(343a) Improving the Robustness of a Pharmaceutical Crystallization Process

Improving the Robustness of a Pharmaceutical Crystallization Process

Alexander Marchut, Fred Nordstrom, Ketan Patel, and Lakshmi Bhagavatula

Process Research and Development (Process Engineering, Solid State Chemistry, and Process Chemistry), Manufacturing Science and Technology

Abbvie

1401 Sheridan Road

North Chicago, IL 60064

Crystallization is often a key component of any pharmaceutical process – the desired active ingredient or intermediate is separated from the solution phase into a solid phase with the desire that impurities remain in the solution phase and the resulting solid particles have reproducible physical properties such as solid form, crystal habit, and particle size.  Pharmaceutical crystallization processes must be robust so that the resulting solid phase properties are reproducible and independent of scale.  We employed Quality by Design techniques to improve a pharmaceutical crystallization resulting in a more reproducible process with a broad design space. Our changes to the process were subject to certain regulatory constraints which will be discussed.