Title:
ORAL ITRACONAZOLE FORMULATIONS AND METHODS OF MAKING THE SAME
Document Type and Number:
WIPO Patent Application WO2002062318
Kind Code:
A3
Abstract:
A method of manufacturing an itraconazole oral dosage from 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.
Inventors:
NAMBURI RANGA RAJU (US)
KERR JOHN ELGIN (US)
KERR JOHN ELGIN (US)
Application Number:
PCT/NL2002/000080
Publication Date:
November 21, 2002
Filing Date:
February 01, 2002
Export Citation:
Assignee:
DSM NV (NL)
NAMBURI RANGA RAJU (US)
KERR JOHN ELGIN (US)
NAMBURI RANGA RAJU (US)
KERR JOHN ELGIN (US)
International Classes:
A61K9/16; A61K9/20; A61K9/48; A61K31/496; A61K47/02; A61K47/04; A61K47/10; A61K47/20; A61K47/32; A61K47/36; A61K47/38; A61K47/42; A61P31/10; (IPC1-7): A61K9/16; A61K31/496
Domestic Patent References:
| WO2000003697A1 | 2000-01-27 | |||
| WO1998000116A1 | 1998-01-08 |
Foreign References:
| US6039981A | 2000-03-21 |
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