Solid-State Properties of Pharmaceutical Materials
1. Auflage September 2017
432 Seiten, Hardcover
Wiley & Sons Ltd
ISBN:
978-1-118-14530-2
John Wiley & Sons
Kurzbeschreibung
This book presents a detailed discussion of important solid-state properties of pharmaceutical materials, as well as methods of solid-state analysis, such as X-Ray powder diffraction, microscopy, infrared spectroscopy, Raman spectroscopy, and solid state NMR. It also reviews important topics such as particle size/surface area, mechanical properties, and those physical and chemical transformations that impact solid-state stability. It discusses important applications of analytical methods of pharmaceutical solids in form selection, mixture analysis, solid dispersions, and nanotechnology.
Weitere Versionen
Presents a detailed discussion of important solid-state properties, methods, and applications of solid-state analysis
* Illustrates the various phases or forms that solids can assume and discussesvarious issues related to the relative stability of solid forms and tendencies to undergo transformation
* Covers key methods of solid state analysis including X-ray powder diffraction, thermal analysis, microscopy, spectroscopy, and solid state NMR
* Reviews critical physical attributes of pharmaceutical materials, mainly related to drug substances, including particle size/surface area, hygroscopicity, mechanical properties, solubility, and physical and chemical stability
* Showcases the application of solid state material science in rational selection of drug solid forms, analysis of various solid forms within drug substance and the drug product, and pharmaceutical product development
* Introduces appropriate manufacturing and control procedures using Quality by Design, and other strategies that lead to safe and effective products with a minimum of resources and time
Preface
Acknowledgments
Chapter 1: Solid State Properties and Pharmaceutical Development
1.1 Introduction
1.2 Solid State Forms
1.3 ICH Q6A Decision Trees
1.4 "Big Questions" for Drug Development
1.5 Accelerating Drug Development
1.6 Solid State Chemistry in Preformulation and Formulation
1.7 Learning before Doing and Quality by Design
1.8 Performance and Stability in Pharmaceutical Development
1.9 Moisture Uptake
1.10 Solid State Reactions
1.11 Noninteracting Formulations - Physical Characterizations
References
Chapter 2: Polymorphs
2.1 Introduction
2.2 How Are Polymorphs Formed?
2.3 Structural Aspect of Polymorphs
2.4 Physical, Chemical, and Mechanical Properties
2.5 Thermodynamic Stability of Polymorphs
2.6 Polymorph Cconversion
2.7 Control of Polymorphs
2.8 Polymorph Screening
2.9 Polymorph Prediction
References
Chapter 3: Solvates and Hhydrates
3.1 Introduction
3.2 Pharmaceutical Importance of Hydrates
3.3 Classification of Pharmaceutical Hydrates
3.4 Water Aactivity
3.5 Stoichiometric Hhydrates
3.6 Nonstoichiometric Hhydrates
3.7 Hydration/Dehydration
3.8 Preparation and Characterization of Hydrates and Solvates
References
Chapter 4: Pharmaceutical Salts
4.1 Introduction
4.2 Importance of Pharmaceutical Salts
4.3 Weak Acid, Weak Base, and Salt
4.4 pH-Solubility Profiles of Ionizable Compounds
4.5 Solubility, Dissolution and Bioavailability of Pharmaceutical Salts
4.6 Physical Stability of Pharmaceutical Salts
4.7 Strategies for S salt Sselection
References
Chapter 5: Pharmaceutical Co-crystals
5.1 Introduction
5.2 Co-crystals and Crystal Engineering
5.3 Co-crystals and Crystal Engineering
5.4 Co-crystals and Crystal Engineering
5.5 Solubility Phase Diagrams for Co-crystals
5.6 Preparation of Co-crystals
5.7 Dissolution and Bioavailability of Co-crystals
5.8 Comparison of Ppharmaceutical Ssalts and Cco-crystals
References
Chapter 6: Amorphous Solids
6.1 Introduction
6.2 The Formation of Amorphous Solids
6.3 Methods of Preparing Amorphous Solids
6.4 The Glass Transition Temperature
6.5 Structural Features of Amorphous Solids
6.6 Molecular Mobility
6.7 Mixtures of Amorphous Solids
6.8 References
Chapter 7: Crystal Mesophases and Nanocrystals
7.1 Introduction
7.2 Overview of Crystal Mesophases
7.3 Liquid Crystals
7.4 Conformationally Disordered (Condis) Crystals
7.5 Plastic Crystals
7.6 Nanocrystals
References
Chapter 8: X-ray Crystallography and Crystal Packing Analysis
8.1 Introduction
8.2 Crystals
8.3 Miller Indices and Crystal Faces
8.4 Determination of the Miller Indices of the Faces of a Crystal
8.5 Determination of Crystal Structure
References
Chapter 9: X-ray Crystallography and Crystal Packing Analysis X-ray Powder Diffraction
