Rice starch based soft chews

Abstract

The present invention relates to a soft chew formulation comprising at least one dietary supplement ingredient and / or at least one pharma- ceutical active, up to 6% by weight of an oil, fat, or mixture thereof, based on the total weight of the soft chew, and starch. The soft chew according to the present invention comprises starch, wherein at least 50% by weight of the total starch weight present in the soft chew is provided by pregelatinized rice flour, and the soft chew is substantially free of palatables of animal origin.

Description

[Technical field]

[0001] The present invention relates to a soft chew comprising at least one dietary supplement ingredient and / or pharmaceutical active for administration to an animal, a process for producing said soft chew, and uses of such a soft chew. [Background technology]

[0002] The acceptance of a medicine or dietary supplement (or supplemental feed) by pets is determined primarily by its smell and taste. The palatability of a chewable medicine is also determined primarily by its texture and the mouthfeel it produces. For dogs, soft structures are significantly more preferable than hard, brittle structures such as tablets.

[0003] In recent years, due to the many constraints that exist in soft chew formulations, there have been many efforts to produce soft chewable dosage forms based on flavored starch extrudates.

[0004] For example, due to restrictions imposed by the European Commission on the importation of animal-derived substances, restrictions also found in many Asian and Latin American countries, it is highly preferred to use as few animal-derived ingredients as possible, ideally none at all. However, animal-origin substances are rich in protein (which provides the soft chew with consistency) and fat (which makes the dough more easily processable). Animal-origin substances are also attractive to carnivores, such as dogs and cats, making the soft chew more palatable. In addition, many dietary supplements and pharmaceutical active ingredients are heat-sensitive, making it necessary to produce the soft chew at ambient temperature to prevent their degradation. Thus, the dough formed into the soft chew must have a viscosity that is compatible with the machines (mixers, moulders, extruders) used to produce the soft chew, which, as explained above, becomes more difficult without the use of animal-origin substances.

[0005] WO2013025183 discloses a multi-textured animal treat. The multi-textured animal treat includes one or more soft components with mechanical joints, which are wrapped around a hard component fixedly attached to the mechanical joints on the soft component. The soft components have a hardness of about 4-89 N and do not include pregelatinized rice flour. The hard components have a hardness of about 110-260 N. In Example 4, it is shown that pregelatinized starch provides a higher hardness (about 250 N) to the hard components than pregelatinized corn flour (215 N).

[0006] WO2017025883 discloses edible animal hard chews intended as dental treats (i.e., for cleaning animal teeth). These edible chews require at least 1 minute of chewing before the product can be ingested, for example, 1-4 minutes of chewing before the product can be ingested. In Example 2 (Table 3), the hardness of such dental treats was determined to be about 300 N.

[0007] US Patent Application Publication No. 20040086616 discloses an extruded starch-based product suitable as a long-lasting dog chew. The extruded starch-based product is described as being tough (hard) yet flexible and can be chewed for about 10 to 25 minutes.

[0008] US Patent Application Publication No. 2006193959 discloses low calorie starch-based chew products that are tough for animals to chew, not brittle, not slimy, easily hydratable for rapid disintegration, and are characterized by a total dietary fiber content of at least 5%.

[0009] The object of the present invention is a soft chew that meets the following criteria: a) Having a palatable taste to animals. b) is nutritionally acceptable to the target animal. c) It is stable over time and does not oxidize (to prevent the decomposition of the active ingredient). d) Substantially free or as free as possible from animal components. e) having a texture, particularly firmness, that is acceptable to animals;

[0010] To meet criteria a) to d), the soft chew should ideally be free of palatables of animal origin and the fat content should be as low as possible, in particular less than 10%. Indeed, too much fat can make the soft chew less nutritionally acceptable and lipid oxidation can have a significant negative effect on the quality of the soft chew, affecting color, nutrition, palatability, odor, taste, stability of active ingredients and shelf life, the most recognizable sign of lipid oxidation being changes in odor and flavor.

[0011] However, low amounts of lipids below 10% make the dough difficult to process (due to the high viscosity of the dough) and result in soft chews with a texture that is not acceptable to the animal (criterion e)). Starting from the teachings of the prior art, some attempts to obtain a processable (e.g. not too viscous) dough resulted in soft chews with a texture that is not acceptable to the animal, especially firmness. Furthermore, a low percentage of lipids in a formulation containing mainly hydrophilic components, combined with a low temperature process, resulted in the exudation of the oil contained in the soft chew.

[0012] The technical problem underlying the present invention is therefore to provide a soft chew that is low in fat, has a good taste and has a texture that is acceptable to animals, and it is also an object of the present invention to provide a process that allows the processing of dough into such a soft chew, preferably without additional heating. Summary of the Invention

[0013] In a first aspect, the present invention provides an improved soft chew formulation comprising: at least one nutraceutical ingredient and / or at least one pharma- ceutical active substance, - 6% by weight or less of an oil, fat, or mixture thereof, based on the total weight of the soft chew; starch, The present invention relates to an improved soft chew formulation, wherein at least 50% by weight of the total starch present in the soft chew is provided by pregelatinized rice flour.

[0014] When pregelatinized rice flour was used in sufficient proportion to the total starch present in the soft chew, the resulting dough had an acceptable viscosity for extrusion, the soft chew had an acceptable texture, particularly firmness, and oil did not exude from the soft chew. Conversely, when native (ungelatinized) starches traditionally used in the manufacture of soft chews, such as native (ungelatinized) rice starch, or potato, corn, or wheat starch, including pregelatinized starches, were used, the dough had a high viscosity and it was difficult to produce soft chews with satisfactory properties, particularly with regard to texture and / or oil exudation.

[0015] In another aspect, the present invention provides a process for producing a soft chew comprising the steps of: i. Consists of: at least one nutraceutical ingredient and / or at least one pharma- ceutical active; At least one starch source; A sufficient amount of pregelatinized rice flour to provide at least 50% by weight of the total starch; - mixing 6% or less by weight of oil, fat, or mixtures thereof based on the total weight of the components; ii. forming a soft chew.

[0016] In another aspect, the present invention relates to a soft chew comprising at least one pharma- ceutical active agent, at least one starch source, and up to 6% by weight of an oil, fat, or mixture thereof based on the total weight of the components, wherein at least 50% by weight of the total starch present in the soft chew is provided by pregelatinized rice flour, and for use as a veterinary medicine.

[0017] In another aspect, the present invention relates to the use of a soft chew, said soft chew comprising at least one dietary supplement ingredient, at least one starch source, and up to 6% by weight of an oil, fat, or mixture thereof based on the total weight of the components, wherein at least 50% by weight of the total starch present in the soft chew is provided by pregelatinized rice flour, for providing health benefits to a pet. [Brief description of the drawings]

[0018] [Figure 1] 1 is a graphical representation of firmness measured for 2g and 6g soft chews. The X-axis represents the soft chew (A, B, C or D, where A2g represents a soft chew of formula A weighing 2g) and the Y-axis provides firmness in kgf. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0019] Unless otherwise stated, all percentages are expressed as weight percent.

