Pharmaceutical Engineering & Drug Delivery

To control the size and shape of crystals during batch crystallization, one must either have an accurate crystal growth and nucleation model or run a series of experiments to find the optimal operating conditions. Since the former is a very intricate and time-consuming task, especially for new...

The present communication describes a systematic methodology for the quantification of the Design Space characteristics of batch pharmaceutical process. The methodology is applicable to processes which are not known in great detail for a mathematical model to be available. The approach designs a...

A feed-forward process control strategy which can compensate for the effect of raw material lot-to-lot variability on final tablet attributes in pharmaceutical tablet development is presented. The approach involves building PLS (partial least squares) models that combine raw material attributes and...

Quality by design is an exercise that relies on quantitative metrics of the quality of a product. For immediate release (IR) film coated products, the uniformity of the coat is traditionally assessed by visual inspection. It is desired to substitute such assessment with a quantitative one. In this...

The same QbD Principles applied to the design of manufacturing processes are applicable to the design of analytical methodology. QbD elements such as understanding the science behind the methods, and improving method reliability by identifying and controlling sources of variability are key. This...

Quality by Design (QbD) is a science and risk based approach for pharmaceutical process development and manufacturing that begins with first defining clinically relevant product attributes and then designing and implementing a process to consistently deliver quality product. Some key aspects of QbD...

QbD is now commonly used in the development of many pharmaceuticals and fine chemicals and include a number of risk management tools. Risk assessments are routinely used within Pfizer during product development and continuous improvement to identify areas where further process understanding is...

A framework using wavelet decomposition coupled with multivariate latent variable methods is proposed to quantitatively characterize the texture appearance of pharmaceutical materials and products. This framework allows having a non-biased measure of the visual characteristic of solid materials...

The regulatory quality guidances (Q8 – Q10) have set the expectation to develop pharmaceutical products based on a comprehensive quality by design approach. These expectations have permeated our industry as the new gold standard. Pharmaceutical development and commercialization programs are now...