Pharmaceutical Dosage Forms and Drug Delivery provides a comprehensive, updated, and integrated overview of the field, merging fundamental physical pharmacy with modern product formulation and clinical application. It explores advanced drug delivery systems, such as nanotechnologies and biologics, alongside foundational concepts for students and industry professionals, focusing on designing, creating, and applying pharmaceutical products. The text highlights modern, targeted delivery mechanisms to improve therapeutic outcomes and includes updated, industry-relevant content on biotechnology and compliance. Throughout this text, emphasis is placed on the scientific rationale behind formulation design, the rigorous evaluation of product quality, and the mechanisms by which drugs are successfully delivered to their sites of action. Pharmaceutical Dosage Forms and Drug Delivery, a comprehensive guide bridging the gap between fundamental physicochemical principles and the practical design of modern therapeutic systems. This book is tailored for pharmacy students, pharmaceutical scientists, and industry professionals seeking to master the science of transforming a raw chemical entity into a safe, effective, and patient-centric medicine. It is our hope that this book serves as an invaluable resource for advancing the science and art of drug delivery.
Dr. J. Thorne, Ph.D. in Pharmaceutics from the University of Oxford is a leading pharmaceutical scientist and educator with over two decades of experience in drug formulation. He made vital contributions to the clinical use of adrenal steroids. He began his career in endocrinology as a medical student at the University of Buffalo, went on to Ohio State and then joined the faculty at Johns Hopkins where Harvard found him. His work bridges the gap between laboratory drug discovery and safe, patient-ready medications. A concise overview of his background includes: Recipient of the Controlled Release Society Excellence in Education Award for his innovative approach to simplifying complex pharmacokinetics. Dr. Thorne's extensive laboratory and clinical expertise forms the backbone of Pharmaceutical Drug Delivery, providing students and professionals with a comprehensive, real world guide to modern pharmaceutics.
Preface 1. DRUG DEVELOPMENT......................................................................................1 1.1 Introduction 1.2 Stagegate Process Of New Drug Discovery And Development 1.3 Pharmaceutical Development 1.4 Regulatory Approval 1.5 Postcommercialization Activities 2. PHARMACEUTICAL CONSIDERATIONS............................................................21 2.1 Introduction 2.2 Advantages Of Pharmaceutical Dosage Forms 2.3 Influential Factors In Dosage Form Design 3. COMPLEXATION AND PROTEIN BINDING.......................................................37 3.1 Introduction 3.2 Types Of Complexes 3.3 Protein Binding 4. COLLOIDAL DISPERSIONS................................................................................58 4.1 Introduction 4.2 Types Of Colloidal Systems 4.3 Preparation Of Colloidal Solutions 4.4 Properties Of Colloidal Solutions 4.5 Physical Stability Of Colloids 5. PHARMACEUTICAL POLYMERS.......................................................................75 5.1 Introduction 5.2 Definitions And Architectures Of Polymers 5.3 Polymer Molecular Weight And Weight Distribution 5.4 Biodegradablity And Biocompatibility 5.5 Physicochemical Properties And Solubility 5.6 Block Copolymers 5.7 Intelligent Or Stimulisensitive Polymers 5.8 Water-Soluble Polymers 5.9 Bioadhesive/Mucoadhesive Polymers 6. DRUG DELIVERY SYSTEMS...............................................................................95 6.1 Introduction 6.2 Targeted Drug Delivery 6.3 Prodrugs 6.4 Soluble Macromolecular Carriers 6.5 Particulate Carrier Systems 6.6 Oral Drug Delivery 6.7 Alternative Routes Of Delivery 7. SUSPENSIONS................................................................................................117 7.1 Introduction 7.2 Types Of Suspensions 7.3 Powder For Suspension 7.4 Quality Attributes 7.5 Formulation Considerations 7.6 Manufacturing Process 8. PHARMACEUTICAL SOLUTIONS....................................................................133 8.1 Introduction 8.2 Types Of Solutions 8.3 Quality Attributes 8.4 Formulation Components And Manufacturing Process 8.5 Solubility 8.6 Stability 9. PARENTERAL DRUG PRODUCTS....................................................................144 9.1 Introduction 9.2 Parenteral Routes Of Administration 9.3 Types Of Parenteral Dosage Forms 9.4 Quality Attributes And Evaluation 9.5 Formulation Components 9.6 Sterilization 10. PROTEIN AND PEPTIDE DRUG DELIVERY......................................................155 10.1 Introduction 10.2 Structure 10.3 Types Of Protein And Peptide Therapeutics 10.4 Protein Characterization 10.5 Instability 10.6 Antigenicity And Immunogenicity 10.7 Drug Product Formulation And Process 11. SEMISOLID DOSAGE FORMS.........................................................................187 11.1 Introduction 11.2 Ointments 11.3 Creams 11.4 Gels And Jellies 11.5 Lotions 11.6 Pastes 11.7 Foams 11.8 Manufacturing Processes 11.9 Analysis Of Semisolid Dosage Forms 12. INSERTS