Veterinary composition comprising oclacitinib

Abstract

The invention relates to veterinary compositions comprising Oclacitinib. Preferably, the compositions are prepared by granulation and comprise an intragranular phase as well as an extragranular phase.

Description

VETERINARY COMPOSITION COMPRISING OCLACITINIB

[0001] Priority is claimed of European patent application no. 22 216 191.1 that was filed on December 22, 2022.

[0002] The invention relates to veterinary compositions comprising Oclacitinib. Preferably, the veterinary compositions are prepared by granulation and comprise an intragranular phase as well as an extragranular phase.

[0003] Oclacitinib (ATC vet code QD11AH90) has the following structure:

[0004] Oclacitinib is commercially available as maleate salt (Apoquel®) and is labeled to treat atopic dermatitis and itchiness (pruritus) caused by allergies in dogs. It is provided in form of chewable tablets at dose strengths of 3.6 mg, 5.4 mg, and 16 mg. The chewable tablets have a core and a coating. The tablet core comprises microcrystalline cellulose, lactose monohydrate, magnesium stearate, and sodium starch glycolate. The tablet coating comprises lactose monohydrate, hypromellose (E464), titanium dioxide (El 71), and Macrogol 400 (E1521).

[0005] WO 2016 073347 Al is directed to a palatable soft chew veterinary composition comprising at least one active agent, at least one binding agent, at least one disintegrant, at least one wetting agent, and at least one flavorant, and methods for controlling or treating a condition in an animal comprising administering the composition to said animal in need thereof.

[0006] WO 2018 217700 Al relates to glucuronide prodrug compounds of Janus kinase (JAK) inhibitors.

[0007] WO 2020 159362 Al relates to solid state forms of oclacitinib maleate and methods for the preparation of the solid state forms of oclacitinib maleate. The solid state forms of oclacitinib maleate of the present invention include amorphous oclacitinib maleate, crystalline tetramethyl urea solvate form ofoclacitinib maleate, crystalline monohydrate form of oclacitinib maleate and crystalline form of oclacitinib maleate (form B).

[0008] WO 2020 172232 Al is directed to a soft chewable composition comprising or containing a therapeutically effective amount of a veterinary active agent, preferably a JAK inhibitor; an animal based pal- atant, a non-animal based palatant, a flavor modifier, and at least one veterinary acceptable excipient that is selected from at least one each of a disintegrant, binder, lubricant, humectant, and glidant; and wherein the soft chewable tablet is compressed with a rotary tablet press; and methods for treating or preventing cancer, asthma, atopic dermatitis, autoimmune disorders, pruritus associated with allergic dermatitis, allergies, and chronic respiratory disease in an animal.

[0009] WO 2022 178201 Al provides an IL-31 horse pruritus model which confirms that IL-31 induces itch in horses and can be used to assess whether certain test compounds can block or reduce the itch in treated horses.

[0010] It is an object of the invention to provide veterinary compositions of Oclacitinib that have advantages to the compositions of the prior art.

[0011] This object has been achieved by the subject-matter of the patent claims.

[0012] A first aspect of the invention relates to a veterinary composition comprising or essentially consisting of o Oclacitinib or a physiologically acceptable salt thereof; o optionally, one or more animal based palatants; o optionally, one or more non-animal based palatants; o optionally, one or more flavor modifiers; o one or more binders; o optionally, one or more lubricants; o one or more humectants; o optionally, one or more glidants; o optionally, one or more disintegrants; and o optionally, one or more diluents.

[0013] Preferably, the veterinary composition according to the invention is for oral administration.

[0014] Preferably, the veterinary composition according to the invention comprises (i) one or more animal based palatants and / or (ii) one or more non-animal based palatants; preferably (i) one or more animal based palatants, or (ii) one or more non-animal based palatants, but not both.

[0015] Preferably, relative to the total weight of the veterinary composition, the total weight content of all animal and / or non-animal based palatants is at most 62.0 wt.-%; preferably at most 61.0 wt.-%; more preferably at most 60.0 wt.-%; still more preferably at most 59.0 wt.-%; yet more preferably at most 58.0 wt.- %; even more preferably at most 57.0 wt.-%; most preferably at most 56.0 wt.-%; and in particular at most 55.0 wt.-%.

[0016] Preferably, relative to the total weight of the veterinary composition, the total weight content of all animal and / or non-animal based palatants is at most 54.0 wt.-%; preferably at most 53.0 wt.-%; more preferably at most 52.0 wt.-%; still more preferably at most 51.0 wt.-%; yet more preferably at most 50.0 wt.- %; even more preferably at most 49.0 wt.-%; most preferably at most 48.0 wt.-%; and in particular at most 47.0 wt.-%.

[0017] Preferably, relative to the total weight of the veterinary composition, the total weight content of all animal and / or non-animal based palatants is at most 46.0 wt.-%; preferably at most 45.0 wt.-%; more preferably at most 44.0 wt.-%; still more preferably at most 43.0 wt.-%; yet more preferably at most 42.0 wt.- %; even more preferably at most 41.0 wt.-%; most preferably at most 40.0 wt.-%; and in particular at most 39.0 wt.-%.

[0018] When the veterinary composition contains both, animal based palatants as well as non-animal based palatants, the total weight content encompasses all animal based palatants and all non-animal based palatants. When the veterinary composition only contains either one or more animal based palatants, or one or more non-animal based palatants, the total weight content encompasses all such one or more animal based palatants, and one or more non-animal based palatants, respectively.

[0019] Palatants are used to alter or enhance the flavor(s) of natural food products such as meats and vegetables, or creating additional flavor for food products that do not have the desired flavors such as snacks and oral medications. Most types of palatants are focused on scent and taste. Artificial palatants are chemically synthesized compounds that are used to flavor food items and are often formulated with the same chemical compounds found in natural palatants. Most artificial flavors are specific and often complex mixtures of singular naturally occurring flavor compounds to either imitate or enhance a natural flavor. These mixtures are formulated by flavorists to give a food product a unique flavor and to maintain flavor consistency between different product batches or after recipe changes. The list of known flavoring agents includes thousands of molecular compounds, and can be combined to achieve flavors like chicken, turkey, beef, pork, lamb, fish, egg, cheese, seafood, smoke, and many others.

[0020] Natural palatants include essential oil, oleoresin, essence or extract, protein hydrolysate, distillate, or any product of roasting, heating or enzymolysis, which contains the flavoring constituents derived from a spice, fruit or fruit juice, vegetable or vegetable juice, edible yeast (active and inactive), herb, bark, bud,root, leaf or any other edible portions of a plant, meat, seafood, poultry, eggs, dairy products, or fermentation products thereof; and can include sweeteners like sucrose; whose primary function in food Is flavoring rather than nutritional. Natural palatants include chicken, turkey, beef, pork, lamb, fish, egg, cheese, seafood, vegetable and vegetable matter, yeast (e.g., Brewer’s yeast) and mixtures thereof. Yeast extracts are also included in the natural flavors.

[0021] Natural meat palatants can be obtained from meat, meat products, organ meat, yeast extracts, vegetable matter, and mixtures thereof. For example, an oral veterinary composition medication might include animal product-based flavorings such as dried or powdered meat and meat parts such as beef, pork, chicken, turkey, fish, and lamb; organ meats such as liver and kidney; meat meals, bone meals and ground bone; and animal-derived food such as casein, milk (which may include dry forms and lowered fat forms, such as dry skim milk), yogurt, gelatin, cheese and egg (collectively, "animal origin flavorings") may be utilized. The natural products may or may not be sterilized by heat or other types of radiation, e.g., gamma-radiation.

[0022] A preferred palatant for the stable, palatable, chewable composition is a natural animal based pal- atant. A preferred animal based palatant is derived from organ meat. The preferred organ meat is derived from pork liver. The preferred animal based palatant is pork liver powder. Preferably, the non-animal based palatant is yeast. The preferred yeast is Brewer’s yeast.

