Author Profile

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.

About The Book

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.

Table of Contents

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, IMPLANTS, AND DEVICES..............................................................201
12.1 Introduction
12.2 Inserts
12.3 Implants
12.4 Devices
13.
TABLETS.........................................................................................................218
13.1 Introduction
13.2 Types Of Tablets
13.3 Tablet Formulation
13.4 Manufacturing Of Tablets
13.5 Evaluation Of Tablets
13.6 Relationship Among Disintegration,
Dissolution, And Absorption
14.
CAPSULES.......................................................................................................245
14.1 Introduction
14.2 Hard Gelatin Capsules
14.3 Soft Gelatin Capsules
14.4 Evaluation Of Capsule Drug Products
14.5 Shelf-Life Tests
15.
BIOTECHNOLOGY-BASED DRUGS..................................................................266
15.1 Introduction
15.2 Gene And Gene Expression
15.3 Gene Silencing
15.4 Gene Silencing Technologies
15.5 Gene Therapy
Bibliography....................................................................................................281
Index...............................................................................................................288