BOOK
Theory and Practice of Physical Pharmacy - E-Book
Gaurav Jain | Roop Krishen Khar | Farhan Jalees Ahmad
(2013)
Additional Information
Book Details
Abstract
A core subject in pharmaceutics, physical pharmacy is taught in the initial semesters of B. Pharm. The methodical knowledge of the subject is required, and is essential, to understand the principles pertaining to design and development of drug and drug products. Theory and Practice of Physical Pharmacy is unique as it fulfils the twin requirements of physical pharmacy students: the authentic text
on theoretical concepts and its application including illustrative exercises in the form of practicals.
- Covers all the topics included in various existing syllabi of physical pharmacy
- Provides an integrated understanding of theory and practical applications associated with physicochemical concepts
- Explore the latest developments in the field of pharmaceutics
- Reviews the relevance of physicochemical principles in the design of dosage form
- Ensures proper recapitulation through sufficient end-of-chapter questions
- Provides valuable learning tool in the form of multiple choice questions
- Multiple choice questions section especially useful for GPAT aspirants
Table of Contents
| Section Title | Page | Action | Price |
|---|---|---|---|
| Front Matter\r | Front Cover | ||
| Copyright\r | iv | ||
| Dedicated\r | v | ||
| Foreword\r | vii | ||
| Preface \r | ix | ||
| Acknowledgements\r | xi | ||
| Contributors\r | xiii | ||
| Contents | xv | ||
| PART A Theory \r | 1 | ||
| Chapter 1 - States of Matter | 3 | ||
| Gaseous State | 3 | ||
| Ideal Gas Law | 3 | ||
| Boyle's.law | 3 | ||
| Charles' law | 4 | ||
| Gay-Lussac's law | 4 | ||
| Avogadro's law | 4 | ||
| Molecular Weight Determination | 5 | ||
| Real Gases | 6 | ||
| Liquid State | 6 | ||
| Viscosity | 7 | ||
| Surface Tension | 7 | ||
| Vapour Pressure | 7 | ||
| Solid State | 8 | ||
| Crystalline Solids | 8 | ||
| Types of crystalline solids | 10 | ||
| Polymorphism | 11 | ||
| Polycrystalline Solids | 12 | ||
| Amorphous Solids | 12 | ||
| Liquid Crystal State | 13 | ||
| Characteristics of Liquid Crystal State | 13 | ||
| Types of Liquid Crystals | 14 | ||
| Supercritical Fluid State | 14 | ||
| Plasma | 15 | ||
| Changes in the State of Matter | 15 | ||
| Liquefaction of Gases | 15 | ||
| Aerosols | 16 | ||
| Boiling Point | 16 | ||
| Melting Point | 17 | ||
| Phase Rule | 17 | ||
| Single component (C=1) system (Fig. 1.7) | 17 | ||
| At triple point | 17 | ||
| At points 1, 2 and 3 | 17 | ||
| Two-component (C=2) system containing liquid phases (Fig. 1.8) | 18 | ||
| Two-component (C=2) system containing solid and liquid phases (Fig. 1.9) | 19 | ||
| Three-component (C=3) system (Fig. 1.10) | 20 | ||
| Chapter 2 - Micromeritics | 23 | ||
| Fundamental Properties of Particles | 24 | ||
| Particle Size and Size Distribution | 24 | ||
| Spherical or symmetrical particle | 24 | ||
| Nonspherical or asymmetrical particle | 25 | ||
| Particle size distribution | 26 | ||
| Average particle size | 27 | ||
| Frequency distribution curve | 28 | ||
