Orel Mizrahi, Teva & Ariel University: "Control of Crystallization PSD usin...

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Orel Mizrahi, Teva & Ariel University: "Control of Crystallization PSD using DynoChem Simulation"

All over the world in the pharmaceutical industry, tons of active pharmaceutical ingredients (API) are disqualified for use due to Particle Size Distribution (PSD) that does not fit specifications. Today process development technology provides solutions for this problem. The most advanced approach in this field is the use of simulation software.

In this research a predictive model for final crystallization of Rasagiline mesylate was built with the aim to control particle size distribution (PSD). From experiments performed to characterize the process SMOM and QMOM models were built. The QMOM model accounted for size dependent growth and showed good fit between experimental data and calculated results for the PSD and for the solute concentration during the crystallization. The model predicts accurately the PSD span and its statistical parameters. A series of additional experiments were performed to test the sensitivity of the model to changes of the main parameters (supersaturation, seed ratio and cooling profile). It was found that the model accurately predicts the PSD under different experimental conditions.

The webinar will start at 16.30 Central Europe, 15.30 London/Dublin, 10.30 US Eastern, 09.30 US Central, 07.30 US Pacific.

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