Pharmaceutical Engineering & Drug Delivery

One of the contributing factors in determining targets for the particle size of an API can be the content uniformity of the dosage forms. This work presents a framework established with a model-based specification for particle size of the API that can be used in a bi-directional mode to: a)...

Since the launch of the Office of New Drug Quality Assessment (ONDQA) CMC pilot program in July 2005, over 40 Quality by Design (QbD) containing applications have been submitted, reviewed, and approved by ONDQA, both within and outside of the pilot. Although challenges still remain, many approaches...

A combination of analytical and statistical methods is used to improve a tablet coating process guided by quality by design principles. A solid dosage form product was found to intermittently exhibit bad taste. A suspected cause was the variability in coating thickness which could lead to the...

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...

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...

Purpose: To provide stepwise guidance for lubrication of pharmaceutical powders through the development of a unifying model which captures lubrication effects during blending and compression. Methods: Literature models of powder properties following lubrication blending over a range of scales and...

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...

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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...

Abstract Science-Based Stability and Packaging Development Under The Umbrella of QbD Rey T Chern Global Pharmaceutical Commercialization Merck Sharp & Dohme A systematic approach for characterization of product stability risks, selection of primary packages and utilization of first-principle...