(536c) Tailoring Desired Powder Properties in Pharmaceutical Development By Crystal Engineering

In order to deliver pharmaceutical materials with powder properties suitable for formulation development, specific solid characteristics (among many evaluated) are determined to be critical for the improvement of process robustness in drug product processing.  A model compound with a challenging crystal habit for solid dosage formulation is evaluated by multiple crystal engineering approaches to alter its physical properties.  A number of material design opportunities were identified to promote the desired powder characteristics during the manufacturing process, including synthesis, crystallization, isolation, as well as post-isolation processing steps.  In this study, the primary approach to enhance powder properties is driven by varying crystal shape and/or particle morphology of the subject material.  Both crystal and particle morphologies can be tailored in (a) crystallization with optimized operating parameters to guide the size and morphology evolution, in (b) crystallization by an alternative means to facilitate controlled assembly formation, and in (c) direct powder processing to impact material properties.  The various crystal engineering techniques encompassed in this study allow target powder properties to be met at different development stages while accommodating frequent process changes.  The design strategy and the results from the applied crystal engineering techniques will be presented.