Abstract
A radial basket-type extruder and a serrated plate spheronizer were used to prepare spherical pellets containing approx. 80% active drug. A response surface experimental design was employed to address the effects of altering microcrystalline cellulose concentration, water concentration, spheronizer speed and spheronizing time on pelletization of this low density drug. Response surfaces were adequately described by quadratic equations which contained significant interaction terms for two of three measured product characteristics. Optimum ingredient concentrations and process conditions were selected from the response surface equations. Product subsequently manufactured under these optimum conditions met expectations. This results in a well-characterized, reproducible process for manufacturing smooth pellets with adequate potency to provide a 500 mg dose in a ‘0’ elongated capsule.
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