Patent ID: 6663897
Filing Date: 2003-12-16
Classification: A61K,A61P

Abstract:
A method of manufacturing an itraconazole oral dosage form that is substantially free of residual methylene chloride, said method comprising the steps of:providing a working solution consisting essentially of an alcohol, a strong acid, itraconazole, a water-soluble polymer, and water, with said itraconazole and said strong acid present in said working solution in a ratio of 1 Mole itraconazole to from 1 to 3 Moles strong acid, and with said strong acid selected from the group consisting of inorganic acids and organic sulphonic acids; providing particles formed from a pharmaceutically acceptable core material; combining said working solution with said particles to produce itraconazole-coated particles; drying said itraconazole-coated particles; and forming said dried itraconazole-coated particles into an itraconazole oral dosage form that is substantially free of residual methylene chloride.