| Cumulative frequency distribution curve | 29 | ||
| Log-probability curve | 30 | ||
| Particle Size Determination Methods | 31 | ||
| Optical Microscopy | 31 | ||
| Advantage | 32 | ||
| Disadvantages | 32 | ||
| Alternative techniques | 32 | ||
| Sieving Technique | 33 | ||
| Advantages | 34 | ||
| Disadvantages | 34 | ||
| Alternative techniques | 34 | ||
| Sedimentation Technique | 34 | ||
| Advantages | 36 | ||
| Disadvantages | 36 | ||
| Alternative techniques | 36 | ||
| Coulter Counter Method (Particle Volume Measurement) | 37 | ||
| Advantages | 38 | ||
| Disadvantages | 38 | ||
| Hatch-Choate equation | 39 | ||
| Particle Number | 39 | ||
| Particle Shape | 40 | ||
| Shape factors | 40 | ||
| Surface-volume shape coefficient | 40 | ||
| Sphericity | 41 | ||
| Elongation | 42 | ||
| Convexity | 42 | ||
| Circularity | 42 | ||
| Particle Surface Area | 42 | ||
| Specific surface | 42 | ||
| Surface Area Determination Methods | 44 | ||
| Adsorption Method | 45 | ||
| Solute adsorption method | 45 | ||
| Gas adsorption method | 46 | ||
| Air Permeability Method | 47 | ||
| Derived Properties Of Powders | 48 | ||
| Packing Geometry | 48 | ||
| Porosity (E) | 49 | ||
| Density (ρ) | 51 | ||
| Density Determination Methods | 52 | ||
| Bulk Density | 52 | ||
| Method I-Graduated cylinder method | 52 | ||
| Method II-Scott volumeter | 52 | ||
| Tapped Density | 53 | ||
| Method I | 53 | ||
| True Density | 54 | ||
| Gas pycnometer | 54 | ||
| Liquid displacement | 55 | ||
| Granular Density | 56 | ||
| Mercury displacement method or mercury porosimetry | 56 | ||
| Bulkiness | 56 | ||
| Flow Property | 57 | ||
| Characterization Of Powder Flow | 58 | ||
| Compressibility Index | 58 | ||
| Angles of repose | 59 | ||
| Static angle of repose | 59 | ||
| Dynamic or kinetic angle of repose | 60 | ||
| Flow Rate Through an Orifice | 61 | ||
| Improvement of Flow Property | 62 | ||
| Chapter 3 - Pharmaceutical Rheology | 65 | ||
| Fundamental Concepts | 65 | ||
| Elastic Deformation and Viscous Flow | 65 | ||
| Elasticity | 65 | ||
| Hooke's law of elasticity | 66 | ||
| Viscosity | 66 | ||
| Newton's law of viscous flow | 66 | ||
| Temperature Dependence of Viscosity | 69 | ||
| Newtonian Fluids | 69 | ||
| Rheogram and viscogram | 70 | ||
| Non-Newtonian Fluids | 71 | ||
| Time-Independent Non-Newtonian Fluids | 71 | ||
| Plasticity | 71 | ||
| Rheogram and viscogram | 71 | ||
| Reason | 72 | ||
| Pseudoplasticity | 73 | ||
| Rheogram and viscogram | 73 | ||
| Reason | 74 | ||
| Dilatancy | 74 | ||
| Rheogram and viscogram | 74 | ||
| Reason | 75 | ||
| Time-Dependent Non-Newtonian Flow | 76 | ||
| Thixotropy | 76 | ||
| Hysteresis loop | 77 | ||
| Bulges and spurs in thixotropy | 78 | ||
| Rheopexy | 79 | ||
| Negative Thixotropy or Antithixotropy | 79 | ||
| Negative Rheopexy | 80 | ||
| Determination of Rheological Properties: Measurement of Viscosity | 81 | ||
| Capillary Viscometers | 81 | ||
| Ostwald viscometer | 82 | ||
| Ubbelohde suspended level viscometer | 83 | ||
| Extrusion rheometer | 83 | ||
| Density-Dependent Viscometers | 84 | ||
