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Wo2 11/141 2 A2 (12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (10) International Publication Number (43) International Publication Date Χ t it Λ A 17 November 2011 (17.11.2011) WO 2 11/141 2 A2 (51) International Patent Classification: (81) Designated States (unless otherwise indicated, for every A61K 9/00 (2006.01) kind of national protection available): AE, AG, AL, AM, AO, AT, AU, AZ, BA, BB, BG, BH, BR, BW, BY, BZ, (21) International Application Number: CA, CH, CL, CN, CO, CR, CU, CZ, DE, DK, DM, DO, PCT/IN20 11/000324 DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, (22) International Filing Date: HN, HR, HU, ID, IL, IN, IS, JP, KE, KG, KM, KN, KP, 10 May 201 1 (10.05.201 1) KR, KZ, LA, LC, LK, LR, LS, LT, LU, LY, MA, MD, ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, (25) Filing Language: English NO, NZ, OM, PE, PG, PH, PL, PT, RO, RS, RU, SC, SD, (26) Publication Language: English SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. (30) Priority Data: 1487/MUM/2010 11 May 2010 ( 11.05.2010) IN (84) Designated States (unless otherwise indicated, for every kind of regional protection available): ARIPO (BW, GH, (71) Applicant (for all designated States except US): CADI- GM, KE, LR, LS, MW, MZ, NA, SD, SL, SZ, TZ, UG, LA HEALTHCARE LIMITED [IN/IN]; Zydus Tower, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, MD, RU, TJ, Satellite Cross Road, Ahmedabad 380 015, Gujarat (IN). TM), European (AL, AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, (72) Inventors; and LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, (75) Inventors/ Applicants (for US only): ROY, Sunilendu SM, TR), OAPI (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, Bhushan [IN/IN]; Cadila Healthcare Limited, Zydus GW, ML, MR, NE, SN, TD, TG). Tower, Satellite Cross Road, Ahmedabad 380 015, Gu jarat (IN). SWAIN, Kapileswar [IN/IN]; Cadila Health Declarations under Rule 4.17 : care Limited, Zydus Tower, Satellite Cross Road, Ahmed — as to applicant's entitlement to apply for and be granted abad 380 015, Gujarat (IN). PATEL, Shailesh Arvindb- a patent (Rule 4.1 7(H)) hai [IN/IN]; Cadila Healthcare Limited, Zydus Tower, Satellite Cross Road, Ahmedabad 380 015, Gujarat (IN). Published: MAGAR, Laxman [IN/IN]; Cadila Healthcare Limited, — without international search report and to be republished Zydus Tower, Satellite Cross Road, Ahmedabad 380 015, upon receipt of that report (Rule 48.2(g)) Gujarat (IN). (74) Agent: KAPPOR, Divya; Subramaniam, Nataraj & A sso ciates, E-556, Greater Kailash-II, New Delhi 110 048 (IN). < o- (54) Title: AQUEOUS PHARMACEUTICAL COMPOSITIONS OF FLUTICASONE AND OLOPATADINE (57) Abstract: The present invention relates to aqueous nasal spray solutions of fluticasone and olopatadine. In particular, the present invention relates to a stable aqueous nasal spray solution comprising combination of fluticasone and olopatadine or phar- maceutically acceptable salts thereof and process of manufacturing thereof. The aqueous composition is particularly suitable for topical administration into the nose in the treatment of inflammatory conditions. AQUEOUS PHARMACEUTICAL COMPOSITIONS OF FLUTICASONE AND OLOPATADINE FIELD OF THE INVENTION The present invention relates to aqueous nasal spray solutions of fluticasone and olopatadine. In particular, the present invention relates to a stable aqueous nasal spray solution comprising combination of fluticasone and olopatadine or pharmaceutically acceptable salts thereof and process of manufacturing thereof. The aqueous composition is particularly suitable for topical administration into the nose in the treatment of inflammatory conditions. BACKGROUND OF THE INVENTION Inflammatory conditions such as allergic disorders are very prevalent throughout the world, causing a very significant cost to society for therapy and in the form of worker absenteeism and decreased worker productivity. These illnesses are frequently manifested in the form of acute or chronic rhinitis, sometimes also described, respectively, as seasonal and perennial rhinitis. The symptoms of allergic rhinitis may include any number of: reddening of the eyes; ocular secretions; nasal congestion; ocular and palatial irritation; sneezing; and hypersecretion. Symptoms typically occur very promptly following exposure to allergens, of which the most common are grass, pollens and mold spores. The incidence of allergic rhinitis is greater during the spring and summer months, but some persons suffer the symptoms during the entire year, with exacerbations during the spring and summer. Several classes of drugs have been utilized for the treatment of inflammatory conditions such as allergic rhinitis, asthma. Intranasal administration of drugs such as