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WO 2015/067959 Al 14 May 2015 (14.05.2015) P O P C T

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WO 2015/067959 Al 14 May 2015 (14.05.2015) P O P C T (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 WO 2015/067959 Al 14 May 2015 (14.05.2015) P O P C T (51) International Patent Classification: (81) Designated States (unless otherwise indicated, for every A61K 31/341 (2006.01) A61K 31/7052 (2006.01) kind of national protection available): AE, AG, AL, AM, A61K 31/405 (2006.01) A61K 45/06 (2006.01) AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, A61K 31/44 (2006.01) A61P 11/00 (2006.01) BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DK, DM, A61K 31/5415 (2006.01) DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, HR, HU, ID, IL, IN, IR, IS, JP, KE, KG, KN, KP, KR, (21) International Application Number: KZ, LA, LC, LK, LR, LS, LU, LY, MA, MD, ME, MG, PCT/GB2014/053321 MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, (22) International Filing Date: PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, SC, 7 November 2014 (07.1 1.2014) SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. (25) Filing Language: English (84) Designated States (unless otherwise indicated, for every (26) Publication Language: English kind of regional protection available): ARIPO (BW, GH, (30) Priority Data: GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, ST, SZ, 13 19762.' 8 November 2013 (08. 11.2013) GB TZ, UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, RU, TJ, TM), European (AL, AT, BE, BG, CH, CY, CZ, DE, (71) Applicant: NORBROOK LABORATORIES LIMITED DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, [GB/GB]; 105 Armagh Road, Newry, Co. Down, Northern LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, Ireland, BT35 6PU (GB). SM, TR), OAPI (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, GW, KM, ML, MR, NE, SN, TD, TG). (72) Inventor: HAUGHEY, James; c/o Norbrook Laboratories Limited, 105 Armagh Road, Newry, Co. Down, Northern Published: Ireland BT35 6PU (GB). — with international search report (Art. 21(3)) (74) Agent: HGF LIMITED; 140 London Wall, Greater Lon don, EC2Y 5DN (GB). © o (54) Title: TULATHROMYCIN AND NONSTEROIDAL ANTI-INFLAMMATORY DRUG COMPOSITIONS (57) Abstract: The present invention relates to novel compositions containing tulathromycin and nonsteroidal anti-inflammatory drugs, pharmaceutical formulations comprising said compositions and their use for treatment and prevention of respiratory diseases in mammals. Tulathromycin and Nonsteroidal Anti-Inflammatory Drug Compositions TechnicalField The present invention relates to novel compositions containing tulathromycin and nonsteroidal anti-inflammatory drugs, pharmaceutical formulations comprising said compositions and their use for treatment and prevention of respiratory diseases in mammals. Background Art Non-steroidal anti-inflammatory drugs (NSAID) are a group of medicaments with analgesic, anti-inflammatory and antipyretic effects. NSAID are widely administered for the treatment of mild to severe pain. Among the most commonly used members of the NSAID class of drugs are aspirin, fluxinin, carprofen, firocoxib and meloxicam. See Peterson K, et ah, "Drug Class Review: Nonsteroidal Antiinflammatory Drugs (NSAIDs)" (Oregon Health and Science University, Portland, Oregon, US, 2010). Macrolides are broad spectrum antibiotics formed by a large lactone ring that varies in size from 12 to 16 atoms. Macrolide antibiotics exhibit good activity against Gram-positive aerobes such as Streptococcus pneumoniae and Haemophilus influenzae. See Zhanel G, et ah, Drugs 2001; 61(4):443-498. Their principal mechanism of action against pathogens involves the direct inhibition of essential protein biosynthesis by selective binding to bacterial 50S ribosomal subunits. In addition to their antimicrobial function, macrolide antibiotics are known to modulate immune cell functions. This class of antibiotics is known to influence the recruitment and infiltration of neutrophils and to alter their ability to secrete histotoxic compounds and proinflammatory cytokines. See Ichikawa Y, et ah, Am. Rev. Respir. Dis. 1992; 146: 196-203, Lee W, et ah, Vet. Res. 2004; 35:213-224, Mikasa K, et ah, J. Antimicrob. Chemother. 1992; 30:339-348, Takeshita K, et ah, Drugs Exp. Clin. Res. 1989; 15:527-533 and Tsuchihashi Y, et ah, Antimicrob. Agents Chemother. 2002; 46:1101-1104. Recent findings also indicate that some macrolides may induce cellular death by apoptosis and block NF-κΒ signaling in T lymphocytes, macrophages or epithelial cells. See Aoshiba K, et al, Antimicrob. Agents Chemother. 1995; 39:872-877, Buret A, et al, Can. J. Vet. Res. 2010; 74:1-10, Chin A, et al, Antimicrob. Agents Chemother. 2000; 44:2465-2470, Chin A, et al, Am. J. Vet. Res. 1998; 59:765-771, Lee W, et al, Vet. Res. 2004; 35:213-224, Leiva M, etal, FEMS Immunol. Med. Microbiol. 2008; 53:343-350, Ou X, et al, Respirology 2008; 13:63-72 and Wu L, et al, Int. Immunopharmacol. 