9.1 Introduction
9.2 X-ray Powder Diffraction of Crystalline Materials
9.3 Qualitative Analysis of Crystalline Materials
9.4 Phase Transformations
9.5 Quantitative Phase Analysis Using XRPD
9.6 Solving Crystal Structures Using Powder X-ray Diffraction
9.7 X-ray Diffraction of Amorphous and Crystal Mesophase Forms
9.8 Pair Distribution Function
9.9 X-ray Ddiffractometers
9.10 Variable Ttemperature XRPD
9.11 References
Chapter 10: Differential Scanning Calorimetry and Thermogravimetric Analysis
10.1 Introduction
10.2 The Basics of Differential Scanning Calorimetry
10.3 Thermal Transitions of Pharmaceutical Materials
10.4 DSC Instrumentation
10.54 Thermogravimetric Analysis
10.65 Operating a TGA Instrument
10.76 Evolved Gas Analysis
10.87 Applications of DSC and TGA
10.8 Optimization of the Freezing-Drying Cycle in Lyophilization
10.9 Determination of Chemical Purity of Organic Compounds
References
Chapter 11: Microscopy
11.1 Introduction
11.2 Light Microscopy
11.3 Polarized Light Microscopy
11.4 Thermal Microscopy
11.5 Functionality of the Light Microscope
11.6 Digital Microscope
11.7 Application of Light Microscopy to Pharmaceutical Materials
11.8 Scanning Electron Microscope
11.9 Environmental Scanning Electron Microscopy (ESEM)
11.10 Atomic Force Microscopy
References
Chapter 12: Vibrational Spectroscopy
12.1 Introduction
12.2 The Nature of Molecular Vibrations
12.3 Fourier Transformed Infrared Spectroscopy
12.4 Material Characterization by FT-IR Spectroscopy
12.5 FT-IR Instrumentation
12.6 Diffuse Reflectance FT-IR
12.7 Attenuated Total Reflectance FT-IR
12.8 FT-IR Microscopy
12.9 Near Infrared Spectroscopy
12.10 Raman Spectroscopy
12.11 Raman Instrumentation and Sampling
12.12 Raman Microscope
12.13 Terahertz Spectroscopy
12.14 Comparison of FT-IR, NIR, Raman, and Terahertz Spectroscopy
References
Chapter 13: Solid-State NMR Spectroscopy
13.1 Introduction
13.2 An Overview of Solid-State 13C CP/MAS NMR Spectroscopy
13.3 Solid State NMR Studies of Pharmaceuticals
13.4 Phase Identification in Dosage Forms
13.5 Other Basic Solid-State NMR Experiments Useful for Pharmaceu-tical Analysis
13.6 Determination of the Domain Structure of Amorphous Dispersions Using SSNMR
References
Chapter 14: Particle and Powder Analysis
14.1 Introduction
14.2 Particles in Pharmaceutical Systems
14.3 Particle Size and Shape
14.4 Particle Size Distribution
14.5 Dynamic Light Scattering
14.6 Zeta Potential
14.7 Laser Diffraction
14.8 Dynamic Image Analysis
14.9 Sieve Analysis
14.10 Bulk Properties of Pharmaceutical Particulates and Powder
14.11 Surface Area Measurement
References
Chapter 15: Hygroscopic Properties of Solids
15.1 Introduction
15.2 Water Vapor Sorption-Desorption
15.3 Water Vapor Sorption Isotherms, Relative Humidity and Water Activity
15.4 Measurement of Water Content and Water Vapor Sorption/Desorption Isotherms
15.5 Measurement of Water Vapor Sorption/Desorption Isotherms
15.56 Modes of Water Vapor Sorption
References
Chapter 16: Mechanical Properties of Pharmaceutical Materials
16.1 Introduction
16.2 Stress and Strain
16.3 Elasticity
16.4 Plasticity
16.5 Viscoelasticity
16.6 Brittleness
16.7 Hardness
16.8 Powder Compression
16.9 Powder Compression Models and Compressibility
16.10 Compactibility and Tensile Strength
16.11 Effect of Solid Form on Mechanical Properties
16.12 Effect of Moisture on Mechanical Properties
16.13 Methods for Testing Mechanical Properties
16.14 Nanoindention
References
Chapter 17: Solubility and Dissolution
17.1 Introduction
17.2 Principle Concepts Associated with Solubility
17.3 Prediction of Aqueous Drug Solubility
17.4 Solubility of Pharmaceutical Solid Forms
17.5 Solubility Determination Using the Shake Flask Method