[0023] In preferred embodiments, the veterinary composition according to the invention comprises (i) either one or more animal based palatants, (ii) or one or more non-animal based palatants, but not one or more animal based palatants in combination with one or more non-animal based palatants.

[0024] Thus, in preferred embodiments, the veterinary composition according to the invention comprises one or more animal based palatants but does not contain Brewer's yeast; preferably does not contain any yeast; more preferably does not contain any non-animal based palatants non-animal based palatants.

[0025] Compared to veterinary compositions of the prior art, e.g. according to WO 2020 / 172232, the veterinary composition according to the invention requires less palatant and does not require any yeast

[0026] It has been found that veterinary compositions, especially chewable tablets, that do not contain any yeast have advantages because yeast is a potential source of microbiological contamination. Further, veterinary compositions that do not contain yeast provide economic advantages, as they enable quicker production timelines, e.g. in view of reduced need for extensive equipment cleaning between successive batches.

[0027] In other preferred embodiments, the veterinary composition according to the invention comprises one or more non-animal based palatants but does not contain animal based palatants.

[0028] Preferably, the veterinary composition according to the invention comprises or essentially consists ofo Oclacitinib or a physiologically acceptable salt thereof; o (i) one or more animal based palatants and / or (ii) one or more non-animal based palatants; preferably (i) one or more animal based palatants, or (ii) one or more non-animal based palatants, but no both; o one or more flavor modifiers; o one or more binders; o one or more lubricants; o one or more humectants; o one or more glidants; o one or more disintegrants; and o one or more diluents.

[0029] The veterinary composition according to the invention comprises Oclacitinib or a physiologically acceptable salt thereof.

[0030] In preferred embodiments of the veterinary composition according to the invention, Oclacitinib is present as Oclacitinib maleate.

[0031] In other preferred embodiments of the veterinary composition according to the invention, Oclacitinib is present as Oclacitinib free base.

[0032] Preferably, relative to the total weight of the veterinary composition, the weight content of Oclacitinib or a physiologically acceptable salt thereof is within the range of from 0. 1 to 10 wt.-%, preferably 0.5 to 7.5 wt.-%, most preferably 1.0 to 5.0 wt.-%.

[0033] The veterinary composition according to the invention optionally comprises one or more animal based palatants.

[0034] Preferred animal based palatants are obtained from chicken, turkey, beef, pork, lamb, or fish; in each case preferably from meat, meat products, organ meat (e.g., liver, kidney, and the like).

[0035] In preferred embodiments of the veterinary composition according to the invention, the one or more animal based palatants are selected from pork liver powder, dried meat, and combinations thereof. Pork liver powder is particularly preferred.

[0036] Preferably, relative to the total weight of the veterinary composition, the weight content of the one or more animal based palatants is within the range of from 0 to 90 wt.-%, preferably 0 to 85 wt.-%, most preferably 0 to 80 wt.-%.

[0037] In preferred embodiments, relative to the total weight of the veterinary composition, the weight content of the one or more animal based palatants, preferably pork liver powder, is within the range of 76±20wt.-%, more preferably 76±15 wt.-%, still more preferably 76±10 wt.-%, and yet more preferably 76±5.0 wt. -%.

[0038] In other preferred embodiments, relative to the total weight of the veterinary composition, the weight content of the one or more animal based palatants, preferably pork liver powder, is within the range of 38±20 wt.-%, more preferably 38±15 wt.-%, still more preferably 38±10 wt.-%, and yet more preferably 38±5.0 wt.-%.

[0039] In further preferred embodiments, relative to the total weight of the veterinary composition, the weight content of the one or more animal based palatants, preferably pork liver powder, is within the range of 2.0± 1.9 wt. -%, more preferably 2.0± 1.7 wt. -%, still more preferably 2.0± 1.5 wt. -%, and yet more preferably 2.0±1.0 wt.-%; preferably wherein the one or more animal based palatants are contained in a coating that surrounds a tablet core.

[0040] The veterinary composition according to the invention optionally comprises one or more non-ani- mal based palatants.

[0041] In preferred embodiments of the veterinary composition according to the invention, the one or more non-animal based palatants are selected from artificial meat flavor, Brewer’s yeast, soy based pork flavor, and combinations thereof.

[0042] In preferred embodiments, the veterinary composition according to the invention comprises a first non-animal based palatant, preferably artificial meat flavor or soy based pork flavor, in combination with a second non-animal based palatant, preferably Brewer's yeast.

[0043] Preferably, the weight content of the first non-animal based palatant, preferably artificial meat flavor or soy based pork flavor, is greater than the weight content of the second non-animal based palatant, preferably Brewer's yeast. In preferred embodiments, the relative weight ratio of the first non-animal based palatant, preferably artificial meat flavor or soy based pork flavor, to the second non-animal based palatant, preferably Brewer's yeast, is within the range of from 10: 1 to 3: 1, more preferably 9: 1 to 4: 1, and still more preferably 8: 1 to 5: 1.

[0044] Preferably, relative to the total weight of the veterinary composition, the weight content of the one or more non-animal based palatants is within the range of from 0 to 90 wt.-%, preferably 0 to 85 wt.-%, most preferably 0 to 80 wt.-%.

[0045] In preferred embodiments, relative to the total weight of the veterinary composition, the weight content of the one or more non-animal based palatants, preferably artificial meat flavor and / or Brewer's yeast, is within the range of 47±20 wt.-%, more preferably 47±15 wt.-%, still more preferably 47±10 wt.- %, and yet more preferably 47±5.0 wt.-%.

[0046] In other preferred embodiments, relative to the total weight of the veterinary composition, the weight content of the one or more non-animal based palatants, preferably soy based pork flavor and / or Brewer's yeast, is within the range of 58±20 wt.-%, more preferably 58±15 wt.-%, still more preferably 58±10 wt.-%, and yet more preferably 58±5.0 wt.-%.

[0047] In further preferred embodiments, relative to the total weight of the veterinary composition, the weight content of the one or more non-animal based palatants, preferably soy based pork flavor and / or Brewer's yeast, is within the range of 1.0±0.9 wt.-%, more preferably 1.0±0.8 wt.-%, still more preferably 1.0±0.7 wt.-%, and yet more preferably 1.0±0.6 wt.-%; preferably wherein the one or more non-animal based palatants are contained in a coating that surrounds a tablet core.

[0048] The veterinary composition according to the invention optionally comprises one or more flavor modifiers.

[0049] In preferred embodiments of the veterinary composition according to the invention, the one or more flavor modifiers are selected from sodium chloride, potassium chloride, and combinations thereof.

[0050] Preferably, relative to the total weight of the veterinary composition, the weight content of the one or more flavor modifiers is within the range of from 0 to 5.0 wt.-%, preferably 0 to 3.0 wt.-%, most preferably 0 to 2.0 wt.-%.

[0051] The veterinary composition according to the invention comprises one or more binders.

[0052] Preferred binders include but are not limited to microcrystalline cellulose, hydroxypropyl cellulose, hydroxypropyl methyl cellulose (hypromellose), ethyl cellulose, polyvinylpyrrolidone (e.g., povidone (Kol- lidon 25, 30, and 90) and co-povidone (Kollidon VA 64), polyethylene glycol, lauroyl macrogol-32 glycerides, stearoyl macrogol-32 glycerides, stearate 6000 WL 1644, glyceryl stearate, glyceryl palmitostearate, glyceryl behenate, cetyl palmitate, hydrogenated castor oil, hydrogenated vegetable oil, stearyl alcohol, paraffin, microcrystalline wax, beeswax, carnauba wax, acacia, xanthan gum, tragacanth gum, gelatin, sucrose, lactose (e.g., hydrous, anhydrous, monohydrate), xylitol, sorbitol, maltitol, com starch, potato starch, carnauba wax, alginate, poloxamer, polyvinyl caprolactam-polyvinyl acetate-polyethylene glycol graft co-pol- ymer and mixtures thereof.

