A - Human Necessities – 61 – K
Patent
A - Human Necessities
61
K
A61K 31/502 (2006.01) A61K 9/08 (2006.01) A61K 31/50 (2006.01) A61P 9/08 (2006.01)
Patent
CA 2490826
The present invention relates to stable and highly purified stable hydralazine hydrochloride compositions and stable hydralazine-containing pharmaceutical compositions. A sterile aqueous injectable pharmaceutical composition suitable for parenteral administration is described comprising a therapeutically effective dose of hydralazine hydrochloride in a pharmaceutically acceptable carrier or diluent wherein said hydralazine hydrochloride is essentially free of phthalazines, hydrazine and metal ions. In addition, a stable sterile aqueous pharmaceutical composition comprising hydralazine hydrochloride in a pharmaceutically acceptable salt or diluent is described that is colorless and has no visible particulate matter.
L'invention concerne des compositions pharmaceutiques stables et hautement purifiées de chlorhydrate d'hydralazine et des compositions pharmaceutiques stables contenant de l'hydralazine. Est décrite une composition pharmaceutique stérile aqueuse injectable adaptée à l'administration parentérale, comprenant une dose thérapeutiquement efficace de chlorhydrate d'hydralazine dans un support ou un diluant pharmaceutiquement acceptable, dans lequel ledit chlorhydrate d'hydralazine est essentiellement exempt de phthalazines, d'hydrazine et d'ions métalliques. Est décrite également une composition pharmaceutique aqueuse stable et stérile contenant de le chlorhydrate d'hydralazine dans un sel ou un diluant pharmaceutiquement acceptable qui est incolore et ne contient pas de matière particulaire visible.
Barbeau Donald L.
Nelson Deanna J.
Barbeau Pharma Inc.
Bioniche Teoranta
Ridout & Maybee Llp
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