[0020] As used herein, when the soft chew contains "substantially no ingredients", it should be understood that the soft chew contains less than 5%, preferably less than 1%, and more preferably 0% of the above listed ingredients.

[0021] As used herein, when a range of values ​​is expressed as "consisting of: x to y," the range includes the endpoints x and y.

[0022] In a first aspect, the present invention provides a soft chew comprising: at least one nutraceutical ingredient and / or at least one pharma- ceutical active substance, - 6% by weight or less of an oil, fat, or mixture thereof, based on the total weight of the soft chew; starch, The soft chew wherein at least 50% by weight of the total starch present in the soft chew is provided by pregelatinized rice flour.

[0023] The present invention more specifically relates to a soft chew comprising: at least one nutraceutical ingredient and / or at least one pharma- ceutical active substance, - 6% by weight or less of an oil, fat, or mixture thereof, based on the total weight of the soft chew; - at least one paratant; starch, At least 50% by weight of the total starch present in the soft chew is provided by pregelatinized rice flour. The soft chew is substantially free of paratants of animal origin; The soft chew has a firmness comprised between 25 and 100N.

[0024] The soft chews according to the present invention are preferably intended for immediate consumption. By "immediate consumption" it is meant that the soft chew is consumed by the animal in less than 1 minute (ie, between 1 second and 60 seconds).

[0025] More preferably, the soft chew according to the present invention is substantially free of paratants of animal origin and substantially free of excipients, i.e., inactive ingredients, of animal origin. In such an embodiment, the only ingredient of animal origin is at least one dietary supplement ingredient and / or at least one pharmaceutical active.

[0026] More preferably, the soft chew according to the present invention contains oil and preferably does not contain fat or a mixture of fat and oil.

[0027] In the sense of the present invention, a soft chew is a shaped body that presents a meat-like or stock cube soft texture that can be easily chewed by animals such as dogs and cats while providing a pleasant mouthfeel to the animal. As used herein, the term soft texture refers to a texture that retains its shape until a certain level of pressure is applied. In the sense of the present invention, a soft chew is an individual dosage form, in particular a veterinary individual dosage form, intended to deliver a pharmaceutical substance or a nutritional supplement to an animal.

[0028] The size and shape of the soft chew can be adapted to the type of animal (dog or cat) and size of the animal. The weight of the soft chew typically ranges from 0.1 g to 20 g, preferably from 0.5 g to 10 g, and most preferably from 1 g to 6 g. In certain embodiments, the soft chew weighs 0.5, 1, 2, 4, or 6 g.

[0029] There are several parameters that can be used to define the texture of a soft chew, e.g. firmness, softness, hardness, toughness, elasticity, breaking force, maturity, skin strength, work of penetration, work of extrusion. The texture of a soft chew can be determined using methods and devices well known in the art, in particular texture analyzers.

[0030] Hardness, firmness, and flexibility all describe the force required to deform a product to a given distance. However, depending on the product type, one word may be preferred over the other. Flexibility and firmness are preferably used to define products that exhibit little or moderate resistance to deformation (low or moderate force is required to deform the product to a given distance). In contrast, hardness is preferably used to define products that exhibit high resistance to deformation (high force is required to deform the product to a given distance).

[0031] In the present invention, a soft chew is defined as a moulded body having a plastic behaviour, i.e. it is not brittle and has a hardness comprised between 25 and 100 N. Preferably, the hardness is comprised between 39 and 79 N, more preferably between 40 and 60 N.

[0032] The firmness of the soft chews was determined on a TA XT Plus texturometer (Stable Micro Systems) using a 0.5 in. (1.27 cm) P / 0,5S spherical probe with the following parameters implemented directly into the texturometer software:

[0033] [Table 1]

[0034] Briefly, the sample (soft chew) was placed on a flat base / surface and a spherical probe was lowered into the sample at a given speed to a distance of 3 mm. The sample was deformed by the probe and the resistance offered by the sample (force required to penetrate 3 mm) was recorded. The measured resistance, expressed in kgf (1 kgf = 9.80665 N), corresponds to the firmness of the soft chew.

[0035] The firmness (hardness / flexibility) of the product can also be expressed by the maximum force (load) reached before the product breaks, or the breaking force. The soft chews of the present invention are characterized by a breaking force of less than 100N, in particular comprised between 20 and 100N, more particularly comprised between 20 and 90N.

[0036] Breaking forces were determined on a TA XT Plus texturometer (Stable Micro Systems) using a 10 mm diameter spherical probe or a 10 mm diameter conical probe (mimicking the shape of a dog or cat tooth) with the following parameters implemented directly in the texturometer software:

[0037] [Table 2]

[0038] Briefly, a sample (4 g, approximately 12 mm thick soft chew) was placed on a flat base / surface and a spherical or conical probe was lowered into the sample at a given speed to a distance of 10 mm. The sample was deformed by the probe until it broke. The resistance offered by the sample (maximum force applied to break the sample) or the breaking force was recorded. The measured resistance, expressed in kgf (1 kgf = 9.80665 N), corresponds to the breaking force of the soft chew. The breaking force measured with the conical probe under these conditions was approximately 63 N, whereas the breaking force measured with the spherical probe was approximately 84 N.

[0039] The soft chew according to the present invention is a starch-based soft chew. The soft chew typically contains 15-50% by weight of starch based on the total weight of the soft chew. Preferably, the soft chew contains 15-25% by weight of starch.

[0040] The soft chew may contain any starch, but the starch is preferably selected from the group consisting of potato starch, wheat starch, barley starch, oat starch, rice starch, tapioca starch, maize (corn) starch, pea starch, and cassava starch. The starch may be ungelatinized, partially gelatinized, or fully gelatinized. Preferably, the starch is partially gelatinized or fully gelatinized.

[0041] To obtain a soft chew having the desired texture and properties according to the invention, at least 50% by weight of the total weight of starch should be provided by pregelatinized rice flour. Preferably, at least 60% by weight, even more preferably at least 70% by weight of the total weight of starch should be provided by pregelatinized rice flour. In particular, 60-100% by weight, more particularly 70-90% by weight of the total weight of starch should be provided by pregelatinized rice flour.

[0042] The pregelatinized rice flour is preferably selected from japonica rice flour, indica rice flour, and javanica rice flour. More preferably, the pregelatinized rice flour is indica rice flour.

[0043] The oil is preferably of non-animal origin, in particular a vegetable oil selected from the group consisting of coconut oil, corn oil, canola oil, cottonseed oil, olive oil, palm oil, peanut oil, rapeseed oil, safflower oil, sesame oil, soybean oil and sunflower oil, or mixtures thereof. Preferably, the oil is sunflower.

[0044] The fat may be a solid fat of animal origin (e.g., butter, lard, or beef tallow) or a solid fat of non-animal origin (e.g., cocoa butter, peanut butter, solid hydrogenated vegetable oils). Preferably, the fat is of non-animal origin.

