Industrial Pharmacy is the science of manufacturing, development, marketing and distribution of drug products, including quality assurance of the developed drug formulation. This book covers all topics required by students of Pharmacy. Industrial Pharmacy is divided into two chapters, and explains the formulation, manufacture, and quality control of tablets, capsules, parenteral dosage forms, liquid orals, ophthalmic dosage form and aerosols. In addition, topics such as 'Pre-formulation', 'Cosmetics' and 'Packaging Material Science' have also been briefly discussed. It has been designed with the objective of imparting knowledge of the pilot plant scaleup considerations of different dosage forms. The students will be able to understand the technology transfer process from R&D to production with the necessary documentation. This book also provides information about drug regulations, roles and responsibilities of drug regulatory requirements. Industrial Pharmacy: Theory and Practice is a definitive book for pharmaceutical scientists. It covers the entire concept of drug development, from basic formulation theories to commercial manufacturing, scale-up, and regulatory compliance. The book systematically breaks down pharmaceutical development core areas and details on mixing, milling, drying, and powder flow characteristics. The application of physical pharmacy, biopharmaceutics, and pharmacokinetics in developing effective drug delivery systems is extensively discussed.
Dr. Roger Charles is a distinguished pharmaceutical scientist and educator with over two decades of experience in drug formulation and delivery systems. Holding a Ph.D. in Pharmaceutics, he has dedicated his career to bridging the critical gap between laboratory scale drug discovery and large-scale industrial manufacturing. Drawing from his extensive tenure in leading pharmaceutical research laboratories and top-tier academic institutions, Dr. Charles brings a wealth of practical and theoretical knowledge to the field. His work primarily focuses on optimizing manufacturing processes, developing advanced novel drug delivery systems, and ensuring strict regulatory compliance in pharmaceutical production. Beyond his contributions to pharmaceutical research, Dr. Charles is a passionate mentor to aspiring pharmacists and engineers. His dedication to elevating educational standards in pharmaceutical sciences inspired the writing of Industrial Pharmacy: Theory and Practice, a comprehensive book designed to equip the next generation of industry professionals with the critical skills needed to navigate the complexities of modern drug manufacturing. Currently, Dr. Charles serves as a Senior Professor and Head of the Department of Pharmaceutics, where he continues to lead innovative research projects and shape the future of pharmaceutical technology.
Preface 1. INDUSTRIAL PHARMACY: INTRODUCTION AND HISTORICAL DEVELOPMENT.........................................1 1.1 The Manufacturing Process 1.2 The Role Of Industrial Pharmacy In Pharmaceutical Manufacturing 1.3 Challenges In Industrial Pharmacy 1.4 Historical Development 1.5 Awareness Of Infectious Diseases 1.6 Dyes As Therapeutics 1.7 First Chemotherapeutics 1.8 Pharmaceuticals During War Times 1.9 Post-World War Ii Era 1.10 Golden Age Of The 1960s 1.11 Modern Times 1.12 Antiparasitic Drugs In Animal Health 2. PILOT PLANT SCALE-UP TECHNIQUE...............................................................25 2.1 General Considerations 2.2 Personnel Requirements 2.3 Training 2.4 Review Of The Formula 2.5 Raw Materials 2.6 Relevant Processing Equipment 2.7 Production Rates 2.8 Process Evaluation 2.9 Preparation Of Master Manufacturing Procedures 2.10 Transfer Of Analytic Methods To Quality Assurance 2.11 Design And Facilities 2.12 Environmental Factors 3. PREFORMULATION..........................................................................................48 3.1 Objectives Of Preformulation Studies 3.2 Physical Properties 3.3 Particle Size Distribution 3.4 Powder Flow Properties 3.5 Solubility 3.6 pKa Determination (Dissociation Constant) 3.7 Partition Coefficient 3.8 Chemical Properties 3.9 Biopharmaceutical Classification System 3.10 Stability Studies 3.11 Drug Excipient Compatibility Studies 3.12 Isolated Key Points 4. TABLETS...........................................................................................................73 4.1 Ideal Characteristics Of Tablet 4.2 Classification Of Tablets 4.3 Starch 4.4 Antifriction Agents 4.5 Miscellaneous Excipients 4.6 Isolated Key Points 5. COATING OF TABLETS....................................................................................130 5.1 Advantages Of Tablet Coating 5.2 Types Of Tablet Coating Process 5.3 Defects In Tablet Coating 5.4 Evaluation Of Coated Tablets 5.5 Isolated Key Points 6. LIQUID ORALS................................................................................................155 6.1 Advantages And Disadvantages Of Liquid Dosage Forms 6.2 Excipients Used In Liquid Dosage Form 6.3 Solutions 6.4 Biphasic Liquids Emulsion And Suspension 6.5 Evaluation Tests Of Liquid Dosage Forms 6.6 Isolated Key Points 7. CAPSULE.........................................................................................................181 7.1 Hard Gelatin Capsules 7.2 Capsule Sizes 7.3 Capsule Shell Filling 7.4 Liquids In Hard Gelatin Capsules 7.5 Soft Gelatin Capsules 7.6 Quality Control Of Capsules 7.7 Isolated Key Points 8. PELLETS..........................................................................................................210 8.1 Methods Of Preparing Pellets 8.2 Manufacturing Process 8.3 Formulation Requirement And Variables 8.4 Process Considerations And Variables 8.5 Characterization Of Pellets 8.6 Isolated Key Points 9. PARENTERAL PRODUCTS............................
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