Pharmaceutical Dosage Forms And Drug Delivery

by Mahato, Ram I.

Edition: 1st

ISBN13: 9780849392856

ISBN10: 0849392853

Format: Hardcover

Pub. Date: 2007-06-07

Publisher(s): CRC Press

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Summary

Integrating aspects of physical pharmacy, biopharmaceuticals, drug delivery, and biotechnology, Pharmaceutical Dosage Forms and Drug Delivery presents basic physico-chemical principles and their application in the design of dosage forms. This book addresses the relevance of these principles to the biopharmaceutical aspects of drugs. It explores the latest developments in the application of biomaterials, including polymers and biotechnology-based agents, to the development of novel dosage forms. In addition, the book discusses physico-chemical parameters used for the design, development, and evaluation of biotechnological dosage forms. This text also provides review questions and answers for students.

List of Illustrations	p. xix
List of Tables	p. xxiii
Foreword	p. xxv
Preface	p. xxvii
Acknowledgments	p. xxix
About the Author	p. xxxi
Drug Development and Regulatory Process	p. 1
Learning Objectives	p. 1
Introduction	p. 1
Identification of New Therapeutic Molecules	p. 2
Extraction from Plants	p. 2
Organic Synthesis	p. 3
Use of Animals	p. 4
Genetic Engineering	p. 4
Gene Therapy	p. 4
Preclinical Research	p. 4
Formulation Development	p. 5
Regulatory Issues	p. 5
Investigational New Drug (IND) Application	p. 5
Clinical Trials	p. 6
Phase I Clinical Trials	p. 6
Phase II Clinical Trials	p. 6
Phase III Clinical Trials	p. 7
New Drug Application (NDA)	p. 7
Approval and Postmarketing Surveillance	p. 7
Abbreviated New Drug Application (ANDA)	p. 8
Role of FDA's Advisory Committees	p. 8
Review Questions	p. 8
Bibliography	p. 9
Pharmaceutical and Formulation Considerations	p. 11
Learning Objectives	p. 11
Introduction	p. 11
Advantages of Pharmaceutical Dosage Forms	p. 11
Influential Factors in Dosage Form Design	p. 12
Molecular Size and Volume	p. 13
Drug Solubility and pH	p. 14
Lipophilicity and Partition Coefficient	p. 16
Polymorphism	p. 17
Stability	p. 19
pKa/Dissociation Constants	p. 20
Degree of Ionization and pH-Partition Theory	p. 24
Limitations of pH-Partition Theory	p. 24
Review Questions	p. 25
Bibliography	p. 26
Biopharmaceutical and Physiological Considerations	p. 29
Learning Objectives	p. 29
Introduction	p. 29
Drug Transport across a Polymeric Barrier	p. 30
Fick's Laws of Diffusion	p. 30
Fick's First Law of Diffusion	p. 30
Fick's Second Law of Diffusion	p. 32
Steady-State Conditions	p. 32
Lag Time	p. 34
Pore Diffusion	p. 34
Matrix (Monolithic)-Type Nondegradable Device	p. 35
Biological Membranes and Drug Absorption	p. 36
Passive Transport	p. 37
Simple Diffusion	p. 37
Carrier-Mediated Transport	p. 37
Channel-Mediated Transport	p. 37
Active Transport	p. 37
Fick's Law of Diffusion and Drug Absorption	p. 38
Dissolution Rate and Noyes-Whitney Equation of Dissolution	p. 40
Factors Influencing Dissolution Rate	p. 41
Physicochemical Properties	p. 41
Thickness of Diffusion Layer	p. 42
Gastrointestinal Fluids	p. 42
Particle Size	p. 42
Crystallinity	p. 42
Porosity and Tortuosity of Solid Particles	p. 43
Temperature	p. 43
Surfactants	p. 43
Drug Absorption and Bioavailability	p. 43
Review Questions	p. 43
Bibliography	p. 45
Complexation and Protein Binding	p. 47
Learning Objectives	p. 47
Introduction	p. 47
Types of Complexation	p. 47
Coordination Complexes	p. 48
Molecular Complexes	p. 48
Drug Complexes	p. 50
Polymer Complexes	p. 50
Inclusion Complexes	p. 50
Drug Interaction with Plasma Proteins	p. 52
