Pharmaceutical Engineering & Drug Delivery

As the momentum for implementation of Quality by Design progresses in the pharmaceutical industry, more tools are being implemented to create better understanding of process parameters and their impact on critical quality attributes. Utilizing models and statistics have become a key instrument in...

The manufacture of pharmaceutical drug products has benefited significantly from a QbD approach, including the enabling of continuous production over batch processing. Developing and improving processes for continuous manufacture requires the combined use of process data with process and...

The key components of the QbD concept, namely, the Design Space and PAT, do draw extensively for their realization on tools from the domain of process systems engineering methodology. Both the challenges and the opportunities in adapting core PSE methodology, such as process modeling and simulation...

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...

Out of all the pharmaceutical dosage forms, the Quality Target Product Profile (QTPP) for the sterile dosage form is the strictest for obvious reasons. One has to pay attention to the critical quality attributes (CQA) to a great extent. This presentation is focused only on the packaging of sterile...

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...

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...

Drug dose response experiments in animals provide invaluable information about the pharmacokinetics and pharmacodynamics of new therapeutic agents. The drug response curves in various organs such as the liver, heart or brain hold quantitative information to ascertain the laws of drug fate in the...

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...

Drug-loaded thin films are a novel pharmaceutical administration form that is creating an increasing interest in the pharmaceutical industry due to its versatility of application and the feasibility of continuous manufacture. However, accomplishing this in industrial scale requires addressing the...