Table of Contents

Drug Development and Regulatory Process
Introduction
Identification of New Therapeutic Molecules
Preclinical Research
Formulation Development
Regulatory Issues
Pharmaceutical and Formulation Considerations
Introduction
Advantages of Pharmaceutical Dosage Forms
Influential Factors in Dosage Form Design
Biopharmaceutical and Physiological Considerations
Introduction
Drug Transport across a Polymeric Barrier
Fick’s Laws of Diffusion
Pore Diffusion
Matrix (Monolithic)-Type Nondegradable Device
Biological Membranes and Drug Absorption
Dissolution Rate and Noyes–Whitney Equation of Dissolution
Factors Influencing Dissolution Rate
Complexation and Protein Binding
Introduction
Types of Complexation
Drug Interaction with Plasma Proteins
Binding Equilibria
Impact of Plasma Protein Binding on Dosing Regimens

Chemical Kinetics and Stability

Introduction
Rates and Order of Reaction
Factors Affecting Reaction Kinetics
Pathways and Prevention of Chemical Decomposition of Drugs

Interfacial Phenomena

Introduction
Liquid Interfaces
Adsorption at Solid–Gas Interfaces
Adsorption at Solid–Liquid Interface

Rheology

Introduction
Newtonian Flow
Non-Newtonian Flow
Thixotropy

Disperse System Basics

Introduction
Types of Colloidal Systems
Kinetic Properties of Colloids
Electrical Properties
Electrostatic Effect
Electrical Double Layer
Stability of Colloids

Surfactants and Micelles

Introduction
Surfactants
HLB Systems
Micelles
Cloud Point
Pharmaceutical Suspensions
Introduction
Classification of Suspensions
Characteristics of Pharmaceutical Suspensions
Formulation of Suspensions
Flocculation and Deflocculation

Pharmaceutical Emulsions

Introduction
Advantages of Emulsion Dosage Forms
Types of Emulsions
Roles of Interfacial Free Energy on Emulsification
Formulations of Emulsions
Emulsifying Agents

Pharmaceutical Solutions

Introduction
pH and Solubility
Buffer and Buffer Capacity
Vehicles
Types of Solutions
Dry or Lyophilized Mixtures for Solution

Tablets

Introduction
Types of Tablets
Tablet Formulation
Powder Flow and Compressibility
Manufacturing of Tablets
Relationship among Disintegration, Dissolution, and Absorption
Evaluation of Tablets
Capsules
Introduction
Hard Gelatin Capsules
Soft Gelatin Capsules
Evaluation of Capsules

Injectable Dosage Forms

Introduction
Isotonicity..
Parenteral Routes of Administration
Formulation of Parenteral Products
Sterilization of Parenteral Products
Types of Parenteral Dosage Forms
Evaluation of Injectable Products
Semisolid Dosage Forms
Introduction
Ointments
Creams
Gels
Lotions
Pastes
Inserts, Implants, and Devices
Introduction
Inserts
Implants
Suppositories
Aerosol Products
Transdermal Patches

Pharmaceutical Polymers

Introduction
Definitions and Architectures of Polymers
Polymer Molecular Weight and Weight Distribution
Biodegradablity and Biocompatibility
Polymer Solubility
Block Copolymers
Intelligent or Stimuli-Sensitive Polymers
Water-Soluble Polymers
Bioadhesive/Mucoadhesive Polymers

Drug Delivery Systems

Introduction
Prodrugs
Soluble Macromolecular Carriers
Particulate Carrier Systems
Oral Drug Delivery
Alternative Routes of Delivery

Protein-and Peptide-Based Dosage Forms

Introduction
Structure of Peptides and Proteins
Hydrophobicity of Peptides and Proteins
Solubility of Peptides and Proteins
Instability of Peptides and Proteins
Formulation of Proteins and Peptides
Antibody-Based Therapy and Delivery
Antigenicity and Immunogenicity

Biotechnology-Based Dosage Forms

Introduction
Genes and Gene Expression
Gene Silencing
Classification of Gene-Silencing Technologies
Gene Therapy
Each chapter contains Learning Objectives, Review Questions, and a Bibliography.
Answers to Review Questions
Index