STABLE AND PRESERVED PHARMACEUTICAL COMPOSITIONS OF BILASTINE

The invention relates to an aqueous pharmaceutical composition comprising:a) bilastine, or a pharmaceutically acceptable salt or solvate thereof,b) benzalkonium chloride, in combination with at least one further preservative selected from the group comprising phenylethyl alcohol, benzyl alcohol, sod...

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Bibliographische Detailangaben
Hauptverfasser: MARCIANES MORENO, Patricia, HERNÁNDEZ HERRERO, Gonzalo, TATO CERDEIRAS, Paloma, GONZALO GOROSTIZA, Ana, GONZÁLEZ FERNÁNDEZ, Paula
Format: Patent
Sprache:eng ; fre ; ger
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Beschreibung
Zusammenfassung:The invention relates to an aqueous pharmaceutical composition comprising:a) bilastine, or a pharmaceutically acceptable salt or solvate thereof,b) benzalkonium chloride, in combination with at least one further preservative selected from the group comprising phenylethyl alcohol, benzyl alcohol, sodium benzoate, chlorbutanol, phenoxyethanol, cetrimide and 2-(ethylmercuriomercapto)benzoic acid sodium salt,c) a suspending agent, andd) 2-hydroxypropyl-β-cyclodextrin;wherein the pH of the aqueous pharmaceutical composition is between 3.5 and 5.5.The invention also relates to said compositions for use in the treatment and/or prevention of a disorder or disease susceptible to amelioration by antagonism of H1histamine receptor and/or of a corticosteroid-responsive disease through nasal administration.The invention also relates to a process for preparing the aqueous pharmaceutical composition above mentioned.