[0053] In preferred embodiments of the veterinary composition according to the invention, the one or more binders are selected from polyethylene glycol, xanthan gum, poloxamer, polyvinyl caprolactam-polyvinyl acetate-polyethylene glycol graft co-polymer and combinations thereof.

[0054] Preferably, relative to the total weight of the veterinary composition, the weight content of the one or more binders is within the range of from 1.0 to 15 wt.-%, preferably 2.0 to 12 wt.-%, most preferably 3.0 to 10 wt.-%.

[0055] The veterinary composition according to the invention optionally comprises one or more lubricants.

[0056] In preferred embodiments of the veterinary composition according to the invention, the one or more lubricants are selected from magnesium stearate, glyceryl monostearate, sodium stearyl fumarate, stearic acid, and combinations thereof.

[0057] Preferably, relative to the total weight of the veterinary composition, the weight content of the one or more lubricants is within the range of from 0 to 5.0 wt.-%, preferably 0 to 3.0 wt.-%, most preferably 0 to 2.0 wt.-%.

[0058] The veterinary composition according to the invention comprises one or more humectants.

[0059] Preferred humectants include but are not limited to hydrous and anhydrous solvents. Preferred humectants include but are not limited to mineral oil, glycerin, glycerol formal, miglyol (e.g., miglyol 812, miglyol 840), Solutol HS 15 (poly glycol mono- and di-esters of 12-hydroxystearic acid), ethylene glycol, propylene glycol, methoxypropanol, diethylene glycol monoethyl ether, diethylene glycol monomethyl ether, diethylene glycol monobutyl ether, tetraglycol, triethylene glycol, butyl diglycol, dimethylacetamide, dimethylformamide, n-methylformamide, dipropylene glycol n-butyl ether, ethanol, isopropanol, methanol, ethylene glycol monoethyl ether, ethylene glycol monomethyl ether, dipropyleneglycol monomethyl ether, dipropyleneglycol monomethyl ether, dipropyleneglycol monomethyl ether, triethylene glycol monoethyl ether, triethylene glycol monomethyl ether, polyethylene glycols, methoxypolyethylene glycols, polypropylene glycols, polybutylene glycols, diethylene monoethylether acetate, diethylene monobutylether acetate, monomethylacetamide, liquid polyoxyethylene glycols, 2-pyrrolidone, propylene carbonate, butylene carbonate, tetrahydrofurfuryl alcohol, solketal, xylene, dimethyl isosorbide, short-, medium- and long chain, and aromatic fatty acids, for example butyric acid, capric acid, succinic, adipic, sebacic, capriylic acid, lauric acid, myristic acid, stearic acid, linoleic acid, and benzoic acid, triglycerides, for example, castor oil, cottonseed oil, sesame oil, linseed oil, safflower oil, peanut oil, soybean oil, coconut oil, olive oil, com oil, and almond oil.

[0060] Humectants may also include glyceryl stearates, glyceryl hexanoates, caprylic / capric glycerides, triacetin, glyceryl cocoate, caprylic glycerides, glyceryl, glyceryl stearates, glyceryl hexanoates, glyceryl monooleate, glyceryl ricinoleate, capric glycerides, succinic acid, isopropyl myristate, ethyl oleate, ethyl laurate, dibutyl adipate, propylene glycol monocaprylate, propylene glycol monolaurate, spider esters, dibutyl sebacate, dibutyl adipate, 2-pyrrolidone, and N-methyl pyrrolidone.

[0061] In preferred embodiments of the veterinary composition according to the invention, the one or more humectants are selected from glycerol, sorbitol, maltitol, and combinations thereof.

[0062] Preferably, relative to the total weight of the veterinary composition, the weight content of the one or more humectants is within the range of from 1 to 30 wt.-%, preferably 3 to 25 wt.-%, most preferably 5.0 to 20 wt.-%.

[0063] The veterinary composition according to the invention optionally comprises one or more glidants.

[0064] In preferred embodiments of the veterinary composition according to the invention, the one or more glidants are selected from colloidal silicon dioxide, talc, ascorbyl palmitate, calcium palmitate, and combinations thereof.

[0065] Preferably, relative to the total weight of the veterinary composition, the weight content of the one or more glidants is within the range of from 0 to 5.0 wt.-%, preferably 0 to 3.0 wt.-%, most preferably 0 to 2.0 wt.-%.

[0066] The veterinary composition according to the invention optionally comprises one or more disinte- grants.

[0067] Preferred disintegrants include but are not limited to cellulose, carboxymethyl cellulose calcium, carboxymethyl cellulose sodium, hydroxypropyl starch, lactose monohydrate, hydroxypropyl cellulose, cro- spovidone, magnesium aluminum silicate, guar gum, alginic acid, sodium alginate, calcium alginate, chitosan, croscarmellose sodium (e.g., Ac-Di-Sol®), citric acid, and sodium starch glycolate.

[0068] In preferred embodiments of the veterinary composition according to the invention, the one or more disintegrants are selected from sodium starch glycolate, crospovidone, croscarmellose sodium, starch, and combinations thereof.

[0069] Preferably, relative to the total weight of the veterinary composition, the weight content of the one or more disintegrants is within the range of from 0 to 50 wt.-%, preferably 0 to 45 wt.-%, most preferably 0 to 40 wt.-%.

[0070] The veterinary composition according to the invention optionally comprises one or more diluents.

[0071] In preferred embodiments of the veterinary composition according to the invention, the one or more diluents are selected from starch, microcrystalline cellulose, mannitol, lactose, and combinations thereof.

[0072] Preferably, relative to the total weight of the veterinary composition, the weight content of the one or more diluents is within the range of from 0 to 20 wt.-%, preferably 0 to 15 wt.-%, most preferably 0 to 10 wt.-%.

[0073] The veterinary composition according to the invention may comprise one or more surfactants. Surfactants may be nonionic, anionic, cationic, or zwitterionic. Preferred surfactants include but are not limitedto macrogol 15 hydroxystearate, sodium lauryl sulfate, polyoxyethylene sorbitan fatty acid esters, sorbitan laurate, sorbitan stearate and combinations thereof.

[0074] In preferred embodiments of the veterinary composition according to the invention, the one or more surfactants are selected from polyoxyethylene sorbitan fatty acid esters, sodium lauryl sulfate and combinations thereof.

[0075] In preferred embodiments, the veterinary composition according to the invention comprises or essentially consists of o Oclacitinib maleate; o (i) one or more animal based palatants and / or (ii) one or more non-animal based palatants; preferably (i) one or more animal based palatants, or (ii) one or more non-animal based palatants; selected from pork liver powder, artificial meat flavor, soy based pork flavor, and Brewer's yeast; o sodium chloride; o polyethylene glycol; o xanthan gum; o glyceryl monostearate; o magnesium stearate; o glycerol; o silicon dioxide; o croscarmellose sodium; and o starch.

[0076] In particularly preferred embodiments, the veterinary composition according to the invention comprises or essentially consists of o Oclacitinib maleate; o pork liver powder; o sodium chloride; o polyethylene glycol; o xanthan gum; o glyceryl monostearate; o magnesium stearate; o glycerol; o silicon dioxide; o croscarmellose sodium; and o starch.

[0077] Preferably, the veterinary composition according to the invention comprises or essentially consists of o 2.9±1.5 wt.-% Oclacitinib maleate; o 76.0±20 wt.-% pork liver powder; preferably 76.0±15 wt.-%, more preferably 76.0±10 wt.-%, still more preferably 76.0±5.0 wt.-%; o 0.5±0.3 wt.-% sodium chloride; o 5.0±2.5 wt. -% polyethylene glycol; o 0.5±0.3 wt.-% xanthan gum; o 0.7±0.4 wt.-% glyceryl monostearate; o 0.7±0.4 wt.-% magnesium stearate; o 7.5±4.0 wt.-% glycerol; o 1.0±0.5 wt.-% silicon dioxide; o 2.6±1.3 wt.-% croscarmellose sodium; and o 2.6± 1.3 wt. -% starch.

