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ANTOINE AL-ACHI, PhD, CT (ASCP), is Associate Professor of Pharmaceutics in the College of Pharmacy & Health Sciences at Campbell University. He is also the former head of the Formulation Development Division of Campbell's Pharmaceutical Sciences Institute (CUPSI).
MALI RAM GUPTA, PhD, is Associate Professor of Pharmaceutical Sciences and Director of Pharmaceutical Education & Research Center (PERC) in the College of Pharmacy & Health Sciences. Prior to joining the faculty at Campbell University, he spent twenty-five years in various positions at Revlon, including director of quality control and assurance.
WILLIAM CRAIG STAGNER, PhD, RPh, is Professor of Pharmaceutical Sciences and Director of Campbell University's Center for Analysis of Pharmaceutical Biomaterials. Prior to joining the faculty at Campbell, he established the Pharmaceutics Department at Glaxo Research Institute.
Dedication
Acknowledgement
Preface
Foreword
SECTION I PREFORMULATION
1 Mathematical Concepts
1.1 Introduction
1.2 The Simple Linear Relationship
1.3 Exponential Rules
1.4 The Logarithmic Rules
1.5 Differential Equations
1.6 Expanding and Reducing Formulas
References for Chapter 1
Glossary for Chapter 1
2 Thermodynamics
2.1 Introduction
2.2 The Zeroth Law of Thermodynamics
2.3 The First Law of Thermodynamics
2.4 The Second Law of Thermodynamics
2.5 The Third Law of Thermodynamics
2.6 Polymorphism
2.7 Physical Stability of Crystal Forms
2.8 Solubility
References for Chapter 2
Glossary for Chapter 2
3 Solubility and Dissolution
3.1 Introduction
3.2 Concentration Units
3.3 What Should Be Done when Alcohol is Prescribed in a Formulation?
3.4 The Partition Coefficient
3.5 Disintegration and Dissolution
3.6 Concluding Remarks
References for Chapter 3
Glossary for Chapter 3
4 Biological Aspects of Formulations
4.1 Introduction
4.2 Bioavailability and Bioequivalence
4.3 Protocols for Determining Bioequivalence
4.4 Bioequivalence Procedure
4.5 FDA Approved Methods for Bioequivalence Studies
4.6 Approaches for Improving Bioavailability
References for Chapter 4
Glossary for Chapter 4
5 Interfacial Properties
5.1 Introduction
5.2 Liquid-Solid Interface
5.3 Dosage Form Applications
References for Chapter 5
Glossary for Chapter 5
6 Adsorption Phenomenon
6.1 Introduction
6.2 Adsorption on Filters
6.3 Adsorption of Proteins
References for Chapter 6
Glossary for Chapter 6
7 Rheological Principles
7.1 Introduction
7.2 Newtonian Systems
7.3 Non-Newtonian Systems
7.4 Viscoelasticity
7.5 Reynolds Number
7.6 Concluding Remarks
References for Chapter 7
Glossary for Chapter 7
8 Chemical Stability and Shelf-life Determination
8.1 Introduction
8.2 Shelf-Life Determination
8.3 Stability of Biotechnology Products
References for Chapter 8
Glossary for Chapter 8
9 Particle Science
9.1 Introduction
9.2 Particle Size Estimation and Distribution
9.3 Micronization
9.4 Particle Size Preparation and Reduction for Pulmonary Delivery
9.5 Polymeric Particulate Matter
9.6 Nanoparticles
9.7 Segregation of Particles
References for Chapter 9
Glossary for Chapter 9
10 Basic Statistics and Design of Experiment Concepts
10.1 Descriptive Statistics
10.2 Inferential Statistics
10.3 Statistical Applications in Quality Control Testing
10.4 Design of Experiment (DOE)
References for Chapter 10
Glossary for Chapter 10
11 Formulation Development Concepts
11.1 Preformulation
11.2 Scale-up Considerations
11.3 Combination Products
11.4 Rate-controlled Drug Delivery
11.5 Drug Delivery Technologies for Improving Oral Delivery
11.6 Drug Delivery Technologies for Improving Transmucosal Delivery
11.7 Drug Delivery Technologies for Transdermal Delivery
11.8 Special Considerations for Biotechnology and Protein Delivery Systems
11.9 Drug/Excipient and Excipient/Excipient Interactions
11.10Presence of Contaminants in Formulation
11.11Other Considerations
References for Chapter 11
Glossary for Chapter 11
SECTION II PRODUCT DESIGN
12 Introduction to Product Design
12.1 Formulation Design
12.2 Process Design
12.3 Container Closure System (CCS) Design
References for Chapter 12
Glossary for Chapter 12
Appendix 12.1 FDA Route of Administration Nomenclature
Appendix 12.2 FDA Drug Dosage Form Nomenclature
Appendix 12.3 USP Dosage Form Nomenclature
Appendix 12.4 FDA Package Type Nomenclature
Appendix 12.5 USP Packaging Nomenclature
Appendix 12.6 USP Packaging Fabrication Materials and Closure Types
13 Tablet Product Design
13.1 Introduction
13.2 Formulation Design
