Patent / 2015
A process for control of particle size distribution of active pharmaceutical ingredients
A new scalable process to control the particle size and the particle size distribution in active pharmaceutical ingredients (API), comprises 5 steps: (i) a suspension prepn. in a mixt. of solvents in which the API and/or excipient is partially sol. in one of the solvents; (ii) particle size redn. of the suspension; (iii) aging; (iv)stopping the aging by solvent removal; and (v) optionally, a step of isolating the processed ingredients in the form of powder.