abstract |
A process for manufacturing a powdered preparation of a biologically active compound of (sub) micron size chosen from the group consisting of Saquinavir, Orlistat, Isotretionoin, Sulfamethoxazole, Diazepam, Moclobemide and Bosentan, comprising the steps of: (1) dissolving said biologically active compound under high pressure in compressed dimethyl ether containing a surface modifier chosen from the group consisting of polyethylene glycol ether of lauryl, -cetyl-stearyl and oleyl alcohols or sodium di-isooctyl sulphosuccinate; (2a) rapidly expand the compressed solution of the aso (1) thus precipitating the dissolved compound; or (2b) spraying the compressed solution of step (1) to form an antisolvent chosen from compressed carbon dioxide or water optionally containing a surface modifier chosen from the group consisting of a polyethylene glycol ether of lauryl, -acetyl,-stearyl and ¿ oleyl alcohols or sodium di-isooctyl sulphosuccinate, under vacuum, atmospheric pressure or elevated pressure; (3) optionally converting the anti-solvent phase of step (2b) into a powder preparation using conventional process technique powder. |