Abstract
Spherical crystallization enables the direct preparation of crystal agglomerates of active pharmaceutical ingredients (APIs) with improved crystal handling properties. The continuous spherical crystallization of albuterol sulfate as a model API was developed using a mixed-suspension, mixed-product removal (MSMPR) crystallizer. The application of a solvent recycling system for reuse of the antisolvent in the single-stage MSMPR crystallizer was also demonstrated. Spherical agglomerates of albuterol sulfate were obtained via antisolvent crystallization using the MSMPR crystallizer with water as the solvent and an ethyl acetate/emulsifier (Pluronic L-121) mixture as the antisolvent. Steady-state continuous spherical crystallization was rapidly achieved after 30 min, and a yield of >95% was obtained. The influence of process parameters such as the solvent/antisolvent ratio, emulsifier concentration, residence time, and reactor scale on the properties of the agglomerates formed during the crystallization proces...
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