| Falling sphere viscometer | 84 | ||
| Bubble viscometer | 85 | ||
| Rotational Viscometers | 85 | ||
| Cup and bob viscometers | 85 | ||
| Cone and plate viscometers | 87 | ||
| Penetrometers | 88 | ||
| Non-Newtonian Corrections | 88 | ||
| Measurement of Thixotropy | 89 | ||
| Structural Breakdown with Increasing Rates of Shear (M) | 89 | ||
| Structural Breakdown with Time at Constant Rate of Shear (B) | 89 | ||
| Viscoelasticity | 90 | ||
| Viscoelasticity Mechanism | 91 | ||
| Viscoelastic Models | 91 | ||
| Maxwell model | 92 | ||
| Kelvin-Voigt model | 92 | ||
| Standard linear solid model (Maxwell form) | 93 | ||
| Weichert model | 93 | ||
| Viscoelastic Creep | 94 | ||
| Specialized Pharmaceutical Applications of Rheology | 95 | ||
| Yield Value and Suspensions | 95 | ||
| Plug Flow-Artifactual Observations | 95 | ||
| Rheological Use of Mixing Equipment | 96 | ||
| Biorheology | 96 | ||
| Chapter 4 - Surface and Interfacial Phenomena | 99 | ||
| Surface-Active Agents (Surfactants) | 99 | ||
| Classification of Surfactants | 100 | ||
| Anionic surfactants | 100 | ||
| Alkali soaps (sodium and potassium stearate) | 101 | ||
| Metallic soaps (calcium stearate) | 101 | ||
| Amine soaps | 101 | ||
| Alkyl sulphates and phosphates (sodium lauryl sulphate) | 101 | ||
| Alkyl sulphonates (sodium dioctyl sulphosuccinate also known as aerosol AT) | 101 | ||
| Cationic surfactants | 101 | ||
| Ampholytic surfactants | 101 | ||
| Nonionic surfactants | 101 | ||
| Sorbitan esters (Spans) | 102 | ||
| Polysorbates (Tweens) | 102 | ||
| Polymeric surfactants | 102 | ||
| Hydrophilic-Lipophilic Balance Concept | 104 | ||
| Calculation of HLB value | 105 | ||
| Required HLB | 106 | ||
| Determination of Surfactant Amount | 107 | ||
| Application of Surfactants | 108 | ||
| Medicinal applications | 108 | ||
| Pharmaceutical applications | 108 | ||
| Surface And Interfacial Tension | 109 | ||
| Expression of Surface Tension | 110 | ||
| In terms of force per unit length | 110 | ||
| In terms of energy per unit area increase | 111 | ||
| In terms of pressure difference across curved surface | 112 | ||
| Measurement Of Surface And Interfacial Tension | 112 | ||
| Capillary Rise Method | 112 | ||
| Upward force due to surface tension | 113 | ||
| Downward force due to the weight of the liquid | 113 | ||
| Drop Weight and Drop Count Methods | 114 | ||
| Wilhelmy Plate Method | 116 | ||
| Ring Detachment Method (du Nouy tensiometer) | 117 | ||
| Spinning Drop Method | 118 | ||
| Wetting And Contact Angle | 119 | ||
| Spreading | 120 | ||
| Spreading Coefficient (S) | 121 | ||
| Work of adhesion (WJa) | 121 | ||
| Work of cohesion (WJc) | 121 | ||
| Critical Micelle Concentration | 123 | ||
| Influence of CMC on the Physical Properties | 123 | ||
| Factors Affecting CMC | 125 | ||
| Molecular structure of the surfactant | 125 | ||
| Hydrocarbon chain in the hydrophobic group | 125 | ||
| Hydrophilic group | 125 | ||
| Effect of additives | 126 | ||
| Effect of temperature | 126 | ||
| Effect of counterions | 126 | ||
| Surface Films | 126 | ||
