(187f) Designing a Fit-for-Purpose Agglomeration Method for Pharmaceutical Crystals

Chenchi Wang, Daniel Hsieh, Mario Hubert, Chiajen Lai.

Research and Development, Bristol-Myers Squibb Company, New Brunswick, New Jersey

In pharmaceutical development various particle engineering techniques are commonly employed to alter crystal morphology, improve crystal size, or increase purity of the active pharmaceutical ingredient (API).  Crystal agglomeration is an alternative method to improve slurry and powder properties, especially for materials with a crystal habit or size that is difficult to change by classical crystallization techniques.  In a crystal agglomeration process, the primary crystals can be directed to form agglomerates in a multi-solvent system.  The formation of agglomerates can significantly improve slurry filterability or bulk powder properties compared to the primary crystals.  A “fit-for-purpose” method will be presented that can be used to identify suitable conditions to encourage crystal agglomeration.  Multiple case studies will be presented in detail to demonstrate how specific slurry or powder properties can be attained through the crystal agglomeration approach.