13.3 Process Design
13.4 Container Closure System (CCS) Design
13.5 Risk Management
13.6 Attribute Tests
13.7 New Drug Application (NDA) Stability Assessment
References for Chapter 13
Glossary for Chapter 13
Appendix 13.1 Hygroscopicity Classification System
Appendix 13.2 Diluents and Direct Compression Binders
Appendix 13.3 Wet Granulation Binders
Appendix 13.4 Hot Melt Excipients
Appendix 13.5 Disintegrants
Appendix 13.6 Lubricants
Appendix 13.7 Antiadherants and Antisticking Agents
Appendix 13.8 Glidants and Flow-aids
Appendix 13.9 Wetting Agents
Appendix 13.10 Nominal Screen Mesh Number and Sieve Opening in Microns
14 Capsule Product Design
14.1 Introduction
14.2 Hard-shell Capsules
14.3 Soft-shell Capsules
14.4 Formulation and Process Optimization
14.5 Container Closure System
14.6 Risk Management
14.7 Attribute Tests
14.8 New Drug Application (NDA) Stability Assessment
References for Chapter 14
Glossary for Chapter 14
Appendix 14.1 Aldehyde Levels in Commonly Used Capsule Excipients
Appendix 14.2 Aldehyde Levels in Commonly Used Liquid-Fill Capsule Excipients
Appendix 14.3 Capsule Liquid-Fill Excipients
15 Dispersed System Product Design
15.1 Introduction
15.2 Formulation Design
15.3 Process Design
15.4 Container Closure System Design
15.5 Risk Management
15.6 Attribute Tests
15.7 New Drug Application (NDA) Stability Assessment
References for Chapter 15
Glossary for Chapter 15
Appendix 15.1 Suspending, Viscosity Enhancing, and Structural Modifying Agents
Appendix 15.2 Sweetening Agents
Appendix 15.3 Flocculating Agents and Buffers
Appendix 15.4 Emulsifying Agents
Appendix 15.5 Required HLB (RHLB) for Oils and Waxes
16 Aerosol Product Design
16.0 Introduction
16.1 Formulation Design
16.2 Container Closure System Design
16.3 Risk Management
16.4 Attribute Tests
16.5 New Drug Application (NDA) Stability Assessment
References for Chapter 16
Glossary for Chapter 16
Appendix 16.1 Aerosol Excipients
17 Sterile Injectable Product Design
17.1 Introduction
17.2 Formulation Design
17.3 Process Design
17.4 Container Closure System Design
17.5 Risk Management
17.6 Attribute Tests
17.7 New Drug Application (NDA) Stability Assessment
References for Chapter 17
Glossary for Chapter 17
Appendix 17.1 Injectable Solvents and Cosolvents
Appendix 17.2 Injectable Surfactants, Solubilizing, Emulsifying, and Thickening Agents
Appendix 17.3 Injectable Buffers and pH Adjusting Agents
Appendix 17.4 Injectable Antimicrobial Preservatives
Appendix 17.5 Injectable Antioxidants
Appendix 17.6 Stability Constants for Selected Sequestering Agents
Appendix 17.7 Injectable Bulking Agents, Protectants, and Tonicity Adjusting Agents
Appendix 17.8 Eutectic Temperatures for Selected Compounds
Appendix 17.9 Glass Collapse Temperate, Tgc, Maximally Freeze-Concentrated Glass Transition Temperature, T?g, and Material Glass Transition Temperature, Tg, for Selected Excipients
18 Ophthalmic Product Design
18.1 Introduction
18.2 Formulation Design
18.3 Process Design
18.4 Container Closure System Design
18.5 Attribute Tests
18.6 New Drug Application (NDA) Stability Assessment
References for Chapter 18
Glossary for Chapter 18
Appendix 18.1 Ophthalmic Excipients
19 Transdermal Product Design
19.1 Introduction
19.2 Formulation Design
19.3 Conclusion
References for Chapter 19
Glossary for Chapter 19
Appendix 19.1 Transdermal Excipients
20 Oral Modified-Release Product Design
20.1 Introduction
20.2 Coatings
20.3 Matrix Systems
20.4 Gastroretentive Devices
20.5 Osmotic Controlled Release
20.6 Conclusion
References for Chapter 20
Glossary for Chapter 20
Appendix 20.1 FDA Nomenclature for Oral Modified Release Dosage Forms
SECTION III REGULATORY SCIENCE
21 Regulatory Practices and Guidelines
21.1 Worldwide Regulatory Agencies
21.2 Good Manufacturing Practice
21.3 FDA Inspection and Regulatory Actions
References for Chapter 21
Glossary for Chapter 21
22 Compounding Pharmacy Regulations
22.1 Introduction
22.2 Compounding Guidelines
22.3 FDA Compliance Policy Guides
22.4 Good Compounding Practices
22.5 Stability Criteria and Beyond-Use-Dating of Compounded Preparations
22.6 Verification
22.7 Patient Counseling
22.8 Pharmacy Compounding Accreditation
References for Chapter 22
Glossary for Chapter 22
Appendix 22.1 List of Compounding Drugs that were Withdrawn or Removed from the Market for Safety Reasons
Appendix 22.2 List of Bulk Drug Substances for Compounding and Subsequent Use in Animals to which CVM would not Ordinarily Object
Appendix 22.3 Formulation Record