| Insoluble Monomolecular Films | 127 | ||
| Interfacial Complex Condensed Films | 128 | ||
| Lamellar Liquid Crystalline Films | 128 | ||
| Adsorption Phenomena | 128 | ||
| Adsorption Isotherm | 129 | ||
| Langmuir isotherm | 131 | ||
| Freundlich isotherm | 132 | ||
| BET isotherm | 133 | ||
| Factors Affecting Adsorption | 134 | ||
| Applications of Adsorption | 135 | ||
| Electrical Properties Of Interfaces | 136 | ||
| Electrical Double Layer | 136 | ||
| Specialized Surfactant Based Systems | 138 | ||
| Liquid Crystals | 138 | ||
| Vesicular Systems | 138 | ||
| Liposomes | 138 | ||
| Niosomes | 138 | ||
| Chapter 5 - Buffers and Isotonic Solutions | 141 | ||
| Buffer equation | 141 | ||
| Autoionization of Water | 141 | ||
| Buffer Equation for Weak Acid and Its Salt | 142 | ||
| Buffer Equation for Weak Base and Its Salt | 143 | ||
| Buffer Capacity | 145 | ||
| Buffer Preparation | 147 | ||
| Standard Buffer Solution | 148 | ||
| Selection of Buffer System | 150 | ||
| Pharmaceutical Buffers | 150 | ||
| Stabilization of Drug Substances in Formulations by Buffers | 150 | ||
| Use of Buffers to Study the pH-stability Profile of Drug Substances | 151 | ||
| Use of Buffers to Study the pH Dependence of Drug Substance Solubility | 151 | ||
| Biological Buffers | 152 | ||
| Buffered Isotonic Solutions | 152 | ||
| Methods of Adjusting Tonicity | 154 | ||
| Class I Methods | 154 | ||
| Cryoscopic method | 154 | ||
| Sodium chloride equivalent method | 155 | ||
| Class II Methods | 157 | ||
| White-Vincent method | 157 | ||
| Sprowls method | 158 | ||
| Tonicity Application | 159 | ||
| Ophthalmic medication | 159 | ||
| Parenteral medication | 159 | ||
| Chapter 6 - Complexation and Protein Binding | 161 | ||
| Classification of Complexes | 162 | ||
| Coordination Complexes | 163 | ||
| Inorganic Complexes | 164 | ||
| Chelates | 166 | ||
| Olefin Complexes | 167 | ||
| Aromatic Complexes | 168 | ||
| Organic Molecular Complexes | 169 | ||
| Charge-Transfer Complexes | 169 | ||
| Quinhydrone Complex | 170 | ||
| Picric Acid Complexes | 171 | ||
| Hydrogen-Bonded Complexes | 171 | ||
| Caffeine complexes | 171 | ||
| Polymeric Complexes | 172 | ||
| Inclusion Compound (Or No Bond Complexes) | 172 | ||
| Clathrates | 173 | ||
| Example | 174 | ||
| Channel Lattice Complexes | 174 | ||
| Intercalation Compound or Layer-type Complexes | 175 | ||
| Monomolecular Inclusion Compounds | 175 | ||
| Example: Cyclodextrins | 175 | ||
| Macromolecular Inclusion Compounds | 177 | ||
| Methods of Analysis | 177 | ||
| Job's Method of Continuous Variation | 177 | ||
| pH Titration Method | 179 | ||
| Phase-Distribution Method | 180 | ||
| Solubility Method | 181 | ||
| Protein Binding: Small Molecule-Macromolecule Complexes | 182 | ||
| Significance of Protein Binding | 182 | ||
| Binding Equilibria | 183 | ||
| Methods for Determining Protein Binding | 186 | ||
| Equilibrium dialysis method | 186 | ||
| Dynamic dialysis | 187 | ||
| Ultracentrifugation | 188 | ||
| Thermodynamic Treatment of Stability Constants | 188 | ||
| Chapter 7 - Colloidal Dispersions | 191 | ||
