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Poorly Soluble Drugs: Dissolution and Drug Release by Gregory K. Webster (Englis
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Specificaties
- Objectstaat
- ISBN-13
- 9789814745451
- Book Title
- Poorly Soluble Drugs
- ISBN
- 9789814745451
- Publication Year
- 2016
- Type
- Textbook
- Format
- Hardcover
- Language
- English
- Publication Name
- Poorly Soluble Drugs : Dissolution and Drug Release
- Item Height
- 1.7in
- Item Length
- 9.3in
- Publisher
- Pan Stanford Publishing
- Item Width
- 6.3in
- Item Weight
- 38.5 Oz
- Number of Pages
- 728 Pages
Over dit product
Product Information
This book is the first text to provide a comprehensive assessment of the application of fundamental principles of dissolution and drug release testing to poorly soluble compounds and formulations. Such drug products are, vis-¿is their physical and chemical properties, inherently incompatible with aqueous dissolution. However, dissolution methods are required for product development and selection, as well as for the fulfillment of regulatory obligations with respect to biopharmaceutical assessment and product quality understanding. The percentage of poorly soluble drugs, defined in classes 2 and 4 of the Biopharmaceutics Classification System (BCS), has significantly increased in the modern pharmaceutical development pipeline. This book provides a thorough exposition of general method development strategies for such drugs, including instrumentation and media selection, the use of compendial and non-compendial techniques in product development, and phase-appropriate approaches to dissolution development. Emerging topics in the field of dissolution are also discussed, including biorelevant and biphasic dissolution, the use on enzymes in dissolution testing, dissolution of suspensions, and drug release of non-oral products. Of particular interest to the industrial pharmaceutical professional, a brief overview of the formulation and solubilization techniques employed in the development of BCS class 2 and 4 drugs to overcome solubility challenges is provided and is complemented by a collection of chapters that survey the approaches and considerations in developing dissolution methodologies for enabling drug delivery technologies, including nanosuspensions, lipid-based formulations, and stabilized amorphous drug formulations.
Product Identifiers
Publisher
Pan Stanford Publishing
ISBN-10
9814745456
ISBN-13
9789814745451
eBay Product ID (ePID)
235692660
Product Key Features
Publication Name
Poorly Soluble Drugs : Dissolution and Drug Release
Format
Hardcover
Language
English
Publication Year
2016
Type
Textbook
Number of Pages
728 Pages
Dimensions
Item Length
9.3in
Item Height
1.7in
Item Width
6.3in
Item Weight
38.5 Oz
Additional Product Features
Lc Classification Number
Rs201.S6
Reviews
"Even those who have been developing dissolution methods for years will find valuable information, since this text goes well beyond the basics of dissolution development for poorly soluble drugs. . . . The book walks through the lifecycle of a dissolution method for a poorly soluble compound, starting with solubility and intrinsic dissolution, including use of surfactants, has chapters that address several of the strategies used for formulation development and the staged approach to development of dissolution methods, provides chapters on alternatives to the traditional USP dissolution Apparatus 1 and 2, including Apparatus 3 and 4 and noncompendial approaches, then moves to some of the most interesting information describing biorelevant dissolution, clinically relevant dissolution, QbD approaches, and regulatory considerations. . . . Overall, this is a book that I strongly recommend for everyone involved in dissolution method development. It goes into much greater detail than similar texts and provides practical information that will prove helpful in addressing the concepts presented, both from a scientific and a regulatory perspective." --Dissolution Technologies , February 2017
Table of Content
The Modern Pharmaceutical Development Challenge: BCS Class II and IV Drugs Gregory K. Webster, Robert G. Bell, and J. Derek Jackson Solubility Determinations for Pharmaceutical API Kofi Asare-Addo and Barbara R. Conway Use of Surfactants in Dissolution Testing Amit Gupta Intrinsic Dissolution Evaluation of Poorly Soluble Drugs Michele Georges Issa and Humberto Gomes Ferraz Oral Delivery of Poorly Soluble Drugs Dev Prasad, Akash Jain, and Sudhakar Garad A Staged Approach to Pharmaceutical Dissolution Testing Gregory K. Webster, Xi Shao, and Paul D. Curry, Jr. Development and Application of in vitro Two-Phase Dissolution Method for Poorly Water-Soluble Drugs Ping Gao, Yi Shi, and Jonathan M. Miller The Use of Apparatus 3 in Dissolution Testing of Poorly Soluble Drug Formulations G. Bryan Crist 9. Use of Apparatus 4 in Dissolution Testing, Including Sparingly and Poorly Soluble Drugs Rajan Jog, Geoffrey N. Grove, and Diane J. Burgess Dissolution of Nanoparticle Drug Formulations John Bullock Dissolution of Lipid-Based Drug Formulations Stephen M. Cafiero Dissolution of Stabilized Amorphous Drug Formulations Justin R. Hughey Dissolution of Pharmaceutical Suspensions Beverly Nickerson, Michele Xuemei Guo, Kenneth J. Norris, and Ling Zhang Dissolution Testing of Poorly Soluble Drugs: "Biorelevant Dissolution" Mark McAllister and Irena Tomaszewska Clinically Relevant Dissolution for Low-Solubility Immediate-Release Products Paul A. Dickinson, Talia Flanagan, David Holt, and Paul W. Stott The QbD Approach to Method Development and Validation for Dissolution Testing Alger D. Salt Regulatory Considerations in Dissolution and Drug Release of BCS Class II and IV Compounds Robert G. Bell and Laila Kott Dissolution of Liquid-Filled Capsules Based Formulations Rampurna Prasad Gullapalli Current and Emerging Non-compendial Methods for Dissolution Testing Namita Tipnis and Diane J. Burgess
Copyright Date
2016
Target Audience
College Audience
Topic
Pharmacy, Chemistry / Analytic, Pharmacology
Dewey Decimal
615.19
Dewey Edition
23
Illustrated
Yes
Genre
Science, Medical
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