GB2558268A

GB2558268A - An animal feed supplement for treating gastric ulceration in equines

Info

Publication number: GB2558268A
Application number: GB1622123.6A
Authority: GB
Inventors: Lee Mitson David
Original assignee: Individual
Current assignee: Individual
Priority date: 2016-12-23
Filing date: 2016-12-23
Publication date: 2018-07-11
Anticipated expiration: 2036-12-23
Also published as: GB201622123D0; GB2558268B

Abstract

An extract of Ficus glomerata is used for preventing and/or treating gastric ulceration or colic in equines such as horses. The extract may be provided together with an appropriate excipient as a pharmaceutical composition or feed supplement, and may be provided in various forms such as powder, tablet, pellet, paste, or syrup. The excipient may be a typical pharmaceutical or supplement excipient such as a binder or flavouring agent. The extract may be obtained from the fruit of Ficus glomerata. The extract may be obtained by preparing an extract from Ficus glomerata using a solvent such as ethanol, filtering the liquid extract, and drying the extract to obtain a powder.

Description

(71) Applicant(s):

David Lee Mitson

Fox Farm, Crowfield, Northants, Northamptonshire, NN13 5TW, United Kingdom (72) Inventor(s):

David Lee Mitson (74) Agent and/or Address for Service:

A A Thornton & Co

Old Bailey, LONDON, EC4M 7NG, United Kingdom (51) INT CL:

A23K 50/20 (2016.01) A23K 10/30 (2016.01)

A61K 36/60 (2006.01) (56) Documents Cited:

US 20040121029 A1 'GastroKind' gastric support supplement by Science Supplements, available around January 2017 (http:// www.sciencesupplements.co.uk/products/horsestomach.html).

(58) Field of Search:

INT CLA23K, A61K

Other: WPI, EPODOC, BIOSIS, MEDLINE, XPSPRNG, XPESP. Patent fulltext. Internet keyword search.

(54) Title of the Invention: An animal feed supplement for treating gastric ulceration in equines Abstract Title: Treating equine gastric ulceration or colic using extract of Ficus glomerata (57) An extract of Ficus glomerata is used for preventing and/or treating gastric ulceration or colic in equines such as horses. The extract may be provided together with an appropriate excipient as a pharmaceutical composition or feed supplement, and may be provided in various forms such as powder, tablet, pellet, paste, or syrup. The excipient may be a typical pharmaceutical or supplement excipient such as a binder or flavouring agent. The extract may be obtained from the fruit of Ficus glomerata. The extract may be obtained by preparing an extract from Ficus glomerata using a solvent such as ethanol, filtering the liquid extract, and drying the extract to obtain a powder.

1/3

Fig.1: Deep ulceration with diptheritic membrane in glandular mucosa.

Fig. 2: Glandular mucosal erosions at the pylorus

2/3

Fig. 3: Squamous mucosal ulceration at the margo plicatus

Fig. 4: Margo plicatus six weeks post treatment

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Fig. 5 Margo plicatus pre-treatment

Fig 6. Margo plicatus post-treatment

Title

An animal feed supplement for treating gastric ulceration in Equines

Field of the Invention

The present invention relates to animal feed supplements. More particularly, the present invention relates to equine feed supplements comprising an extract of Ficus glomerata to improve the overall health and to prevent or treat gastric ulceration in equines such as a horse, and to equine gastric ulcer management methods. The invention also relates to a new use of Ficus glomerata in the treatment of gastric ulceration in equines, and to a process for preparing a feed supplement comprising an extract of Ficus glomerata.

Background of the Invention

Studies of horses using gastroscopy have indicated a high prevalence of gastric ulceration. This ranges from very high in racehorses (>80%) to much lower rates in horses that spend a significant amount of time at pasture. Gastric ulceration in horses can be caused by pharmaceuticals such as phenylbutazone (commonly referred to as “bute”, a nonsteroidal anti-inflammatory drug (NSAID) used for the short-term treatment of pain and fever in animals), but are more commonly caused by large, infrequent meals, restricted forage intake and behavioural stress. Gastric ulceration in horses can also be caused due to excess acids in stomach, stress, bacteria and parasites that cause equine gastric ulceration.

In addition to this, “colic” which refers to abdominal pain that may be caused by many different problems is prevalent in horses. In horses, most of these problems involve the gastrointestinal tract. Conditions that cause colic are often placed in functional categories such as ileus, obstruction, strangulation, enteritis, and ulceration.