| Classification of Colloids | 192 | ||
| Lyophilic Colloids | 192 | ||
| Lyophobic Colloids | 193 | ||
| Association Colloids (Micelles) | 193 | ||
| Preparation of Colloidal Dispersions | 194 | ||
| Lyophilic Colloids | 194 | ||
| Lyophobic Colloids | 194 | ||
| Condensation methods | 194 | ||
| Dispersion methods | 195 | ||
| Properties of Colloidal Dispersions | 195 | ||
| Kinetic Properties | 195 | ||
| Brownian motion | 195 | ||
| Diffusion | 196 | ||
| Sedimentation | 196 | ||
| Osmotic pressure | 196 | ||
| Viscosity | 197 | ||
| Optical Properties | 197 | ||
| Light scattering | 197 | ||
| Electrical Properties | 197 | ||
| Stability of Colloidal Systems | 198 | ||
| Stability of lyophobic colloids-DLVO theory | 198 | ||
| Stability of lyophilic colloids | 200 | ||
| Interaction of Colloids | 200 | ||
| Colloidal Drug-Delivery Systems | 201 | ||
| Chapter 8 - Pharmaceutical Suspensions | 203 | ||
| Utility Of Suspensions | 204 | ||
| Theoretical Considerations | 204 | ||
| Particle Size Consideration | 204 | ||
| Interfacial Region | 206 | ||
| Wetting and Contact Angle | 207 | ||
| Particle Behaviour and Interactions | 208 | ||
| Electric double layer | 208 | ||
| Flocculated and Deflocculated Suspensions | 209 | ||
| Formulation Components | 211 | ||
| Wetting Agents | 211 | ||
| Deflocculants and Dispersing Agents | 211 | ||
| Flocculating Agents | 211 | ||
| Suspending Agents | 212 | ||
| Organoleptic Agents | 212 | ||
| Suspension Formation | 213 | ||
| Precipitation Method | 213 | ||
| Dispersion Method | 214 | ||
| Controlled Flocculation | 214 | ||
| Structured Vehicle | 215 | ||
| Stability of Suspension | 215 | ||
| Chemical Stability | 215 | ||
| Physical Stability | 216 | ||
| Sedimentation rate | 216 | ||
| Particle growth | 217 | ||
| Crystal growth or Ostwald ripening | 217 | ||
| Polymorphic transformation | 217 | ||
| Crystal habit | 218 | ||
| Temperature cycling | 218 | ||
| Evaluation of Suspension Stability | 218 | ||
| Organoleptic Aspects (Colour, Taste and Flavour) | 218 | ||
| Sedimentation Parameters | 219 | ||
| Sedimentation volume | 219 | ||
| Degree of flocculation | 219 | ||
| Rheologic Methods | 220 | ||
| Electrokinetic Techniques | 221 | ||
| Particle Size Changes | 221 | ||
| Packaging | 221 | ||
| Pharmaceutical Nanosuspensions | 221 | ||
| Chapter 9 - Pharmaceutical Emulsions | 223 | ||
| Utility of Emulsions | 224 | ||
| Theoretical Considerations | 225 | ||
| Reduction of Interfacial Tension: Thermodynamic Stabilization | 226 | ||
| Interfacial Film Formation: Mechanical Barrier to Coalescence | 226 | ||
| Monomolecular film formation by surface-active agents | 226 | ||
| Multimolecular film formation by hydrophilic colloids | 227 | ||
| Solid particle film formation by finely divided solids | 228 | ||
| Electrical Repulsion: Electrical Barrier to Approach of Particles | 228 | ||
| Formulation Components | 229 | ||
| Oil Phase | 229 | ||
| Emulsifiers | 230 | ||
| Determination of emulsifier amount | 231 | ||
| Auxiliary Emulsifiers | 231 | ||
| Hydrophilic colloids | 231 | ||
| Finely divided solids | 232 | ||
