Design and Manufacture of Pharmaceutical Tablets
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About this ebook
- Incorporates important mathematical models and computational applications
- Includes unique content on central composite design and augmented simplex lattice
- Provides background on important design principles with emphasis on quality-based design (QBD) of pharmaceutical dosage forms
Reynir Eyjolfsson
Dr. Eyjolfsson entered pharmacy in 1959, having studied at the University of Iceland and then at the Pharmaceutical University of Denmark, Copenhagen 1961-1964 (MsPharm 1964). Dr. Eyjolfsson earned a Ph.D. in the chemistry of natural product from same university in 1968. He moved to Iceland in 1971 and has worked with drug formulation science at Pharmaco, Delta, Actavis until 2010. Dr. Eyjolfsson is an author of approximately 30 scientific papers in peer reviewed journals mainly on phytochemistry and pharmaceutics. He has designed many different dosage forms but mostly conventional tablets and slow release tablets.
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Reviews for Design and Manufacture of Pharmaceutical Tablets
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- Rating: 1 out of 5 stars1/5Best book ever about tablet production I have ever read
Book preview
Design and Manufacture of Pharmaceutical Tablets - Reynir Eyjolfsson
Design and Manufacture of Pharmaceutical Tablets
Reynir Eyjolfsson
Table of Contents
Cover
Title page
Copyright Page
Dedication
Preface
Abbreviations
Chapter One: Introduction
Abstract
1.1. General considerations [1, 2]
1.2. Particle sizes [3]
1.3. Excipients [4]
1.4. Equipment
1.5. Mixing of pharmaceutical powders [5]
1.6. Design of experiments [6–9]
Chapter Two: Conventional-Release (CR) Tablets
Abstract
2.1. Low-dose tablet by direct compression (DC)
2.2. High-dose tablet by direct compression
2.3. Low-solubility API, low-dose tablet by wet granulation (WG) [1]
2.4. Soluble API, low-dose tablet by wet granulation
2.5. Low-solubility API, high-dose tablet by wet granulation
2.6. Soluble API, high-dose tablet by wet granulation [2]
Chapter Three: Slow-Release (SR) Tablets
Abstract
3.1. Slow-release tablet using a lipophilic release control agent
3.2. Slow-release tablet using Eudragit and Methocel as release control agents
3.3. Slow-release tablet using a mixture of Methocels as release control agent [1]
Index
Copyright Page
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Notices
Knowledge and best practice in this field are constantly changing. As new research and experience broaden our understanding, changes in research methods, professional practices, or medical treatment may become necessary.
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ISBN: 978-0-12-802182-8
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Dedication
This book is dedicated to my fellow pioneers at Pharmaco, Delta, and later Actavis, who laid the foundations to what Actavis is today: the third largest pharmaceutical generics company in the world.
Preface
Many excellent books have been written about the design and manufacture of pharmaceutical tablets, but they are all more or less theoretical, offering few and limited examples of real-life formulations. Almost invariably, these examples lack information on processing details, stability (shelf life), dissolution, and bioavailability. In view of this, there is really a need for a book describing real-life practical examples that have been validated and researched as to bioavailability. These aspects frequently appear daunting to newcomers to tablet formulation science and even to experienced professionals. From this author’s experience the conclusion is: If only I had had a book on the practical aspects of these matters when I started my career in this field things would have been much easier and more satisfying.
This book is an attempt to improve on this situation by offering nine real-life tablet formulations and processing examples. In order to avoid conceivable commercial conflicts the identities of the active pharmaceutical ingredients (APIs) are not revealed but some of their physicochemical properties are disclosed.
Primarily, theoretical aspects are not dealt with in this book as they are readily available elsewhere. There is emphasis on design of experiments (DOE) but this is mostly restricted to practical examples. Also, mixing of pharmaceutical powders is given special attention. This author admits that his views may be in conflict with the practices generally employed in the pharmaceutical industry but he is of the opinion that if his approach to powder mixing were followed, problems with tablet content uniformity would be virtually nonexistent!
Best thanks to the wonderful staff at Elsevier Inc., particularly my editors, Ms. Kristine Jones and Ms. Molly McLaughlin, for their patience and never-failing help.
Hafnarfjordur, Iceland, July 2014
Reynir Eyjolfsson, reynirey@mmedia.is
Abbreviations
Al/Al aluminum/aluminum
Al/PVC aluminum/polyvinyl chloride
ANOVA analysis of variance
API active pharmaceutical ingredient
ASL augmented simplex