ABSTRACT
Introduction ............................................................................................................ 184 Importance of In Vitro Drug Product Characterization .......................................... 184 Types of Solid Oral Dosage Forms ........................................................................ 184 Factors Affecting In Vitro Drug Product Dissolution ............................................ 185
Factors Related to Drug Substance ................................................................... 185 Solubility of the Drug Substance ................................................................. 186 Polymorphism .............................................................................................. 187 Salt Factor and “pH” of the Diffusion Layer ................................................ 187 Surface Area and Particle Size ..................................................................... 188
Formulation Factors .......................................................................................... 188 Manufacturing Process Factors ......................................................................... 189 Dissolution/Drug Release Test Conditions ....................................................... 189
In Vitro Drug Product Performance Evaluation ..................................................... 190 Disintegration Test ............................................................................................ 190 Dissolution Test-IR Solid Oral Dosage Forms ............................................... 190 Drug Release Test-MR Solid Oral Dosage Forms .......................................... 192 Dissolution/Drug Release Profile Comparisons ................................................ 193
Applications of In Vitro Dissolution ...................................................................... 198 Product Development ........................................................................................ 198 Quality Assurance ............................................................................................. 199 Product Stability ................................................................................................ 199 Comparability Assessment ................................................................................ 199 Waivers of In Vivo Bioequivalence Requirements ............................................ 199
Formulation Proportionality ......................................................................... 199 Biopharmaceutics Classification System .....................................................200 In Vitro/In Vivo Correlations ........................................................................ 201
Limitations of In Vitro Dissolution ........................................................................ 201 Future Direction .....................................................................................................202 Summary ................................................................................................................202 Websites .................................................................................................................203 References ..............................................................................................................203