| Viscosity Modifiers | 232 | ||
| Preservatives | 232 | ||
| Antioxidant | 232 | ||
| Emulsification Techniques (Emulsion Formation) | 233 | ||
| Conventional Method | 235 | ||
| Condensation Method | 235 | ||
| Phase Inversion Technique | 235 | ||
| Low-Energy Emulsification | 235 | ||
| Spontaneous Emulsification | 236 | ||
| Production Aspects | 236 | ||
| Foaming During Agitation | 237 | ||
| Emulsion Type | 237 | ||
| Microemulsions | 238 | ||
| O/w micellar solution | 240 | ||
| W/o micellar solution | 240 | ||
| Stability of Emulsions | 240 | ||
| Physical Stability | 240 | ||
| Symptoms of Instability | 241 | ||
| Flocculation | 242 | ||
| Creaming | 242 | ||
| Coalescence and breaking | 243 | ||
| Phase inversion | 244 | ||
| Chemical Stability | 244 | ||
| Oxidation | 244 | ||
| Microbial Contamination | 244 | ||
| Assessment of Emulsion Shelf Life | 244 | ||
| Stress Conditions | 245 | ||
| Ageing and temperature | 245 | ||
| Centrifugation | 245 | ||
| Agitation | 246 | ||
| Rheology of Emulsion | 246 | ||
| Chapter 10 - Diffusion and Drug Release | 249 | ||
| Laws of Diffusion | 249 | ||
| Fick's First Law | 250 | ||
| Fick's Second Law | 251 | ||
| Steady-State Diffusion | 252 | ||
| Measurement of Diffusion | 253 | ||
| Applications of Diffusion Principles | 254 | ||
| Drug Absorption by Passive Diffusion | 254 | ||
| Drug Absorption by Facilitated Diffusion | 255 | ||
| Percutaneous or Transdermal Absorption | 255 | ||
| Ostwald Ripening in Emulsions | 255 | ||
| Bioadhesion and Mucoadhesion | 256 | ||
| In Vitro Permeation Studies | 256 | ||
| Osmotically Controlled Delivery Systems | 256 | ||
| Drug Release from Polymer Matrices | 257 | ||
| Reservoir Systems | 258 | ||
| Matrix/monolithic Systems | 258 | ||
| Membrane-Matrix System | 260 | ||
| Diffusion During Swelling of Matrix | 261 | ||
| Diffusion in Matrix Erosion | 261 | ||
| Chapter 11 - Drug Dissolution | 263 | ||
| Dissolution Mechanism | 264 | ||
| Reaction-Limited Model | 264 | ||
| Interfacial barrier model (Limited solvation theory) | 264 | ||
| Danckwert model | 265 | ||
| Diffusion-Limited Model or Film Theory | 265 | ||
| Noyes-Whitney Relationship | 266 | ||
| Hixon-Crowell Cubic Root Law | 266 | ||
| Factors Affecting Dissolution | 267 | ||
| Factors Affecting the Surface Area of the Drug (S) | 267 | ||
| Particle size | 267 | ||
| Wetting | 267 | ||
| Manufacturing processes | 267 | ||
| Formulation ingredients | 268 | ||
| Factors Affecting the Saturation Solubility of the Drug (Cs) | 268 | ||
| GL pH | 268 | ||
| Crystalline state | 269 | ||
| Drug complex | 269 | ||
| pKa and pH profile | 269 | ||
| Temperature | 270 | ||
| Factors Affecting Dissolution Volume (V) | 270 | ||
| Factors Affecting Diffusivity (D) | 270 | ||
| Factors Affecting the Thickness of Hydrodynamic Layer (h) | 271 | ||
| Dissolution Test Parameters | 271 | ||
| Eccentricity of the stirring device | 271 | ||
| Alignment of the stirring element | 271 | ||
| Vibration | 271 | ||
| Agitation intensity | 271 | ||
| Intrinsic Dissolution | 272 | ||
| Compendial Dissolution Methods | 273 | ||
