GB2401044A

GB2401044A - Composition for treatment of skin conditions, such as sweet itch in horses, comprising an alcohol, an oil and a derivative of benzene

Info

Publication number: GB2401044A
Application number: GB0409694A
Authority: GB
Inventors: Julie Elizabeth Almond
Original assignee: Individual
Current assignee: Individual
Priority date: 2003-05-02
Filing date: 2004-04-30
Publication date: 2004-11-03
Anticipated expiration: 2024-04-30
Also published as: GB0409694D0; GB2401044B; GB0310147D0

Abstract

A composition is provided for use in the treatment or prophylaxis of a skin condition, such as Sweet Itch (ie summer seasonal recurrent dermatitis or summer eczema), in a subject, such as a horse, which comprises an alcohol, an oil and a derivative of benzene. The use of a composition for the treatment or prophylaxis of a skin condition in a subject, and the use of a composition for the manufacture of a medicament for the treatment or prophylaxis of a skin condition in a subject are also provided. A process for preparing the composition comprises admixing the ingredients. The alcohol is preferably methanol, ethanol, methylated spirit or surgical spirit. The oil is preferably a mineral oil, such as liquid paraffin, or an essential oil. The benzene derivative is preferably benzyl alcohol, benzyl cinnamate or an ester of benzoic acid, especially benzyl benzoate. The composition may also be used to treat mastitis, mud fever, dermatitis, chronic itching, flea and insect bites, and ringworm.

Description

240 1 044

A COMPOSITION FOR USE IN THE TREATMENT OR PROPHYLAXIS

OF A SKIN CONDITION IN A SUBJECT

The present invention relates to a composition for use in the treatment of a skin condition in a subject, a composition for use as a medicament, and a process for preparing a composition. In particular, the invention relates to a composition for use in the treatment of Sweet Itch in horses, ponies or donkeys.

Many types of animals, such as dogs, cats, horses and ponies may suffer prom skin conditions or ailments. A condition called Sweet Itch, also known as Summer Seasonal Recurrent Dermatitis (SSRD) or Summer Eczema, is a problem that affects thousands of horses, ponies and donkeys in many countries of the world to various degrees. Virtually all breeds and types of ponies and horses can be affected, from tiny Shetland ponies to heavyweight draught horses, although the condition is rare in English Thoroughbreds. About 5% of the UK horse population suffer from Sweet Itch. Reports suggest that as many as 60% of horses and ponies are affected in South Australia.

Sweet Itch is an allergic skin disease and an immune system problem. The disease is caused by a delayed hypersensitivity to insect bites resulting in an over-vigorous response from the animal's immune system. In the process of repelling invading insect saliva the horse may attack some of it's own skin cells 'by mistake' and the resulting cell damage causes the symptoms described as Sweet Itch.

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em:: c:e tt. :: :: À e c e À c ec a e À e In the UK, several species (ofthe 1,000 or so that exist) ofthe Culicoides midge and, to a lesser extent, the larger, hump- backed Simulium Equinum, a member of the blackfly family, are responsible for biting animals which can lead to the symptoms of Sweet Itch. Each has a preferred feeding site on a horse. Most common are the "dorsal feeders" who bite, and cause damage around the horse's ears, poll, mane, withers, rump, and tail head. The "ventral t'eeders" are less common, and tend to cause itching around the horse's face, chest and belly.

Culicoides flies mainly rest among herbage and are most active in twilight, calm conditions. Breeding sites are commonly in aquatic habitats, decaying vegetation, manure or water troughs. They are very small and can pass through conventional mosquito netting. The flies typically breed throughout the spring, summer and autumn. Consequently, due to the life cycle of the flies, Sweet Itch is a seasonal disease occurring between March and October in the UK.

Symptoms include severe pruritus (itching), hair loss, skin thickening and flaky dandruff. Exudative dermatitis (weeping sores, sometimes with a yellow crust of dried serum) may occur. Without attention, sores can suffer secondary infection. The top of the tail and the mane are most commonly affected. The neck, withers, hips, 2 0 ears and forehead, and in more severe cases, the mid-line of the belly, the saddle area, the sides of the head, the sheath or udder and the legs may also suffer. The animal may swish its tail vigorously, roll frequently and attempt to scratch on anything within reach. It may pace endlessly and seek excessive mutual grooming from other animals.

Sul'f'erers may also scratch out their mane with their hind fleet and bite vigorously at e ::: . À : : . . . their own tail, flanks and heels. There can be a marked change in temperament, that is lethargy with frequent yawning and general lack of 'sparkle' may occur, or the horse may become impatient and, when ridden, lack concentration. Whey flying insects are around the horse may become agitated, with repeated head shaking.

Sweet Itch can therefore be very distressing for horses and their owners alike.

Conventional therapies have typically involved natural methods of minimising midge attack or the use of chemical products to treat the condition. For instance, the horse may be kept away from marshy, boggy fields; ensuring that pasture is kept well drained and away from rotting vegetation; stabling the horse at dusk and dawn when midge feeding is at its peak, and closing stable doors and windows.

