EP0593552A1 — Process for preparing drug substances in beadlet form.

USPTO Abstract

Drug substances in beadlet form are prepared with high bulk density spray-coating onto inert core particles, using coater-granulator apparatus, comprising: forming a fluidised bed of particles of inert core material within the processing chamber of a coater-granulator apparatus by passing a gaseous current between the rotating disc and the inner wall of the processing chamber; and forming beadlets by layering a drug onto the particles of the core material by spray-coating with a solution of the drug; characterised in that during beadlet formation, the spray-coated particles are (i) transferred to a drying zone surrounding the processing chamber, (ii) carried through the drying zone by a gaseous current, and (iii) returned to the processing chamber; the recirculation process being continued until beadlets having the desired drug load are formed.