Oral itraconazole formulations and methods of making the same

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United States of America Patent

PATENT NO 6663897
APP PUB NO 20020150620A1
SERIAL NO

09933032

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ATTORNEY / AGENT: (SPONSORED)

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Abstract

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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.

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Patent Owner(s)

Patent OwnerAddress
STIEFEL LABORATORIES INC251 LITTLE FALLS DRIVE WILMINGTON DE 19808

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Inventor(s)

Inventor Name Address # of filed Patents Total Citations
Kerr, John Elgin Winterville, NC 2 1
Namburi, Ranga Raju Greenville, NC 2 1

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