NL1037940C2 - Composition for the treatment of hoof-related inflammations or infections in ungulate animals. - Google Patents

Description

Composition for the treatment of hoof-related inf laminations or infections in ungulate animals

The present invention relates to a composition comprising zinc oxide, a zinc salt and a humectant. The 5 invention furthermore relates to the use thereof in the treatment or prophylaxis of infections or inflammations of hooves of an animal.

Thrush is a bacterial infection which manifests itself by inflammations of hooves of animals, horses in 10 particular. If left untreated, the infection may result in softening of the hoof and discharge of a foul smelling fluid. When left untreated, parts of the hoof may degenerate and the animal may not be able to walk anymore due to the experience of pain to the hoof. At present, the symptoms of 15 thrush can be reduced in a treatment comprising the use of certain liquids or liquid compositions which all have their particular drawbacks. An inherent problem of using liquids is that this does not provide sufficient sustained and prolonged efficacy as liquids run-off too quickly and 20 generally only disinfect the affected area. Certain liquids, such as alcohol, evaporate immediately after application, whereas yet others, such as formaldehyde, may have carcinogenic properties. Use of yet other compositions may result in hardening of the frog, whereas this tissue should 25 in essence be soft and resilient.

Equine canker is another form of hoof-related disorder(s) which occurs in horses and related animals. Equine canker may be chronic, hyperplastic, and is characterized by exudative pododermatitis and is usually 30 accompanied by proliferative growth. Equine canker can affect all horny structures of the hoof, e.g. frogs, coronets, spurs, chestnuts, of one or more feet. Treatment may comprise oral administering of corticosteroids, such as 1037940 2 prednisolone. A draw-back of this treatment is that such corticosteroids usually have highly undesirable side-effects .

One object of the present invention is to provide 5 a solution to, inter alia, the above problems by providing a composition, and method for the production thereof, for the treatment of hoof-related infections or inflammations, thrush and equine canker in particular. Another object of the present invention is to provide a method of treatment of 10 such hoof-related infections or inflammations.

This object is achieved by the composition, method and use of the composition according to the appended claims.

In particular, this object is achieved by a composition comprising zinc oxide, zinc chloride and an 15 oxygen permeable humectant.

It was surprisingly found that the composition according to the invention was particularly efficacious in the treatment of hoof-related infections or inflammations, such as thrush which, inter alia, occurs in horses, ponies 20 and related equines. Furthermore, the composition was shown to be effective in the treatment of equine canker and mud fever in horses, the latter being a skin infection of the lower parts of the leg above the hoof.

Besides that the composition has disinfection 25 properties and causes the treated area of the hoof to become dry and allows it to harden, the composition moreover provides a moisture-proof layer such that the treated hoof will remain sufficiently dry and allows the hoof to recover. These properties of the composition are advantageously 30 combined with sufficient air-permeability of the residual thin layer or film which covers the affected area after application of the composition to the hoof. An important advantage thereof is, inter alia, that the amount of 3 pathogenic bacteria can be effectively reduced to the extent that the infection or inflammation will be reduced. More prolonged treatment of the affected area of the hoof, which usually encompasses several weeks, results in absence of the 5 symptoms and a complete curing of the hoofs of the animal.

As was confirmed by an in vitro laboratory test, the composition according to the invention is effective at least against bacteria which are implicated in infections and inflammations of hooves of animals. Such bacteria, such 10 as Fusobacterium necrophorum, were effectively killed making the composition particularly suitable for treating hoof-related infections or inflammations which are caused by or correlated to this bacterium. Such topical conditions include thrush in horses or related animals.

15 The humectant herein is an oxygen-permeable humectant which, after application to the affected area, leaves a residual, layer or film on the affected area which is gas permeable. One advantage thereof is that the composition has particular efficacy against bacteria which 20 are anaerobic and implicated in hoof-related infections and inflammations. A non-gas permeable humectant likely has suitable efficacy against aerobic bacteria, but may not provide sufficient activity against such anaerobic organisms .

25 In a preferred embodiment, the composition further comprises an effective amount of alpha bisabolol. Such an effective amount comprises between 0,1 and 0,5 weight percent of the composition.

In a preferred embodiment, zinc oxide is present 30 in an effective amount of between 30 to 70 weight percent, preferably 40 to 60 weight percent, more preferably between 45 to 55 weight percent, most preferably about 49 weight percent.

