METHODS FOR WET GRANULATING AZITHROMYCIN

The present invention relates to a method of forming non-dihydrate azithromycin granules, comprising mixing non-dihydrate azithromycin particles, with a granulating amount of a granulating liquid, and, optionally, with one or more excipients, to form wet granules which comprise non-dihydrate azithro...

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Hauptverfasser: JOHNSON, BARBARA ALICE, FERGIONE, MICHAEL B
Format: Patent
Sprache:eng ; fre ; ger
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Beschreibung
Zusammenfassung:The present invention relates to a method of forming non-dihydrate azithromycin granules, comprising mixing non-dihydrate azithromycin particles, with a granulating amount of a granulating liquid, and, optionally, with one or more excipients, to form wet granules which comprise non-dihydrate azithromycin and the granulating liquid. The granules are then dried to remove the granulating liquid. The invention further relates to a pharmaceutical composition comprising granules of a non-dihydrate azithromycin and at least one pharmaceutically acceptable excipient. The invention also relates to pharmaceutical formulations comprising granules of non-dihydrate azithromycin. The invention further relates to granules of dihydrate azithromycin wherein the granules comprises 98-100% dihydrate azithromycin and from about 0-2%, total weight, of one or more pharmaceutically acceptable excipients.