Pharmaceutical Engineering & Drug Delivery

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...

Can A Design Space Be Built On Material Attributes Alone?

Nov 10, 2010
James N. Michaels
In April, 2009, the PhRMA Drug Product Technical Group sponsored an industry workshop to explore the practicality and limitations of defining a design space in terms of material attributes rather than process variables. This presentation summarizes and expands on the output of this workshop. A...

Impact of API Particle Size On a Sustained Release Oral Tablet Formulation

Nov 10, 2010
Sarina G. Harris Ma
The objective of this study was to understand the impact of API particle size on various blend and tablet quality attributes of a sustained release oral tablet formulation produced via a direct compression process. The API primary particle size and agglomerate size were identified as critical...

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