abstract |
A process for the manufacture of free-flowing uniformly sized microspheres for the sustained release of therapeutically active ingredient comprising: a) preparing a first dispersed phase comprising a therapeutically active ingredient, a biodegradable polymer and an organic solvent; b) mixing the first dispersed phase with a aqueous phase to form an emulsion; c) spraying the emulsion into a vessel (20) equipped with organic solvent removal means; d) passing the suspension of microspheres through screens and collecting a fractionated size of the microspheres on the surface of the screens; e) drying the microspheres wherein steps a to e are carried out without manual intervention, in equipment connected in series, substantially unexposed to the environment; |