Introduction to Pharmaceutical Technology Development

Journey from Lab to Shelf of Commercial Pharmaceutical Drugs

1st Edition - February 24, 2025
Imprint: Academic Press
Author: Yaser Dahman
Language: English
Paperback ISBN:
9 7 8 - 0 - 4 4 3 - 2 3 8 4 8 - 2
eBook ISBN:
9 7 8 - 0 - 4 4 3 - 2 3 8 4 9 - 9

Introduction to Pharmaceutical Technology Development: Journey from Lab to Shelf of Commercial Pharmaceutical Drugs is a complete reference and learning resource for those wor… Read more

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Introduction to Pharmaceutical Technology Development: Journey from Lab to Shelf of Commercial Pharmaceutical Drugs is a complete reference and learning resource for those working in pharmaceutics or aspiring to join the industry. The book provides a comprehensive view into all aspects of drug discovery, approval, and production. Using examples of well-known drugs and their journeys from lab to market, the book provides a comprehensive overview of all steps involved in bringing new drugs, including biologics, to the shelves.

Topics covered include Drug Discovery, Pharmaceutical Formulations of Different Dose Form, Analytical Testing and Development, Unit Operations and Design for Major Equipment, Basics of Analytics and Process Validations and Protocols (DQ, IQ, OQ, PQ) in FDA-Regulated Industries.
This book provides graduate students from several areas with a solid foundation of the Pharmaceutic industry across key stages on new drug lifecycle.