[0078] In further particularly preferred embodiments, the veterinary composition according to the invention comprises or essentially consists of o Oclacitinib maleate; o pork liver powder; o sodium chloride; o polyethylene glycol; o xanthan gum; o glyceryl monostearate; o magnesium stearate; o glycerol; o silicon dioxide; o croscarmellose sodium; and o starch.

[0079] Preferably, the veterinary composition according to the invention comprises or essentially consists of o 2.9±1.5 wt.-% Oclacitinib maleate; o 38.0±19.0 wt.-% pork liver powder; preferably 38.0±15 wt.-%, more preferably 38.0±10 wt.-%, still more preferably 38.0±5.0 wt.-%; o 0.5±0.3 wt.-% sodium chloride;o 5.4±2.7 wt.-% polyethylene glycol; o 0.5±0.3 wt.-% xanthan gum; o 0.7±0.4 wt.-% glyceryl monostearate; o 0.7±0.4 wt.-% magnesium stearate; o 13.0±6.5 wt.-% glycerol; o 1.0±0.5 wt.-% silicon dioxide; o 3.3±1.7 wt.-% croscarmellose sodium; and o 34.0±17.0 wt.-% starch.

[0080] In other particularly preferred embodiments, the veterinary composition according to the invention comprises or essentially consists of o Oclacitinib maleate; o artificial meat flavor; o Brewer's yeast; o sodium chloride; o polyethylene glycol; o xanthan gum; o glyceryl monostearate; o magnesium stearate; o glycerol; o silicon dioxide; o croscarmellose sodium; and o starch.

[0081] Preferably, the veterinary composition according to the invention comprises or essentially consists of o 2.9±1.5 wt.-% Oclacitinib maleate; o 40.0±20.0 wt.-% artificial meat flavor; preferably 40.0±15 wt.-%, more preferably 40.0±10 wt.-%, still more preferably 40.0±5.0 wt.-%; o 7.0±3.5 wt.-% Brewer's yeast; o 0.5±0.3 wt.-% sodium chloride; o 6.0±3.0 wt. -% polyethylene glycol; o 1.0±0.5 wt. -% xanthan gum; o 0.7±0.4 wt.-% glyceryl monostearate; o 0.9±0.5 wt.-% magnesium stearate;o 13.0±6.5 wt.-% glycerol; o 1.0±0.5 wt.-% silicon dioxide; o 6.0±2.0 wt.-% croscarmellose sodium; and o 21.0± 10.5 wt. -% starch.

[0082] In additional particularly preferred embodiments, the veterinary composition according to the invention comprises or essentially consists of o Oclacitinib maleate; o soy based pork flavor; o Brewer's yeast; o sodium chloride; o polyethylene glycol; o xanthan gum; o glyceryl monostearate; o magnesium stearate; o glycerol; o silicon dioxide; o croscarmellose sodium; and o starch.

[0083] Preferably, the veterinary composition according to the invention comprises or essentially consists of o 2.9±1.5 wt.-% Oclacitinib maleate; o 51.0±25.5 wt.-% soy based pork flavor; preferably 51.0±15 wt.-%, more preferably 51.0±10 wt.-%, still more preferably 51.0±5.0 wt.-%; o 7.0±3.5 wt.-% Brewer's yeast; o 0.5±0.3 wt.-% sodium chloride; o 6.0±3.0 wt. -% polyethylene glycol; o 0.5±0.3 wt. -% xanthan gum; o 0.7±0.4 wt.-% glyceryl monostearate; o 0.7±0.4 wt.-% magnesium stearate; o 13.0±6.5 wt.-% glycerol; o 1.0±0.5 wt.-% silicon dioxide; o 4.0±2.0 wt.-% croscarmellose sodium; and o 12.7±6.4 wt. -% starch.

[0084] In additional particularly preferred embodiments, the veterinary composition according to the invention comprises or essentially consists of o Oclacitinib maleate or Oclacitinib free base; o glyceryl monostearate; o polyethylene glycol, optionally in combination with xanthan gum; o glycerol; o pork liver powder; o silicon dioxide; o croscarmellose sodium and / or crospovidone; o starch and / or microcry stalline cellulose; o sodium chloride; and o magnesium stearate.

[0085] Preferably, the veterinary composition according to the invention is palatable.

[0086] Preferably, the veterinary composition according to the invention is chewable.

[0087] Preferably, the veterinary composition according to the invention is a palatable soft chew veterinary composition.

[0088] Preferably, the veterinary composition according to the invention has been prepared by granulation.

[0089] Preferably, the veterinary composition according to the invention has been prepared by melt granulation.

[0090] Melt granulation is advantageous because the granulate can be produced using melt granulation technique, where a binder is added to a mixture of powders. This mixture is then heated to the desired temperature to achieve particle granulation. This technological approach requires less specialized equipment compared to the processes of the prior art, e.g. WO 2020 / 172232, where the binder is dissolved in glycerol at 90-100°C and where maintaining the binder in dissolved form requires keeping the temperature above 70°C, i.e. specialized equipment with heated pipes and spraying nozzles.

[0091] When the veterinary composition according to the invention is prepared by melt granulation, the procedure can be expedited because no binder needs to be dissolved in glycerol. Consequently, melt-granulated veterinary compositions according to the invention have economic advantages compared to the compositions obtained in accordance with the prior art, e.g. WO 2020 / 172232.

[0092] Another advantage of melt granulation is that the hot granulate can simply be cooled or be allowed to cool to ambient temperature. In contrast, prior art manufacturing processes such as those described inWO 2020 / 172232 involve curing the granulate for about 1 to 3 hours in a fluid bed dryer. This is disadvantageous because it significantly extends the production duration of the formulation.

[0093] Preferably, the veterinary composition according to the invention comprises or essentially consists of an intragranular phase and an extragranular phase.

[0094] Preferably, the intragranular phase comprises or essentially consists of o at least a portion of Oclacitinib or physiologically acceptable salt thereof; o at least a portion of (i) one or more animal based palatants and / or (ii) one or more non-animal based palatants; preferably (i) one or more animal based palatants, or (ii) one or more non-animal based palatants; o at least a portion of one or more flavor modifiers; o at least a portion of the one or more binders; o at least a portion of one or more disintegrants; o at least a portion of one or more glidants; and o optionally, at least a portion of one or more lubricants.

[0095] Preferably, the extragranular phase comprises or essentially consists of o optionally, at least a portion of one or more glidants; o at least a portion of one or more disintegrants; o optionally, at least a portion of (i) one or more animal based palatants and / or (ii) one or more non-animal based palatants; preferably (i) one or more animal based palatants, or (ii) one or more non-animal based palatants; and o at least a portion of one or more lubricants.

[0096] Another aspect of the invention relates to a veterinary dosage form, preferably tablet comprising the veterinary composition according to the invention as described above.

[0097] Preferably, the veterinary dosage form, preferably tablet according to the invention is chewable.

[0098] Preferably, the veterinary dosage form, preferably tablet according to the invention is palatable.

[0099] In preferred embodiments, the veterinary dosage form, preferably tablet according to the invention contains 3.6 mg Oclacitinib, preferably as Oclacitinib maleate.

[0100] In further preferred embodiments, the veterinary dosage form, preferably tablet according to the invention contains 5.4 mg Oclacitinib, preferably as Oclacitinib maleate.

[0101] In other preferred embodiments, the veterinary dosage form, preferably tablet according to the invention contains 16 mg Oclacitinib, preferably as Oclacitinib maleate.

[0102] Another aspect of the invention relates to the veterinary dosage form, preferably tablet according to the invention as described above, that comprises a coating, preferably a palatable coating.

[0103] The coated veterinary dosage form preferably comprises or essentially consists of a core and a coating, whereas the coating is palatable and preferably comprises (i) one or more animal based palatants and / or (ii) one or more non-animal based palatants. In preferred embodiments, the core comprises neither animal based palatants nor non-animal based palatants.

