A - Human Necessities – 61 – K
Patent
A - Human Necessities
61
K
A61K 31/495 (2006.01) A61K 9/08 (2006.01) A61K 47/02 (2006.01)
Patent
CA 2420556
The invention relates to infusions of 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo- 7-(1-piperazinyl)-quinoline-3-carboxylic acid (ciprofloxacin) which are stable in storage and which can be obtained by mixing between 0.015 and 0.5 g of active ingredient for 100 ml of aqueous solution with sulphuric acid or sodium hydrogen sulfate in a quantity equal to or less than 0.96 mole per mole of active ingredient, sufficient for dissolving the active ingredient and stabilising the solution. The invention also relates to methods for producing the infusions and the use thereof. The inventive infusions enable the acid content to be reduced, are more stable in storage with the same acid content than other known solutions, and enable a larger proportion of secondary components to be tolerated in the active ingredient than previous standard infusions of ciprofloxacins.
L'invention concerne des solutions stables au stockage, pour perfusion d'acide 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-pip~razinyl)-quinoline-3-carboxylique (ciprofloxacine), qui s'obtiennent par m~lange de 0,015 ~ 0,5 g de principe actif pour 100 ml de solution aqueuse avec de l'acide sulfurique ou de l'hydrog~nosulfate de sodium dans des proportions inf~rieures ou ~gales ~ 0,96 mole par mole de principe actif, suffisamment ~lev~es pour provoquer la dissolution du principe actif et pour stabiliser la solution. L'invention concerne ~galement des proc~d~s servant ~ produire ces solutions pour perfusion de ciprofloxacine ainsi que l'utilisation de ces dernires. Ces solutions pour perfusion permettent de r~duire la teneur en acide, pr~sentent, pour une mÚme teneur en acide, une meilleure stabilit~ au stockage que les autres solutions connus et permettent la tol~rance d'une proportion plus importante de composants secondaires dans le principe actif que les solutions pour perfusion de ciprofloxacine utilis~es jusqu'~ pr~sent.
Eschenbach Bernd
Hniopek Tilo
Muller Hans-Jorg
Sommermeyer Klaus
Fetherstonhaugh & Co.
Fresenius Kabi Deutschland Gmbh
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