There are many clinical signs that may be suggestive of the presence of gastric ulcers in equine, such as weight loss, loss of performance, poor hair coat, mild colic, mental dullness or attitude changes resenting being girthed, behavioural changes, behavioural changes around feeding time, but a definitive diagnosis can only be made by gastroscopy (inserting an endoscope into the stomach to observe the stomach lining).

Gastric ulcers in horses are found either in the glandular, lower region of the stomach which is exposed to acid secretions on a more or less constant basis or in the upper squamous region where acid can reach through splashing during movement of the horse and stomach.

Various different scoring systems for Gastric ulcers in equine have been proposed but the most common is a 0-4 scale developed by Andrews et al. (1999). . Grades 2 or above are considered clinically significant

- the epithelium and the mucous membrane does not appear hyperemic (red), nor hyperkeratoic i.e. yellow in the squamous region - (healthy and non-ulcerated stomach lining)

- the mucosa is intact, but certain regions are red and hyperkeratoic (scaly), and small lesions - (mild ulcers)

- the mucosa is intact, but lesions are shallow and isolated or multifocal, large lesions (moderate ulcers)

- lesions are severe, large, single or multifocal, extensive and superficial

- lesions are extensive, deep ulceration and bleeding

Changes in management includes increasing the amount of roughage in the diet, increasing the number of feedings use supplements, giving probiotics, a nutritional digestive supplement to support healthy gut structure and function, especially of the hindgut while suppressing stomach adds.

In additional to this, different medications are used for three purposes: (1) to decrease acid production, (2) to buffer the acid that is produced, and (3) to protect the lining of the stomach from the effects of the acid. H2 blockers (such as cimetidine, ranitidine), proton pump inhibitors, buffers (antacids) and protectants (sucralfate) are used for these purposes.

The most commonly used drug to treat equine gastric ulcers is omeprazole. Omeprazole is a gastric acid proton pump inhibitor (PPI) which reduces the secretion of protons (acid) into the stomach. This raises the pH within the stomach and allows the ulcers to heal. However, use of omeprazole for a prolonged period of time and at a high dosage is undesirable since raising the stomach pH long term is undesirable as an acid environment in the stomach is required for normal digestion, including the first stage in protein digestion in stomach and for killing many micro-organisms that are ingested with feed.

Furthermore, in some cases the long term use of proton pump inhibitor (PPI) has been associated with an increased risk of fractures and atypical myopathy. Omeprazole is also very expensive and many horse owners are unable to afford repeated treatment with this drug. Whilst omeprazole is considered effective for squamous ulcers, it is generally recognised to be less effective for glandular ulcers.

Another treatment that is commonly used to treat equine gastric ulcers is sucralfate which is an aluminium salt of sugar. In the acid environment of the stomach sucralfate becomes thick and viscous and functions as a physical barrier between the ulcer and the stomach acid. However, sucralfate should be given every ~6h and at different times to other medications as it can interfere with their absorption. Further long term use of sucralfate may cause higher levels of aluminium to accumulate and weaken the bones or have an effect on the brain. In addition, there is currently a shortage of sucralfate for equine use.

Many non-prescription supplements that are marketed for horses with gastric ulcers are simply inorganic alkaline compounds such as magnesium hydroxide which temporarily increase stomach pH.

Thus, whilst there are a number of Prescription Only Medicine (POM) licensed for use in the treatment for gastric ulcers in horses, these are expensive, and do not treat both forms of ulcers (i.e. squamous and glandular ulcers) and have increased risk of side effects with long term use.

Thus, there is a need for a therapy for preventing and/or treating gastric ulceration in equines, especially in horses.

Summary of the Invention

According to an aspect of the present invention, there is provided an equine feed supplement for preventing or treating gastric ulceration in equines comprising an extract of Ficus glomerata and at least one or more excipient suitable for equine supplement formulation. The feed supplement preferably comprises alfalfa.

According to another aspect of the present invention, there is provided a feed supplement for use in the prevention or treatment of gastric ulceration in equines, comprising an extract of Ficus glomerata.

According to another aspect of the present invention, there is provided a feed supplement for use in the treatment of colic in equines, comprising an extract of Ficus glomerata.

According to another aspect of the present invention, there is provided a pharmaceutical composition for preventing or treating gastric ulceration in equines comprising an extract of Ficus glomerata and at least one or more pharmaceutically acceptable excipient.