2009; 9:1105-1109. However, the precise mechanisms underlying the anti-inflammatory and proapoptotic activities of macrolides in neutrophils remain unclear. Tulathromycin is a triamilide macrolide characterized by a 15-membered ring composed of 3 polar amine groups. This particular structure distinguishes it from other macrolides. See Evans N, Vet. Ther. 2005; 6:83-95. The drug is used in the treatment and prevention of respiratory diseases in cattle and swine. The therapeutic success of tulathromycin is partially attributed to its pharmacodynamic concentration in appropriate tissues and low inhibitory concentrations against various bacterial pathogens. Tulathromycin also has a very high affinity for uptake within neutrophils and, to a lesser extent, macrophages, which helps target the delivery of the drug to infected tissues. Compared to other antibiotics used in the treatment and prevention of bovine respiratory disease, tulathromycin has shown superior clinical efficacy and clears the infection and inflammation for reasons that remain not completely understood. See Nutsch R, et al , Vet. Ther. 2005; 6:167-179, Mount J, et al, Can. J. Vet. Res. 2009; 73:49-57, Skogerboe T, et al, Vet. Ther. 2005; 6:180-196. Summary of the Invention The present invention relates to a composition comprising tulathromycin and at least one nonsteroidal anti-inflammatory drug ("NSAID"). Surprisingly, the same antibiotic efficacy is attained when a lower than recommended amount of tulathromycin is used in the presence of a NSAID. In addition to the obvious economic benefits of this composition, a lower tulathromycin have the further advantage of reducing the risk of developing antibiotic-resistant bacteria. In a first aspect, the present invention is directed to a composition comprising tulathromycin and at least one NSAID. In a second aspect, the present invention refers to a pharmaceutical formulation comprising the composition of the first aspect and at least one pharmaceutically acceptable carrier, additive, adjuvant or vehicle. In a third aspect, the present invention relates to a process for preparing the pharmaceutical formulation of the invention, which comprises mixing the composition of the first aspect and at least one pharmaceutically acceptable carrier, additive, adjuvant or vehicle. In a fourth aspect, the present invention refers to a composition according to the first aspect or a pharmaceutical formulation according to the second aspect for its use as a medicament. In a fifth aspect, the present invention is directed to a composition according to the first aspect or a pharmaceutical formulation according to the second aspect for its use in the treatment or prevention of respiratory diseases in mammals. Alternatively, the present invention is directed to the use of the composition according to the first aspect in the manufacture of a medicament for the treatment or prevention of a respiratory disease in mammals. In a sixth aspect, the present invention refers to a method of treating or preventing the inception of a respiratory disease in a subject, which comprises administering to the subject a therapeutically effective amount of the composition of the first aspect or the pharmaceutical formulation of the third aspect of the invention. Description of the Embodiments This invention relates to a novel composition that enables the administration of a lower yet effective dosage of tulathromycin to subjects suffering, or in risk of suffering, respiratory diseases. The components of the composition are tulathromycin and at least one NSAID. The NSAID can be an acetic acid derivative, an enolic acid derivative, a fenamic acid derivative, a propionic acid derivative, a salicylic acid derivative, a selective cyclooxigenase-2 inhibitor, a sulphoanilide compound or a pharmaceutically acceptable salt, isomer, enantiomer or tautomers thereof. 1. Definitions The term "auxiliary" as used herein, means any component, other than the active substance(s) intentionally added to the formulation of a dosage form. Exemplary auxiliaries are acids (e.g. citric or tartaric acid), alcohols, a bicarbonate (e.g. sodium or potassium), binders, colorants, excipients, disintegrants, fillers, flavoring agents, flavor masking agents, foaming agents, lubricants, plastizicers, pore-forming agents, sodium chloride, stabilizers, sugars and sweeteners. Some auxiliaries can serve multiple purposes (e.g. filler and disintegrant). See US Pharmacopoeia. The term "pharmaceutically acceptable salt" as used herein, refers o any salt of acidic or basic nature which may be formed with any of the compounds of the invention. Examples of acidic salts include, but are not limited to, the hydrochloride, hydrobromide, hydroiodide, nitrate, sulfate, bisulfate, phosphate, acid phosphate, isonicotinate, acetate, lactate, salicylate, citrate, acid citrate, tartrate, pantothenate, bitartrate, ascorbate, succinate, maleate, gentisinate, fumarate, gluconate, glucaronate, saccharate, formate, benzoate, glutamate, methanesulfonate, ethanesulfonate, benzenesulfonate, p-toluenesulfonate and pamoate salts. Examples of basic salts include, but are not limited, to the calcium, magnesium, sodium and potassium salts.
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