Crystallization of pharmaceutical ingredients, especially those that possess several polymorphic forms, particle size, and morphology critical properties, are among the most serious and least understood manufacturing procedures.
Many processes and product failures can be traced to a poor understanding or lack of control of crystallization procedures. Clearly, the pharmaceutical industry requires more competitive and robust process by knowledge of molecular complexity and solid form challenges, due to the impact of material properties for production efficiency related to the solid implication on drug product formulation.
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In-process techniques in development scale were used to reach the desired active ingredient requirements, and then define a suitable tool to control Critical Quality Attributes. The techniques used also reduced process cycle time.
In the examples described,the crystallization and engineering processes were performed at lab scale by measuring Metastable Zone Width (MSZW), using a reactor calorimeter with a particle size analyzer.
A variety of in situ analytical methods applied, combined with chemometric tools for the analysis of multivariate process information, provided a basis for the improvement in modelling, simulation, and control of crystallization procedures.
Online recorded data together with chemical properties parameters (purity, polymorphic form, crystallinity, hygroscopicity, morphology) assessed by offline controlling techniques, were the starting points for intended processes for high quality products.