Integrated Pharmaceutics - Applied Preformulation, Product Design, and Regulatory Science

This work is an examination of all aspects of the science in developing effective dosage form for drug delivery
 
Pharmaceutics refers to the subfield of pharmaceutical sciences that develops drug delivery products or devices to optimize the drug's performance once administered. This multidisciplinary field draws on physical chemistry, organic chemistry, and biophysics to generate and refine these crucial elements of medical care. Moreover, incorporating such disparate dimensions of drug product design as material properties and legal regulation bridges the gap between effective chemicals and viable medical treatments.
 
Integrated Pharmaceutics provides a comprehensive introduction to the creation and manufacture of effective dosage forms for drug delivery. It presents its subject following the principles of physical pharmacy, product design, and drug regulations. This tripartite structure allows readers to move from theory to practice, beginning from a firm foundation of physical pharmacy principles, including drug solubility and stability estimation, rheology, and interfacial properties. From there, it proceeds to discussions of drug product design and of harmonizing pharmaceutical design with the regulatory regimens and technological standards of the United States, European Union, and Japan.
 
Readers of the second edition of Integrated Pharmaceutics will also find:
* A glossary defining key terms, extensive informative appendices, and a list of references leading to the primary literature in the field for each chapter
* Earlier chapters are expanded, with additional new chapters including one entitled "Biotechnology Products"
* Supplementary instructor guide with questions and solutions available online for registered professors
* Updated regulatory guidelines including quality by design, design space analysis, process analytical technology, polymorphism characterization, blend sample uniformity, and stability protocols
 
Integrated Pharmaceutics is a useful textbook for graduate students in pharmaceutical sciences, drug formulation and design, and biomedical engineering. In addition, professionals in the pharmaceutical industry, including regulatory bodies, will find it a helpful reference guide.

List of contents

Foreword to Second Edition xv
 
Foreword to First Edition xvi
 
Preface to Second Edition xvii
 
Preface to First Edition xviii
 
About the Companion Website xx
 
Part I Applied Preformulation 1
 
1 Mathematical Concepts 3
 
1.1 Introduction 3
 
1.2 Significant Figures and Rounding off Numbers 3
 
1.3 The Simple Linear Relationship 4
 
1.4 Exponential Rules 6
 
1.5 Logarithmic Rules 6
 
1.6 Differential Equations 7
 
1.7 Expanding and Reducing Formulas 9
 
1.8 Weights and Measures 9
 
References 10
 
Glossary 10
 
2 Thermodynamics 11
 
2.1 Introduction 11
 
2.2 The Zeroth Law of Thermodynamics 11
 
2.3 The First Law of Thermodynamics 11
 
2.4 The Second Law of Thermodynamics 12
 
2.5 The Third Law of Thermodynamics 13
 
2.6 Polymorphism 13
 
2.7 Physical Stability of Crystal Forms 14
 
2.8 Solubility 14
 
References 15
 
Glossary 16
 
3 Solubility and Dissolution 18
 
3.1 Introduction 18
 
3.2 Methods of API Solubility Enhancement 19
 
3.3 Nonionic, Ionic, and Acid-Base Concepts Related to Solubility and Dissolution 29
 
3.4 The Solubility of Gas in Liquid 29
 
3.5 The Solubility of Liquid in Liquid 30
 
3.6 The Solubility of Solid in Liquid 30
 
3.7 Disintegration and Dissolution 31
 
3.8 Concentration Units 34
 
3.9 The Partition Coefficient 39
 
3.10 Concluding Remarks 41
 
References 41
 
Glossary 44
 
Appendix 45
 
4 Biological Aspects of Formulations 46
 
4.1 Introduction 46
 
4.2 Bioavailability and Bioequivalence 46
 
4.3 Protocols for Determining Bioequivalence 48
 
4.4 Bioequivalence Procedure 49
 
4.5 FDA-Approved Methods for Bioequivalence Studies 49
 
4.6 Approaches to Improving Bioavailability 50
 
References 52
 
Glossary 53
 
5 Interfacial Properties 54
 
5.1 Introduction 54
 
5.2 Liquid-Solid Interface 54
 
5.3 Liquid-Liquid Interface 55
 
5.4 Dosage-Form Applications 55
 
5.5 Case Study: HLB Determination 58
 
5.6 Case Study: Determination of Required HLB (rHLB) 58
 
References 58
 
Glossary 59
 
6 Adsorption Phenomenon 60
 
6.1 Introduction 60
 
6.2 Adsorption on Filters 66
 
6.3 Adsorption of Proteins 66
 
References 66
 
Glossary 68
 
7 Rheological Principles 69
 
7.1 Introduction 69
 
7.2 Newtonian Systems 69
 
7.3 Non-Newtonian Systems 70
 
7.4 Viscoelasticity 72
 
7.5 Reynolds Number 74
 
7.6 Concluding Remarks 76
 
References 76
 
Glossary 77
 
8 Chemical Stability and Shelf-Life Determination 78
 
8.1 Introduction 78
 
8.2 Shelf-Life Determination 79
 
8.3 Stability of Biotechnology Products 84
 
8.4 Compounded Products and Their Beyond-Use Dates 86
 
References 102
 
Glossary 107
 
9 Particle Science 108
 
9.1 Introduction 108
 
9.2 Miromeritics 108
 
9.3 Micronization 113
 
9.4 Particle Size Preparation and Reduction for Pulmonary Delivery 114
 
9.5 Polymeric Particulate Matter 115
 
9.6 Nanoparticles 116
 
9.7 Segregation of Particles 121
 
9.8 Case Studies: Microscopic Particle Size Analysis, Determining Statistically Valid Sample Size, and Comparison of Sieve and Focused Beam Reflectance Measurement Chord Length Particle Size

About the author

Antoine Al-Achi, PhD, is a Professor of Pharmaceutical Sciences at the College of Pharmacy & Health Sciences at Campbell University in North Carolina. He is also a former track head of the Industrial Pharmacy graduate major and former Head of the Formulation Development Division of Campbell's Pharmaceutical Sciences Institute. Mali Ram Gupta, PhD, is an Associate Professor Emeritus of Pharmaceutical Sciences and Director of Pharmaceutical Education & Research (PERC) in the College of Pharmacy & Health Sciences Campbell University. Prior to joining Campbell in 2005, he spent over 25 years managing QA/QC departments of various pharma, cosmetic, and diagnostic companies. William Craig Stagner, PhD, is a Professor Emeritus of Pharmaceutical Sciences at the College of Pharmacy & Health Sciences Campbell University. In his time at Glaxo Research Institute (1987-95), he established the Pharmaceutics Department.

Product details

• Authors: Antoine Al-Achi, Antoine Gupta Al-Achi, Mali Ram Gupta, William Stagner, William Craig Stagner
• Publisher: Wiley, John and Sons Ltd
• Languages: English
• Product format: Hardback
• Released: 10.10.2022
• EAN: 9781119574699
• ISBN: 978-1-119-57469-9
• No. of pages: 816
• Subject: Natural sciences, medicine, IT, technology > Chemistry > Miscellaneous