[0045] The amount of oil, preferably vegetable oil, fat or mixture thereof, is comprised between 3 and 6% by weight, more preferably about 5%, based on the total weight of the soft chew. An amount of up to 6% of oil, fat or mixture thereof allows the level of lipids in the soft chew to be kept below 10%.

[0046] Preferably, the soft chew according to the present invention contains oil, preferably vegetable oil, in an amount comprised between 3 and 6% by weight, more preferably about 5% by weight based on the total weight of the soft chew.

[0047] Thus, the present invention further relates to a soft chew as described herein which comprises 10% or less by weight lipid.

[0048] In the sense of the present invention, the amount of "6% by weight or less of oil, fat, or mixtures thereof" refers to the amount of oil, fat, or mixtures thereof present in the dough and soft chew used to prepare the soft chew.

[0049] The amount of "10% or less lipid by weight" refers to the amount of lipid, including oils and fats and other lipids contributed by other ingredients of the improved soft chew formulations according to the present invention, as measured in the soft chew by analytical methods known in the art and include, for example, solvent extraction-gravimetric methods or gas chromatography.

[0050] The soft chews of the present invention comprise at least one dietary supplement ingredient and / or at least one pharmaceutical active. The active ingredient is preferably a veterinary active ingredient or a veterinary dietary supplement ingredient.

[0051] The pharma- ceutical active agent may be selected from the group consisting of anesthetics, corticosteroids, NSAIDs, antibiotics, antiemetics, parasiticides, and JAK-1 inhibitors.

[0052] The NSAID may be selected from among meloxicam, grapiprant, carprofen, naproxen, tolfenamic and meclofenamic acids, flunixin and indomethacin.

[0053] The anthelmintic drug may be selected from among macrocyclic lactones such as abamectin, moxidectin, avermectin, ivermectin, selamectin or sidectin, milbemycin; benzimidazoles such as mebendazole, fenbendazole, oxfendazole, albendazole, thiabendazole or carbendazole; imidazothiazoles such as levamisole or pyrantel pamoate; salicylanilides such as closantel or niclosamide.

[0054] Antibiotics include penicillins, aminopenicillins (e.g., amoxicillin, ampicillin, hetacillin), cephalosporins (e.g., cefovecin, cefuroxime, ceftiofur), quinolones (e.g., ciprofloxacin, enrofloxacin, difloxacin, orbifloxacin, marbofloxacin); chloramphenicols (e.g., chloramphenicol, thiamphenicol, florfenicol); tetracyclines (e.g., chlortetracycline, tetracycline, The anti-inflammatory drug may be selected from among: amidocycline, oxytetracycline, doxycycline, minocycline; macrolides (e.g., erythromycin, tyrosine, tilmicosin, clarithromycin, azithromycin, tulathromycin); lincosamides (e.g., lincomycin, clindamycin); aminoglycosides (e.g., gentamicin, amikacin, kanamycin, apramycin, tobramycin, neomycin, dihydrostreptomycin, paromomycin).

[0055] The antiemetic may be selected from maropitant and aprepitant.

[0056] Parasiticides may be selected from organochlorines, organophosphates, carbamates, amidines, pyrethrins and synthetic pyrethroids, benzoyl ureas, juvenile hormone analogues, macrocyclic lactones, neonicotinoids, phenylpyrazoles, spinosyns (such as spinosad), isoxazolines (such as fluralaner, afoxolaner, sarolaner, and lotilaner), and meta-diamides (modoflaner).

[0057] The JAK-1 inhibitor can be selected from among oclacitinib, momelotinib, tofacitinib, and ruxolitinib.

[0058] Preferred pharmacoactive agents are grapiprant, oclacitinib, fluralaner, and modofuranel.

[0059] In the sense of the present invention, a nutraceutical ingredient refers to an ingredient whose purpose is to support or maintain the health of a target animal.For example, a nutraceutical ingredient can provide nutritional benefits to a target animal.Nutraceutical ingredients include, in particular, vitamins, minerals, plant extracts, and combinations thereof.

[0060] Vitamins include, for example, vitamin A, vitamin E, vitamin B12, vitamin B3, d-pantothenic acid (vitamin B5), folic acid, vitamin B6, vitamin B1, vitamin D3, vitamin C, vitamin B2, and provitamins (e.g., β-carotene or panthenol).

[0061] The minerals include potassium, sodium, manganese, zinc, iron, calcium, copper, cobalt, iodine, chlorine, and selenium. The minerals may be in the form of a suitable salt.

[0062] Other contemplated dietary supplement ingredients include lecithin, phosphatidylserine, antioxidants (such as Pycnogenol), Gingko biloba extract, Bacopa monnieri extract, huperzine A, omega-3 polyunsaturated fatty acids (DHA, EPA, etc.); flavonoids or extracts of plants containing flavonoids (such as blueberry or maqui berry), anthocyanins, flavan-3-ols, epigallocatechin-gallate (ECGC) and proanthocyanidins, isoflavones (e.g. puerarin and genistein), and flavonols (e.g. rutin and troxerutin); cytochrome C, monosodium glutamate, N-acetylcysteine, zinc methionine, biotin, L-carnitine, phytoceramides, prebiotics, probiotics, postbiotics, casein phosphopeptides, L-theanine or green tea extract, ashwagandha and fish protein hydrolysates.

[0063] In certain embodiments, the dietary supplement ingredient is selected from the group consisting of eggshell membrane; krill powder or krill oil, astaxanthin or astaxanthin source, such as algae, yeast, salmon, trout, krill, shrimp, and crayfish; Boswellia serrata; hyaluronic acid or its salt; and vitamin D3.Preferably, the dietary supplement is a mixture of at least two, at least three, or at least four dietary supplement ingredients selected from the group consisting of eggshell membrane; krill powder, astaxanthin or astaxanthin source, such as algae, yeast, salmon, trout, krill powder or krill oil, shrimp, and crayfish; Boswellia serrata; hyaluronic acid or its salt; and vitamin D3. Even more preferably, the dietary supplement is a mixture of eggshell membrane, krill powder or krill oil, astaxanthin, Boswellia serrata, hyaluronic acid or a salt thereof, and vitamin D3.

[0064] In a preferred embodiment, the dietary supplement ingredient is selected from the group consisting of eggshell membrane; krill powder, astaxanthin or astaxanthin source, such as algae, yeast, salmon, trout, krill, shrimp, and crayfish; Boswellia serrata; hyaluronic acid or its salt; and vitamin D3, preferably a mixture of two, three, four, or five of them.In another most preferred embodiment, the dietary supplement ingredient is selected from the group consisting of eggshell membrane; krill powder, astaxanthin or astaxanthin source, such as algae, yeast, salmon, trout, krill, shrimp, and crayfish; Boswellia serrata and hyaluronic acid or its salt.

[0065] Nutraceutical ingredients may be present in the soft chew in any amount as needed to obtain the desired therapeutic effect or health benefit.