[0104] In preferred embodiments, the core comprises or essentially consists of o Oclacitinib maleate or Oclacitinib free base; o one or more diluents; preferably microcrystalline cellulose; o one or more binders; preferably lactose; more preferably lactose monohydrate; o one or more disintegrants; preferably selected from sodium starch glycolate and crospovidone; o optionally, one or more lubricants.

[0105] In preferred embodiments, the palatable coating comprises or essentially consists of o one or more binders; preferably hypromellose; o one or more glidants; preferably talc; o one or more humectants; preferably propylene glycol; o one or more animal based palatants; preferably pork liver powder; o optionally, one or more one or more non-animal based palatants; preferably Brewer's yeast; o optionally, one or more colorants.

[0106] Another aspect of the invention relates to the veterinary composition according to the invention as described above or the veterinary dosage form, preferably tablet according to the invention as described above for use in the treatment of pruritus, preferably caused by a parasitic infection or infestation in an animal, preferably dog.

[0107] “Animal”, as used herein, unless otherwise indicated, refers to an individual animal that is a mammal. Specifically, mammal refers to a vertebrate animal that is human and non-human, which are members of the taxonomic class Mammalia. Non-exclusive examples of non-human mammals include companion animals and livestock. Non-exclusive examples of a companion animal include: dog, cat, and horse. Preferred companion animals are dog and cat. More preferred is dog. Non-exclusive examples of livestock include: pig, llama, rabbits, goat, sheep, deer, elk, and cattle.

[0108] “Infection” or Infestation”, as used herein, unless otherwise indicated, refers to the state or condition of having parasites on or in the body.

[0109] Preferably, the veterinary composition and veterinary dosage form are for the treatment and prevention of atopic dermatitis, pruritus associated with allergic dermatitis and allergies in a companion animal. Preferably, the companion animal is a dog or horse.

[0110] Another aspect of the invention relates to a process for the preparation of the veterinary composition according to the invention as described above or of a veterinary dosage form according to the invention as described above, said process comprising the step of(a) melt granulating a mixture comprising Oclacitinib or physiologically acceptable salt thereof and one or more binders.

[0111] Preferably, the process comprises the steps of:(a) mixing Oclacitinib or physiologically acceptable salt thereof with one or more palatants, one or more flavor modifiers (e.g. sodium chloride), one or more binders (e.g., polyethylene glycol and xanthan gum), one or more disintegrants (e.g., croscarmellose sodium and starch), one or more glidants (e.g., silicon dioxide), and optionally one or more lubricants (e.g., magnesium stearate and glyceryl monostearate) at elevated temperature to prepare a granulate with melt granulation;(b) optionally, heating one or more humectants (e.g. glycerol) to 50-100°C;(c) optionally, mixing one or more humectants (e.g. glycerol) with the granulate;(d) milling the granulate;(e) optionally, curing the granulate;(f) providing an extragranular mixture comprising one or more glidants (e.g., silicon dioxide), one or more disintegrants (e.g., croscarmellose sodium and starch), and one or more palatants (e.g., pork liver and brewer’s yeast)(g) blending the extragranular mixture;(h) milling the extragranular mixture;(i) blending the optionally cured granulate with the extragranular mixture;(j) sifting one or more lubricants (e.g., magnesium stearate and glyceryl monostearate) into the blend;(k) blending the mixture of the blend and the one or more lubricants;(l) compressing the final blend to prepare tablets; and(m) packaging tablets in bottles and / or blisters.

[0112] Preferably, step (a) is performed by means of high shear granulator.

[0113] Preferably, step (a) is performed at an elevated temperature of 50-80°C.

[0114] Preferably, step (c) is performed at high speed with impeller and chopper.

[0115] Preferably, step (e) is performed for 1-3 hours.

[0116] Preferably, step (e) is performed at 20-80°C.

[0117] Preferably, step (e) is performed by means of a fluid bed dryer.

[0118] Preferably, step (i) is performed by means of a bin blender.

[0119] Preferably, step (k) is performed by means of a bin blender.

[0120] Preferably, step (1) is performed by means of a rotary press.EXAMPLES

[0121] The following examples further illustrate the invention but are not to be construed as limiting its scope.Examples 1 to 4:

[0122] Compositions containing the following ingredients in the following amounts are prepared:

[0123] Active agent (oclacitinib maleate) is mixed in high shear granulator with one or more palatants, flavor modifier (e.g. sodium chloride), one or more binders (e.g., polyethylene glycol and xanthan gum), one or more disintegrants (e.g., croscarmellose sodium and starch), glidant (e.g., silicon dioxide), and optionally one or more lubricants (e.g., magnesium stearate and glyceryl monostearate).

[0124] While mixing, dry blend is heated to 50-80°C, to prepare granulate with melt granulation.

[0125] Glycerol is optionally heated to 50-100°C. Glycerol is mixed with the granulate. Mixture of granulate and glycerol is mixed at higher speeds with impeller and chopper. Prepared granulate is milled and then cured for 1 -3 hours at 20-80°C in fluid bed dryer.

[0126] Extragranular mixture is comprised ofglidant (e.g., silicon dioxide), one or more disintegrants (e.g., croscarmellose sodium and starch), one or more palatants (e.g., pork liver and brewer’s yeast). Components of extragranular mixture are blended together and then milled. Cured granulate is blended with extragranular mixture in bin blender. One or more lubricants (e.g., magnesium stearate and glyceryl monostearate) are sifted into the blend. Mixture of blend and one or more lubricants is blended in bin blender.

[0127] Final blend is compressed using a rotary tablet press. Tablets are packaged in bottles and / or blisters.Examples 5 to 10 - chewable tablets:

[0128] Chewable tablets having the following compositions were prepared:

[0129] Example 5:

[0130] Oclacitinib maleate was mixed with intragranular excipients, except glycerol, in a high shear granulator. While mixing, dry blend was heated to 70°C to prepare a granulate with melt granulation. Glycerol was heated to 85 °C and mixed with the granulate at higher speeds with impeller and chopper. Prepared granulate was cooled to about 20 to 30°C in a fluidized bed dryer. Cooled granulate was milled. Extragran- ular croscarmellose sodium and com starch were added and blended together with the granulate in a bin blender. Magnesium stearate was sifted into the blend, the obtained mixture was blended in the bin blender and compressed using a rotary tablet press.

[0131] Example 6

[0132] Oclacitinib maleate was mixed with intragranular excipients, except glycerol, in a high shear granulator. While mixing, dry blend was heated to 60°C to prepare a granulate with melt granulation. Glycerol was heated to 85 °C and mixed with the granulate at higher speeds with impeller and chopper. Prepared granulate was cooled in a convection dryer to about 20 to 30°C and milled. Extragranular croscarmellose sodium and com starch were added and blended together with the granulate in a bin blender. Magnesium stearate was sifted into the blend, the obtained mixture was blended in the bin blender and compressed using a rotary tablet press.

[0133] Example 7:

[0134] Binder solution was prepared by dissolving PEG 3350 and glyceryl monostearate in glycerol at 85- 100°C. Oclacitinib maleate was mixed with the remaining intragranular excipients in a high shear granulator. While mixing, dry blend was heated to 70°C to prepare a granulate with melt granulation. Binder solution was mixed with the granulate at higher speeds with impeller and chopper. Prepared granulate was milled and then cured for 0.5 to 3 hours at between 50 and 60°C in a fluidized bed dryer. Cured granulate was cooled to about 20 to 30°C in fluidized bed dryer. Cooled granulate was milled. Extragranular croscarmel- lose sodium and com starch were added and blended together with the granulate in a bin blender. Magnesium stearate was sifted into the blend, the obtained mixture was blended in the bin blender and compressed using a rotary tablet press.