Such methods may help in slight to moderate cases of Sweet Itch but it is generally inadvisable to stable horses for long periods of time especially because they are free to scratch the sores. Chemical products which have previously been used to treat Sweet Itch include fly repellents, insecticides, corticosteroids, anti-histamines and greases.

Some of these products may irritate the skin and cause drowsiness and side effects.

There has now been developed an improved composition for use in the treatment of 2 0 Sweet Itch which reduces the abovementioned problems, is cost- effective to prepare and which may be administered to the animal relatively easily.

According to an aspect of the invention, there is provided a composition for use in the treatment or prophylaxis of a skin condition, the composition comprising: an alcohol; e ee ece an oil; and a derivative of benzene.

The alcohol may be a primary, secondary or tertiary alcohol and it may have a branched or unbranched chain structure. The alcohol may comprise methanol or ethanol, or may comprise a combination of alcohols such as in the case of surgical spirit or methylated spirit.

The alcohol is present to sterilise and clean the skin. In addition the alcohol can harden the skin, which can, for example, help prevent further insect bites.

The oil of the composition of the invention may comprise a mineral oil. The oil may be obtained from petroleum or a petroleum based compound by fractional distillation.

In a preferred embodiment, the oil comprises medicinal liquid paraffin. Light liquid paraffin is particularly preferred because of its lower density compared to standard liquid paraffin. It has been found that if the density of the oil is too great it can result in adverse skin reactions such as pore clogging or hair loss. Alternatively, the oil may comprise an essential oil derived from a plant source.

The oil moisturises and conditions the skin, which helps in the healing process of 2 o damaged areas of skin.

The benzene derivative may comprise or include a benzyl alcohol is a local anaesthetic with disinfectant properties. The derivative may comprise an ester such as benzyl cinnamate which is the ester formed from benzyl alcohol and cinnamic acid ede: :e..

Àe:: c:e ce À me: Àe. À .. se.: and has antibacterial and antifungal properties. Benzyl benzoate, an ester formed from benzyl alcohol and benzoic acid, has skin soothing properties and is also useful as an insect repellent and insecticide.

The composition may be formulated as a liquid, lotion, cream, ointment or gel.

The alcohol may be present in an amount of 10% to 90% by weight based on the weight of the composition. It is preferred that the alcohol is present in an amount of 30% to 60% by weight based on the weight of the composition.

The oil may be present in an amount of 10% to 90% by weight based on the weight of the composition; preferably in an amount of 30% to 60% by weight.

The benzene derivative may be present in an amount of 2% to 60% by weight based on the weight of the composition; preferably in an amount of 20% to 40% by weight.

The composition may include bronopol (2-bromo-2-nitro-propane). Bronopol is useful as a preservative.

2 0 The composition may further comprise from 1% to 10% by weight of an emulsifying or surface active agent such as sodium lauryl sulphate; preferably 3% to 6% by weight.

::: me: À:e t:: À ce: ce À À Àe eee The composition may further comprise a fragrancing compound to improve the olifactory acceptability of the composition. Aloe extract, camomile and tea tree oil are useful additives because they provide the advantageous properties of both skin conditioning and fragrancing.

In one embodiment, the composition may comprise substantially the same amount of the alcohol and the oil.

If required the balance of the composition may comprise an inert, physiologically acceptable carrier or diluent such as distilled water.

According to a further aspect the present invention provides for the use of a composition as described herein in the treatment or prophylaxis of a skin condition in a subject.

The present invention also provides for the use of a composition as described herein for the manufacture of a medicament for the treatment or prophylaxis of a skin condition in a subject. The medicament may include a therapeutically effective amount of the composition.

The skin condition to be treated by the composition of the invention may be Sweet Itch. The subject to be treated may be an animal such as an equine, bovine, canine or feline animal. Examples of animals which may be treated include horses, ponies, donkeys, mules, cows, bulls, oxen, deer, antelope, sheep, zebras, giraffes, camels, ::: ee: l:e l:: amp: ce À ces cee dogs and cats.

The composition of the invention may be administered to a subject in a topical formulation. The formulation may be applied directly to the affected areas or sores of an animal suffering from a skin condition. The formulation may be applied to the animal manually by rubbing it into the animal's skin or by using a suitable applicator means, for example a cloth or brush.

It is preferred that the composition is applied by spraying it onto the animal's skin.

Alternatively, subcutaneous injection of the composition into the affected area or the area surrounding the sores may be carried out.

The efficacy ofthe treatment has been found to be improved if the affected skin ofthe animal is degreased before application of the composition for treatment of the skin 1 5 condition.

The composition ofthe invention is particularly suitable for the prophylactic treatment of Sweet Itch in horses, ponies, donkeys, mules and other animals, and for minimising the symptoms of the disease in animals suffering from Sweet Itch. Advantageously, 2 0 the composition may be administered with minimal distress to an animal, for example, a horse, and relatively rapid relief and recovery may be experienced by the horse.

Furthermore, the composition of the invention may be used to treat other skin conditions in a subject, such as mastitis, mud fever, dermatitis, chronic itching, flea and insect bites, and ringworm.

