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AssigneeWockhardt Limited
InventorsDilip G. Saoji, Rajendra N. Nagori, Ravindra D. Yeole, Nitin Shetty, Milind C. Shukla, Noel J. de Souza
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The present invention relates to a pharmaceutical composition in aqueous solution form useful for parenteral application to a subject for treatment or prevention of infective disease. In particular the present invention relates to such a composition having as an active agent S-(−)-9-fluoro-6,7-dihydro-8-(4-hydroxypiperidin-1-yl)-5-methyl-1-oxo-1H,5H-benzo[i,j]quinolizine-2-carboxylic acid, S-(−)-9-fluoro-6,7-dihydro-8-(4-hydroxypiperidin-1-yl)-5-methyl-1-oxo-1H,5H-benzo[i,j]quinolizine-2-carboxylic acid 0.2 hydrate or S-(−)-9-fluoro-6,7-dihydro-8-(4-hydroxypiperidin-1-yl)-5-methyl-1-oxo-1H,5H-benzo[i,j]quinolizine-2-carboxylic acid arginine salt or a benzoquinolizine-2-carboxylic acid antibiotic drug. The field of the invention also includes processes for the preparation of such a composition, the use of such a composition in preparation of a medicament, and to the therapeutic or prophylactic use of such a composition.
A pharmaceutical composition for therapeutic or prophylactic administration to a subject having an infective disease or at risk for contracting an infective disease, the composition comprising an aqueous carrier having in solution therein (a) a benzoquinolizine-2-carboxylic acid antimicrobial drug or salt, polymorphic form, enantiomeric form, other isomeric or racemic form thereof in a therapeutically or prophylactically effective drug concentration that is above the practical limit of solubility of the drug in a substantially isotonic aqueous solution at a physiologically compatible pH, and (b) a pharmaceutically acceptable solubilising agent selected from a basic amino-acid, a cyclodextrin, a cyclodextrin polymer or derivative theref or a mixture thereof in a concentration sufficient to maintain the drug in solution at drug concentration that is above the practical limit of solubility of the drug in a substantially isotonic aqueous solution at a physiologically compatible pH.
Dependencies are inferred from the claim text.