corticosteroids and their combinations with antihistaminics are frequently be used to treat nasal symptoms including seasonal allergic rhinitis, perennial allergic rhinitis, perennial non-allergic rhinitis, nasal polyps, as well as prevention of post surgical polyps, chronic sinusitis, recurrent sinusitis, asthma, grass pollen rhinitis, hay fever, snoring, cluster headache, and other diseases and disorders. The nasal administration of drugs allows for their deposition to the nose, sinuses, and other nasal cavities. It is known to use antihistamines in nasal sprays and eye drops to treat allergy- related conditions. Thus, for example, it is known to use the antihistamine olopatadine (usually as hydrochloride salt) as a nasal spray for treating seasonal or perennial allergic rhinitis, or as eye drops against seasonal or perennial allergic conjuctivitis. It is also known to treat these conditions using a corticosteroid, which will suppress nasal and ocular inflammatory conditions. Among the corticosteroids known for nasal use are, for example, beclomethasone, mometasone, fluticasone, budesonide and cyclosenide. Corticosteroids known for ocular anti-inflammatory use include betamethasone sodium, dexamethasone sodium and prednisolone acetate, for example. Fluticasone is a synthetic corticosteroid used for the treatment of asthma, allergic rhinitis. It's salt, Fluticasone furoate is having scientific name S-(f!uoromethyl) (6S, 8S, 9R, 10S, 11S, 13S, 14S, 16R, 17R) 6,9-difluoro-l 1, 17-dihydroxy-10, 13, 16- trimethyl-3-oxo-6,7,8,l l,12,14,15,16-octahydrocyclopenta[a] phenantrhene -17- carbothiolate. Fluticasone furoate was first disclosed in US Patent No. 6,787,532. Another salt of fluticasone known as fluticasone propionate having scientific name- S-fluoromethyl 6[alpha],9[alpha]-difluoro-ll[beta]-hydroxy-16[alpha]-methyl- 17- propionyloxy-3-oxoandrost-l,4-diene-17[beta]-carbothioate, was first disclosed in US Patent No. 4,335,121. Olopatadine hydrochloride is a selective histamine Hl-receptor antagonist and it is used for the treatment of ocular symptoms of seasonal allergic conjunctivitis. The compound may be administered in a solid oral dosage form or as an ophthalmic solution. The scientific name of olopatadine hydrochloride is ([(Z)-3- (dimethylamino)propylidene]-6,U-dihydrodibenz[b,e]oxepin-2- acetic acid hydrochloride). Olopatadine hydrochloride was first disclosed in US Patent No. 5,1 16,863. Olopatadine is stated to be an effective treatment for symptoms of allergic rhinitis and urticaria (e.g., sneezing, nasal discharge and nasal congestion), as well as in the treatment of various skin diseases, such as eczema and dermatitis. Currently, olopatadine hydrochloride is commercially available from Alcon under the trademark PATANASE® which is in the form of aqueous nasal spray solution. It is also known that the combination therapy of anti-histamine agent and corticosteroid is the preferred treatment due to diverse symptoms associated with inflammatory conditions for example, in allergic rhinitis. Thus, it would be highly desirable, however, to provide a treatment that combines the olopatadine (effects of anti-histamine treatments) and fluticasone (effects of corticosteroid treatments), in a pharmaceutically acceptable formulation, which is tolerated in situ, without significantly disrupting the potency of the constituent pharmaceuticals. The administration of combination of intranasal fluticasone and intranasal olopatadine results in superior relief of seasonal allergic rhinitis symptoms compared with monotherapy (Allergy Asthma Proc. Mar 2010; 3 1(2): 132-40). European Patent Application No. EP 0780127 A discloses a of glucocorticoid and a leukotriene inhibiting antihistamine with an intranasal carrier. European Patent No. EP 1227812 B discloses use of desloratadine in the manufacture of medicament for treating rhinitis by a combination therapy comprising topical application of desloratadine and mometasone furoate. US Patent Application No. 2009136430 discloses topically administrable formulation for the sustained remission of atopical dermatitis consisting essentially of at least one antihistamine and at least one compound selected from corticosteroids and glucocorticosteroids dissolved in a pharmacologically acceptable carrier. European Patent No. EP 1519731 B discloses a pharmaceutical formulation which comprises azelastine or a salt, solvate or physiologically functional derivatives thereof, and fluticasone or a pharmaceutically acceptable ester thereof. International (PCT) Publication No. WO 2006/058022 discloses compositions comprising azelastine or pharmaceutically acceptable salts or esters thereof. The patent application also discloses compositions of azelastine
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