Pharmaceutical Sciences Series
Zusatzinfo	XIV, 199 p. 102 illus., 57 illus. in color.
Verlagsort	Cham
Sprache	englisch
Maße	155 x 235 mm
Gewicht	481 g
Themenwelt	Medizin / Pharmazie ► Pharmazie ► PTA / PKA
	Naturwissenschaften ► Chemie ► Technische Chemie
	Technik
Schlagworte	CPP • excipients • globule size • In Vitro Testing • IVRT and IVPT • MDRS • optical microscopy of emulsions • particle characterization • Particle Size • PEG • rheology • Rheometry • SEM • semi-solid microstructure • state of API • suspended API • Thixotropy • topical dosage forms • viscometry • viscosity
ISBN-10	3-030-17354-2 / 3030173542
ISBN-13	978-3-030-17354-8 / 9783030173548
Zustand	Neuware