17.6 High Throughput Screening of Solubility
17.7 Solubility Measurement of Metastable Forms
17.8 Kinetic Solubility Measurement
17.9 Solubility Determination of Drugs in Polymer Matrices
17.10 Dissolution Testing
17.11 Non-sink Dissolution Test
17.12 Intrinsic Dissolution Studies
References
Chapter 18: Physical Stability of Solids
18.1 Introduction
18.2 Underlying Basis for Physical Instability in Pharmaceutical Systems
18.3 Disorder in Crystals
18.4 Examples of the Role of Process-Induced Disorder in Solid-State Physical Instability in Pharmaceutical Systems
18.5 Considerations in Evaluating Solid-State Physical Stability
References
Chapter 19: Chemical Stability of Solids
19.1 Introduction
19.2 Examples of Chemical Reactivity in the Solid State
19.3 Some General Principles That Establish the Rate of Chemical Reactions in Solution
19.4 The Role of Crystal Defects in Solid-State Reactions
19.5 Chemical Reactivity in the Amorphous Solid State
19.6 Chemical Reactivity and Processed-Induced- -Disorder
19.7 The Effects of Residual Water on Solid-State Chemical Reactivity
19.8 Drug- Excipient Interactions
19.9 Summary
References
Chapter 20: Solid-State Properties of Proteins
20.1 Introduction
20.2 Solution Properties of Proteins
20.3 Amorphous Properties of Proteins
20.4 Crystalline Properties of Proteins
20.5 Local Molecular Motions and the Dynamical Transitional Temperature, Td
20.6 Solid-State Physical and Chemical Stability of Proteins
20.7 Cryoprotection and Lyoprotection
References
Chapter 21: Form Selection of Active Pharmaceutical Ingredients
21.1 Introduction
21.2 Form Selection
21.3 Amorphous Form Screening
21.4 Salt Selection
21.5 Co-crystal Screening
21.6 Polymorph Screening
21.7 Slurrying
21.8 High-throughput Screening
21.9 Crystallization in Cconfined Sspace
21.10 Non-solvent Based Polymorph Screening
21.11 Polymer Induced Heteronucleation
21.12 Physical Characterization
21.13 Thermodynamic Stability and Form Selection
References
Chapter 22: Mixture Analysis
22.1 Introduction
22.2 Limitations of Wet Chemistry
22.3 Pharmaceutical Analysis in the Solid State
22.4 Development and Validation of a Calibration Model
22.5 Measurement of Amorphous Content
22.6 Detection of the Degree of Crystallinity
22.7 Quantification of Mixtures of Polymorphs
22.8 Salt and Free Form Composition
22.9 Process Analytical Technology (PAT)
22.10 Physical and Chemical Attributes of a Process
22.11 Selection of Process Analyzers
References
Chapter 23: Product Development
23.1 Chemistry, Manufacture, and Control (CMC)
23.2 Preformulation
23.3 Drug Excipient Compatibility
23.4 Solid Dispersions
23.5 Abuse-Deterrent Dosage Forms
23.6 Drug Eluting Stents (DES)
23.7 Dry Powder Inhalers (DPI)
23.8 Lyophilization and Biopharmaceutical Products
References
Chapter 24: Quality by Design
24.1 Introduction
24.2 Quality by Design Wheel
24.3 Learning before Doing (LbD)
24.4 Risk Based Orientation
24.5 API Attributes and Process Design
24.6 Development and Design Space
24.7 Process Design - Crystallization
24.8 Phase Transformations during Wet Granulation
24.9 Dissolution Tests with an In-Vitro in-Vivo Correlation (IVIVC) for Quality by Design
24.10 Conclusion
References
Acknowledgments
Chapter 1: Solid State Properties and Pharmaceutical Development
1.1 Introduction
1.2 Solid State Forms
1.3 ICH Q6A Decision Trees
1.4 "Big Questions" for Drug Development
1.5 Accelerating Drug Development
1.6 Solid State Chemistry in Preformulation and Formulation
1.7 Learning before Doing and Quality by Design
1.8 Performance and Stability in Pharmaceutical Development
1.9 Moisture Uptake
1.10 Solid State Reactions
1.11 Noninteracting Formulations - Physical Characterizations
References
Chapter 2: Polymorphs
2.1 Introduction
