Aqueous clear solutions of fluocinolone acetonide for treatment of otic inflammation
AssigneeLaboratorios Salvat, S.A.
InventorsJaume RUIZ I POL, Francisca IZQUIERDO TORRES
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Abstract
A pharmaceutical otic sterile preservative-free composition in the form of a clear aqueous solution comprising 0.01-0.10% (w/v) of Fluocinolone Acetonide, optionally accompanied by 0.1-0.8% of Ciprofloxacin or a pharmaceutically acceptable salt thereof, a nonionic surfactant, a tonicity adjusting agent and a viscosity increasing agent. It is useful for the prevention and/or treatment of otic inflammation, optionally accompanied by bacterial infection, and for administration from single-use containers.
Claims14
A pharmaceutical otic sterile preservative-free composition in the form of a clear aqueous solution comprising the following ingredients, in w/v percentages:
- (i) 0.01-0.10% of Fluocinolone Acetonide, optionally accompanied by 0.1-0.8% of Ciprofloxacin or a pharmaceutically acceptable salt thereof;
- (ii) a total of 0.5-4.0% of one or more pharmaceutically acceptable nonionic surfactants with a hydrophilic-lipophilic balance (HLB) value between 14 and 18;
- (iii) a total of 0.5-4.0% of one or more pharmaceutically acceptable tonicity adjusting agents;
- (iv) a total of 0.05-1.00% of one or more pharmaceutically acceptable viscosity increasing agents;
- (v) optionally, an amount of one or more pharmaceutically acceptable pH adjusting agents in q.s. to adjust pH 4.0-5.0;
- and
- (vi) water
Dependencies are inferred from the claim text.