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Claims for Patent: 8,932,610

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Claims for Patent: 8,932,610

Title:Aqueous clear solutions of fluocinolone acetonide for treatment of otic inflammation
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.
Inventor(s): Ruiz I Pol; Jaume (Esplugues de Llobregat, ES), Izquierdo Torres; Francisca (Esplugues de Llobregat, ES)
Assignee: Laboratorios Salvat, S.A. (Esplugues de Llobregat (Barcelona), ES)
Application Number:12/730,681
Patent Claims: 1. 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 Polysorbate 80; (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) more than 90% water; wherein the composition is substantially free from particles in suspension and lacks non-aqueous solvents.

2. The pharmaceutical composition according to claim 1, wherein the one or more pharmaceutically acceptable tonicity adjusting agents is selected from the group consisting of dextrose, glycerin, sorbitol, mannitol, xylitol, polyethylene glycol, propylene glycol, dextran, potassium chloride, sodium chloride, calcium chloride, sodium phosphate, potassium phosphate, sodium bicarbonate, calcium carbonate, sodium lactate, and mixtures thereof.

3. The pharmaceutical composition according to claim 2, wherein the pharmaceutically acceptable tonicity adjusting agent is glycerin.

4. The pharmaceutical composition according to claim 1, wherein the one or more pharmaceutically acceptable viscosity increasing agents is selected from the group consisting of polyvinylpyrrolidone, polyvinyl alcohol, xanthan gum, guar gum, welan gum, tragacanth gum, ceratonia gum, agar, methylcellulose, ethyl cellulose, hydroxyethyl cellulose, hydroxyethylmethyl cellulose, hydroxypropyl cellulose, sodium carboxymethylcellulose, calcium carboxymethylcellulose, polyethylene glycol, glycerin, carrageenan, sodium alginate, potassium alginate, propylene glycol alginate, sodium hyaluronate, carbomers, maltodextrin, and mixtures thereof.

5. The pharmaceutical composition according to claim 4, wherein the one or more pharmaceutically acceptable viscosity increasing agent is a polyvinylpyrrolidone selected from the group consisting of Povidone K 25, Povidone K 30, Povidone K 90F, and mixtures thereof.

6. The pharmaceutical composition according to claim 5, wherein the pharmaceutically acceptable viscosity increasing agent is Povidone K 90F.

7. The pharmaceutical composition according to claim 1, comprising one or more pharmaceutically acceptable pH adjusting agents, wherein the one or more pharmaceutically acceptable pH adjusting agent is selected from the group consisting of citric acid, sodium citrate, potassium citrate, calcium citrate, lithium citrate, tartaric acid, sodium tartrate, potassium tartrate, calcium tartrate, lithium tartrate, phosphoric acid, sodium dihydrogenphosphate, sodium monohydrogenphosphate, lithium phosphate, potassium phosphate, calcium phosphate, sodium carbonate, sodium hydrogencarbonate, lactic acid, sodium lactate, potassium lactate, calcium lactate, acetic acid, sodium acetate, potassium acetate, calcium acetate, sulphuric acid, sodium sulphate, potassium sulphate, boric acid, sodium borate, maleic acid, lithium maleate, sodium maleate, potassium maleate, calcium maleate, succinic acid, lithium succinate, sodium succinate, potassium succinate, calcium succinate, hydrochloric acid, nitric acid, sodium hydroxide, potassium hydroxide, triethanolamine, diisopropanolamine, and mixtures thereof.

8. The pharmaceutical composition according to claim 1, wherein the w/v percentages are as follows: (i) 0.02-0.03% of Fluocinolone Acetonide, optionally accompanied by 0.2-0.4% of Ciprofloxacin or a pharmaceutically acceptable salt thereof; (ii) 2-3% of Polysorbate 80; (iii) 2-3% of glycerin; (iv) 0.1-0.3% of Povidone K 90F; (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) more than 90% water.

9. The pharmaceutical composition according to claim 1, wherein the pharmaceutical composition is sterilized and contained in disposable single-dose containers for topical use in drop form.

10. A method for the prevention and/or treatment of otic inflammation, optionally accompanied by bacterial infection, in an individual, comprising the topical administration to the individual of a therapeutically effective amount of the pharmaceutical composition of claim 1.

11. The method according to claim 10, wherein the otic inflammation is eczematoid external otitis, keloids, granular myringitis, bullous myringitis or sudden deafness.

12. The method according to claim 10, wherein the otic inflammation accompanied by bacterial infection is diffuse external otitis, localized external otitis, traumatic tympanic membrane perforations, herpes zoster oticus, otitis media with effusion, otorrhea through tympanostomy tubes, acute otitis media with tympanostomy tubes, acute otitis media or chronic suppurative otitis media.
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