Control strategy definition for a drug product continuous wet granulation process: Industrial case study.

This paper describes the specific control strategy of the commercial manufacturing process of an immediate release tablet formulation based on continuous twin-screw wet granulation. This control strategy has been defined by a multidisciplinary team using an enhanced approach, in alignment with the quality by design principles. During process development, experiments have been performed according to multivariate designs first to identify critical material attributes and critical process parameters and then, to define process conditions generating a product having the required quality.

Method optimization for drug impurity profiling in supercritical fluid chromatography: Application to a pharmaceutical mixture.

A supercritical chromatographic method for the separation of a drug and its impurities has been developed and optimized applying an experimental design approach and chromatogram simulations. Stationary phase screening was followed by optimization of the modifier and injection solvent composition. A design-of-experiment (DoE) approach was then used to optimize column temperature, back-pressure and the gradient slope simultaneously.

Relevant bounds on hierarchical levels in the description of mechanisms.

Mechanisms pervade the sciences, and a significant portion of scientific research is concerned with their discovery and description. This paper is concerned with the latter, categorizing the components that should be included in the description of a mechanism. In describing mechanisms, the question of relevant level of description often arises; the question is where, if anywhere, one should halt a reductionist approach.