Oral itraconazole formulations and methods of making the same
US6663897B2 · kind B2 · utility
Assignee
Inventors
Key dates
| Filing date | Aug 20, 2001 |
| Grant date | Dec 16, 2003 |
| Priority date | — |
| Expiry date | Aug 20, 2021 |
Classification
- Technology area (CPC A)Human Necessities
- CPC primaryA61P31/10
- WIPO fieldPharmaceuticals
- WIPO sectorChemistry
Abstract
A method of manufacturing an itraconazole oral dosage form that is substantially free of residual methylene chloride comprises the steps of: (a) providing a working solution comprising an alcohol, a strong acid (preferably an inorganic acid or organic sulphonic acid), itraconazole, a water-soluble polymer, and water, with the itraconazole and the strong acid preferably present in the working solution in a ratio of 1 Mole itraconazole to 1-3 Moles acid; (b) providing particles formed from a pharmaceutically acceptable core material; (c) combining the working solution with the particles to produce itraconazole-coated particles; (d) drying the itraconazole-coated particles; and (e) forming the dried itraconazole-coated particles into an itraconazole oral dosage form that is substantially free of residual methylene chloride. The products of such methods and methods of use thereof are also disclosed.
Source: USPTO / EPO open patent data. Objective bibliographic and citation counts.