Binding Equilibria	p. 52
Protein Binding	p. 54
Impact of Plasma Protein Binding on Dosing Regimens	p. 55
Review Questions	p. 56
Bibliography	p. 57
Chemical Kinetics and Stability	p. 59
Learning Objectives	p. 59
Introduction	p. 59
Rates and Order of Reaction	p. 59
Zero-Order Reactions	p. 60
First-Order Reactions	p. 61
Second-Order Kinetics	p. 63
Factors Affecting Reaction Kinetics	p. 65
Catalysis	p. 65
Effect of Temperature	p. 65
Effect of Solvent	p. 67
Effect of pH	p. 67
Presence of Additives	p. 67
Pathways and Prevention of Chemical Decomposition of Drugs	p. 68
Hydrolysis	p. 68
Control of Drug Hydrolysis	p. 69
Oxidation	p. 70
Control of Drug Oxidation	p. 72
Photolysis	p. 72
Control of Photodegradation of Drugs	p. 72
Review Questions	p. 73
Bibliography	p. 73
Interfacial Phenomena	p. 75
Learning Objectives	p. 75
Introduction	p. 75
Liquid Interfaces	p. 75
Surface and Interfacial Tensions	p. 75
Surface Free Energy	p. 75
Adsorption at Solid-Gas Interfaces	p. 77
Physical Adsorption	p. 77
Chemical Adsorption	p. 73
Adsorption Isotherms	p. 78
Freundlich Adsorption Isotherm	p. 78
Langmuir Adsorption Isotherm	p. 79
BET Adsorption Isotherm	p. 80
Type of Isotherms	p. 80
Adsorption at Solid-Liquid Interface	p. 81
Factors Affecting Adsorption from Solution	p. 81
Application of Adsorption	p. 82
Wettability and Wetting Agents	p. 83
Wetting Agents	p. 83
Protein Adsorption	p. 84
Review Questions	p. 84
Bibliography	p. 85
Rheology	p. 87
Learning Objectives	p. 87
Introduction	p. 87
Newtonian Flow	p. 87
Temperature Dependence and Viscosity of Liquids	p. 88
Non-Newtonian Flow	p. 88
Plastic Flow	p. 88
Pseudoplastic Flow	p. 90
Dilatant Flow	p. 90
Thixotropy	p. 91
Hysteresis Loop	p. 91
Negative Thixotropy	p. 93
Pharmaceutical Applications of Rheology	p. 93
Review Questions	p. 94
Bibliography	p. 94
Disperse System Basics	p. 95
Learning Objectives	p. 95
Introduction	p. 95
Types of Colloidal Systems	p. 96
Lyophilic Colloids	p. 96
Lyophobic Colloids	p. 96
Association Colloids	p. 97
Kinetic Properties of Colloids	p. 97
Brownian Movement	p. 97
Diffusion	p. 96
Sedimentation	p. 96
Electrical Properties	p. 99
Ionization	p. 99
Ion Adsorption	p. 100
Ion Dissolution	p. 100
Electrostatic Effect	p. 100
Electrical Double Layer	p. 100
Nerst and Zeta Potentials	p. 102
DLVO Theory	p. 102
Electrophoretic Phenomena	p. 102
Stability of Colloids	p. 103
Aggregation	p. 104
Coagulation	p. 104
Flocculation	p. 104
Review Questions	p. 104
Bibliography	p. 105
Surfactants and Micelles	p. 107
Learning Objectives	p. 107
Introduction	p. 107
Surfactants	p. 107
Types of Surfactants	p. 108
Anionic Surfactants	p. 108
Cationic Surfactants	p. 109
Nonionic Surfactants	p. 109
Ampholytic Surfactants	p. 109
HLB Systems	p. 110
Micelles	p. 111
Types of Micelles	p. 114
CMC and Micellar Size	p. 114
Micellar Solubilization	p. 115
Factors Affecting Solubilization	p. 115
Nature of Surfactants	p. 115
Nature of Solubilizates	p. 116
Effect of Temperature	p. 116
Effect of pH	p. 116
Pharmaceutical Applications of Micellar Solubilization	p. 116
Thermodynamics of Solubilization	p. 117
Krafft Point	p. 118
Cloud Point	p. 119
Review Questions	p. 119
Bibliography	p. 120
Pharmaceutical Suspensions	p. 123
Learning Objectives	p. 123
Introduction	p. 123
Classification of Suspensions	p. 123
Characteristics of Pharmaceutical Suspensions	p. 124
Formulation of Suspensions	p. 125
Flocculation and Deflocculation	p. 126
Properties of Deflocculated (Dispersed) Particles	p. 129
Properties of Flocculated Particles	p. 129
Suspension Stability	p. 130
Adhesion of Suspension Particles to Containers	p. 130
Sedimentation Parameters	p. 130