[0135] Example 8:

[0136] Oclacitinib maleate was mixed with intragranular excipients, except glycerol, in a high shear granulator. While mixing, dry blend was heated to 55°C to prepare a granulate with melt granulation. Glycerol was heated to about 80 to 100°C and mixed with the granulate at higher speeds with impeller and chopper. Prepared granulate was milled and then cured for 0.5 to 3 hours at between 50 and 60°C in a fluidized bed dryer. Cured granulate was cooled to about 20 to 30°C in the fluidized bed dryer. Cooled granulate was milled. Extragranular croscarmellose sodium and com starch were added and blended together with the granulate in a bin blender. Magnesium stearate was sifted into the blend, the obtained mixture was blended in the bin blender and compressed using a rotary tablet press.

[0137] Example 9:

[0138] Oclacitinib maleate was mixed with intragranular excipients, except glycerol, in a high shear granulator. While mixing, dry blend was heated to 70°C to prepare a granulate with melt granulation. Glycerol at room temperature was mixed with the granulate at higher speeds with impeller and chopper. Prepared granulate was cooled in a convection dryer to about 20 to 30°C and then milled. Extragranular croscarmellose sodium and com starch were added and blended together with the granulate in a bin blender. Magnesium stearate was sifted into the blend, the obtained mixture was blended in the bin blender and compressed using a rotary tablet press.

[0139] Example 10:

[0140] Oclacitinib base was mixed with intragranular excipients, except glycerol, in a high shear granulator. While mixing, dry blend was heated to 70°C to prepare a granulate with melt granulation. Glycerol was heated to 85 °C and mixed with the granulate at higher speeds with impeller and chopper. Prepared granulate was milled and then cooled to about 20 to 30°C in a fluidized bed dryer. Cooled granulate was milled. Extragranular croscarmellose sodium and com starch were added and blended together with the granulatein a bin blender. Magnesium stearate was sifted into the blend, the obtained mixture was blended in the bin blender and compressed using a rotary tablet press.Examples 11 to 13 - coated tablets:

[0141] Coated tablets having the following compositions were prepared:

[0142] Example IT.

[0143] Oclacitinib maleate was mixed with microcrystalline cellulose, lactose monohydrate, and sodium starch glycolate in a bin blender. Magnesium stearate was sifted into the blend. The obtained mixture was mixed in the bin blender and compressed using a rotary tablet press.

[0144] In preparing the palatable coating suspension, hypromellose was mixed with purified water to form a uniform suspension. Separately yellow and red iron oxide was mixed with purified water and homogenized. Separately, talc, pork liver powder, and brewer's yeast were combined in water and homogenized. The hypromellose suspension and iron oxide suspensions were added to this mixture, along with propylene glycol. The combined suspension underwent additional mixing for uniform dispersion. Tablet cores were coated with a palatable coating dispersion.

[0145] Example 12'.

[0146] Oclacitinib maleate was mixed with microcrystalline cellulose, lactose monohydrate, and cro- spovidone in a bin blender. Magnesium stearate was sifted into the blend. The obtained mixture was mixed in the bin blender and compressed using a rotary tablet press.

[0147] In preparing the palatable coating suspension, hypromellose was mixed with purified water to form a uniform suspension. Separately yellow and red iron oxide was mixed with purified water and homogenized. Separately, talc, pork liver powder, and brewer's yeast were combined in water and homogenized. The hypromellose suspension and iron oxide suspensions were added to this mixture, along with propylene glycol. The combined suspension underwent additional mixing for uniform dispersion. Tablet cores were coated with a palatable coating dispersion.

[0148] Example 13:

[0149] Oclacitinib base was mixed with microcrystalline cellulose, lactose monohydrate, sodium starch glycolate in a bin blender. Magnesium stearate was sifted into the blend. The obtained mixture was mixed in the bin blender and compressed using a rotary tablet press.

[0150] In preparing the palatable coating suspension, hypromellose was mixed with purified water to form a uniform suspension. Separately yellow and red iron oxide was mixed with purified water and homogenized. Separately, talc and pork liver powder were combined in water and homogenized. The hypromellose suspension and iron oxide suspensions were added to this mixture, along with propylene glycol. The combined suspension underwent additional mixing for uniform dispersion. Tablet cores were coated with a palatable coating dispersion.Examples 14 to 17 - chewable tablets:

[0151] Chewable tablets having the following compositions were prepared:

[0152] Oclacitinib maleate was mixed with intragranular excipients, except glycerol, in a high shear granulator. While mixing, dry blend was heated to 70°C to prepare a granulate with melt granulation. Glycerol was heated to 85 °C and mixed with the granulate at higher speeds with impeller and chopper. Prepared granulate was cooled to about 20 to 30°C in a fluidized bed dryer. Cooled granulate was milled. Extragran- ular croscarmellose sodium and com starch were added and blended together with the granulate in a bin blender. Magnesium stearate was sifted into the blend, the obtained mixture was blended in the bin blender and compressed using a rotary tablet press.

Claims

Patent claims:

1. A veterinary composition comprising or essentially consisting of o Oclacitinib or a physiologically acceptable salt thereof; o optionally, one or more animal based palatants; o optionally, one or more non-animal based palatants; o optionally, one or more flavor modifiers; o one or more binders; o optionally, one or more lubricants; o one or more humectants; o optionally, one or more glidants; o optionally, one or more disintegrants; and o optionally, one or more diluents.

2. The veterinary composition according to claim 1, which comprises one or more animal based palatants but which does not contain Brewer's yeast; preferably not any yeast; more preferably not any non-animal based palatants.

3. The veterinary composition according to claim 1 or 2, wherein relative to the total weight of the veterinary composition, the total weight content of all animal and / or non-animal based palatants is at most 62.0 wt.-%; preferably at most 61.0 wt.-%; more preferably at most 60.0 wt.-%; still more preferably at most 59.0 wt.-%; yetmore preferably at most 58.0 wt.-%; even more preferably at most 57.0 wt.-%; most preferably at most 56.0 wt.-%; and in particular at most 55.0 wt.-%.

4. The veterinary composition according to any of the preceding claims, wherein relative to the total weight of the veterinary composition, the total weight content of all animal and / or non-animal based palatants is at most 54.0 wt.-%; preferably at most 53.0 wt.-%; more preferably at most 52.0 wt.-%; still more preferably at most 51.0 wt.-%; yet more preferably at most 50.0 wt.-%; even more preferably at most 49.0 wt.-%; most preferably at most 48.0 wt-%; and in particular at most 47.0 wt.-%.

5. The veterinary composition according to any of the preceding claims, wherein relative to the total weight of the veterinary composition, the total weight content of all animal and / or non-animal based palatants is at most 46.0 wt.-%; preferably at most 45.0 wt.-%; more preferably at most 44.0 wt.-%;still more preferably at most 43.0 wt.-%; yet more preferably at most 42.0 wt.-%; even more preferably at most 41.0 wt.-%; most preferably at most 40.0 wt.-%; and in particular at most 39.0 wt.-%.

6. The veterinary composition according to any of the preceding claims, wherein relative to the total weight of the veterinary composition, the weight content of the one or more animal based palatants, preferably pork liver powder, is within the range of 76±20 wt.-%, more preferably 76±15 wt.-%, still more preferably 76±10 wt.-%, and yet more preferably 76±5.0 wt.-%.

7. The veterinary composition according to any of the preceding claims, wherein relative to the total weight of the veterinary composition, the weight content of the one or more animal based palatants, preferably pork liver powder, is within the range of 38±20 wt.-%, more preferably 38±15 wt.-%, still more preferably 38±10 wt.-%, and yet more preferably 38±5.0 wt.-%.

8. The veterinary composition according to any of the preceding claims, which comprises one or more non-animal based palatants but which does not contain animal based palatants.

9. The veterinary composition according to any of the preceding claims, wherein relative to the total weight of the veterinary composition, the weight content of the one or more non-animal based palatants, preferably artificial meat flavor and / or Brewer's yeast, is within the range of 47±20 wt.-%, more preferably 47±15 wt.-%, still more preferably 47±10 wt.-%, and yet more preferably 47±5.0 wt.-%.