4

Furthermore, the composition comprises a zinc salt, in particular an organic zinc salt. In a preferred embodiment, the composition comprises a zinc salt in an amount of between 0.1 to 5 weight percent, preferably 0.2 to 5 3 weight percent, more preferably 0.5 to 2 weight percent, most preferably about 1 weight percent. The zinc salt according to the invention can be selected from the group consisting of zinc chloride, zinc sulphate or zinc acetate.

The humectant of the composition according to the 10 present invention is selected from glycerine or glycerine triacetate, or another suitable glycerine derivative that can be used as humectant as meant herein. The humectant can further encompass other suitable substances which prevent desiccation of the affected area to occur while preventing 15 water to come into direct contact with the affected area and forming a gas-permeable film or layer. One advantage of including glycerine is that this substance also has a thickening effect, which, when used in a suitable range according to the invention, provides a suitable viscosity to 20 the composition. Such a humectant of the invention is present in an amount of between 10 to 30 weight percent, preferably 12 to 28 weight percent, more preferably 15 to 25 weight percent, most preferably about 20 weight percent.

In another embodiment, the composition of the 25 present invention further comprises water in an amount of between 20 to 40 weight percent, preferably 25 to 35 weight percent, more preferably about 28 weight percent.

In yet another embodiment, the composition further comprises a thickening agent and/or a colorant.

30 The thickening agent can be a cellulose polymer, such as hydroxy-ethyl-cellulose. The thickening agent is present in any suitable amount to provide a composition of suitable consistency. The thickening agent may be present in 5 an amount of between about 0.1 to about 2 weight percent of the composition. In a preferred embodiment, the amount of hydroxy-ethyl-polymer is used in an amount of 1.6 weight percent.

5 The colorant is added to allow one to recognize that the composition of the invention is used. In a preferred embodiment, the colorant is color powder blue FD & C blue NO.1 (INCI C.I. 42090) in an amount of less than 0.1%. However, any suitable colorant may be used.

10 Another aspect of the present invention relates to a method for producing the composition of the invention comprising mixing zinc oxide with a humectant and adding a zinc salt, such as zinc oxide, zinc sulphate or zinc acetate, to the thus obtained mixture to obtain a lipophilic 15 phase; mixing water with the therein dissolved thickening agent to obtain a hydrophilic phase and mixing the lipophilic and hydrophilic phases.

In one embodiment, the colorant may be added to the mixture according to the invention after the phases are 20 mixed. In another embodiment, a colorant is added to the lipophilic phase. It will be clear to the skilled person when to add a colorant, based on the properties of the colorant of choice.

Yet another aspect of the invention relates to the 25 use of the composition according to the present invention as a medicament. Besides that it is believed that this is the first disclosure of the present composition, this is also believed to be the first disclosure of the use thereof in the treatment or prophylaxis of an infection or inflammation 30 of a hoof of an animal.

Yet again another aspect of the invention relates to the treatment of an infection or inflammation in a hoofed animal, comprising of topically administering the 6 composition according to the present invention to an affected area of the hoof of the animal. The composition of the present invention is in particular effective to treat thrush, equine canker and mud-fever occurring in equines, in 5 particular horses.

The treatable infections or inflammations to hooves of animals using the composition of the present invention are mainly caused by bacteria, in particular anaerobic such as Fusobacterium necrophorum, which survive 10 in wet, muddy soils.

The scope of the present invention thus includes, next to its demonstrated use in the treatment of hoof-related disorders, such as thrush and equine canker, or skin-related disorders, such as mud-fever, its use in the 15 treatment of other infections related to the hoof or skin, such as white line disease. Furthermore, the scope of the present invention clearly also includes the treatment of hoof-related infections or inflammations of other ungulate animals, in particular cattle, such as cows, sheep or goats. 20 Whereas treatment of hoof-disorders in farm animals may, from an economical point of view, not be the preferred choice as such animals can be sold on the meat-market, this situation is clearly distinct from animals kept in zoological gardens, zoos, animal parks or children's 25 farms. Such economic considerations usually do not apply when deciding whether or not to treat ungulate or hoofed animals kept in captivity for amusement purposes. It thus lies within the scope of the invention to treat ungulate or hoofed animals suffering from hoof-related infections or 30 inflammations which are treatable with the composition.

In a preferred embodiment, the hoof of an odd-toed ungulate animal which suffers from a bacterial infection or inflammation to its hoof is treated with the composition of 7 the present invention. In particular are hoofed animals selected from horses, ponies, donkeys, mules or hinnies treated from bacterial infections or inflammations of a hoof with the composition of the present invention.