[0066] The soft chew according to the present invention preferably comprises 1-20% by weight, more preferably 1-10% by weight, of at least one dietary supplement ingredient and / or at least one pharma- ceutical active, based on the total weight of the soft chew.

[0067] In the soft chews according to the present invention, the at least one paratant may be any ingredient known to improve the acceptability of the formulation by animals. Paratants are well known in the art and are commercially available from companies such as Kemin Industries, Diana Pet Food (SPF), or AFB International.

[0068] When the paratant is of animal origin, it can be derived from animal tissue, for example. Notable examples are hydrolyzed or non-hydrolyzed pork liver and chicken liver. In one embodiment, the paratant is chicken liver powder.

[0069] Preferably, the palatant is of non-animal origin. Non-animal origin flavoring agents include chemically synthesized compounds used to flavor foods; yeast, especially brewer's yeast; essential oils; oleoresins; essences or extracts, vegetable protein hydrolysates; distillates; and any product of roasting, heating, or enzymatic decomposition that contains flavor components derived from spices, fruits or fruit juices, vegetables or vegetable juices, edible yeasts (active and inactive), herbs, bark, buds, roots, leaves, or any other edible parts of plants.

[0070] Most non-animal origin palatants are a mixture of ingredients that are kept secret by the palatant manufacturer. The major palatant manufacturers are Diana Pet Food, Kemin Industries, and AFB International. The non-animal origin palatant sold by Kemin Industries belongs to the PALASURANCE P series of flavor enhancers range. It uses plant-based proteins and Maillard technology to create pet-friendly aromas and flavors that are compatible with all animal proteins. The non-animal origin palatants sold by Diana Pet Food include palatant, which is described as a blend of plant derivatives, yeasts, sugars, nutritional additives, mineral substances, sensory additives, and preservatives.

[0071] In a preferred embodiment, Paratant is a blend of botanical derivatives, yeasts, sugars, nutritional additives, mineral substances, sensory additives, and preservatives sold by SPF Diana.

[0072] The soft chew according to the present invention preferably comprises 5-30% by weight, more preferably 10-20% by weight, more preferably about 15% or 20% by weight of at least one palatant, based on the total weight of the soft chew.

[0073] In a particular embodiment, the soft chew according to the present invention comprises 15-50% by weight of starch based on the total weight of the soft chew and 5-30% by weight of palatant based on the total weight of the soft chew.

[0074] The soft chew according to the present invention preferably comprises: at least one wetting agent; at least one binder; ●Water, at least one protein source, preferably of non-animal origin, At least one emulsifier, and - Further comprising one or more additional ingredients selected from the group consisting of at least one preservative and / or antioxidant.

[0075] In the soft chew according to the present invention, at least one humectant may be present.

[0076] In the sense of the present invention, a humectant refers to a substance that is hygroscopic, e.g. has an affinity for forming hydrogen bonds with water molecules, and is capable of keeping the soft chew dough moist. Humectants are well known to those skilled in the art.

[0077] Preferably, the humectant is a polyol or a mixture of polyols. Examples of polyols useful as humectants are ethylene glycol, propylene glycol, sugar polyols (e.g., glycerol, sorbitol, xylitol, and maltitol), polymer polyols (e.g., polydextrose, maltodextrin, and molasses). More preferably, the humectant is selected from glycerol, sorbitol, maltodextrin, and molasses or mixtures thereof, and mixtures of glycerol and sorbitol.

[0078] The soft chew according to the present invention comprises 10-30% by weight, preferably 15-25% by weight, more preferably about 20, 21, or 22% by weight of at least one humectant, based on the total weight of the soft chew.

[0079] In the soft chew according to the invention, at least one binder may be present. In the sense of the present invention, binder or binding agent refers to a substance used to improve the binding properties of the powder mass and aid in the formation of the soft chew.

[0080] Any suitable binder known in the art may be used. In one embodiment, the binder is selected from gums (such as xanthan gum or guar gum), waxes, alginates, cellulose and derivatives thereof (such as methylcellulose or microcrystalline cellulose), starch derivatives, and polymers (such as povidone, methacrylates, and polyethylene oxide), or any combination of any two or more thereof. Preferably, the binder is selected from cellulose powder and gum arabic, more preferably a mixture of cellulose powder and gum arabic.

[0081] The soft chew according to the present invention comprises 0.1-5 wt. %, preferably 2-3 wt. %, of at least one binder, based on the total weight of the soft chew.

[0082] In the soft chew according to the present invention water may be present.

[0083] In the present invention, the amount of water present in the soft chew can be determined using methods well known in the art such as the Karl Fischer method (e.g., KF titrator, KF oven / evaporator, moisture meter) and thermogravimetric analysis, particularly the Karl Fischer method.

[0084] The addition of water is beneficial in the manufacture of soft chews according to the invention, particularly in the workability of the dough, as detailed in another aspect of the invention.

[0085] The soft chew according to the present invention may comprise 10-25% by weight water, preferably 15-20% by weight water, based on the total weight of the soft chew.

[0086] The soft chews according to the invention can be further characterized by their water activity. Typically, the soft chews according to the invention have a water activity aw value of less than 0.80, preferably less than 0.70. Most preferred is a water activity aw in the range of 0.60 to 0.70, such a water activity level being compatible with storage of the soft chews at room temperature for a sufficient period of several months.

[0087] In the soft chew according to the invention, at least one protein source, preferably a protein source of non-animal origin, may be present.

[0088] The protein source of the present invention may be derived from a variety of sources known to those of skill in the art, including plant sources, animal sources, and yeast sources.

[0089] Animal sources include, for example, meat, meat by-products, dairy products, and eggs. Meat includes, for example, chicken, fish, and mammalian (e.g., cow, pig, sheep, and goat) meat. Meat by-products include, for example, lungs, kidneys, brains, liver, stomach, and intestines (free of all or essentially all of their contents).

[0090] The non-animal protein sources preferably comprise vegetable protein sources selected from the group consisting of soy protein, including soy protein isolate, pea protein, flaxseed protein, corn protein, wheat protein (gluten), oat protein, barley protein, alfalfa protein, rye protein, rice protein and potato protein; and fungal sources, preferably yeast protein, including inactivated brewer's yeast.

[0091] Preferably, the protein source is of non-animal origin and is selected from inactivated brewer's yeast, soy protein, wheat protein (gluten), and pea protein.

[0092] The soft chew according to the present invention comprises 1-15% by weight, preferably 2-10% by weight, of at least one protein source, preferably a protein source of non-animal origin, based on the total weight of the soft chew.

[0093] In a preferred embodiment, the soft chews according to the present invention are gluten free.

[0094] Gluten is a group of seed storage proteins found in certain cereal grains, particularly rye, oats, wheat and barley.

[0095] A gluten-free formulation for the soft chew is particularly beneficial for animals with gluten intolerance.

