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WO 2014/053555 Al 10 April 2014 (10.04.2014) P O P C T

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WO 2014/053555 Al 10 April 2014 (10.04.2014) 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 2014/053555 Al 10 April 2014 (10.04.2014) P O P C T (51) International Patent Classification: AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, A61K 9/50 (2006.01) A61K 47/46 (2006.01) BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DK, DM, DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, (21) International Application Number: HN, HR, HU, ID, IL, IN, IS, JP, KE, KG, KN, KP, KR, PCT/EP2013/070561 KZ, LA, LC, LK, LR, LS, LT, LU, LY, MA, MD, ME, (22) International Filing Date: MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, 2 October 2013 (02. 10.2013) OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, (25) Filing Language: English TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, (26) Publication Language: English ZW. (30) Priority Data: (84) Designated States (unless otherwise indicated, for every 12187156.0 4 October 2012 (04. 10.2012) EP kind of regional protection available): ARIPO (BW, GH, GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, SZ, TZ, (71) Applicant (for all designated States except US) : NO- UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, RU, TJ, VARTIS AG [CH/CH]; Lichtstrasse 35, CH-4056 Basel TM), European (AL, AT, BE, BG, CH, CY, CZ, DE, DK, (CH). EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, SM, (72) Inventors; and TR), OAPI (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, GW, (71) Applicants (for US only): ISELE-FINK, Ute [DE/CH]; KM, ML, MR, NE, SN, TD, TG). Novartis Animal Health, Inc., Schwarzwaldallee 215, CH- 4058 Basel (CH). REITZ, Claudia [DE/CH]; Novartis Declarations under Rule 4.17 : Animal Health, Inc., Schwarzwaldallee 215, CH-4058 — as to applicant's entitlement to apply for and be granted a Basel (CH). patent (Rule 4.1 7(H)) (74) Agent: LIPHARDT, Bernd; Novartis Animal Health Inc, Published: Patent Group, Werk Rosental, Postfach, CH-4002 Basel (CH). — with international search report (Art. 21(3)) (81) Designated States (unless otherwise indicated, for every kind of national protection available): AE, AG, AL, AM, o (54) Title: VETERINARY DRUG SYSTEM o (57) Abstract: The present invention concerns a veterinary drug administration system comprising a first container comprising a li quid animal food that is based on animal meat, water and optionally further excipients, and a second container comprising one or more veterinary drugs in solid form, wherein the contents of the first and second container are combined prior to use. The veterinary o drug products of the invention have an improved palatability and are especially useful for administration to companion animals, in particular cats. Veterinary Drug System The present invention relates to a new veterinary drug administration system imparting an improved palatability to a given drug which is especially useful for administration to non- human animals, in particular cats. Oral administration of a drug to a non-human animal can be a real challenge depending on the nature of the drug and animal. For example, cats are known to be delicate with respect to any kind of oral medication, and administration thereof often requires special measures. In addition, many veterinary drugs have an unpleasant taste and therefore have to be made attractive, for example, by adding suitable flavors. Various solutions to increase the palatability of veterinary drugs have been proposed, such as the addition of suitable aromas or flavors, coating drugs with one or more protective layers, creation of a specific drug consistency like a soft chewable or a more crunchy formulation. However, said known solutions often don't provide a satisfactory palatability, especially in cases of drugs which have to be taken on a regular basis, such as endoparasiticides, ectoparasiticides or drugs for treating chronic diseases. A further approach would be to include the drug into a suitable animal food which is, however, problematic from a regulatory perspective. First of all, the food must have a constant, reproducible quality. In addition, the drug must be stable within the animal food, and the veterinary drug product as a whole has to have a sufficient shelf life, for example, of at least one year or more. While solid products, such as coated drug pellets incorporated in yeast or a drug incorporated in a chewable formulation with high meat contents, are known, for example, from WO2003/075895 or WO2005/013714, no products of a veterinary drug in a liquid animal food have been contemplated yet, most likely for stability reasons. A liquid consistency, however, would be very beneficial , as animals such as cats often prefer to lick liquids out of a bowl instead of digesting solids. Accordingly, it is an object of the present invention to provide a veterinary drug product which is based on a liquid animal food and still has a shelf life sufficient, for example, for a prescription drug. The present invention, according to one aspect, therefore concerns a veterinary drug administration system comprising a first container comprising a liquid animal food that is based on meat, water and optionally further excipients, wherein the water contents is ≥80% (w/w), based on the entire animal food, and a second container comprising one or more veterinary drugs in solid form, wherein the contents of the first and second container are combined prior to use. According to the present invention, the term meat comprises all kinds of animal meat, for example, from domestic animals and productive livestock, e.g. pigs, horses, cattle, sheep, goats and poultry including chicken, duck, goose and turkey, or from fish, or mixtures thereof, as well as artificial meat flavors which are well-known from the food industry. Preferably, the liquid animal food is based on animal meat, in particular on animal meat, for example, from pig, cattle, chicken or fish. The animal meat may be based on human food- grade meat or on animal by-products such as slaughterhouse waste containing all kinds of animal tissue, such as skin, sinews, bowels and meat. In order to prepare the liquid animal food, the meat, preferably after having been chopped and/or homogenized, is mixed with water and optionally further excipients, and the mixture is then filled in a plurality of first containers which are closed or sealed afterwards. Finally, the mixture within the first containers is sterilized, preferably by application of heat and/or pressure. For example the first containers are autoclaved at a temperature of about 80 to 140°C for about 5 to 30 minutes, in particular 10-25 minutes. The liquid animal food according to the present invention contains ≥80% (w/w) and preferably ≥85% (w/w) water, based on the entire formulation. Overall meat contents may vary, for example, between 1 and 20% (w/w), preferably 1.5 and 15% (w/w), more preferably 2 to 10% (w/w), and in particular 4 and 8 % (w/w), based on the entire formulation. Main components of said meat are proteins and fat, besides minerals and vitamins. Further excipients contained in the liquid animal food or gravy may be, for example: (i) thickeners, for example carrageen, xanthan gum, locust bean gum, guar gum, cornstarch, oat meal flour, microcrystalline cellulose, hydroxyethyl cellulose, carboxymethyl cellulose; (ii) antioxidants, for example propyl 3,4,5-trihydroxybenzoate, BHA (2-t-butyl-4- methoxyphenol), BHT (2,6-di-t-butyl-4-methylphenol), tocopherols (alpha, beta, or delta- tocopherol, tocopherol esters, alpha-tocopherol acetate), alkyl gallates such as propyl gallate, tert. butyl hydroquinone, butylated hydroxyanisole or butylated hydroxytoluene. According to a preferred embodiment of the invention, the liquid animal food is devoid of an antioxidant. (iii) preservatives, for example sorbic acid and its salts, benzoic acid and its salts, ascorbic acid and its salts, for example sodium ascorbate, citric acid and its salts, or EDTA salts, for example disodium EDTA. According to a preferred embodiment of the invention, the liquid animal food is devoid of a preservative. (iv) additional aromas or flavors, for example sweeteners such as sugar, fructose or xylose; amino acids such as glycine, lysine, methionine or cystein. (v) colors such as iron oxide or gravy browning. Preferred excipients of the liquid animal food are one or more thickeners, mainly for consistency adjustment. The further excipients most preferably comprise one or more thickeners and one or more additional aromas or flavors. Further excipients, if contained in the liquid animal food, are present in an amount of, for example, from 0.1 to 19% (w/w), preferably from 0.5 to 10% (w/w), more preferably from 1 to 7% (w/w), and in particular from 1 to 5% (w/w), based on the entire formulation. Preferred formulations of the liquid animal food comprise: (i) 1 to 10 % (w/w) animal meat, 0.1 to 19 % (w/w) further excipients and water ad 100 % (w/w). (ii) 2 to 10% animal meat, 0.5 to 10% further excipients and water ad 100% (all (w/w); (iii) 4 to 8 % animal meat, 0.5 to 10% further excipients, and water ad 100% (all (w/w); The energy contents of a liquid animal food according to the invention is in general low, for example, < 1 kcal/g and preferably <0.5 kcal/g. Therefore, the liquid animal food according to the invention is in general not a complete meal but, for example, a snack which may be provided to the animal as a treat.
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