Determine Crystal Growth Kinetic Parameters From Experimental Data
Estimate Parameters For Salting Out Crystallization
Predictive modeling is increasingly utilized to gain better understanding of processes and reduce the number of experiments required for process development, optimization and understanding. In the pharmaceutical industry, modeling is typically utilized in late stage projects to provide additional data for Quality-by-Design (QbD) and for design space verification and confirmation. All models require the knowledge of appropriate kinetic parameters which are typically acquired from experiments. PAT tools are well suited to generate a wealth of data that can be used to estimate crystal growth kinetic parameters to be utilized in predictive models.
In this study, two approaches are presented to extract crystal growth kinetic parameters. The methods are applied to a salting out crystallization that affords elongated, columnar crystals. Two parameter estimation approaches are utilized:
- A GlaxoSmithKline-developed algorithm that returns growth parameters in two growth directions
- A parameter-estimation routine developed by Scale-up systems Ltd. in collaboration with GlaxoSmithKline
The two approaches provided similar growth kinetic parameters that were utilized to perform simulations to predict process behavior under different process conditions.
Lotfi Derdour of GlaxoSmithKline discusses how to determine crystal growth kinetic parameters (and breakage descriptors) from experimental data. The two models used to determine crystallization growth kinetic parameters are the GlaxoSmithKline Matlab-based and Dynochem models. The effects of process parameters on supersaturation profiles are studied, including the rate of addition of counter ion, the concentration of counter ion, and the agitation speed. In this presentation, the methods are applied to determine experimental salt concentration.
This webinar presents practical examples and case studies in crystallization kinetics from the pharmaceutical industry.
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About the Presenter
Lotfi Derdour Ph.D
Associate Fellow, GlaxoSmithKline
Lotfi Derdour completed his Bachelor's in Chemical Engineering as the top student in his class and earned his my Master's in Industrial Chemistry with an industrial placement at "Institut Français du Pétrole". Lotfi's Master's research work focused on determining kinetics of size variable catalyst supports during drying. Lotfi's Doctoral work focused on developing a semi-theoretical model to predict drying kinetics. After completing his PhD, he followed up with a Post Doctoral tenure in crystallization development under the direction of Prof. Gilles Févotte. His Post Doc was one of the pioneering studies on in situ infrared spectroscopy to monitor and control crystallization processes. Lotfi then joined Apotex Pharmachem as a Process Development Engineer, where he worked in the development of manufacturing processes for Active Pharmaceutical Ingredients (APIs). He later joined AstraZeneca and Bristol-Myers Squibb as a Crystallization Scientist. Lotfi is now with GlaxoSmithKline as an Associate Fellow with a focus on finishing technologies (Crystallization/Filtration/Drying). He also contributes as a technical consultant in Engineering and Particle Sciences. Lotfi has published 14 original research articles in crystallization and drying, 12 as first author and 9 as corresponding author. He also authored 5 patents in crystallization, 2 as sole inventor.
Who Should View This Webinar?
Chemists and Chemical Engineers interested in crystallization process design, including crystal growth kinetic parameters, in the Pharmaceutical, Chemical, and Consumer Products Industries as well as in Academia.
