Pharmaceutical Process Scale-UpMichael Levin CRC Press, 12 dec 2001 - 584 pagina's Focusing on scientific and practical aspects of process scale-up, this resource details the theory and practice of transferring pharmaceutical processes from laboratory scale to the pilot plant and production scale. It covers parenteral and nonparenterel liquids and semi-solids, products derived from biotechnology, dry blending and powder handling, |
Inhoudsopgave
Dimensional Analysis and ScaleUp in Theory and Industrial Application | 1 |
Parenteral Drug ScaleUp | 43 |
Nonparenteral Liquids and Semisolids | 57 |
ScaleUp Considerations for BiotechnologyDerived Products | 95 |
Batch Size Increase in Dry Blending and Mixing | 115 |
Powder Handling | 133 |
ScaleUp in the Field of Granulation and Drying | 151 |
Batch Size Increase in Fluid Bed Granulation | 171 |
Engineering Aspects of Process ScaleUp and Pilot Plant Design | 311 |
A Collaborative Search for Efficient Methods of Ensuring Unchanged Product Quality and Performance During ScaleUp of Immediate Release Solid ... | 325 |
Appendix A | 353 |
Appendix B | 373 |
Appendix C | 415 |
Appendix D | 447 |
Appendix E | 469 |
Appendix F | 499 |
ScaleUp of the Compaction and Tableting Process | 221 |
Practical Aspects of Tableting ScaleUp | 239 |
Dimensional Analysis of the Tableting Process | 253 |
ScaleUp of Film Coating | 259 |
Appendix G | 517 |
Appendix H | 551 |
Back Cover | 565 |
Veelvoorkomende woorden en zinsdelen
achieved addition amount analysis and/or annual report application application/compendial approach appropriate approved batch bioequivalence blend blender cell changes characteristics coating compaction components compression considered container correlation defined dependent described determined dissolution dissolution profiles Documentation dosage form drug product drug substance drying edited effect equipment established evaluation example excipients factors Figure flow fluid fluid bed fluidization force formulation function granulation guidance heat identified important increase industry Level liquid long-term manufacturing mass material mean measured mechanical method mill mixing operating oral parameters particle performed pharmaceutical phase physical powder predictability pressure principles problem properties range recommended reference relate release requirements result rotation scale scale-up shear similar solid solution specific speed spray stability data strength studies supplement surface Table tablet temperature tion transfer unit variables vitro vivo volume