| Dissolution Apparatus | 275 | ||
| Basket Apparatus (USP Apparatus 1) | 275 | ||
| Paddle Apparatus (USP Apparatus 2) | 276 | ||
| Dissolution Conditions | 277 | ||
| Dissolution Profile Comparison | 279 | ||
| Difference factor (f1) | 279 | ||
| Similarity factor (f2) | 279 | ||
| In Vitro-In Vivo Correlation | 280 | ||
| Level A | 280 | ||
| Level B | 281 | ||
| Level C | 281 | ||
| Multiple level C | 281 | ||
| Biopharmaceutical Classification System | 281 | ||
| Solubility | 282 | ||
| Permeability | 282 | ||
| Dissolution | 282 | ||
| Chapter 12 - Kinetics, Degradation and Stability | 285 | ||
| Rate of Reaction | 285 | ||
| Elementary Reaction | 286 | ||
| Nonelementary Reaction | 286 | ||
| Order of Reaction | 287 | ||
| Molecularity of Reaction | 287 | ||
| Types of Reaction | 287 | ||
| Zero-Order Reaction | 287 | ||
| Example | 289 | ||
| First-Order Reaction | 289 | ||
| Example | 290 | ||
| Second-Order Reaction | 290 | ||
| Example | 292 | ||
| Apparent/Pseudo-Zero-Order Reaction | 293 | ||
| Pseudo-First-Order Reaction | 294 | ||
| Example | 294 | ||
| Determination of Order of Reaction | 294 | ||
| Graphical Substitution Method | 294 | ||
| Half-Life Method | 295 | ||
| Complex Reactions | 295 | ||
| Reverse/Opposing Reactions | 296 | ||
| Consecutive/Series Reactions | 297 | ||
| Side/Parallel Reactions | 298 | ||
| Factors Influencing Reaction Rates | 300 | ||
| Temperature | 300 | ||
| Collision theory | 300 | ||
| Transition-state theory | 302 | ||
| Influence of temperature | 303 | ||
| Calculation of Ea | 304 | ||
| Method 1 | 304 | ||
| Method 2 | 305 | ||
| Medium Effects: Solvent, Ionic Strength and Dielectric Constant | 306 | ||
| Solvent | 306 | ||
| Ionic strength | 307 | ||
| Dielectric constant | 308 | ||
| pH-Specific Acid-Base Catalysis | 309 | ||
| General Acid-Base Catalysis | 310 | ||
| Decomposition and Stabilization of Pharmaceuticals | 311 | ||
| Degradative Pathways | 311 | ||
| Hydrolysis | 311 | ||
| Ester hydrolysis | 311 | ||
| Amide hydrolysis | 312 | ||
| Ring alteration | 313 | ||
| Protection from hydrolysis | 314 | ||
| Oxidation | 316 | ||
| Initiation | 316 | ||
| Propagation | 316 | ||
| Hydroperoxide decomposition | 316 | ||
| Termination | 316 | ||
| Protection from Oxidation | 317 | ||
| Photolysis | 318 | ||
| Racemization | 319 | ||
| Stability Testing | 320 | ||
| ICH Stability Guidelines | 320 | ||
| Thermal cycling studies | 321 | ||
| Photostability studies | 322 | ||
| Expiration Dating of Pharmaceuticals | 323 | ||
| Accelerated Stability Studies (Shelf-Life Determination) | 324 | ||
| Prediction of shelf life from accelerated stability-testing data | 325 | ||
| Practical Example: Estimation of degradation from accelerated data: First-order case | 326 | ||
| Solution | 326 | ||
| Limitations of Accelerated Stability Testing | 327 | ||
| Other Techniques for Stability Prediction | 328 | ||
| Experiment 1 Ternary Phase Diagram | 333 | ||
| Objective | 333 | ||
| Requirements | 333 | ||
| Procedure | 333 | ||
| Observation and Calculation | 334 | ||
| Result | 335 | ||
