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In Vitro Drug Release Testing of Special Dosage Forms by Nikoletta Fotaki (Hardback)
£115.95
Out of stock
Product Ref. (e.g. ISBN, SKU)
9781118341476
Published:
19 Dec 2019
Format:
Hardback
Number of pages:
312 pages
Dimensions:
243.8x177.8x20.3mm
Weight:
0.771kgs
Author:
"In the mid 1960s people realized that drug dissolution/release has a significant impact on the therapeutic effect of orally administered drugs. Both the United States Food and Drug Administration (FDA) and United States Pharmacopoeia introduced dissolution requirements for oral drug products and the first dissolution tests became a quality control (QC) tool to ensure batch-to-batch consistency. As a consequence, from the 1970s on, several dissolution test methods were adopted as official QC methods for solid oral dosage forms. In the late 1990s, the increasing number of official dissolution apparatus and dissolution methods in the USP was complemented by the release of various FDA guidances pertaining to in vitro dissolution testing of solid oral dosage forms and its application from a regulatory point of view. Since then dissolution/drug release testing has expanded considerably with a variety of apparatus and methods in international
Guides readers on the proper use of in vitro drug release methodologies in order to evaluate the performance of special dosage forms
In the last decade, the application of drug release testing has widened to a variety of novel/special dosage forms. In order to predict the in vivo behavior of such dosage forms, the design and development of the in vitro test methods need to take into account various aspects, including the dosage form design and the conditions at the site of application and the site of drug release. This unique book is the first to cover the field of in vitro release testing of special dosage forms in one volume. Featuring contributions from an international team of experts, it presents the state of the art of the use of in vitro drug release methodologies for assessing special dosage forms' performances and describes the different techniques required for each one.
In Vitro Drug Release Testing of Special Dosage Forms covers the in vitro release testing of: lipid based oral formulations; chewable oral drug products; injectables; drug eluting stents; inhalation products; transdermal formulations; topical formulations; vaginal and rectal delivery systems and ophthalmics. The book concludes with a look at regulatory aspects.
Covers both oral and non-oral dosage forms Describes current regulatory conditions for in vitro drug release testing Features contributions from well respected global experts in dissolution testingIn Vitro Drug Release Testing of Special Dosage Forms will find a place on the bookshelves of anyone working with special dosage forms, dissolution testing, drug formulation and delivery, pharmaceutics, and regulatory affairs.
About the Author: Editors Nikoletta Fotaki, PhD, is Reader in Pharmaceutics, Department of Pharmacy and Pharmacology, University of Bath, UK. Her research interests are focused on the prediction of drug absorption through the oral and non-oral route; prediction of drug absorption in special populations (paediatrics; disease states), biorelevant dissolution methods, formulation development, and physiologically based pharmacokinetic modeling. Sandra Klein, PhD, is Professor of Pharmaceutical Technology, Department of Pharmacy, University Greifswald, Germany. Her research is focused on developing bio-predictive in vitro models and oral dosage forms for special patient groups, particularly the paediatric and geriatric population; the design of predictive and accelerated test methods for lozenges, vaginal delivery systems and depot parenterals, and in establishing formulation strategies for enhancing the bioavailability of poorly soluble drugs.
| Number of pages | 312 |
|---|
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