Appendix 22.4 Compounding Record
23 IND and NDA Phase Appropriate New Drug Development Process
23.1 Introduction
23.2 Preclinical Development Overview
23.3 Phase Appropriate Clinical Trials Overview
23.4 Investigational New Drug (IND)
23.5 NDA Review Process
References for Chapter 23
Glossary for Chapter 23
24 Generics, Biosimilars, and OTCs
24.1 Generic Drugs
24.2 Biosimilar Drugs
24.3 OTC Drugs
References for Chapter 24
Glossary for Chapter 24
Appendix 24.1 Office of Generic Drugs QbR Quality Overall Summary Outline
25 Accelerated New Drug Approval & Expedited Access of New Therapies
25.1 Background
25.2 Expedited Review and Approval of New Therapies
25.3 Expanded Access to New Therapies
25.4 Orphan Drugs
25.5 Pediatric Drugs
25.6 Pediatric Drug Development and the Orphan Drug Act Incentives
25.7 Common EMEA/FDA Application for Orphan Medicinal Product Designation
References for Chapter 25
Glossary for Chapter 25
26 Post Drug Approval Activities
26.1 Postmarket Requirements and Commitments
26.2 Post Approval Manufacturing Changes
26.3 Clinical Phase 4 Studies: Postmarketing Surveillance & Risk Assessment
26.4 Prescription Drug Advertising and Promotional Labeling Direct-to-Consumers
References for Chapter 26
Glossary for Chapter 26
Appendix 26.1 MedWatch
27 Drug Master Files & EU Dossiers
27.1 Drug Master Files
27.2 European Marketing Authorization Dossiers
References for Chapter 27
Glossary for Chapter 27
28 Commissioning & Qualification
28.1 Regulatory Requirements
28.2 Preliminary C & Q Activities
28.3 Commissioning
28.4 Qualification & Validation
28.5 Qualification Protocols
28.6 Process Validation (PV)
28.7 Cleaning Validation
28.8 Computer Systems Validation
28.9 Change Control
28.10 Revalidation
References for Chapter 28
Glossary for Chapter 28
29 Quality Sytems & Controls
29.1 Pharmaceutical Quality System
29.2 Quality Systems Approach to CGMP Regulations
29.3 Inspection of Pharmaceutical Quality Control Laboratories
29.4 Pharmacopoeias
29.5 Analytical Instrument Qualification (AIQ)
29.6 Validation of Analytical Procedures
29.7 Stability Testing of New Drug Substances and Products
References for Chapter 29
Glossary for Chapter 29
Appendix 29.1 Application of Process Performance and Product Quality Monitoring System throughout the Product Lifecycle
Appendix 29.2 Application of Corrective Action and Preventative Action System throughout the Product Lifecycle
Appendix 29.3 Application of Change Management System throughout the Product Lifecycle
Appendix 29.4 Application of Management Review of Process Performance and Product Quality throughout the Product Lifecycle
Appendix 29.5 21 CFR CGMP Regulations Related to Management Responsibilities
Appendix 29.6 21 CFR CGMP Regulations Related to Resources
Appendix 29.7 21 CFR CGMP Regulations Related to Manufacturing Operations
Appendix 29.8 21 CFR CGMP Regulations Related to Evaluation Activities
Appendix 29.9 Pharmacopoeias Comparison
Appendix 29.10 Recommended Validation Characteristics of the Various Types of Tests
Appendix 29.11 Forced Degradation Parameters for Drug Substance (API)
Appendix 29.12 Decision Flow Chart for Photostability Testing Of Drug Products
Appendix 29.13 Stability Studies Test
Appendix 29.14 Decision Tree for Data Evaluation for Retest Period or Shelf Life Estimation for Drug Substances or Product (Excluding Frozen Products)
30 Safety, Toxicology, & Pharmacogenomics
30.1 Nonclinical Safety Studies
30.2 Safety Pharmacology Studies
30.3 Carcinogenicity Studies of Pharmaceuticals
30.4 Genotoxicity Testing
30.5 Immunotoxicity Studies
30.6 Safety Reporting Requirements
30.7 Pharmacogenomics
References for Chapter 30
Glossary for Chapter 30
Appendix 30.1 Selection of Maximum Recommended Starting Dose for Drugs Administered Systematically to Normal Volunteers
Appendix 30.2 Conversion of Animal Doses to Human Equivalent Doses Based on Body Surface Area
Appendix 30.3 Recommended Duration of Repeated-Dose Toxicity Studies to Support the Conduct of Clinical Trials
Appendix 30.4 Recommended Duration of Repeated-Dose Toxicity Studies to Support Marketing
31 Regulatory Science Initiatives for Advancing Public Health
31.1 Advancing Regulatory Science for Public Health ? The Promise of Regulatory Science
31.2 Advancing Regulatory Science at FDA ? Strategic Plan for Regulatory Science
31.3 A Collaborative Implementation Framework
References for Chapter 31
Glossary for Chapter 31
Index
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