[0096] In the soft chew according to the invention, at least one emulsifier may be present. In the present invention, an emulsifier (or emulsifying agent or emulgent) refers to a substance that acts as a stabilizer between hydrophobic components (e.g. oils) and hydrophilic excipients (e.g. starches and wetting agents).

[0097] Any suitable emulsifier may be used in the soft chews according to the present invention. Preferred emulsifiers are lecithins, including soybean lecithin and sunflower lecithin.

[0098] The soft chew according to the present invention comprises 1 to 5% by weight, preferably 1 to 2% by weight, more preferably 1.5 or 2% by weight of at least one emulsifier based on the total weight of the soft chew.

[0099] In the soft chew according to the present invention, at least one preservative and / or antioxidant may be present.

[0100] In the present invention, a preservative is a substance that prevents microbial contamination and improves the stability of a formulation containing a dietary supplement and / or pharmaceutical ingredient.

[0101] Preservatives are well known in the art and can be selected depending on the active ingredient and / or formulation.

[0102] The preservative is preferably selected from acids, alcohols, phenols, parabens, sorbates, thiols, phenylmercuric salts, or any combination of any two or more thereof. In a preferred embodiment, the preservative is a mold inhibitor, such as propionic acid mixed with sorbic acid and benzoic acid, or a water-soluble combination of buffered acetic acid and citric acid.

[0103] In the present invention, antioxidants are substances used to protect active ingredients from oxidation. Some preservatives can also act as antioxidants.

[0104] Any antioxidant known in the art may be used. Preferably, the antioxidant is selected from propyl gallate, ascorbic acid and its derivatives, sodium formaldehyde sulfoxylate, malic acid, fumaric acid, edetic acid, thiols, polyphenols, sodium EDTA, sodium ascorbate, sodium metabisulfite, butylated hydroxytoluene, butylated hydroxyanisole, or natural substances (such as flavanoids, tocopherols, carotenes, cysteine, etc.), or any combination of any two or more thereof.

[0105] The soft chew according to the present invention comprises 0.25-2% by weight, preferably 1-2% by weight, of at least one preservative and / or antioxidant.

[0106] Other optional ingredients may also be present, including lubricants such as magnesium stearate, fumaric acid, sodium stearyl fumarate, among others, or disintegrants such as sodium starch glycolate, crospovidone (Polyplasdone XL™) and croscarmellose sodium (Ac-Di-Sol™).

[0107] In a particular embodiment, the soft chew according to the present invention is substantially free of ingredients of animal origin and therefore contains less than 10% by weight of material of animal origin, advantageously less than 6.0% by weight, preferably less than 5.5% by weight of material of animal origin based on the total weight of the soft chew.

[0108] Preferably, the soft chew according to the invention comprises as further ingredients at least one palatant, preferably a palatant of non-animal origin, at least one humectant, and water.

[0109] Thus, the present invention also provides a method for producing a method for the treatment of atopic dermatitis. at least one nutraceutical ingredient and / or at least one pharma- ceutical active substance, - 6% by weight or less of an oil, fat, or mixture thereof, based on the total weight of the soft chew; - Starch, - at least one paratant of non-animal origin; at least one wetting agent, water, The soft chew formulations include those in which at least 50% by weight of the total starch present in the soft chew is provided by pregelatinized rice flour.

[0110] The present invention relates to at least one nutraceutical ingredient and / or at least one pharma- ceutical active substance, - 6% by weight or less of an oil, fat, or mixture thereof, based on the total weight of the soft chew; - Starch, - at least one paratant of non-animal origin; at least one wetting agent, at least one binder, -Water, at least one protein source of non-animal origin, at least one emulsifier, at least one preservative and / or antioxidant. Further included are soft chew formulations, wherein at least 50% by weight of the total starch present in the soft chew is provided by pregelatinized rice flour.

[0111] In a preferred embodiment, the present invention also provides a soft chew formulation that is substantially free of excipients of animal origin, comprising: at least one nutraceutical ingredient and / or at least one pharma- ceutical active substance, - 6% by weight or less of an oil, fat, or mixture thereof, based on the total weight of the soft chew; - Starch, - at least one paratant of non-animal origin; at least one wetting agent, -Water, -Optionally, at least one binder; at least one protein source of non-animal origin; At least one emulsifier; and at least one preservative and / or antioxidant. The soft chew formulations include those in which at least 50% by weight of the total starch present in the soft chew is provided by pregelatinized rice flour.

[0112] The present invention also provides a soft chew as described above, comprising: at least one nutraceutical ingredient and / or at least one pharma- ceutical active substance, - 15-25% by weight of starch based on the total weight of the soft chew, wherein at least 50% by weight of the total starch weight, preferably 60% by weight of said starch, even more preferably at least 70% by weight of said starch is provided by pregelatinized rice flour; at least one protein source of non-animal origin, at least one vegetable oil, at least one emulsifier, - at least one paratant of non-animal origin; at least one wetting agent, - water.

[0113] In certain embodiments, the soft chew comprises: - 1-10% by weight, based on the total weight of the soft chew, of at least one nutraceutical ingredient and / or at least one pharma- ceutical active substance; - 15-25% by weight of starch based on the total weight of the soft chew, wherein at least 50% by weight of the total starch weight, preferably 60% by weight, even more preferably at least 70% by weight of said starch is provided by pregelatinized rice flour; at least one protein source of non-animal origin, - 3-6% by weight of at least one vegetable oil, based on the total weight of the soft chew; at least one emulsifier, - at least one paratant of non-animal origin; at least one wetting agent, -Contains water.

[0114] In another particular embodiment, the soft chew comprises, based on the total weight of the soft chew: - 1 to 10% by weight of at least one nutraceutical ingredient and / or at least one pharma- ceutical active substance; - 15 to 25% by weight of starch, where at least 50% by weight, preferably 60% by weight, of the total starch weight is provided by pregelatinized rice flour; - 2 to 10% by weight of a protein source of non-animal origin; - 3 to 6% by weight of at least one vegetable oil, - 10 to 20% by weight of at least one paratant of non-animal origin; - 10 to 25% by weight of at least one non-aqueous wetting agent; -15 to 20% by weight of water.

[0115] In a more preferred embodiment, the soft chew comprises: - 1-10% by weight, based on the total weight of the soft chew, of at least one nutraceutical ingredient and / or at least one pharma- ceutical active substance; - 15-25% by weight of starch based on the total weight of the soft chew, wherein at least 50% by weight of the total starch weight, preferably 60% by weight, even more preferably at least 70% by weight of said starch is provided by pregelatinized rice flour; - 1 to 11% by weight, based on the total weight of the soft chew, of at least one protein source of non-animal origin; - 3-6% by weight of at least one vegetable oil, based on the total weight of the soft chew; - 1 to 3% by weight, based on the total weight of the soft chew, of at least one emulsifier; - 10 to 20% by weight, based on the total weight of the soft chew, of at least one paratant of non-animal origin; - 10-25% by weight of at least one humectant, based on the total weight of the soft chew; -Contains 15 to 20% by weight of water based on the total weight of the soft chew.