Title of Book
Cover image
Title page
Table of Contents
Copyright
Preface
Acknowledgment
Chapter 1. The modern-day drug discovery
1 Introduction
2 History
3 Drug discovery process
3.1 FDA versus the European drug approval system
3.2 The Dallas Buyers Club
3.2.1 Getting the first medication for AIDS FDA approved
3.2.2 Alternative medications
4 Generic drugs
5 Development and technology
5.1 Single-cell analysis tools
5.2 Multiplex single-cell proteomics methods
5.3 Mass spectrometry technologies
5.3.1 Time-of-flight mass spectrometers
5.3.2 Orbitrap mass spectrometers
5.4 High-throughput X-ray crystallography
5.4.1 Protein expression
5.4.2 Protein purification and characterization
5.4.3 Protein crystallization
5.4.4 Structure determination
5.4.5 Lead discovery from high-throughput crystallography
6 Drug discovery examples
6.1 Statins
6.2 Cimetidine
6.3 Aspirin and willow bark
6.4 Beta blockers
6.5 Barbiturates
7 Market analysis
7.1 Costs of production and development
7.2 Revenue
7.3 Canada versus the rest of the world
7.4 Threats to market
7.5 Future prospect
8 Recommendations
9 Conclusion
Nomenclature
Chapter 2. Pharmaceutical product formulation of different dosage forms
1 Introduction
1.1 Enteral drugs
1.2 Parenteral drugs
1.3 Topical drugs
2 Literature review
2.1 Solid medication
2.1.1 Drug delivery systems
2.1.2 Stability testing
2.1.3 Unit operations
2.1.4 Tablet example - acetaminophen
2.2 Liquid medication
2.2.1 Drug delivery systems
2.2.2 Stability testing
2.2.3 Unit operations
2.2.4 Parenteral example - morphine
2.3 Topical medication
2.3.1 Drug delivery systems
2.3.2 Stability testing
2.3.3 Unit operations
2.3.4 Topical example - protopic
2.4 Process validation
2.5 Good manufacturing practices (GMP)
2.5.1 Failure to comply
3 Suggested improvements
3.1 Solid medication
3.2 Liquid medication
3.3 Topical medication
4 Conclusion
Nomenclature
Chapter 3. Analytical testing and development in pharmaceutical technology
1 Introduction
2 Analytical method
2.1 Titrimetric methods of analysis
2.1.1 Procedures and preparation
2.1.2 Acid-Base titration
2.1.3 Redox titration
2.1.4 Gas phase titration
2.1.5 Complexometric titration
2.1.6 Zeta potential titration
2.2 Chromatographic methods of analysis
2.2.1 High performance liquid chromatography (HPLC)
2.2.2 Gas chromatography (GC)
2.3 Chromatographic detection systems
2.3.1 Flame ionization detectors (FID)
2.3.2 Thermal conductivity detectors (TCD)
2.3.3 Electron capture detectors (ECD)
2.3.4 Mass spectrometry detectors (MS)
2.4 Spectroscopic methods of analysis
2.4.1 Spectrophotometry (UV-VIS)
2.4.2 Nuclear magnetic resonance (NMR)
2.4.3 Mass spectroscopy
2.4.4 Near infrared spectroscopy
2.5 Electrophoresis
2.5.1 Types of electrophoresis separations
2.5.2 Affecting factors
2.6 Electrochemical testing
3 Recent improvements
3.1 Titrimetric methods of analysis
3.2 Electrochemical testing
3.3 Electrophoretic methods
4 Conclusion
Nomenclature
Chapter 4. Unit operations and design for pharmaceuticals manufacturing and production
1 Introduction
2 Drying
2.1 Modes of heat transfer
2.2 Periods of drying
2.3 Critical moisture content
2.4 The falling-rate period
2.5 Drying methods for pharmaceutical products
2.5.1 Tray drying
2.5.2 Fluid-bed drying
2.5.3 Vacuum dryer
3 Milling
3.1 Hammer mills
3.2 Tumbling mills
3.3 Fluidized bed mills
4 Mixing
4.1 Tumbler mixers
4.2 Convective mixers
4.3 High shear mixers
4.4 Fluidized mixers
4.5 Selection of mixers
5 Tablet press
5.1 Single tablet press
5.2 Rotary tablet press
5.2.1 Components of the rotary punch tableting machine
5.2.2 Operating steps of rotary tablet press
6 Tablet coating
6.1 Tablet coating process
6.2 Perforated coating pan
6.3 Fluidized bed-coater
7 Future perspective
8 Conclusion
Chapter 5. Basics of process validation and equipment qualification protocols (DQ, IQ, OQ, PQ) in FDA-regulated industries
1 Process validations
2 Equipment qualification phases
2.1 Design qualification (DQ)
2.2 Installation qualification (IQ)
2.2.1 Responsibilities
2.3 Operational qualification (OQ)
2.3.1 Modular versus holistic testing
2.3.2 Documentation of OQ
2.3.3 3Practical implementation procedure
2.4 Performance qualification (PQ)
3 Lean manufacturing
4 Conclusion
Nomenclature
Chapter 6. Case studies in validation and protocols of pharmaceutical industry
1 Introduction
1.1 Design qualifications – DQ
1.1.1 Case study 1 – Commercial off-the-shelf
1.1.2 Case study 2 – Single-use technology
1.2 Installation qualifications – IQ
1.2.1 Factory acceptance testing
1.2.2 Commissioning tasks
1.2.3 IQ testing
1.3 Operational qualifications – OQ
1.3.1 Case study 1 – Blending powder
1.3.2 Case study 2 – Programmable logic controller
1.3.3 Case study 3 – Barrier isolators
1.4 Performance qualifications – PQ
1.4.1 Stages
1.4.2 Case study – High-Performance Liquid Chromatography
1.5 Future developments
2 Conclusion
Nomenclature
Chapter 7. Formulation, manufacturing and packaging of pharmaceutical dosage forms
1 General considerations in dosage form design
2 Tablets
2.1 Formulation
2.2 Novel tableting technologies: Tablet-in tablet design
2.3 Solid oral dosage forms for vaccines
2.4 Pharmaceutical tablets
2.5 Tablet manufacturing
2.6 Packaging
2.7 Packaging process of aspirin
2.8 Stability
2.9 Degradation
3 Liquids
3.1 Formulation
3.2 Liquid oral dosage forms for vaccines
3.3 Ophthalmic liquid dosage forms
3.4 Manufacturing
