2010

An Integrated Quality-by-Design (QbD) Approach towards Design Space Definition of Key Unit Operations In the Manufacturing of Solid Dosage Forms by Discrete Element Method (DEM) and Computational Fluid Dynamics (CFD) Simulation

Nov 10, 2010
Siegfried Adam
Combined Quality-by-Design and computer simulation approaches (discrete element method and computational fluid dynamics) are presented to characterize key unit operations of solid dosage form manufacturing, namely powder blending and tablet coating. The aim is to evaluate the impact of formulation...

Mixture DOE and Design Space

Nov 10, 2010
Patrick J. Whitcomb
Present a case study on mixture DOE involving five components used to formulate a pharmaceutical tablet. The goal is to achieve a sustained release by optimizing the concentration of a hydrophilic polymer in relation to the proportions of a drug and three excipients. Four responses (two related to...

Practical Application of Q8 and Q9 Principles in Pharmaceutical Development

Nov 10, 2010
Erik Gout
The presentation “Practical application of Q8 and Q9 principles in pharmaceutical development” gives an overview of the current practice in pharmaceutical development within the Oral Solid Dosage form Development department of Abbott in Weesp, the Netherlands. The presentation starts at the point...

Computational Predictive Models Applied to Scale-up of Solid Oral Drug Products

Nov 10, 2010
Mary T. am Ende
The budget-restricted pharmaceutical environment is countered by the heightened expectations for drug products to be developed using science-based principles. These two opposing factors have created a crucial opportunity for engineering principles to be applied and implemented across the industry...

GENENTECH: A Rich History of Chemical Engineering Innovation

Nov 10, 2010
Ann L. Lee
Throughout its history, Genentech scientists and engineers pioneered and then exploited the use of recombinant DNA technology to develop and manufacture proteins and monoclonal antibodies for therapeutic use. Today an entire industry uses these genetic engineering techniques in pursuit of novel...

PVA-Calcium Oxide Composite Membrane for Direct Methanol Fuel Cell

Nov 10, 2010
Norfamila Che Mat
The large scale utilization of Nafion® in Direct Methanol Fuel Cell( DMFC) is still constrained by high methanol permeability and high temperature dehydration. The methanol crossover in DMFC can be minimized by using pervaporation membrane such as Poly-vinyl alcohol (PVA) due to higher water...

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