[0116] In another aspect, the present invention relates to a process for producing a soft chew as defined herein, comprising the following steps: i. Consists of: at least one nutraceutical ingredient and / or at least one pharma- ceutical active; At least one starch source; A sufficient amount of pregelatinized rice flour to provide at least 50% by weight of the total starch; ● Not more than 6% by weight of oil, fat, or mixtures thereof based on the total weight of the constituents; ● Optionally, at least one paratant, preferably of non-animal origin, at least one wetting agent, at least one binder, ○Water, at least one protein source, preferably of non-animal origin, at least one emulsifier, and with one or more further ingredients selected from the group consisting of at least one preservative and / or antioxidant; ii. forming a soft chew.

[0117] Preferably, step i. of mixing is carried out at room temperature, i.e. without the use of an external heat source. Carrying out the process at room temperature allows the use of heat-sensitive nutraceutical ingredients and / or pharmaceutical active substances without degradation. As a non-limiting example, the process allows the obtaining of soft chews containing probiotics without killing the probiotic bacteria during the process.

[0118] Steps i. and ii. can be performed simultaneously or separately, depending on the machine used.

[0119] In one embodiment, the mixing occurs prior to forming the soft chew.

[0120] In the first option, mixing is carried out in a mixer until a homogeneous dough is obtained. It was found that mixers traditionally used to produce soft chews (such as those traditionally used in the pharmaceutical and food industries) were unable to obtain a homogeneous dough because the mixture was too viscous without heating during mixing (to prevent possible degradation of the active substance). Therefore, mixers with Z-arm, T-arm or S-arm, preferably Z-arm, more traditionally used in the plastics industry, were preferred.

[0121] In the second option, the mixing takes place in an extruder: all ingredients of the soft chew may be loaded into the inlet port and mixed in the extruder during transport to the discharge port, or the solid ingredients may be loaded into the inlet port and liquid may be added through an additional inlet port located on the barrel of the extruder to provide the dough.

[0122] The resulting dough in a mixer or extruder is then formed into soft chews of appropriate size and weight.

[0123] The soft chews can be formed by any method known in the art, using a variety of molding machines, such as those shown in U.S. Patents 3,486,186, 3,887,964, 3,952,478, 4,054,967, 4,097,961, 4,182,003, 4,334,339, 4,338,702, 4,343,068, 4,356,595, 4,372,008, 4,535,505, 4,597,135, 4,608,731, 4,622,717, 4,69 Molding machines or tablet presses disclosed in US Patent Publication Nos. 7,308, 4,768,941, 4,780,931, 4,818,446, 4,821,376, 4,872,241, 4,975,039, 4,996,743, 5,021,025, 5,022,888, 5,655,436, and 5,980,228, and in U.S. Patent Application No. 2014 / 0141055, may be utilized in the present invention. Formax F6 molding machines and rotary molding machines, including those described in U.S. Patent Application Publication No. 2014 / 0141055 (MFT-200 of Kruger & Salecker, Bad Schwartau), are specifically contemplated.

[0124] In another embodiment, the mixing and forming is done using an extruder. All ingredients of the soft chew may be loaded into the inlet port and mixed in the extruder during transport to the discharge port, or the solid ingredients may be loaded into the inlet port and liquid may be added through an additional inlet port located on the barrel of the extruder. The soft chew is shaped (formed) by the die of the extruder and the extrudate is cut into soft chews of appropriate size and weight.

[0125] For the purposes of the present invention, the term extruder refers to single-screw, twin-screw and multi-screw extruders, planetary roller extruders, vacuum filler extruders and cascade extruders, extruders equipped with pushers, but is not limited to these extruder variants. Preferably, the extruder is an extruder equipped with a pusher.

[0126] Preferably, in the process for producing the soft chews described above, in step i. of mixing, the solids are mixed together first, and then the liquid is added. More preferably, at least one oil and water are added sequentially to the solids. In one particular embodiment, at least one oil is added to the solids first, and then water is added. It has been observed that adding at least one oil before adding water to the solid ingredients results in less oil oozing out of the soft chews.

[0127] The process may additionally comprise an additional drying step after step ii., which is a third drying step iii., said drying step being preferably carried out at room temperature for at least 15 minutes.

[0128] In the sense of the present invention, the drying step refers to a maturation step whose purpose is to favour the phenomena of starch cross-linking and network reorganisation to a more stable state and to avoid the chews sticking together.

[0129] The drying step is preferably carried out by leaving the soft chew on a flat surface to dry for a sufficient time after formation of the soft chew. It has been found that neither heating nor cooling promotes ripening of the soft chew. Thus, the drying step may be carried out at room temperature (e.g., 15 to 30°C), at a lower temperature (e.g., -15 to 15°C), or at an elevated temperature (e.g., 30 to 60°C). The drying time can be readily determined by one skilled in the art. Preferably, the soft chew is dried for 15 minutes to 24 hours, more preferably 1 hour to 12 hours, especially about 1 hour.

[0130] Thus, the present invention, in a more particular embodiment, provides a process for producing a soft chew as defined above, comprising the following steps: i. Consists of: at least one nutraceutical ingredient and / or at least one pharma- ceutical active; At least one starch source; A sufficient amount of pregelatinized rice flour to provide at least 50% by weight of the total starch; ● 6% by weight or less of at least one oil, fat, or mixture thereof; ● Optionally, at least one paratant, preferably of non-animal origin, at least one wetting agent, at least one binder, ○Water, at least one protein source, preferably of non-animal origin, at least one emulsifier, and with one or more further ingredients selected from the group consisting of at least one preservative and / or antioxidant; ii. forming a soft chew; iii. drying the soft chew.

[0131] After drying, the soft chews can be packaged in bottles or containers, which can be glass containers, glass bottles, plastic (e.g., HDPE) bottles, or plastic (e.g., HDPE) containers.

[0132] Therefore, the present invention also relates to a process as described above, comprising step iv. of packaging the soft chew.

[0133] In another aspect, the present invention relates to a soft chew as previously described, in particular comprising at least one dietary supplement ingredient and / or at least one active pharmaceutical ingredient and up to 6% by weight of an oil, fat or mixture thereof based on the total weight of the constituents, said soft chew comprising at least one starch source, wherein at least 50% by weight of the total starch present in the soft chew is provided by pregelatinized rice flour, for use as a medicament in non-human animals. Preferably, the soft chew according to the present invention is for use as a medicament in dogs or cats.

[0134] The present invention also relates to the use of the soft chew as described above for treating a disease in a non-human animal, comprising at least one dietary supplement ingredient and / or at least one active pharmaceutical ingredient, up to 6% by weight of an oil, fat or mixture thereof based on the total weight of the components, and at least one starch source, wherein at least 50% by weight of the total starch present in the soft chew is provided by pregelatinized rice flour.