2.2 How Are Polymorphs Formed?
2.3 Structural Aspect of Polymorphs
2.4 Physical, Chemical, and Mechanical Properties
2.5 Thermodynamic Stability of Polymorphs
2.6 Polymorph Cconversion
2.7 Control of Polymorphs
2.8 Polymorph Screening
2.9 Polymorph Prediction
References
Chapter 3: Solvates and Hhydrates
3.1 Introduction
3.2 Pharmaceutical Importance of Hydrates
3.3 Classification of Pharmaceutical Hydrates
3.4 Water Aactivity
3.5 Stoichiometric Hhydrates
3.6 Nonstoichiometric Hhydrates
3.7 Hydration/Dehydration
3.8 Preparation and Characterization of Hydrates and Solvates
References
Chapter 4: Pharmaceutical Salts
4.1 Introduction
4.2 Importance of Pharmaceutical Salts
4.3 Weak Acid, Weak Base, and Salt
4.4 pH-Solubility Profiles of Ionizable Compounds
4.5 Solubility, Dissolution and Bioavailability of Pharmaceutical Salts
4.6 Physical Stability of Pharmaceutical Salts
4.7 Strategies for S salt Sselection
References
Chapter 5: Pharmaceutical Co-crystals
5.1 Introduction
5.2 Co-crystals and Crystal Engineering
5.3 Co-crystals and Crystal Engineering
5.4 Co-crystals and Crystal Engineering
5.5 Solubility Phase Diagrams for Co-crystals
5.6 Preparation of Co-crystals
5.7 Dissolution and Bioavailability of Co-crystals
5.8 Comparison of Ppharmaceutical Ssalts and Cco-crystals
References
Chapter 6: Amorphous Solids
6.1 Introduction
6.2 The Formation of Amorphous Solids
6.3 Methods of Preparing Amorphous Solids
6.4 The Glass Transition Temperature
6.5 Structural Features of Amorphous Solids
6.6 Molecular Mobility
6.7 Mixtures of Amorphous Solids
6.8 References
Chapter 7: Crystal Mesophases and Nanocrystals
7.1 Introduction
7.2 Overview of Crystal Mesophases
7.3 Liquid Crystals
7.4 Conformationally Disordered (Condis) Crystals
7.5 Plastic Crystals
7.6 Nanocrystals
References
Chapter 8: X-ray Crystallography and Crystal Packing Analysis
8.1 Introduction
8.2 Crystals
8.3 Miller Indices and Crystal Faces
8.4 Determination of the Miller Indices of the Faces of a Crystal
8.5 Determination of Crystal Structure
References
Chapter 9: X-ray Crystallography and Crystal Packing Analysis X-ray Powder Diffraction
9.1 Introduction
9.2 X-ray Powder Diffraction of Crystalline Materials
9.3 Qualitative Analysis of Crystalline Materials
9.4 Phase Transformations
9.5 Quantitative Phase Analysis Using XRPD
9.6 Solving Crystal Structures Using Powder X-ray Diffraction
9.7 X-ray Diffraction of Amorphous and Crystal Mesophase Forms
9.8 Pair Distribution Function
9.9 X-ray Ddiffractometers
9.10 Variable Ttemperature XRPD
9.11 References
Chapter 10: Differential Scanning Calorimetry and Thermogravimetric Analysis
10.1 Introduction
10.2 The Basics of Differential Scanning Calorimetry
10.3 Thermal Transitions of Pharmaceutical Materials
10.4 DSC Instrumentation
10.54 Thermogravimetric Analysis
10.65 Operating a TGA Instrument
10.76 Evolved Gas Analysis
10.87 Applications of DSC and TGA
10.8 Optimization of the Freezing-Drying Cycle in Lyophilization
10.9 Determination of Chemical Purity of Organic Compounds
References
Chapter 11: Microscopy
11.1 Introduction
11.2 Light Microscopy
11.3 Polarized Light Microscopy
11.4 Thermal Microscopy
11.5 Functionality of the Light Microscope
11.6 Digital Microscope
11.7 Application of Light Microscopy to Pharmaceutical Materials
11.8 Scanning Electron Microscope
11.9 Environmental Scanning Electron Microscopy (ESEM)
11.10 Atomic Force Microscopy
References
Chapter 12: Vibrational Spectroscopy
12.1 Introduction
12.2 The Nature of Molecular Vibrations
12.3 Fourier Transformed Infrared Spectroscopy
12.4 Material Characterization by FT-IR Spectroscopy
12.5 FT-IR Instrumentation
12.6 Diffuse Reflectance FT-IR
12.7 Attenuated Total Reflectance FT-IR
