PREPARATION OF A PHARMACEUTICALLY ACTIVE INGREDIENT COMPRISING A DESOLVENTISING STEP

摘要

The invention relates to a method for desolventising a contaminated solid particulate composition containing: - at least 10 wt.% of a solid pharmaceutically active ingredient or of a solid intermediate product of the manufacture of a pharmaceutically active ingredient; - not more than 70 wt.% of contaminating solvent; and - optionally, up to 89 wt.% of inert carrier; said method comprising the steps of: a) contacting the contaminated solid particulate composition with a liquefied gas; b) allowing the contaminating solvent to become entrained in the liquefied gas; c) separating liquefied gas containing entrained contaminating solvent from the residual solid particulate composition; and d) removing liquefied gas from the residual solid particulate composition through evaporation; wherein all of the aforementioned steps are performed at a temperature below 100 ºC and below the critical temperature of the liquefied gas, and wherein steps a) to c) are performed at a pressure of at least 5 bar. Although the present method employs mild processing conditions, it enables essentially complete solvent removal.