77c Minimizing Particle Agglomeration during Agitated Drying

William Bartels, Jose E. Tabora, John Wasylyk, Jessica Defreese, and Prashant Deshpande. Bristol-Myers Squibb Company, One Squibb Drive, New Brunswick, NJ 08903

Drying of pharmaceutical intermediates and APIs in agitated filter dryers can be challenging due to crystal agglomeration during continuous agitation. Pilot scale production of a pharmaceutical intermediate was studied to evaluate the effect of drying conditions on the degree of crystal agglomeration present in the dried product. In addition to standard dryer operational parameters, the drying progress was monitored using mass spectrometry to analyze the composition of the vent gasses. Measured powder properties of the finished product included: bulk/tap density, agglomeration via sieve cut analysis, agglomerate hardness, particle size distribution, BET surface area, and optical microscopy. This presentation will detail the process and analytical data collected during pilot scale processing and highlight key operational parameters which appear to influence crystal agglomeration during agitated vacuum drying. Optimization of drying parameters to minimize agglomeration will also be discussed. Potential effects from upstream processing such as crystallization and filtration conditions were also considered and will be addressed.