A - Human Necessities – 61 – K
Patent
A - Human Necessities
61
K
A61K 9/16 (2006.01) A61K 31/7048 (2006.01) A61K 31/7052 (2006.01)
Patent
CA 2470055
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 particles of 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 azitrhromycin wherein the granules comprises 98% or more dihydrate azithromycin and from about 2% to 0%, total weight, of one or more pharmaceutically acceptable excipients.
L'invention concerne un procédé permettant de former des granules d'azithromycine non-dihydrate et consistant à mélanger des particules d'azithromycine non-dihydrate avec une quantité de granulation d'un liquide de granulation et éventuellement avec des particules d'un ou de plusieurs excipients, de manière à former des granules humides renfermant une azithromycine non-dihydrate et le liquide de granulation. Les granules sont ensuite séchées aux fins d'élimination du liquide de granulation. L'invention concerne également une composition pharmaceutique renfermant des granules d'une azithromycine non-dihydrate et au moins un excipient acceptable sur le plan pharmaceutique ; ainsi que des formulations pharmaceutiques comprenant des granules d'azithromycine non-dihydrate. L'invention concerne enfin des granules d'azithromycine non-dihydrate comprenant au moins 98 % d'azithromycine non-dihydrate et entre environ 2 % et 0 %, en poids total, d'au moins un excipient acceptable sur le plan pharmaceutique.
Fergione Michael Bruce
Johnson Barbara Alice
Pfizer Products Inc.
Smart & Biggar
LandOfFree
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