BILASTINE COMPOSITION FOR ONCE-DAILY PARENTERAL ADMINISTRATION

The invention relates to an aqueous parenteral pharmaceutical composition comprising: a) 0.96-2.60% w/v of bilastine, or a pharmaceutically acceptable salt or solvate thereof, b) 10-30% w/v of a β-cyclodextrin selected from unmodified β-cyclodextrin, C1-C6 alkyl-β-cyclodextrin, C1-C6 hydroxyalkyl β-...

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Hauptverfasser: FERNÁNDEZ HERNANDO, María Nieves, EGUSQUIAGUIRRE MARTÍN, Susana Patricia, HERNÁNDEZ HERRERO, Gonzalo, DÍAZ TOMÉ, Victoria, ARRANZ GUTIÉRREZ, Paula, ARANA REY, Eider, GONZALO GOROSTIZA, Ana, OTERO ESPINAR, Francisco Javier
Format: Patent
Sprache:eng
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Zusammenfassung:The invention relates to an aqueous parenteral pharmaceutical composition comprising: a) 0.96-2.60% w/v of bilastine, or a pharmaceutically acceptable salt or solvate thereof, b) 10-30% w/v of a β-cyclodextrin selected from unmodified β-cyclodextrin, C1-C6 alkyl-β-cyclodextrin, C1-C6 hydroxyalkyl β-cyclodextrin, C1-C6 carboxyalkyl-β- cyclodextrin, carbonyl-β-cyclodextrin, C1-C6 sulfoalkylether β-cyclodextrin and mixtures thereof, wherein the pH value of the composition is between 3.0 and 7.2, both lower and upper limits of the range included and wherein parenteral is selected from intravenous or intramuscular; and its use in the treatment and/or prevention of conditions mediated by H1 histamine receptor, such as allergic disorders or diseases and allergic symptoms; particularly when immediate action is required.