[0135] The present invention also relates to a method for treating a non-human animal in need thereof for a disease comprising administering to said non-human animal a soft chew comprising at least one dietary supplement ingredient and / or at least one active pharmaceutical ingredient, up to 6% by weight of an oil, fat or mixture thereof based on the total weight of the components, and at least one starch source, wherein at least 50% by weight of the total starch present in the soft chew is provided by pregelatinized rice flour.

[0136] The present invention also relates to the use of a soft chew as previously described, comprising at least one dietary supplement ingredient and / or at least one active pharmaceutical ingredient, up to 6% by weight of an oil, fat or mixture thereof, based on the total weight of the components, and at least one starch source, wherein at least 50% by weight of the total starch present in the soft chew is provided by the pregelatinized rice flour according to the present invention for the manufacture of a medicament for non-human animals.

[0137] The term "treatment" as used herein, and related terms such as "treating" and "treat", generally refers to the treatment of non-human animals in which some desired therapeutic effect is achieved. The therapeutic effect can be, for example, inhibition of progression of a disease or condition, including slowing the rate of progression, stopping the rate of progression, amelioration, and cure. Treatment as a preventative measure is also included. Treatment also includes combination treatments and therapies, in which two or more treatments or therapies are used in combination, for example, sequentially or simultaneously.

[0138] In a preferred embodiment of the present invention, - the dietary supplement is selected from the group consisting of eggshell membrane; krill powder, astaxanthin or a source of astaxanthin, such as algae, yeast, salmon, trout, krill, shrimp, and crayfish; Boswellia serrata; hyaluronic acid or a salt thereof; and vitamin D3. Preferably, the dietary supplement is a mixture of at least two, at least three, or at least four dietary supplements selected from the group consisting of eggshell membrane; krill powder, astaxanthin or a source of astaxanthin, such as algae, yeast, salmon, trout, krill, shrimp, and crayfish; Boswellia serrata; hyaluronic acid or a salt thereof; and vitamin D3. Even more preferably, the dietary supplement is a mixture of eggshell membrane, krill powder, astaxanthin, Boswellia serrata, hyaluronic acid or a salt thereof, and vitamin D3, - treatment is prophylaxis or treatment and the disease is a joint disorder, in particular arthritis or osteoarthritis, preferably in the treatment of arthritis in dogs and / or for supporting healthy bones, for supporting joint flexibility and / or mobility, or for supporting the viscosity of synovial fluid.

[0139] In another preferred embodiment of the present invention, at least one pharmacologic active substance is an isoxazoline selected from afoxolaner, sarolaner, lotinaler, and afoxolaner, preferably fluralaner; The treatment is the prevention and / or treatment of an ectoparasitic infestation, preferably a flea or tick infestation.

[0140] In a further preferred embodiment of the present invention, at least one pharmacologic active substance is a JAK-1 inhibitor selected from oclacitinib, momelotinib, tofacitinib, N-methyl-6-[methyl(7H-pyrrolo[2,3-d]pyrimidin-4-yl)amino]spiro[3.3]heptane-2-sulfonamide and ruxolitinib, preferably oclacitinib or N-methyl-6-[methyl(7H-pyrrolo[2,3-d]pyrimidin-4-yl)amino]spiro[3.3]heptane-2-sulfonamide, The treatment is the treatment of pruritus associated with allergic dermatitis and / or the treatment of clinical symptoms of atopic dermatitis, particularly in dogs.

[0141] In yet another preferred embodiment of the present invention, - at least one pharmacologic active substance is grapiprant; - Treatment is the treatment of osteoarthritis pain and inflammation, especially in dogs.

[0142] In yet another preferred embodiment of the present invention, at least one pharma- ceutical active substance is modoflanel; The treatment is the prevention and / or treatment of ectoparasitic infestations, preferably flea or tick infestations, in particular in dogs and cats.

[0143] In another aspect, the present invention relates to the use of the aforementioned soft chew comprising at least one dietary supplement ingredient to provide a health benefit to a non-human animal.

[0144] In a preferred embodiment of the present invention, - the dietary supplement is selected from the group consisting of eggshell membrane; krill powder, astaxanthin or a source of astaxanthin, such as algae, yeast, salmon, trout, krill, shrimp, and crayfish; Boswellia serrata; hyaluronic acid or a salt thereof; and vitamin D3. Preferably, the dietary supplement is a mixture of at least two, at least three, or at least four dietary supplements selected from the group consisting of eggshell membrane; krill powder, astaxanthin or a source of astaxanthin, such as algae, yeast, salmon, trout, krill, shrimp, and crayfish; Boswellia serrata; hyaluronic acid or a salt thereof; and vitamin D3. Even more preferably, the dietary supplement is a mixture of eggshell membrane, krill powder, astaxanthin, Boswellia serrata, hyaluronic acid or a salt thereof, and optionally vitamin D3; - The health benefit is selected from supporting healthy bones, supporting joint flexibility and / or mobility, and supporting synovial fluid viscosity.

[0145] The present invention also relates to a method for providing a health benefit to a non-human animal, comprising administering to said non-human animal a soft chew comprising at least one dietary supplement ingredient according to the present invention.

[0146] According to the invention, the non-human animal is preferably a companion animal, in particular selected from the group consisting of dogs, cats and ferrets. More preferably, the companion animal is a dog. EXAMPLES

[0147] Example 1: General procedure for the preparation of soft chews Four different soft chews, A-D, were prepared according to the following general method.

[0148] All solid ingredients were weighed and placed in a mixer as a sandwich: half of the excipients were added into the mixer, followed by the active ingredient blend, and finally the other half of the excipients. The solid blend was mixed.

[0149] The oil was added to the solid blend and the blend was mixed.

[0150] The liquid blend containing water, cellulose, humectants (glycerol / sorbitol / molasses / maltodextrin) was dispensed onto the solid / oil blend and the whole was mixed again until visually homogenous.

[0151] The dough was charged to the entrance of the extruder and the blend was extruded. The extrudate was cut into individual soft chews of 2 grams, 4 grams, or 6 grams.

[0152] The individual soft chews were then left to mature on trays at ambient temperature for approximately 1 hour and then conditioned in closed and sealed boxes (approximately 30 soft chews per box).

[0153] Example 2: Composition of soft chews: Four compositions were evaluated containing 37% (composition A), 49% (composition B), and 71% (compositions C and D) starch derived from rice flour, based on the total weight of starch. The compositions are detailed in Table 1.

[0154] [Table 3] Table 1 (all amounts of ingredients are given as weight % of the total weight of the soft chew). * : A blend of botanical derivatives, yeast, sugars, nutritional additives, mineral substances, sensory additives, and preservatives.

[0155] Example 3: Characterization of Soft Chews Example 3.1: Moisture and Water Activity Determination of moisture content and water activity of the soft chews was performed using standard methods (Karl Fischer and Capacitive Sensor, respectively) and the results are provided in Table 2.

[0156] [Table 4]

[0157] The moisture content of the soft chews ranged from 14 to 17%. The Aw was below 0.7, which is compatible with long-term storage at ambient temperature.

