ITRACONAZOLE GRANULATIONS: PHARMACEUTICAL FORMULATIONS FOR ORAL ADMINISTRATION AND METHOD OF PREPARING SAME

摘要

The present invention relates to a fast-dissolving oral formulation comprising an itraconazole and a pH-independent hydrophilic polymer preparation and the following non-active excipients: a filler and/or binder, a disintegrating agent and a lubricant. The present invention also relates to a method of preparing these formulations comprising co-dissolving itraconazole and a pH-independent hydrophilic polymer in an appropriate solvent system, producing a solution; loading a first set of excipients into a fluidized bed spray granulator, forming a powder; and spraying the solution onto the powder forming a granulation.