Pharmaceutical Engineering & Drug Delivery

Automation and Control of Drug-On-Demand Technology

Oct 16, 2011
Laura Hirshfield
After the implementation of initiatives such as PAT and QbD, there has been a drive towards efficient manufacturing in the pharmaceutical industry. The concept of "mini-manufacturing" of drugs, as opposed to mass production of drugs, has shown promise in this area. We describe one such "mini-...

QbD - It's Not Just for Breakfast Anymore

Oct 16, 2011
Paul C. Collins
We are approaching the ten-year mark for the Quality by Design initiative in the pharmaceutical industry. Much has been accomplished and demonstrated, particularly with regard to enhanced understanding of processes and better definition of processing parameters such as CPPs. Design space has become...

Using QbD to Asses the Factors That Affect Stability and Packaging

Oct 16, 2011
Stephanie Krogmeier
Packaging is often the last step in drug product (DP) development; however packaging is extremely important in determining the marketability of a product. The ability to predict whether a product can be stored at room temperature early in development can affect how the drug is developed. In order...

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...

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...

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...

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