À À Àe:: .:. 'e. À ee: e.. . À ee. Age: The present invention also provides a process for preparing a composition for use in the treatment or prophylaxis of a skin condition, the process comprising the steps of: providing ingredients comprising an alcohol, an oil and a derivative of benzene; and mixing the ingredients to form the composition.

Examples of a preferred embodiment of the invention shall now be described.

Example l - Preparation of the composition A composition was prepared in a glass beaker by adding 40% by weight of surgical spirits, 40% by weight of liquid paraffin, 10% by weight of benzyl benzoate and l 0% by weight of aloe Vera plant extract. The ingredients were mixed until a substantially homogeneous composition was formed.

Example l - Use of the composition The composition prepared in Example l was poured into a aerosol spray device having a cleicontainer to hold the composition. The container is specified to be clear because this allows the composition to be viewed. In this embodiment there is 2 0 no emulsifying agent and it would be necessary to agitate the composition before use in order to homogenise it if the components have become separated. An effective amount of the composition was sprayed onto an affected area of a horse suffering from Sweet Itch so as substantially to cover the sore areas of the horse.

Approximately one hour after the composition had been administered there was a ::: amp: eve e:: À id: I- À ce ee notable improvement in the temperament of the horse and the condition of the affected skin area. Dependant on the severity of the Sweet Itch, it may be required to apply several treatments in order to alleviate the symptoms of the disease.

Example 2 - Preparation of the Composition A composition was prepared in a glass beaker by adding 2 litres of industrial methylated spirits (99% pure, available from British Chemical Products), 2 litres of! pure light liquid paraffin (available from Pinewood Healthcare) and 1 1itre of benzyl benzoate (25% w/v, available from William Ransom & Son).

The ingredients were admixed until a homogenous composition was formed. The composition was dispensed into SOml aliquots in clear containers.

Example 2 - Use of the Composition A horse suffering from Sweet Itch was prepared by degreasing the affected area. The composition was administered in aerosol form over the affected area. Approximately one hour after the composition had been administered there was a notable 2 0 improvement in the temperament of the horse and the condition of the affected skin area.

Claims

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l. A composition for use in the treatment or prophylaxis of a skin condition, the composition comprising: - an alcohol; - an oil; and a derivative of benzene.
2. A composition according to Claim I, wherein the alcohol comprises methanol.
3. A composition according to Claim l, wherein the alcohol comprises ethanol.
4. A composition according to any of Claims l to 3, wherein the oil comprises a mineral oil.
5. A composition according to any preceding claim, wherein the oil is derived from a petroleum-based compound.
6. A composition according to any preceding Claim, wherein the oil comprises liquid paraffin.
7. A composition according to Claim 6, wherein the liquid paraffin comprises light liquid paraffin.

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8. A composition according to any of Claims I to 3, wherein the oil comprises an essential oil.
9. A composition according to any preceding Claim, wherein the benzene derivative includes a benzyl group.
IO. A composition according to any preceding Claim, wherein the benzene derivative comprises an ester.
11. A composition according to Claim 10, wherein the benzene derivative comprises an ester of benzoic acid.
12. A composition according to any preceding Claim, wherein the benzene derivative comprises benzyl benzoate.
13. A composition according to any preceding Claim, wherein the alcohol is present in the amount of 10% to 90% by weight based on the weight of the composition.

2 0
14. A composition according to any preceding Claim, wherein the oil is present in the amount of 10% to 90% by weight based on the weight ofthe composition.
lS. A composition according to any preceding Claim, wherein the benzene derivative is present in the amount of 2% to 60% by weight based on the weight of the ::: te: .:e ':: À amp: ce. À e.e eee: composition.
16. A composition according to any preceding Claim, further comprising an emulsifying agent.
17. A composition according to Claim 16, wherein the emulsifying agent is present in the amount of 1% to 10% by weight based on the weight of the composition.
18. A composition according to any preceding Claim, further comprising bronopol.
19. A composition according to any pre ceding Claim, further comprising a fragrancing compound.
20. A composition according to any preceding Claim, further comprising aloe extract.
21. The use of a composition according to any proceeding Claim in the treatment 2 0 or prophylaxis of a skin condition in a subject.
22. The use of a composition according to any of Claims I to 20 for the manufacture of a medicament for the treatment or prophylaxis of a skin condition in a subject.

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23. Use according to Claim 22, wherein the medicament includes a therapeutically effective amount of the composition.
24. Use according to any of Claims 21 to 23, wherein the skin condition is Sweet Itch.
25. Use according to any of Claims 21 to 24, wherein the subject is an animal.
26. Use according to Claim 25, wherein the subject is equine, bovine, canine or 1 0 feline.
27. Use according to Claim 25 or Claim 26, wherein the subject is a horse, pony, donkey or mule.
28. A process for preparing a composition for use in the treatment or prophylaxis of a skin condition, the process comprising the steps of: providing ingredients comprising an alcohol, an oil and a derivative of benzene; and - admixing the ingredients to form the composition.
29. A composition substantially as hereinbefore described.
30. Use substantially as hereinbefore described.

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3 l. A process substantially as hereinbefore described.