Pharmaceutical Process Scale-Up
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, granulation and drying, fluid bed applications, compaction and tableting, and film coating and regulatory requirements for scale-up and postapproval changes. Drawing on the experience of twenty contributing researchers, the book employs dimensional analysis as a unified scientific approach to quantify similar processes on different scales.
Wat mensen zeggen - Een review schrijven
We hebben geen reviews gevonden op de gebruikelijke plaatsen.
Parenteral Drug ScaleUp
Nonparenteral Liquids and Semisolids
ScaleUp Considerations for BiotechnologyDerived Products
Batch Size Increase in Dry Blending and Mixing
ScaleUp in the Field of Granulation and Drying
Batch Size Increase in Fluid Bed Granulation
Engineering Aspects of Process ScaleUp and Pilot Plant Design
A Collaborative Search for Efficient Methods of Ensuring Unchanged Product Quality and Performance During ScaleUp of Immediate Release Solid ...
ScaleUp of the Compaction and Tableting Process
Practical Aspects of Tableting ScaleUp
Dimensional Analysis of the Tableting Process
ScaleUp of Film Coating
accelerated stability data and/or annual report application application/compendial batch records batch with three binder bioavailability Bioequivalence Documentation Biopharmaceutics Classification System bioreactor biowaiver blend blender buffer capsule CDER cell CGMP changed drug coating process compaction components compression controlling excipients correlation density dimensional analysis dissolution profiles dissolution testing droplet drug product drug substance drying emulsification equipment evaluation example flow fluid bed fluidization formulation granulation guidance impeller IVIVC Level 1 Change liquid long-term stability data magnesium stearate manufacturing material mill mixer mixing nozzle operating principles oral dosage form parameters particle permeability Pharm pharmaceutical powder prior approval supplement production batches release solid oral rotation scale scale-up shear shear rate sodium lauryl sulfate solid oral dosage specific spray rate stability data reported subclasses tablet press temperature therapeutic index tion unchanged drug product unit operations variables velocity viscoelastic viscosity vitro dissolution vitro release Vivo Bioequivalence