12.8 FT-IR Microscopy
12.9 Near Infrared Spectroscopy
12.10 Raman Spectroscopy
12.11 Raman Instrumentation and Sampling
12.12 Raman Microscope
12.13 Terahertz Spectroscopy
12.14 Comparison of FT-IR, NIR, Raman, and Terahertz Spectroscopy
References
Chapter 13: Solid-State NMR Spectroscopy
13.1 Introduction
13.2 An Overview of Solid-State 13C CP/MAS NMR Spectroscopy
13.3 Solid State NMR Studies of Pharmaceuticals
13.4 Phase Identification in Dosage Forms
13.5 Other Basic Solid-State NMR Experiments Useful for Pharmaceu-tical Analysis
13.6 Determination of the Domain Structure of Amorphous Dispersions Using SSNMR
References
Chapter 14: Particle and Powder Analysis
14.1 Introduction
14.2 Particles in Pharmaceutical Systems
14.3 Particle Size and Shape
14.4 Particle Size Distribution
14.5 Dynamic Light Scattering
14.6 Zeta Potential
14.7 Laser Diffraction
14.8 Dynamic Image Analysis
14.9 Sieve Analysis
14.10 Bulk Properties of Pharmaceutical Particulates and Powder
14.11 Surface Area Measurement
References
Chapter 15: Hygroscopic Properties of Solids
15.1 Introduction
15.2 Water Vapor Sorption-Desorption
15.3 Water Vapor Sorption Isotherms, Relative Humidity and Water Activity
15.4 Measurement of Water Content and Water Vapor Sorption/Desorption Isotherms
15.5 Measurement of Water Vapor Sorption/Desorption Isotherms
15.56 Modes of Water Vapor Sorption
References
Chapter 16: Mechanical Properties of Pharmaceutical Materials
16.1 Introduction
16.2 Stress and Strain
16.3 Elasticity
16.4 Plasticity
16.5 Viscoelasticity
16.6 Brittleness
16.7 Hardness
16.8 Powder Compression
16.9 Powder Compression Models and Compressibility
16.10 Compactibility and Tensile Strength
16.11 Effect of Solid Form on Mechanical Properties
16.12 Effect of Moisture on Mechanical Properties
16.13 Methods for Testing Mechanical Properties
16.14 Nanoindention
References
Chapter 17: Solubility and Dissolution
17.1 Introduction
17.2 Principle Concepts Associated with Solubility
17.3 Prediction of Aqueous Drug Solubility
17.4 Solubility of Pharmaceutical Solid Forms
17.5 Solubility Determination Using the Shake Flask Method
17.6 High Throughput Screening of Solubility
17.7 Solubility Measurement of Metastable Forms
17.8 Kinetic Solubility Measurement
17.9 Solubility Determination of Drugs in Polymer Matrices
17.10 Dissolution Testing
17.11 Non-sink Dissolution Test
17.12 Intrinsic Dissolution Studies
References
Chapter 18: Physical Stability of Solids
18.1 Introduction
18.2 Underlying Basis for Physical Instability in Pharmaceutical Systems
18.3 Disorder in Crystals
18.4 Examples of the Role of Process-Induced Disorder in Solid-State Physical Instability in Pharmaceutical Systems
18.5 Considerations in Evaluating Solid-State Physical Stability
References
Chapter 19: Chemical Stability of Solids
19.1 Introduction
19.2 Examples of Chemical Reactivity in the Solid State
19.3 Some General Principles That Establish the Rate of Chemical Reactions in Solution
19.4 The Role of Crystal Defects in Solid-State Reactions
19.5 Chemical Reactivity in the Amorphous Solid State
19.6 Chemical Reactivity and Processed-Induced- -Disorder
19.7 The Effects of Residual Water on Solid-State Chemical Reactivity
19.8 Drug- Excipient Interactions
19.9 Summary
References
Chapter 20: Solid-State Properties of Proteins
20.1 Introduction
20.2 Solution Properties of Proteins
20.3 Amorphous Properties of Proteins
20.4 Crystalline Properties of Proteins
20.5 Local Molecular Motions and the Dynamical Transitional Temperature, Td
20.6 Solid-State Physical and Chemical Stability of Proteins
20.7 Cryoprotection and Lyoprotection
References
Chapter 21: Form Selection of Active Pharmaceutical Ingredients
21.1 Introduction
21.2 Form Selection
