Pharmaceutically active particles of a monomodal particle size distribution and method

摘要

A method of obtaining improved reproducibility of dissolution profiles of dosage forms containing pharmaceutically active particles includes steps of screening raw pharmaceutically active particles to obtain or isolate particles having a desired monomodal particle size distribution. The particles having a monomodal particle size distribution may be incorporated into a solid oral dosage form to provide a highly reproducible dissolution profile. Two or more collections or particles having different monomodal particle size distributions may be combined and incorporated into solid oral dosage forms to provide predictable dissolution profiles.