| Experiment 2 Particle Size By Optical Microscopy | 336 | ||
| Objective | 336 | ||
| Requirements | 336 | ||
| Procedure | 336 | ||
| Observations and Calculations | 336 | ||
| Result | 337 | ||
| Experiment 3 Particle Size By Sieving | 338 | ||
| Objective | 338 | ||
| Requirements | 338 | ||
| Procedure | 338 | ||
| Observations and Calculations | 338 | ||
| Result | 340 | ||
| Experiment 4 Flow Property Of Powder | 341 | ||
| Objective | 341 | ||
| Requirements | 341 | ||
| Procedure | 341 | ||
| Observations and Calculations | 341 | ||
| Result | 343 | ||
| Experiment 5 Angle Of Reposex | 344 | ||
| Objective | 344 | ||
| Requirements | 344 | ||
| Procedure | 344 | ||
| Observations and Calculations | 344 | ||
| Observations and Calculations | 345 | ||
| Result | 346 | ||
| Experiment 6 Density Determination | 347 | ||
| Objective | 347 | ||
| Requirements | 347 | ||
| Procedure | 347 | ||
| Observations and Calculations | 347 | ||
| Result | 348 | ||
| Experiment 7 Ostwald Viscometer | 349 | ||
| Objective | 349 | ||
| Requirements | 349 | ||
| Procedure | 349 | ||
| Observations and Calculations | 350 | ||
| Result | 350 | ||
| Experiment 8 Falling Sphere Viscometer | 351 | ||
| Objective | 351 | ||
| Requirements | 351 | ||
| Procedure | 351 | ||
| Observations and Calculations | 351 | ||
| Correction Factor | 352 | ||
| Result | 352 | ||
| Experiment 9 Spreading Coefficient | 353 | ||
| Objective | 353 | ||
| Requirements | 353 | ||
| Procedure | 353 | ||
| Observations and Calculations | 354 | ||
| Result | 354 | ||
| Experiment 10 Critical Micelle Concentration | 355 | ||
| Objective | 355 | ||
| Requirements | 355 | ||
| Procedure | 355 | ||
| Observations and Calculations | 356 | ||
| Calculation of Surface Tension | 356 | ||
| Determination of CMC | 357 | ||
| Result | 357 | ||
| Experiment 11 Buffer preparation | 358 | ||
| Objective | 358 | ||
| Requirements | 358 | ||
| Procedure | 358 | ||
| Observation and Calculation | 359 | ||
| Result | 359 | ||
| Experiment 12 Colloidal Solution | 360 | ||
| Objective | 360 | ||
| Requirements | 360 | ||
| Procedure | 360 | ||
| Observations | 360 | ||
| Result | 360 | ||
| Experiment 13 Physical Stability of Suspension | 361 | ||
| Objective | 361 | ||
| Requirements | 361 | ||
| Procedure | 361 | ||
| Observations and Calculations | 362 | ||
| Result | 363 | ||
| Experiment 14 Dissolutilution Profile of Tabltablet | 364 | ||
| Aim | 364 | ||
| Requirements | 364 | ||
| Procedure | 364 | ||
| Result | 367 | ||
| Experiment 15 Kinetics-I | 368 | ||
| Objective | 368 | ||
| Requirements | 368 | ||
| Procedure | 368 | ||
| Observations and Calculations | 369 | ||
| Table for λ max determination | 369 | ||
| Table for calibration curve | 370 | ||
| Result | 371 | ||
| Experiment 16 Kinetics-II | 372 | ||
| Objective | 372 | ||
| Requirements | 372 | ||
| Procedure | 372 | ||
| Observations and Calculations | 373 | ||
| Data Analysis (Record the following data in Table 5) | 375 | ||
| Result | 376 | ||
| Multiple Choice Questions (useful for GPAT aspirants) | 379 | ||
| MCQ Answer Key | 396 | ||
| Index | 397 |