Thermodynamics for Drug Product Design

A Guide for Pharmaceutical Scientists
1. Auflage 2025
ISBN: 978-1-119-85109-7
Verlag: Wiley

Buch, Englisch, 352 Seiten

Comprehensive reference reviewing how thermodynamic principles underpin the design of drug products and their applications

Written in an easy-to-read and understand style, Thermodynamics for Drug Product Design offers an abundance of real-life drug product design examples, applications, personal anecdotes, and solved problems that contextualize thermodynamic principles for the drug product design scientist. Advanced undergraduate and beginning graduate students will learn to apply thermodynamic principles to create robust drug products and to predict, prevent, analyze, and evaluate the root cause of product failures. Professionals engaged in drug product design will find this book to be a rich and easy to use reference guide.

The first two chapters address some key basics of data reporting and analysis, math, and thermodynamic properties using simple and accessible language. These chapters also help readers understand fundamental underlying definitions and physical relationships required to use thermodynamic laws in the design of drug products. In later chapters, the book focuses on six industrial pharmacy relevant thermodynamic topics: the laws of thermodynamics, Gibbs free energy, equilibrium, drug solubility equilibrium, surface thermodynamics, and adsorption phenomena.

Thermodynamics for Drug Product Design features chapters including: - Data Reporting and Analysis
- Underlying Thermodynamic Physical Property Relationships and Definitions
- The Laws of Thermodynamics
- Gibbs Free Energy
- Equilibrium
- Drug Solubility Equilibrium
- Surface Thermodynamics
- Adsorption Phenomena

What others say:

“…comprehensive, rigorous, and logically organized …the explanations flow effortlessly from the page…”
—BRUNO HANCOCK, PhD, FAAPS, Editor, JPharmSci

“…has a unique style of communicating complex scientific issues…”
—KEN MORRIS, PhD, FAAPS, Professor Emeritus, Founding Director Lachman Institute

“…unusual wide range of subjects…unusual for detail…”
—DALE ERIC WURSTER, PhD, FAAPS, Professor Emeritus, 2019 AAPS President

Autoren/Hrsg.

Stagner, William Craig

Fachgebiete

• Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Pharmazie
• Naturwissenschaften Chemie Physikalische Chemie Thermochemie, Chemische Thermodynamik
• Naturwissenschaften Chemie Chemie Allgemein Pharmazeutische Chemie, Medizinische Chemie
• Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Medizinische Fachgebiete Pharmakologie, Toxikologie

Inhaltsverzeichnis

SI Defining Constants xv

Foreword xix

Preface xxi

Acknowledgments xxv

1 Data Reporting and Analysis 1

1.1 Introduction 1

1.1.1 Fundamental/Base and Derived Physical Quantities 1

1.1.2 Basic Mathematics and Statistics 2

1.2 Physical Quantity Dimensions and Dimensional Analysis 3

1.2.1 Application of Dimensional Analysis 3

1.2.2 Limitations of Dimensional Analysis 4

1.2.3 Dimensionless Numbers 4

1.2.4 Dimensional Nomenclature 4

1.2.5 Dimensional Quantity Algebra or Dimensional Algebra 4

1.3 Data Reporting Using Decimal, Scientific, Normalized Scientific, and E Scientific Numerical Notation 7

1.4 Accuracy 8

1.5 Precision as Measurement Variability and Relative Uncertainty 8

1.6 Valid Measurements 8

1.7 Uncertainty 9

1.7.1 Uncertainty Associated with a Single Measurement 9

1.7.2 Uncertainty Associated with Replicate Measurements 10

1.7.3 Propagation of Error of Combined Measurements and Calculations 10

1.7.4 Author’s Anecdote: A Priori Estimation of Dose Variation Using Propagation of Error Equations 10

1.8 Significant Figures (Digits) for Measured Values and Calculations 12

1.8.1 Rules for Determining Significant Figures for a Measured or Reported Value 12

1.8.2 Determination of Significant Figures for Addition and Subtraction Calculations 13

1.8.3 Determination of Significant Figures for Multiplication and Division Calculations 13

1.8.4 Logarithm Significant Figures 14

1.8.5 Antilogarithm Significant Figures 14

1.9 Rounding Numbers 15

1.10 How Many Digits and Decimals to Use in Research Reports, Tables, and Presentations 15

1.11 Exponents 16

1.11.1 Exponent Properties and Operations 16

1.11.2 Examples of Scientific Exponent Phenomena 17

1.12 Logarithms 18

1.12.1 Logarithmic Properties and Operations 18

1.12.2 Scientific Examples of Base-10 Logarithms (Log10 or Log) 19

1.12.3 Scientific Examples of Base-e Logarithms (Loge or Ln) 20

1.13 Differential and Partial Differential Equations 22

1.13.1 Differential Order of Ordinary Differential Equations 22

1.13.2 First-Order Ordinary Differential Equations 23

1.13.3 First-Order Partial Derivatives 24

1.14 Integral Equations 25

1.15 Basic Descriptive Statistics 26

1.15.1 Central Tendency of Single Values of Sample Data 27

1.15.2 Dispersion of Single Values of Sample Data 28

1.16 Application: Linear Least Squares and Coefficient of Determination 29

References 31

Chapter 1 Problem Set 32

2 Underlying Thermodynamic Physical Property Relationships and Definitions 35

2.1 Introduction 35

2.2 Temperature 35

2.3 Energy, Heat, and Work 36

2.4 System, Surroundings, Boundary, and Universe 36

2.4.1 Isolated System 37

2.4.2 Closed System 37

2.4.3 Open System 37

2.5 Macroscopic Properties and Intensive–Extensive Variables 38

2.6 Thermodynamic State Variables 38

2.6.1 Ideal Gas Law 38

2.6.2 Dalton’s Law 39

2.6.3 Pharmaceutical Application of the Ideal Gas Law and Dalton’s Law: Sterile Vial and Prefilled Syringe Manufacturing 39

2.6.4 Pharmaceutical Application of Dalton’s Law: Determination of Total Gas Pressure of Pressurized Metered Dose Inhalers Formulated with a Mixture of Propellant Gases 41

2.6.5 Pharmaceutical Application of Ideal Gas Law: Determination of a Pressurized Metered-Dose Inhaler when Stored at -20.0 Fahrenheit (-28.9 C) in a Car Glove Compartment in the Middle of Winter 42

2.7 Isothermal, Adiabatic, Isovolumetric, and Isobaric Thermodynamic State Processes 42

2.7.1 Pharmaceutical Application: Using an Adiabatic Calorimeter to Determine the Enthalpy of Solution of a Drug or Material of Interest 43

2.7.2 Pharmaceutical Application: Freeze-Drying as an Isochoric or Isovolumetric Process 45

2.8 Thermodyn

Über Autor(innen)

William Craig Stagner, RPh, MS, PhD is Professor Emeritus and formerly Director of the Campbell University Pharmaceutical Sciences Institute and Director of the Center for Analysis of Pharmaceutical Biomaterials at Campbell University College of Pharmacy & Health Sciences at Buies Creek, NC. Prior to joining the faculty, he founded the Pharmaceutics Department at the Glaxo Research Institute in Research Triangle Park, NC. Among his publications are co-authoring both editions of the Wiley title Integrated Pharmaceutics: Applied Preformulation, Product Design, and Regulatory Science.