Premixed amiodarone parenteral solution and method for...

A - Human Necessities – 61 – K

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A61K 31/343 (2006.01) A61K 47/02 (2006.01) A61K 47/26 (2006.01) A61P 9/06 (2006.01)

Patent

CA 2442365

A premix parenteral solution for intravenous administration having amiodarone, as an active ingredient, solubilized in a solution of water for injection and about 0.4 - 12 mg/ml of a non-ionic surfactant to a concentration range of from 0.2 to 6 mg/ml is disclosed. The solution optionally may include an osmotic agent. No dilution of the solution is required before administering to a patient and the sterile packaged solution has an initial pH within the range of from about 2.9 to about 3.2, preferably about 3.1. Additionally, a method for producing an amiodarone solution suitable for intravenous administration is further disclosed.

L'invention concerne une solution parentérale prémélangée destinée à être administrée par voie intraveineuse, contenant de l'amiodarone en tant que principe actif, solubilisée dans une solution d'eau destinée à être injectée, et environ 0,4 à 12 mg/ml d'un tensioactif non-ionique en concentration variant de 0,2 à 6 mg/ml. La solution peut éventuellement contenir un agent osmotique. Aucune dilution de la solution n'est nécessaire avant l'administration à un patient et la solution conditionnée de manière stérile possède un pH initial compris entre 2,9 et environ 3,2, de préférence de 3,1. Par ailleurs, un procédé de production d'une solution d'amiodarone convenant à l'administration intra-veineuse est décrite.

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