10. The veterinary composition according to any of the preceding claims, wherein relative to the total weight of the veterinary composition, the weight content of the one or more non-animal based palatants, preferably soy based pork flavor and / or Brewer's yeast, is within the range of 58±20 wt.-%, more preferably 58±15 wt.-%, still more preferably 58±10 wt.-%, and yet more preferably 58±5.0 wt.-%.

11. The veterinary composition according to any of the preceding claims, which comprises or essentially consists of o Oclacitinib or a physiologically acceptable salt thereof; o (i) one or more animal based palatants and / or (ii) one or more non-animal based palatants; preferably (i) one or more animal based palatants, or (ii) one or more non-animal based palatants; o one or more flavor modifiers;o one or more binders; o one or more lubricants; o one or more humectants; o one or more glidants; o one or more disintegrants; and o one or more diluents.

12. The veterinary composition according to any of the preceding claims, wherein Oclacitinib is present as Oclacitinib maleate.

13. The veterinary composition according to any of the preceding claims, wherein Oclacitinib is present as Oclacitinib free base.

14. The veterinary composition according to any of the preceding claims, wherein the one or more animal based palatants are selected from pork liver powder, dried meat, and combinations thereof; preferably pork liver powder.

15. The veterinary composition according to any of the preceding claims, wherein the one or more nonanimal based palatants are selected from artificial meat flavor, Brewer’s yeast, soy based pork flavor, and combinations thereof.

16. The veterinary composition according to any of the preceding claims, wherein the one or more flavor modifiers are selected from sodium chloride, potassium chloride, and combinations thereof.

17. The veterinary composition according to any of the preceding claims, wherein the one or more binders are selected from polyethylene glycol, xanthan gum, poloxamer, polyvinyl caprolactam-polyvinyl acetate-polyethylene glycol graft co-polymer and combinations thereof.

18. The veterinary composition according to any of the preceding claims, wherein the one or more lubricants are selected from magnesium stearate, glyceryl monostearate, sodium stearyl fumarate, stearic acid, and combinations thereof.

19. The veterinary composition according to any of the preceding claims, wherein the one or more humectants are selected from glycerol, sorbitol, maltitol, and combinations thereof.

20. The veterinary composition according to any of the preceding claims, wherein the one or more glidants are selected from colloidal silicon dioxide, talc, ascorbyl palmitate, calcium palmitate, and combinations thereof.

21. The veterinary composition according to any of the preceding claims, wherein the one or more disin- tegrants are selected from sodium starch glycolate, crospovidone, croscarmellose sodium, starch, and combinations thereof.

22. The veterinary composition according to any of the preceding claims, wherein the one or more diluents are selected from starch, microcrystalline cellulose, mannitol, lactose, and combinations thereof.

23. The veterinary composition according to any of the preceding claims, which comprises one or more surfactants.

24. The veterinary composition according to claim 23, wherein the one or more surfactants are selected from macrogol 15 hydroxystearate, sodium lauryl sulfate, polyoxyethylene sorbitan fatty acid esters, sorbitan laurate, sorbitan stearate and combinations thereof.

25. The veterinary composition according to claim 23 or 24, wherein the one or more surfactants are selected from polyoxyethylene sorbitan fatty acid esters, sodium lauryl sulfate and combinations thereof.

26. The veterinary composition according to any of the preceding claims, wherein relative to the total weight of the veterinary composition, the weight content of Oclacitinib or a physiologically acceptable salt thereof is within the range of from 0. 1 to 10 wt.-%, preferably 0.5 to 7.5 wt.-%, most preferably 1.0 to 5.0 wt.-%.

27. The veterinary composition according to any of the preceding claims, wherein relative to the total weight of the veterinary composition, the weight content of the one or more animal based palatants is within the range of from 0 to 90 wt.-%, preferably 0 to 85 wt.-%, most preferably 0 to 80 wt.-%.

28. The veterinary composition according to any of the preceding claims, wherein relative to the total weight of the veterinary composition, the weight content of the one or more non-animal based pal- atants is within the range of from 0 to 90 wt.-%, preferably 0 to 85 wt.-%, most preferably 0 to 80 wt.-%.

29. The veterinary composition according to any of the preceding claims, wherein relative to the total weight of the veterinary composition, the weight content of the one or more flavor modifiers is within the range of from 0 to 5.0 wt.-%, preferably 0 to 3.0 wt.-%, most preferably 0 to 2.0 wt.-%.

30. The veterinary composition according to any of the preceding claims, wherein relative to the total weight of the veterinary composition, the weight content of the one or more binders is within the range of from 1.0 to 15 wt.-%, preferably 2.0 to 12 wt.-%, most preferably 3.0 to 10 wt.-%.

31. The veterinary composition according to any of the preceding claims, wherein relative to the total weight of the veterinary composition, the weight content of the one or more lubricants is within the range of from 0 to 5.0 wt.-%, preferably 0 to 3.0 wt.-%, most preferably 0 to 2.0 wt.-%.

32. The veterinary composition according to any of the preceding claims, wherein relative to the total weight of the veterinary composition, the weight content of the one or more humectants is within the range of from 1 to 30 wt.-%, preferably 3 to 25 wt.-%, most preferably 5.0 to 20 wt.-%.

33. The veterinary composition according to any of the preceding claims, wherein relative to the total weight of the veterinary composition, the weight content of the one or more glidants is within the range of from 0 to 5.0 wt.-%, preferably 0 to 3.0 wt.-%, most preferably 0 to 2.0 wt.-%.

34. The veterinary composition according to any of the preceding claims, wherein relative to the total weight of the veterinary composition, the weight content of the one or more disintegrants is within the range of from 0 to 50 wt.-%, preferably 0 to 45 wt.-%, most preferably 0 to 40 wt.-%.

35. The veterinary composition according to any of the preceding claims, wherein relative to the total weight of the veterinary composition, the weight content of the one or more diluents is within the range of from 0 to 20 wt.-%, preferably 0 to 15 wt.-%, most preferably 0 to 10 wt.-%.

36. The veterinary composition according to any of the preceding claims, which comprises or essentially consists of o Oclacitinib maleate; o (i) one or more animal based palatants and / or (ii) one or more non-animal based palatants; preferably (i) one or more animal based palatants, or (ii) one or more non-animal based palatants; selected from pork liver powder, artificial meat flavor, soy based pork flavor, and Brewer's yeast; o sodium chloride; o polyethylene glycol; o xanthan gum; o glyceryl monostearate; o magnesium stearate; o glycerol; o silicon dioxide; o croscarmellose sodium; and o starch.

37. The veterinary composition according to any of the preceding claims, which comprises or essentially consists of o Oclacitinib maleate; o pork liver powder; o sodium chloride; o polyethylene glycol; o xanthan gum; o glyceryl monostearate; o magnesium stearate; o glycerol; o silicon dioxide; o croscarmellose sodium; and o starch.

38. The veterinary composition according to claim 37, which comprises or essentially consists of o 2.9±1.5 wt.-% Oclacitinib maleate; o 76.0±20 wt. -% pork liver powder; o 0.5±0.3 wt.-% sodium chloride;o 5.0±2.5 wt. -% polyethylene glycol ; o 0.5±0.3 wt.-% xanthan gum; o 0.7±0.4 wt.-% glyceryl monostearate; o 0.7±0.4 wt.-% magnesium stearate; o 7.5±4.0 wt.-% glycerol; o 1 ,0±0.5 wt.-% silicon dioxide; o 2.6±1.3 wt.-% croscarmellose sodium; and o 2.6± 1.3 wt. -% starch.

39. The veterinary composition according to any of the preceding claims, which comprises or essentially consists of o Oclacitinib maleate; o pork liver powder; o sodium chloride; o polyethylene glycol; o xanthan gum; o glyceryl monostearate; o magnesium stearate; o glycerol; o silicon dioxide; o croscarmellose sodium; and o starch.

