Pellet comprising itraconazole, method for its preparation and pharmaceutical dosage form comprising thereof

摘要

A pellet comprises (a) a central, rounded or spherical core, (b) a coating film of a water-soluble polymer and itraconazole and (c) a seal-coating polymer layer, whereby the core has a diameter from 250 to 355 um. A method for the preparation of these pellets, by which a) coating 250 to 355 um sugar spheres by spraying onto them with a solution of itraconazole and a water-soluble polymer in an organic solvent consisting of methylene chloride and ethanol in a fluidized-bed granulator equipped with a Wurster bottom spray insert, b) drying the resulting coated cores and c) seal-coating the dried cores by spraying onto them with a solution of a seal-coating polymer in an organic solvent consisting of methylene chloride and ethanol in a fluidized-bed granulator equipped with a Wurster bottom spray insert. A pharmaceutical dosage form comprising an effective antifungal amount of these pellets is described.