5 In order to treat an infection or inflammation occurring in a hoofed animal, the composition is to be applied to the affected area of the hoof once or twice a day. For prophylactic purposes, the composition is to be applied every other day or daily. When treating advanced 10 forms of hoof-infections or inflammations, the composition is to be applied once or twice a day for one or two weeks after which the treatment regime may be less intense for another two weeks. It lies well within the capabilities of the average skilled veterinarian, blacksmith, farrier or 15 plater to determine what the optimal dosage regime is in order to relief the animal of the infection or inflammation of the hoof.

Advantageously, the composition is not applied with bare hands but applied using a device, such as an 20 injector, which allows one to apply the composition directly and effectively into the affected area, in particular the main groove or frog of the hoof. The composition may be squirted on the affected area, preferably using an injector. After such topical application, the composition can easily 25 be spread over the affected area.

Examples

Several horses that suffered from thrush were 30 treated with a composition comprising 49 weight percent zinc oxide (gold seal 99%), 20.6 weight percent glycerine aqua (99.5%), 1 weight percent zinc chloride, 27.8 weight percent demi aqua, 1.6 weight percent hydroxyethylcellulose 8 and less than 0.1 weight percent colorant, i.e. powder blue FD & C blue NO.1 (INCI C.I. 42090). Within few weeks of application of the composition, the animals showed signs of recovery of thrush and the animals were completely free of 5 symptoms upon further treatment with the composition.

In similar manner, horses suffering from equine canker were treated with the same composition as used to treat thrush. Also in this case the symptoms diminished and the animals were completely free of symptoms after prolonged 10 treatment, up to about six months. Treatment using the composition according to the invention usually commences after surgical removal by a veterinary surgeon or skilled blacksmith of as much as possible of the areas to be treated of the affected hoof.

15 In case of mud-fever in horses, the composition as used for the treatment of thrush was topically applied to the affected areas of the legs of horses after which the infection reduced.

10379*0

Claims (3)

A composition for use in the treatment or prevention of infection or inflammation of a hoof of an animal, consisting of zinc oxide, a zinc salt and a wetting agent (s), preferably an oxygen-permeable wetting agent. The composition for use according to claim 1, wherein the composition is administered locally to an affected / infected area of the animal's hoof. 3. composition for use according to claim 1 or 2, wherein the composition is applied to the affected area, preferably with the aid of an injector. 4. composition for use according to any of claims 1-3, wherein the hoof of the animal suffers from a bacterial infection, in particular an infection with / by an anaerobic bacterium. A composition for use according to any of claims 1-4, wherein the hoofed animal is an unpleasant hoofed animal. A composition for use according to any of claims 1-5, wherein the hoofed animal is selected from a horse, pony, donkey or mule. 7. A composition for use according to any of claims 1-6, wherein the infection or inflammation is rock-ray or hoof cancer. A composition for use according to any of claims 1-7, wherein the treatment reduces the number of anaerobic bacteria present in the affected area of the hoof. 50 g. composition consisting of zinc oxide, a zinc salt and a wetting agent, preferably an oxygen-permeable wetting agent. The composition of claim 9, wherein the zinc oxide is present in an amount of between 30 to 1037940, 70 weight percent, preferably 40 to 60 weight percent, more preferably between 45 and 55 weight percent, most preferably about 49 weight percent. 11. compositions according to claim 9 or 10, In which the zinc salt is present in an amount of between 0.1 to 5% by weight, preferably 0.2 to 3% by weight, more preferably 0.5-2% by weight, most preferably about 1% by weight. The composition of any one of claims 9 to 11, wherein the wetting agent is selected from glycerin or glycerine triacetate. A composition according to any one of claims 9 to 12, wherein the wetting agent is present in an amount of between 10 to 30 weight percent, preferably 12 to 28 weight percent, more preferably 15 to 25 weight percent, most preferably about 20 weight percent. 14. A composition according to any one of claims 9-13, wherein the composition further comprises water in an amount of 20 to 40% by weight, preferably 25 to 35% by weight, more preferably about 28% by weight. The composition of any one of claims 9 to 14, wherein the composition further comprises a thickener and / or a colorant. 16. A composition according to any one of claims 9-15, wherein in the composition contains about 49 percent by weight of zinc oxide, about 1 weight percent of zinc salt, preferably zinc chloride, and about 21 weight percent of a wetting agent, preferably glycerin. A method of producing the composition according to any of claims 9-16, comprising mixing zinc oxide with a wetting agent and adding a zinc salt to the thus-obtained mixture to obtain a lipophilic phase; mixing water with the thickener to obtain a hydrophilic phase and mixing the lipophilic and hydrophilic phase. 1037940