40. The veterinary composition according to claim 39, which comprises or essentially consists of o 2.9±1.5 wt.-% Oclacitinib maleate; o 38.0± 19.0 wt. -% pork liver powder; o 0.5±0.3 wt.-% sodium chloride; o 5.4±2.7 wt.-% polyethylene glycol; o 0.5±0.3 wt.-% xanthan gum; o 0.7±0.4 wt.-% glyceryl monostearate; o 0.7±0.4 wt.-% magnesium stearate; o 13.0±6.5 wt.-% glycerol; o 1 ,0±0.5 wt.-% silicon dioxide; o 3.3±1.7 wt.-% croscarmellose sodium; ando 34.0±17.0 wt.-% starch.

41. The veterinary composition according to any of the preceding claims, which comprises or essentially consists of o Oclacitinib maleate; o artificial meat flavor; o Brewer's yeast; o sodium chloride; o polyethylene glycol; o xanthan gum; o glyceryl monostearate; o magnesium stearate; o glycerol; o silicon dioxide; o croscarmellose sodium; and o starch.

42. The veterinary composition according to claim 41 , which comprises or essentially consists of o 2.9±1.5 wt.-% Oclacitinib maleate; o 40.0±20.0 wt.-% artificial meat flavor; o 7.0±3.5 wt.-% Brewer's yeast; o 0.5±0.3 wt.-% sodium chloride; o 6.0±3.0 wt. -% polyethylene glycol ; o 1 ,0±0.5 wt.-% xanthan gum; o 0.7±0.4 wt.-% glyceryl monostearate; o 0.9±0.5 wt.-% magnesium stearate; o 13.0±6.5 wt.-% glycerol; o 1 ,0±0.5 wt.-% silicon dioxide; o 6.0±2.0 wt.-% croscarmellose sodium; and o 21.0± 10.5 wt. -% starch.

43. The veterinary composition according to any of the preceding claims, which comprises or essentially consists of o Oclacitinib maleate;o soy based pork flavor; o Brewer's yeast; o sodium chloride; o polyethylene glycol; o xanthan gum; o glyceryl monostearate; o magnesium stearate; o glycerol; o silicon dioxide; o croscarmellose sodium; and o starch.

44. The veterinary composition according to claim 43, which comprises or essentially consists of o 2.9±1.5 wt.-% Oclacitinib maleate; o 51.0±25.5 wt. -% soy based pork flavor; o 7.0±3.5 wt.-% Brewer's yeast; o 0.5±0.3 wt.-% sodium chloride; o 6.0±3.0 wt. -% polyethylene glycol ; o 0.5±0.3 wt.-% xanthan gum; o 0.7±0.4 wt.-% glyceryl monostearate; o 0.7±0.4 wt.-% magnesium stearate; o 13.0±6.5 wt.-% glycerol; o 1.0±0.5 wt. -% silicon dioxide ; o 4.0±2.0 wt.-% croscarmellose sodium; and o 12.7±6.4 wt.-% starch.

45. The veterinary composition according to any of the preceding claims, which comprises or essentially consists of o Oclacitinib maleate or Oclacitinib free base; o glyceryl monostearate; o polyethylene glycol, optionally in combination with xanthan gum; o glycerol; o pork liver powder; o silicon dioxide;o croscarmellose sodium and / or crospovidone; o starch and / or microcrystalline cellulose; o sodium chloride; and o magnesium stearate.

46. The veterinary composition according to any of the preceding claims, which is palatable.

47. The veterinary composition according to any of the preceding claims, which is chewable.

48. The veterinary composition according to any of the preceding claims, which is a palatable soft chew veterinary composition.

49. The veterinary composition according to any of the preceding claims, which has been prepared by granulation.

50. The veterinary composition according to any of the preceding claims, which has been prepared by melt granulation.

51. The veterinary composition according to any of the preceding claims, which comprises or essentially consists of- an intragranular phase; preferably a melt granulated intragranular phase; and- an extragranular phase.

52. The veterinary composition according to claim 51, wherein the intragranular phase comprises or essentially consists of o at least a portion of Oclacitinib or physiologically acceptable salt thereof; o at least a portion of (i) one or more animal based palatants and / or (ii) one or more non-animal based palatants; preferably (i) one or more animal based palatants, or (ii) one or more non-animal based palatants; o at least a portion of one or more flavor modifiers; o at least a portion of the one or more binders; o at least a portion of one or more disintegrants; o at least a portion of one or more glidants; and o optionally, at least a portion of one or more lubricants.

53. The veterinary composition according to claim 51 or 52, wherein the extragranular phase comprises or essentially consists of o optionally, at least a portion of one or more glidants; o at least a portion of one or more disintegrants; o optionally, at least a portion of (i) one or more animal based palatants and / or (ii) one or more nonanimal based palatants; preferably (i) one or more animal based palatants, or (ii) one or more nonanimal based palatants; and o at least a portion of one or more lubricants.

54. A tablet comprising the veterinary composition according to any of the preceding claims.

55. The tablet according to claim 54, which is chewable.

56. The tablet according to claim 54 or 55, which is palatable.

57. The tablet according to any of claims 54 to 56, which comprises a coating; preferably a palatable coating.

58. The tablet according to any of claim 54 to 57, which comprises or essentially consists of a core and a palatable coating, wherein the palatable coating comprises (i) one or more animal based palatants and / or (ii) one or more non-animal based palatants59. The tablet according to claim 58, wherein the core comprises neither animal based palatants nor nonanimal based palatants.

60. The tablet according to claim 58 or 59, wherein the core comprises or essentially consists of o Oclacitinib maleate or Oclacitinib free base; o one or more diluents; preferably microcrystalline cellulose; o one or more binders; preferably lactose; more preferably lactose monohydrate; o one or more disintegrants; preferably selected from sodium starch glycolate and crospovidone; o optionally, one or more lubricants.

61. The tablet according to any of claims 58 to 60, wherein the palatable coating comprises or essentially consists of o one or more binders; preferably hypromellose; o one or more glidants; preferably talc; o one or more humectants; preferably propylene glycol; o one or more animal based palatants; preferably pork liver powder; o optionally, one or more one or more non-animal based palatants; preferably Brewer's yeast; o optionally, one or more colorants.

62. The tablet according to any of claims 54 to 61, which contains 3.6 mg Oclacitinib, preferably as Oclacitinib maleate.

63. The tablet according to any of claims 54 to 61, which contains 5.4 mg Oclacitinib, preferably as Oclacitinib maleate.

64. The tablet according to any of claims 54 to 61, which contains 16 mg Oclacitinib, preferably as Oclacitinib maleate.

65. A process for the preparation of a veterinary composition according to any of claims 1 to 53 or of a tablet according to any of claims 54 to 64, said process comprising the step of(a) melt granulating a mixture comprising Oclacitinib or physiologically acceptable salt thereof and one or more binders.

66. The process according to claim 65, which comprises the steps of:(a) mixing Oclacitinib or physiologically acceptable salt thereof with one or more palatants, one or more flavor modifiers, one or more binders, one or more disintegrants, one or more glidants, and optionally one or more lubricants at elevated temperature to prepare a granulate with melt granulation;(b) optionally, heating one or more humectants (e.g. glycerol) to 50-100°C;(c) optionally, mixing one or more humectants (e.g. glycerol) with the granulate;(d) milling the granulate;(e) optionally, curing the granulate;(f) providing an extragranular mixture comprising one or more glidants (e.g., silicon dioxide), one or more disintegrants (e.g., croscarmellose sodium and starch), and one or more palatants (e.g., pork liver and brewer’s yeast)(g) blending the extragranular mixture;(h) milling the extragranular mixture;(i) blending the optionally cured granulate with the extragranular mixture;(j) sifting one or more lubricants (e.g., magnesium stearate and glyceryl monostearate) into the blend;(k) blending the mixture of the blend and the one or more lubricants;(l) compressing the final blend to prepare tablets; and(m) packaging tablets in bottles and / or blisters.

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