Claims for Patent: 10,588,913

Summary for Patent: 10,588,913

Title:	Aqueous suspension agent containing glucocorticosteroid nanoparticles
Abstract:	An aqueous suspension containing as an active component a glucocorticosteroid compound is described. The aqueous suspension contains nanoparticles of a glucocorticosteroid compound and a dispersion stabilizer. The nanoparticles have a mean particle diameter of 300 nm or less and a D90 particle diameter of 450 nm or less. The pharmaceutical compositions containing the aqueous suspension are for parenteral administrations, injections, eye drops or ear drops. More specifically the aqueous suspensions containing glucocorticosteroid nanoparticles are used as an eye drop for treating or preventing inflammatory diseases of the eye or an ear drop for treating or preventing inflammatory diseases of the ear.
Inventor(s):	Tada Takahiro, Kagami Kazuhiro, Kikuchi Kenta
Assignee:	Activus Pharma Co., Ltd.
Application Number:	US15571986
Patent Claims:	1. An aqueous suspension comprising:nanoparticles of a glucocorticosteroid compound;a physiologically acceptable salt;glycerin;hydrogenated soybean lecithin; andanhydrous citric acid;wherein a mean particle diameter of the nanoparticles is 300 nm or less and a D90 particle diameter of the nanoparticles is 450 nm or less.3. The aqueous suspension of claim 1 , wherein the glucocorticosteroid compound is one or more substances selected from the group consisting of clobetasol propionate claim 1 , diflorasone diacetate claim 1 , dexamethasone propionate claim 1 , difluprednate claim 1 , mometasone furoate claim 1 , diflucortolone valerate claim 1 , betamethasone butyrate propionate claim 1 , fluocinonide claim 1 , hydrocortisone butyrate propionate claim 1 , beclomethasone dipropionate claim 1 , deprodone propionate claim 1 , betamethasone valerate claim 1 , dexamethasone valerate claim 1 , prednisolone valerate acetate claim 1 , fluocinolone acetonide claim 1 , hydrocortisone butyrate claim 1 , clobetasone butyrate claim 1 , alclometasone dipropionate claim 1 , triamcinolone acetonide claim 1 , flumethasone pivalate claim 1 , prednisolone and hydrocortisone.4. The aqueous suspension of claim 1 , further comprising a dispersion stabilizer.5. The aqueous suspension of claim 4 , wherein the dispersion stabilizer is polyoxyethylene polyoxypropylene glycol and/or polyvinyl alcohol.6. The aqueous suspension of claim 1 , further comprising a viscosity modifier.7. The aqueous suspension of claim 6 , wherein the viscosity modifier is one or more substances selected from the group consisting of methyl cellulose claim 6 , hydroxypropyl methylcellulose and polyvinyl alcohol.8. The aqueous suspension of claim 6 , comprising 1 to 10 mg/mL of the viscosity modifier.9. A pharmaceutical composition comprising the aqueous suspension of .10. The pharmaceutical composition of claim 9 , for parenteral administration.11. The pharmaceutical composition of claim 10 , which is for an injection or for a topical preparation.12. The pharmaceutical composition of claim 11 , which is for a topical preparation for an eye claim 11 , an ear claim 11 , a nose or a lung.13. The pharmaceutical composition of claim 12 , which is an eye drop claim 12 , an ear drop claim 12 , a nose drop claim 12 , or an inhaler.14. A kit for preparing the pharmaceutical composition of claim 9 , comprising nanoparticles of a glucocorticosteroid compound.15. A method for manufacturing the pharmaceutical composition of claim 9 , comprising mixing the glucocorticosteroid compound claim 9 , the physiologically acceptable salt claim 9 , the glycerin claim 9 , the hydrogenated soybean lecithin and the anhydrous citric acid.16. The method for manufacturing of claim 15 , comprising mixing the glucocorticosteroid compound claim 15 , the physiologically acceptable salt claim 15 , the glycerin claim 15 , the anhydrous citric acid the hydrogenated soybean lecithin claim 15 , a physiologically acceptable polyol and/or water claim 15 , and a dispersion stabilizer.