Preformulation in Solid Dosage Form Development
Published on 7. January 2008
616 pages
978-0-8493-6086-2 (ISBN)
Description
During the onset of any clinical trial there are many factors and variables to consider. Funding, time restraints, and regulatory agency guidelines are factors that often influence which variables will be studied, leaving other important information out of the study. Preformulation in Solid Dosage Form Development covers every topic of critical imp
More details
Series
Language
English
Place of publication
Baton Rouge
United States
Publishing group
Taylor & Francis Inc
Target group
Professional and scholarly
Industrial and product development pharmacists; pharmaceutical scientists; medicinal, physical, surface, colloid, and analytical chemists; and upper-level undergraduate and graduate students in these disciplines.
Illustrations
290 s/w Abbildungen, 60 s/w Tabellen, 10 s/w Photographien bzw. Rasterbilder
290 b/w images, 60 tables and 10 halftones
File size
10,55 MB
ISBN-13
978-0-8493-6086-2 (9780849360862)
Copyright in bibliographic data and cover images is held by Nielsen Book Services Limited or by the publishers or by their respective licensors: all rights reserved.
Schweitzer Classification
Other editions
Additional editions
Moji Christianah Adeyeye | Harry G. Brittain
Preformulation in Solid Dosage Form Development
Book
01/2008
1st Edition
CRC Press
€274.80
Shipment within 15-20 days
Persons
MOJI CHRISTIANAH ADEYEYE is currently a Professor of Pharmaceutics and Pharmaceutical Technology, a Fulbright Scholar, and a member of the graduate faculty at the School of Pharmacy, Duquesne University, Pittsburgh, Pennsylvania. She graduated from the University of Nigeria, Nsukka and the University of Georgia, Athens, where she earned her B.S., M.S., and Ph.D. respectively. Her research interests include, preformulation, drug/excipient characterization, delivery systems with a focus on bioavailability and bioequivalence of solid, semi-solid and liquid dosage forms (conventional, modified release). She has worked extensively on nonsteroidal anti-inflammatory drugs, steroids and excipients such as cyclodextrins, microcrystalline cellulose and silicified microcrystalline cellulose. She has published over 40 manuscripts and two patents and given over 100 scientific presentations. She was the past President of the Nigerian American Association of Pharmaceutical Scientists (NAAPS) and former Chair of the AAPS Preformulation Focus Group. She is the Founder and President of a non-profit organization-Drugs for AIDS and HIV Patients (DAHP) whose focus is to care and provide treatment for HIV/AIDS orphans and widows. She is a member of AAPS, APHA, CRS, AACP, AAUP and Christian Connections for International Health.
HARRY G. BRITTAIN is Founder of the Center for Pharmaceutical Physics, Milford, New Jersey. Previously, Dr. Brittain was Vice President for Pharmaceutical Development at Discovery Laboratories, Inc. He also served as Director of Pharmaceutical Development at Ohmeda Inc., and led a variety of groups within the Analytical R&D Department at Bristol-Myers Squibb Co. Dr. Brittain has authored more than 275 research publications and book chapters and has presented numerous invited lectures and short courses in pharmaceutics. He is editor of several books including Physical Characterization of Pharmaceutical Solids, Polymorphism in Pharmaceutical S
HARRY G. BRITTAIN is Founder of the Center for Pharmaceutical Physics, Milford, New Jersey. Previously, Dr. Brittain was Vice President for Pharmaceutical Development at Discovery Laboratories, Inc. He also served as Director of Pharmaceutical Development at Ohmeda Inc., and led a variety of groups within the Analytical R&D Department at Bristol-Myers Squibb Co. Dr. Brittain has authored more than 275 research publications and book chapters and has presented numerous invited lectures and short courses in pharmaceutics. He is editor of several books including Physical Characterization of Pharmaceutical Solids, Polymorphism in Pharmaceutical S
Content
1. Introduction and Overview. 2. Preliminary Preformulation. 2.1. Accelerating the Course of Preliminary-Preformulation through Prediction of Molecular Physical Properties and Integrated Analytical Data Management. 2.2. Prediction of Crystallographic Characteristics. 2.3. Salt Selection for Pharmaceutical Compounds. 2.4. Intelligent Preformulation Design and Predictions using Artificial Neural Networks. 3. Profiling the Drug Substance. 3.1. Developing a Profile of the Active Pharmaceutical Ingredient. 3.2. Particle Morphology and Characterization in Preformulation. 3.3. Preparation and Identification of Polymorphs and Solvatomorphs. 3.4. X-Ray Diffraction Methods for the Characterization of Solid Pharmaceutical Materials. 3.5. Spectroscopic Methods for the Characterization of Drug Substances. 3.6. Thermal Analysis and Calorimetric Methods for the Characterization of New Crystal Forms. 3.7. Solubility Methods for the Characterization of New Crystal Forms. 4. Development of the Ideal Formulation. 4.1. Overview of the Solid Dosage Form Preformulation Program . 4.2. Drug-Excipient Interactions Appropriate to Solid Dosage Forms. 4.3. Methods for the Determination of the Physical and Chemical Stability of a New Solid Dosage Form. 4.4. Dissolution Testing. 5. Beyond Preformulation. 5.1. Structure, Content, and Format of the Preformulation Report. 5.1. Significance of Drug Substance Physicochemical Properties in Regulatory Quality by Design.