21.3 Amorphous Form Screening
21.4 Salt Selection
21.5 Co-crystal Screening
21.6 Polymorph Screening
21.7 Slurrying
21.8 High-throughput Screening
21.9 Crystallization in Cconfined Sspace
21.10 Non-solvent Based Polymorph Screening
21.11 Polymer Induced Heteronucleation
21.12 Physical Characterization
21.13 Thermodynamic Stability and Form Selection
References
Chapter 22: Mixture Analysis
22.1 Introduction
22.2 Limitations of Wet Chemistry
22.3 Pharmaceutical Analysis in the Solid State
22.4 Development and Validation of a Calibration Model
22.5 Measurement of Amorphous Content
22.6 Detection of the Degree of Crystallinity
22.7 Quantification of Mixtures of Polymorphs
22.8 Salt and Free Form Composition
22.9 Process Analytical Technology (PAT)
22.10 Physical and Chemical Attributes of a Process
22.11 Selection of Process Analyzers
References
Chapter 23: Product Development
23.1 Chemistry, Manufacture, and Control (CMC)
23.2 Preformulation
23.3 Drug Excipient Compatibility
23.4 Solid Dispersions
23.5 Abuse-Deterrent Dosage Forms
23.6 Drug Eluting Stents (DES)
23.7 Dry Powder Inhalers (DPI)
23.8 Lyophilization and Biopharmaceutical Products
References
Chapter 24: Quality by Design
24.1 Introduction
24.2 Quality by Design Wheel
24.3 Learning before Doing (LbD)
24.4 Risk Based Orientation
24.5 API Attributes and Process Design
24.6 Development and Design Space
24.7 Process Design - Crystallization
24.8 Phase Transformations during Wet Granulation
24.9 Dissolution Tests with an In-Vitro in-Vivo Correlation (IVIVC) for Quality by Design
24.10 Conclusion
References
Stephen R. Byrn, PhD is Charles B. Jordan Professor of Medicinal Chemistry in the School of Pharmacy, Purdue University. Dr. Byrn has founded and directed several programs at Purdue University including CAMP, the Center for AIDS Research, the Molecules to Market program, and Purdue's graduate programs in regulatory and quality compliance. Dr. Byrn has served as chair of the Pharmaceutical Sciences Advisory Committee to the FDA and Chair of the Drug Substances Technical Committee, Product Quality Research Initiative. Dr. Byrn is co-founder of SSCI, Inc. a cGMP research and information Company.
George Zografi, PhD is the Edward Kremers Professor Emeritus of Pharmaceutical Sciences, School of Pharmacy, University of Wisconsin-Madison. He was the recipient of the APhA Ebert Prize in 1984 and 2001, the AAPS Dale E. Wurster Award for Pharmaceutics in 1990 and its Distinguished Scientist Award in 1995, as well as the Volwiler Research Achievement Award of the American Association of Colleges of Pharmacy. Xiaoming Chen, PhD is currently the Director of Formulation Development in Antares Pharma Inc. Prior to that, he held various positions in pharmaceutical product development at Schering-Plough, OSI Pharmaceuticals, Astellas Pharma, and Shionogi Inc. He has published over a dozen of papers in peer-reviewed journals and is a co-inventor of four US patents.
George Zografi, PhD is the Edward Kremers Professor Emeritus of Pharmaceutical Sciences, School of Pharmacy, University of Wisconsin-Madison. He was the recipient of the APhA Ebert Prize in 1984 and 2001, the AAPS Dale E. Wurster Award for Pharmaceutics in 1990 and its Distinguished Scientist Award in 1995, as well as the Volwiler Research Achievement Award of the American Association of Colleges of Pharmacy. Xiaoming Chen, PhD is currently the Director of Formulation Development in Antares Pharma Inc. Prior to that, he held various positions in pharmaceutical product development at Schering-Plough, OSI Pharmaceuticals, Astellas Pharma, and Shionogi Inc. He has published over a dozen of papers in peer-reviewed journals and is a co-inventor of four US patents.
