SOLID MIXTURES OF CYCLODEXTRINS PREPARED VIA MELT-EXTRUSION

摘要

1. Process for preparing a solid mixture comprising one or more cyclodextrins and one or more active ingredients wherein said process encompasses a melt-extrusion step, comprising the following substeps: a) mixing one or more cyclodextrins with one or more active ingredients, and b) optionally mixing additives; c) heating the thus obtained mixture until melting of one of the components; d) forcing the thus obtained mixture through one or more nozzles; e) cooling the mixture till it solidifies. 2. A process according to claim 1 which is performed on a twin-screw extruder. 3. A process according to claim 1 or claim 2 wherein the active ingredient is insoluble. 4. A process according to any one of claims 1 to 3 wherein the melt extrudate is milled to a powdered form. 5. A solid mixture comprising one or more cyclodextrins and one or more active ingredients obtainable by the process according to claim 1 wherein the active ingredient is embedded into the cyclodextrin. 6. A solid mixture according to claim 5 that is in amorphous form or in the form of a solid solution. 7. A solid mixture according to claim 5 cyclodextrin is hydroxypropyl-.beta.-cyclodextrin or dimethyl-.beta.-cyclodextrin. 8. A solid mixture according to claim 5 wherein the active ingredient is itraconazole. 9. A pharmaceutical composition comprising a therapeutically effective amount of melt extrudate produced according to claim 1 and other excipients. 10. A pharmaceutical composition comprising a therapeutically effective amount of mlled melt extrudate produced according to claim 4 and other excipients.