According to another aspect of the present invention, there is provided a pharmaceutical composition for use in the prevention or treatment of gastric ulceration in equines, comprising an extract of Ficus glomerata.

According to another aspect of the present invention, there is provided a pharmaceutical composition for use in the treatment of colic in equines, comprising an extract of Ficus glomerata.

According to another aspect of the present invention, there is provided an extract of Ficus glomerata for use in a method for preventing and/or treating gastric ulceration or colic in equines.

According to another aspect of the present invention, there is provided a process for obtaining an extract of Ficus glomerata for treating gastric ulceration or colic in equines, the process comprising: (a) preparing an extract from one or more part of Ficus glomerata per se using a solvent; (b) filtering the liquid extract; and c) drying the extract to obtain a powder. The one or more part of Ficus glomerata per se may be a fruit.

According to another aspect of the present invention, there is provided a method of producing an equine feed supplement for preventing or treating gastric ulceration or colic in equines, comprising mixing together an extract of Ficus glomerata and at least one or more additive or excipient.

According to another aspect of the present invention, there is provided a method of producing a pharmaceutical composition for preventing or treating gastric ulceration or colic in equines, comprising mixing together an extract of Ficus glomerata and at least one or more pharmaceutically acceptable excipient.

According to another aspect of the present invention, there is provided a method of preventing and/or treating gastric ulceration in equines comprising administrating to an equine in need of treatment an effective amount of an extract of Ficus glomerata.

According to another aspect of the present invention, there is provided use of one or more part of Ficus glomerata perse, or an extract of Ficus glomerata for preventing or treating gastric ulceration or colic in equines. The part of Ficus glomerata for use is preferably a fruit.

According to another aspect of the present invention, there is provided use of one or more part of Ficus glomerata perse, or an extract of Ficus glomerata for increasing the pH in the stomach of equines having colic or gastric ulceration. The one or more part of Ficus glomerata for use is preferably a fruit.

The foregoing and other features and advantages of the invention will be more readily understood upon consideration of the following detailed description of the invention, and the accompanying drawings.

Brief description of the drawings

The drawings illustrate certain aspects of some of the embodiments of the present invention.

Figure 1 shows a photograph of deep ulceration with diptheritic membrane in glandular mucosa.

Figure 2 shows a photograph of glandular mucosal erosions at the pylorus.

Figure 3 shows a photograph of squamous mucosal ulceration at the margo plicatus.

Figure 4 shows a photograph of margo plicatus 6 weeks post treatment.

Figure 5 shows a photograph of Margo plicatus ulcerated area pre-treatment.

Figure 6 shows a photograph of margo plicatus post-treatment. It can be seen that the ulcerated area is fully healed apart from a couple of small, focal, reddened areas at the pylorus.

Detailed Description of the invention

The present invention provides an extract of Ficus glomerata as such, or in the form of a feed supplement or a pharmaceutical composition for use in the prevention and/or treatment of gastric ulceration in an equine. The extract of Ficus glomerata may be provided alone, or in combination with other medications for preventing and/or treating gastric ulceration in an equine.

The present invention provides an equine feed supplement for preventing and/or treating gastric ulceration in an equine comprising an extract of Ficus glomerata, preferably along with alfalfa.

The term “Equine” used herein includes all members of the equine family, such as horses, donkeys and zebras. Examples and descriptions presented herein typically refer to horses, but should be understood to include all members of the equine family.

Ficus glomerata (also known as Ficus racemose) is a species of plant in the family Moraceae. Common names include the cluster fig tree, Indian fig tree or goolar (gular) fig. It is native to Australia, Malaysia, Southeast Asia and the Indian subcontinent. It has many medicinal applications including in Ayurveda medicine for Daha hara - relieving a burning sensation, as in gastritis. Other uses are reported to be: healing fractured bones and wounds; improving skin tone and complexion; cleansing and disinfecting wounds; relieving burning sensation in neuropathy or in the eyes.

The inventor of the present application, surprisingly found that when a small number of horses with gastric ulceration that was considered to be refractory to standard treatment with omeprazole, were fed with an extract of Ficus glomerata, showed an unexpected almost complete healing of gastric ulceration in these horses.