Sedimentation and Stoke's Law	p. 131
Review Questions	p. 132
Bibliography	p. 133
Pharmaceutical Emulsions	p. 135
Learning Objectives	p. 135
Introduction	p. 135
Advantages of Emulsion Dosage Forms	p. 135
Types of Emulsions	p. 135
Oil-in-Water Emulsions	p. 136
Water-in-Oil Emulsions	p. 136
Multiple Emulsions	p. 137
Microemulsions	p. 137
Roles of Interfacial Free Energy on Emulsification	p. 137
Formulations of Emulsions	p. 138
Emulsifying Agents	p. 138
Surfactants	p. 140
Hydrophilic Colloids	p. 140
Finely Divided Solid Particles	p. 141
Types of Instability in Emulsions	p. 141
Creaming and Sedimentation	p. 141
Breaking and Coalescence	p. 142
Phase Inversion	p. 143
Microbial Growth	p. 143
Review Questions	p. 143
Bibliography	p. 144
Pharmaceutical Solutions	p. 145
Learning Objectives	p. 145
Introduction	p. 145
pH and Solubility	p. 146
Buffer and Buffer Capacity	p. 146
Vehicles	p. 148
Types of Solutions	p. 148
Syrups	p. 148
Elixirs	p. 149
Tinctures	p. 149
Miscellaneous Solutions	p. 149
Dry or Lyophilized Mixtures for Solution	p. 150
Review Questions	p. 150
Bibliography	p. 150
Tablets	p. 153
Learning Objectives	p. 153
Introduction	p. 153
Types of Tablets	p. 153
Swallowable Tablets	p. 153
Effervescent Tablets	p. 154
Chewable Tablets	p. 154
Buccal and Sublingual Tablets	p. 154
Lozenges	p. 154
Coated Tablets	p. 154
Controlled-Release Tablets	p. 155
Immediate-Release Tablets	p. 156
Tablet Formulation	p. 156
Diluents	p. 156
Adsorbents	p. 157
Moistening Agents	p. 157
Binding Agents	p. 157
Glidants	p. 158
Lubricants	p. 158
Disintegrants	p. 158
Miscellaneous	p. 159
Powder Flow and Compressibility	p. 159
Manufacturing of Tablets	p. 159
Relationship among Disintegration, Dissolution, and Absorption	p. 160
Evaluation of Tablets	p. 161
Review Questions	p. 161
Bibliography	p. 163
Capsules	p. 165
Learning Objectives	p. 165
Introduction	p. 165
Hard Gelatin Capsules	p. 166
Advantages and Disadvantages of Hard Gelatin Capsules	p. 166
Formulation of Hard Gelatin Capsules	p. 167
Soft Gelatin Capsules	p. 168
Formulation of Soft Gelatin Capsules	p. 169
Evaluation of Capsules	p. 170
Review Questions	p. 171
Bibliography	p. 171
Injectable Dosage Forms	p. 173
Learning Objectives	p. 173
Introduction	p. 173
Isotonicity	p. 174
Parenteral Routes of Administration	p. 174
Intravenous Route	p. 174
Intramuscular Route	p. 175
Subcutaneous Route	p. 175
Other Routes	p. 175
Formulation of Parenteral Products	p. 176
Physicochemical Properties of the Drug	p. 176
Excipients in Parenteral Formulations	p. 176
Vehicles	p. 177
Sterilization of Parenteral Products	p. 177
Filtration	p. 177
Dry Heat Sterilization	p. 178
Steam Sterilization	p. 178
Radiation Sterilization	p. 178
Types of Parenteral Dosage Forms	p. 178
Solutions	p. 178
Suspensions	p. 179
Emulsions	p. 179
Dry Powders	p. 179
Evaluation of Injectable Products	p. 179
Sterility	p. 180
Pyrogens	p. 180
Particulate Matters	p. 180
Review Questions	p. 181
Bibliography	p. 181
Semisolid Dosage Forms	p. 183
Learning Objectives	p. 183
Introduction	p. 183
Ointments	p. 183
Types of Ointment Bases	p. 183
Hydrocarbon Bases	p. 184
Absorption Bases	p. 184
Emulsion Bases	p. 184
Water-Soluble Bases	p. 185
Incorporation of Drugs into Ointment	p. 185
Creams	p. 185
Gels	p. 186
Lotions	p. 187
Pastes	p. 187
Review Questions	p. 187
Bibliography	p. 188
Inserts, Implants, and Devices	p. 189
Learning Objectives	p. 189
Introduction	p. 189
Inserts	p. 189
Implants	p. 191
Suppositories	p. 192
Aerosol Products	p. 193
Nebulizers	p. 193
Metered-Dose Inhalers (MDIs)	p. 195
Powder Inhalers	p. 195
Transdermal Patches	p. 196
Review Questions	p. 197
