Session 2: Physical Property Based Crystallization Process Development

Moderator: Dr. Jian Wang (J-Star)

The Crystallisation Structural Pathway of Para Amino Benzoic acid: From Solvated Molecule through Solute Clustering and Nucleation to the Growth of Facetted Crystals

In solution phase crystallisation processes, understanding and controlling the transition pathway associated with the assembly of molecules from their solvated state, into three-dimensional, ordered crystalline-solids, represents a significant grand challenge for the physical-chemical sciences. Crystallisation can be sub-divided into three-dimensional nucleation and two-dimensional, surface-mediated, crystal growth stages.

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Facilitating DS/DP development through integrated solid-state and crystallization development

Crystallization is an important and economic unit operation for the purification of pharmaceutical API. It also serves as the key step to define the required quality attribute of the API (e.g. solid form, particle size distribution) that would impact the subsequent processing (e.g. filtration, drying, milling) and drug product performance (e.g. dissolution, content uniformity). To successfully bring a compound into the market, an integrated approach to link the development of API solid form, isolation and dosage form is essential to ensure the robust delivery of the desired drug product quality, throughout the scale.

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A Challenging Path to Controlled Nano-API Crystallization and Isolation

Controlled crystallization of an API in submicron size was enabled based on an accurate solubility profile and a growth inhibition property via semi-continuous processing, to meet special formulation requirements. This process was also challenged by isolation of nano-API crystals to meet the low specification of residual salt content.

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