3.5 Packaging
3.6 Packaging process of the COVID-19 vaccines
3.7 Stability
3.8 Degradation
3.8.1 Covid-19 vaccine stability and degradation
3.8.2 Naloxone stability and degradation
3.8.3 EpiPen stability and degradation
4 Topical
4.1 Formulation
4.2 Manufacturing
4.3 Stability
4.4 Degradation
5 Good manufacturing practices
6 Dosage forms in summary
7 Conclusions
Nomenclature
Chapter 8. Basics of biopharmaceuticals development, production, and quality
1 Introduction
2 Upstream processing
2.1 Cells and proteins
2.2 Dispensing room
2.3 CIP/SIP systems
2.4 Media preparation area
2.5 Cell culture/fermentation
2.6 Inoculum
2.7 Bioreactors
3 Downstream processing
3.1 Cell separation: Solid-liquid separation
3.2 Capturing: Precipitation/crystallization
3.3 Cell disintegration: Cell lysis
3.3.1 High pressure homogenization
3.3.2 Microfluidizer
3.3.3 Bead mill
3.3.4 Ultrasonication
3.3.5 Chemical disruption and enzymatic digestion
3.4 Extraction
3.5 Refolding
3.6 Purification: Chromatography
3.6.1 Membrane chromatography
3.6.2 Affinity chromatograph
3.6.3 Ion exchange chromatography
3.6.4 Size exclusion chromatography
4 Formulation
4.1 Buffers and pH
4.2 Tonicity modifiers
4.3 Surfactants
4.4 Preservatives
4.5 Stabilizers
4.6 Aggregation
4.7 Fragmentation
4.8 Oxidation
5 Sterile filtration, aseptic filling, and freeze drying
5.1 Sterile filtration
5.2 Aseptic filling
5.3 Freeze-drying: Lyophilization
6 Future prospects
7 Conclusions
Nomenclature
Chapter 9. Key unit operations in biopharmaceuticals productions
1 Introduction
1.1 Process development and scale-up
1.2 Manufacturing
1.3 Production facility
2 Upstream processing
2.1 Inoculum
2.2 Bioreactor stage
2.3 Primary recovery (harvest)
3 Downstream processing
3.1 Filtration
3.1.1 Direct flow filtration (DFF)
3.1.2 Tangential flow filtration (TFF)
3.2 Centrifugation
3.3 Sedimentation
3.4 Precipitation
3.5 Flocculation
3.6 Liquid-liquid extraction
3.7 Chromatography
3.8 Crystallization
3.9 Drying
4 Formulation
5 Process development
5.1 Expression system
5.2 Stages of process development
5.3 Development activities
5.4 Upstream processing
5.5 Downstream processing
6 Current trends and suggested improvements
7 Conclusion
Chapter 10. Overview of good manufacturing practices (GMP)
1 Introduction
2 Literature review
2.1 Complaints and recalls
2.1.1 Common deficiencies
2.2 Quality management systems
2.2.1 The quality system
2.3 Traceability
2.3.1 Types and organization of documentation
2.3.2 Case study – Devonport Incident
2.4 Hygiene in production
2.4.1 Personal hygiene
2.4.2 Case study: Bayer Pharma AG – November 14, 2017
2.5 Suitable facilities
2.5.1 Ancillary areas
2.5.2 Storage areas
2.5.3 Weighing areas
2.5.4 Production areas
2.5.5 Quality control areas
2.5.6 Case study: Tubilux Pharma
2.6 Qualified personnel
2.6.1 Key personnel: Requirements
2.6.2 Key personnel: Roles
3 Suggested improvements
4 Conclusions
Nomenclature
Chapter 11. Clinical research: Ethics & regulatory affair
1 Introduction
2 Social and clinical value
2.1 Scientific validity
2.1.1 Fair subject selection
2.1.2 Favorable risk-benefit ratio
2.2 Independent review
2.3 Informed consent
2.4 Respect for the potential and enrolled subject
3 Clinical research
3.1 Background
3.2 Improvement of medication
3.3 Outline of a clinical research report
3.4 Moral principle of clinical research
3.5 Ethical practices
3.6 Clinical research involves humans
3.7 Establishments in clinical research practices
3.8 Regulatory affairs
4 Improvement of ethical and regulatory issues
5 Conclusions
Nomenclature
Chapter 12. Journey from lab to shelf: Omeprazole, Atorvastatin-Calcium, Acetazolamide, Allopurinol, Adacel
1 Introduction
2 Omeprazole
2.1 Description
2.2 Discovery
2.3 Formulation
2.4 FDA regulations
2.5 Manufacturing process details
3 Atorvastatin-calcium
3.1 Drug discovery and development
3.2 Formulation
3.3 Regulations
3.4 Manufacturing process
3.5 Dry mixing
3.6 Blending
3.7 Lubrication
3.8 Compression
4 Acetazolamide
4.1 Basic description/background information
4.2 Function
4.3 History and discovery
4.4 Manufacturing process
4.5 Formulation
4.6 Regulations
5 Allopurinol
5.1 Discovery
5.2 Formulation
5.3 Regulations
5.4 Manufacturing process details
6 Adacel
6.1 Discovery
6.2 Formulation
6.3 Regulation
6.4 Manufacturing process
7 Conclusion
Chapter 13. Journey from lab to shelf: Amoxicillin, Alprazolam, Penicillin, Acetaminophen, Metformin
1 Introduction
2 Amoxicillin
2.1 Discovery
2.2 Formulation
2.3 Ethics and regulations
2.4 Manufacturing process details
3 Alprazolam
3.1 Discovery
3.2 Formulation
3.3 Ethics and regulations
3.4 Manufacturing process details
4 Penicillin
4.1 Discovery
4.2 Formulation
4.3 Manufacturing and production
4.3.1 Upstream process
4.3.2 Downstream processing
4.4 Product testing (analytical)
4.5 Ethics and regulations
4.5.1 Ethics
4.5.2 Regulations
5 Acetaminophen
5.1 Discovery
5.2 Formulation
5.3 Manufacturing
5.4 Ethics and regulations
6 Metformin
6.1 Discovery
6.2 Formulation
6.3 Manufacturing
6.4 Ethics and regulations
7 Conclusions
Nomenclature
Index

Life Sciences

Physical Sciences & Engineering

Social Sciences & Humanities

Health

Introduction to Pharmaceutical Technology Development

Journey from Lab to Shelf of Commercial Pharmaceutical Drugs

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Yaser Dahman

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