Bibliography	p. 197
Pharmaceutical Polymers	p. 199
Learning Objectives	p. 199
Introduction	p. 199
Definitions and Architectures of Polymers	p. 199
Polymer Molecular Weight and Weight Distribution	p. 204
Biodegradablity and Biocompatibility	p. 205
Polymer Solubility	p. 205
Block Copolymers	p. 206
Intelligent or Stimuli-Sensitive Polymers	p. 207
Water-Soluble Polymers	p. 208
Bioadhesive/Mucoadhesive Polymers	p. 209
Review Questions	p. 209
Bibliography	p. 210
Drug Delivery Systems	p. 211
Learning Objectives	p. 211
Introduction	p. 211
Prodrugs	p. 212
Soluble Macromolecular Carriers	p. 213
Particulate Carrier Systems	p. 214
Liposomes	p. 215
Types of Liposomes	p. 215
Fabrication of Liposomes	p. 216
Microparticles and Nanoparticles	p. 218
Fabrication of Microparticulates	p. 219
Nanoparticles	p. 223
Oral Drug Delivery	p. 224
Alternative Routes of Delivery	p. 225
Buccal and Sublingual Drug Delivery	p. 225
Nasal Drug Delivery	p. 226
Pulmonary Drug Delivery	p. 227
Ocular Drug Delivery	p. 227
Rectal Drug Delivery	p. 228
Vaginal Drug Delivery	p. 228
Review Questions	p. 229
Bibliography	p. 229
Protein- and Peptide-Based Dosage Forms	p. 231
Learning Objectives	p. 231
Introduction	p. 231
Structure of Peptides and Proteins	p. 232
Primary Structure	p. 234
Secondary Structure	p. 235
Tertiary Structure	p. 235
Quaternary Structures	p. 235
Hydrophobicity of Peptides and Proteins	p. 235
Solubility of Peptides and Proteins	p. 236
Instability of Peptides and Proteins	p. 237
Physical Instability	p. 237
Denaturation	p. 237
Aggregation and Precipitation	p. 238
Surface Adsorption	p. 238
Chemical Instability	p. 238
Hydrolysis	p. 239
Deamidation	p. 239
Oxidation	p. 239
Racemization	p. 240
Disulfide Exchange	p. 240
Formulation of Proteins and Peptides	p. 240
Additives	p. 240
Lyophilized Proteins	p. 241
Chemical Modification	p. 242
PEGylation	p. 242
Antibody-Based Therapy and Delivery	p. 242
Antigenicity and Immunogenicity	p. 244
Review Questions	p. 244
Bibliography	p. 245
Biotechnology-Based Dosage Forms	p. 247
Learning Objectives	p. 247
Introduction	p. 247
Genes and Gene Expression	p. 247
Gene Silencing	p. 248
Classification of Gene-Silencing Technologies	p. 249
Antisense Oligonucleotides	p. 249
Triplex-Forming Oligonucleotides	p. 250
Peptide Nucleic Acids	p. 250
Antisense RNA	p. 250
Aptamers	p. 250
Ribozymes	p. 251
RNA Interference	p. 251
Gene Therapy	p. 251
Retroviral Vector	p. 252
Moloney Murine Leukemia Viruses	p. 253
Lentiviruses	p. 253
Adenoviral Vectors	p. 254
Adeno-Associated Virus Vectors	p. 254
Herpes Simplex Virus Vectors	p. 254
Gene Expression Plasmid	p. 254
Gene Delivery Systems	p. 255
Lipid-Based Gene Delivery	p. 256
Peptide-Based Gene Delivery	p. 257
Polymer-Based Gene Delivery	p. 258
Review Questions	p. 258
Bibliography	p. 259
Answers to Review Questions	p. 261
Drug Development and Regulatory Process	p. 261
Pharmaceutical and Formulation Considerations	p. 261
Biopharmaceutical and Physiological Considerations	p. 266
Complexation and Protein Binding	p. 267
Chemical Kinetics and Stability	p. 269
Interfacial Phenomenon	p. 270
Rheology	p. 271
Disperse System Basics	p. 272
Surfactants and Micelles	p. 275
Pharmaceutical Suspensions	p. 276
Pharmaceutical Emulsions	p. 277
Pharmaceutical Solutions	p. 279
Tablets	p. 279
Capsules	p. 280
Injectable Dosage Forms	p. 280
Semisolid Dosage Forms	p. 281
Inserts, Implants, and Devices	p. 281
Pharmaceutical Polymers	p. 281
Drug Delivery Systems	p. 282
Protein- and Peptide-Based Dosage Forms	p. 283
Biotechnology-Based Dosage Forms	p. 283
Index	p. 285
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