(32c) Crystallization and Milling Development Enabling A High Drug Load Formulation

Dry milling of an Active Pharmaceutical Ingredient (API) provides a reliable means for particle size reduction.  However, dry milling can present a challenge for containment of highly potent or toxic drug substances and can also can result in the generation of a large number of fines which may lead to undesirable processing behavior.  Slurry milling alleviates many of the containment issues associated with particle size reduction.  When combined with controlled crystallization strategies, precise particle size control and favorable processing attributes can be obtained.