[0158] Example 3.2: Sensory evaluation of soft chews The evaluation was subjective. Shape, cohesiveness, texture, and friability were evaluated. The results are reported in Table 3.

[0159] [Table 5]

[0160] In this sensory evaluation, the soft chews can be classified in the following order (from worst to best): Composition B<Composition A<Composition D=Composition C.

[0161] Sensory evaluation showed that a weight percentage of starch provided by rice flour of about 70 (based on total starch) improved the sensory properties of the soft chews. With less than 50% of the total starch provided by rice flour (37% or 49%), the soft chews were less acceptable from the sensory evaluation.

[0162] Example 3.3: Stickiness of Soft Chews Over Time The stickiness of the soft chews was evaluated immediately after manufacture (T0) and after 15 days.

[0163] "Yes" indicates that the soft chew sticks when removed from the package by hand.

[0164] "Slightly" indicates that some of the soft chews stick when removed from the package by hand.

[0165] "No" indicates that the soft chews can be removed individually from the package by hand.

[0166] The results are reported in Table 4.

[0167] [Table 6]

[0168] Based on the above results, the soft chews can be classified from most sticky to least sticky: Composition C>Composition D>Composition A>Composition B.

[0169] From this study it can be concluded that a weight percentage of starch provided by rice flour of about 70 (based on the total amount of starch) significantly reduces the stickiness of the soft chews even after 15 days of storage. With less than 50% (37% or 49%) of the total starch provided by rice flour, the soft chews are sticky.

[0170] Example 3.4. Texture analysis The firmness of the soft chews was determined on a TA XT Plus texturometer (Stable Micro Systems) using a 0.5 in. (1.27 cm) P / 0,5S spherical probe with the following parameters implemented directly into the texturometer software:

[0171] [Table 7]

[0172] Briefly, the sample (soft chew) was placed on a flat base / surface and a spherical probe was lowered into the sample at a given speed to a distance of 3 mm. The sample was deformed by the probe and the resistance offered by the sample (force required to penetrate 3 mm) was recorded. The measured resistance, expressed in kgf (1 kgf = 9.80665 N), corresponds to the firmness of the soft chew.

[0173] The results for the 2g and 6g soft chews are reported in Table 5.

[0174] A graphical representation is also provided in FIG.

[0175] [Table 8]

[0176] From the texture analysis results it can be concluded that increasing the amount of pregelatinized rice flour in the soft chews results in a significant increase in firmness.

[0177] A weight percentage of starch provided by rice flour of about 70 (based on the total amount of starch) has a significant beneficial effect on the texture of the soft chew. Conversely, with less than 50% of the total starch provided by rice flour (37% or 49%), the soft chew is too soft.

[0178] Example 3.5. Oil Exudation Oil leakage was evaluated.

[0179] Briefly, two soft chews, A and C, were placed on a piece of paper for about 12 hours. After this time, the soft chews were removed and the longer size of the oil flakes on the paper was measured to assess the exudation of oil (lipids) from the soft chews.

[0180] The results are provided in Table 6.

[0181] [Table 9]

[0182] A weight percentage of starch provided by rice flour of about 70 (based on the total amount of starch) has a significant beneficial effect on the exudation of oil from the soft chew. Conversely, with less than 50% (37%) of the total starch provided by rice flour, the amount of oil exuded from the soft chew becomes more important.

Claims

1. A soft chew, at least one nutraceutical ingredient and / or at least one pharmaceutical active; 6% by weight or less of an oil, fat, or mixture thereof, based on the total weight of the soft chew; At least one paratant; starch, 1. A soft chew wherein at least 50% by weight of the total starch weight present in said soft chew is provided by pregelatinized rice flour, said soft chew being substantially free of paratants of animal origin, and said soft chew having a firmness comprised between 25 and 100N.

2. 10. The soft chew of claim 1 having a firmness comprised between 39 and 79 Newtons.

3. at least one wetting agent; at least one binder; ●Water, at least one protein source; at least one emulsifier, and 10. The soft chew of claim 1, comprising one or more further ingredients selected from the group consisting of at least one preservative and / or antioxidant.

4. 10. The soft chew of claim 1 comprising 3-6% by weight of an oil, fat, or mixture thereof.

5. 5. The soft chew of claim 4, comprising 3-6% by weight of oil.

6. 10. The soft chew of claim 1, wherein at least 60% by weight of the total starch present in the soft chew is provided by pregelatinized rice flour.

7. 10. The soft chew of claim 1 comprising 15-50% by weight starch, based on the total weight of the soft chew, and 5-30% by weight paratant, based on the total weight of the soft chew.

8. 10. The soft chew of claim 1 comprising 1-20% by weight of at least one nutraceutical ingredient and / or at least one pharmaceutical active, based on the total weight of the soft chew.

9. Based on the total weight of the soft chew, 1-10% by weight of at least one nutraceutical ingredient and / or at least one pharmaceutical active; 15-25% by weight starch, wherein at least 50% by weight of the total starch weight is provided by pregelatinized rice flour; 2 to 10% by weight of a protein source of non-animal origin; 3 to 6% by weight of at least one vegetable oil; 10 to 20% by weight of at least one paratant of non-animal origin; 10 to 25 wt. % of at least one non-aqueous wetting agent; 15-20% by weight of water.

10. 10. The soft chew of claim 1, wherein the dietary supplement ingredient is selected from the group consisting of eggshell membrane; krill powder, astaxanthin, or a source of astaxanthin, such as algae, yeast, salmon, trout, krill, shrimp, and crayfish; Boswellia serrata; hyaluronic acid or a salt thereof; and vitamin D3.

11. 10. The soft chew of claim 1, wherein the soft chew has a breaking force of less than 100N.

12. Steps below: i. the following ingredients: at least one nutraceutical ingredient and / or at least one pharmaceutical active; at least one starch source; a sufficient amount of pregelatinized rice flour to provide at least 50% by weight of the total starch weight; - 6% by weight or less of oil, fat, or mixtures thereof based on the total weight of the components; mixing at least one paratant; ii. forming the soft chew.

13. 13. The process of claim 12, comprising an additional drying step after step ii.

14. 13. The process of claim 12, wherein in step i. of mixing, the solids are first mixed together and then the liquid is added.

15. A soft chew according to any one of claims 1 to 11 for use as a medicine for non-human animals.

16. 16. A soft chew for use according to claim 15, comprising a dietary supplement selected from the group consisting of eggshell membrane; krill powder, astaxanthin or a source of astaxanthin, such as algae, yeast, salmon, trout, krill, shrimp, and crayfish; Boswellia serrata; hyaluronic acid or a salt thereof; and vitamin D3; krill powder, astaxanthin or a source of astaxanthin, such as algae, yeast, salmon, trout, krill, shrimp, and crayfish; Boswellia serrata and hyaluronic acid or a salt thereof, for use in the treatment of arthritis in dogs and / or for supporting healthy bones, for supporting joint flexibility and / or mobility, or for supporting the viscosity of synovial fluid.

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