It was further found that treatment of chronic gastric ulceration (grade 3 and 4 ulcers) of horses with standard drugs such as omeprazole and an extract of Ficus glomerata as a complimentary feed further assisted in faster and complete healing of healing of gastric ulceration. This is particularly useful since higher dosage of omeprazole for longer period of time leads to a number of disadvantages as explained above. For chronic gastric ulceration (grade 3 and 4 ulcers) the horses are treated with a combination of a known drug for treating ulcers along with the feed supplement of the present invention comprising an extract of Ficus glomerata. After sometime, the medication can be stopped and the feed supplement of the present invention can be continued until complete healing is achieved.

The inventor has found that the amount/dosage of omeprazole when treating horses with gastric ulceration can be reduced, if combined with the supplement comprising an extract of Ficus glomerata. Despite the reduced dosage of the drug omeprazole, the inventor found that when used in combination with the supplement comprising an extract of Ficus glomerata resulted in an unexpected complete healing.

As a result of the reduced dosage of known drugs such as omeprazole the side effects of the drugs are also reduced.

An additional advantage of the present invention is that the feed supplement of the present invention comprises an extract of Ficus glomerata, which is 100% natural ingredients, and therefore, there are no side effects in the treatment of gastric ulceration of equines using the extract of Ficus glomerata.

After the initial standard treatment, the medication/drug can be stopped and treatment can be continued with only the feed supplement comprising the extract of Ficus glomerata. This resulted not only in an improved treatment but also decreased side effects caused due to long term use of proton pump inhibitor (PPI) such as increased risk of fractures and atypical myopathy etc.

The inventor has also found that a combinational therapy of omeprazole and an extract of Ficus glomerata has an unexpected improvement in treating severe gastric ulceration in equines, such as horses.

It was also found that horses with mild and moderate gastric ulcers (grade 1 and 2) when fed or provided with an extract of Ficus glomerata on its own also showed complete healing of gastric ulcers.

It has further been found that horses with healthy gut when fed or treated with an extract of Ficus glomerata helps in preventing gastric ulcers and maintaining a healthy gut.

An extract of Ficus glomerata as such, or in the form of a feed supplement or a pharmaceutical composition also reduces the prevalence of colic in horses when fed or treated with the Ficus glomerata extract, either alone or in combination with food, excipients, or other medications.

Ficus glomerata for treating gastric ulcers in Equines may be provided as parts of the plant (or fruit) perse, or as extracts therefrom.

An extract of Ficus glomerata of the present invention is preferably administered to an equine in need thereof in different forms such as, but not limited to, a feed supplemental composition or a pharmaceutical composition (i.e., a pharmaceutically acceptable dosage form).

A “supplemental composition” refers to any substance that may be considered a food or part of a food and provides medical or health benefits, Including the prevention and treatment of disease.

Typically, the feed supplement of the present invention is given to the animal along with alfalfa or grass meal.

The present invention provides an extract of Ficus glomerata for use in the prevention or treatment of gastric ulceration in animals, preferably in equines, and more preferably in horses.

Preferably, the extract of Ficus glomerata is in the form of a powder, a suspension, a solution, a paste or a pellet.

Preferably, the extract of Ficus Glomerata is provided to equines in the form of a powder. The extract of Ficus Glomerata in the form of powder is preferably mixed with alfafa or grass meal and fed to the horse. Preferably, an effective amount of the extract of Ficus glomerata is provided as part of the regular feed to the horses.

The effective amount of the extract of Ficus glomerata for use in the treatment of gastric ulceration in equines is preferably In the range of about 0.1g to about 1000g per day. Preferably, the effective amount is in the range of about 0.1g to about 150g per day. Preferably, the effective amount is in the range of about 150g to about 300g per day. Preferably, the effective amount is in the range of about 300g to about 600g per day. Preferably, the effective amount is in the range of about 600g to about 1000g per day.

Preferably, the extract of Ficus glomerata is given to equines at least once daily for treating gastric ulceration. Preferably, the equine is provided with the extract of Ficus glomerata twice daily. More preferably, the equine is provided with the extract of Ficus glomerata thrice daily.

The present invention provides an equine feed supplement for treating gastric ulceration in equines comprising an extract of Ficus glomerata and at least one or more excipient suitable for equine supplement formulation. The supplement may include alfalfa.

The present invention provides a pharmaceutical composition for treating gastric ulceration in equines comprising Ficus glomerata and at least one or more pharmaceutically acceptable excipient.

The present invention provides an equine feed supplement for use in the prevention or treatment of gastric ulceration in equines, comprising an extract of Ficus glomerata. The supplement preferably comprises at least one or more excipient suitable for equine supplement formulation.

The present invention provides a pharmaceutical composition for use in the prevention or treatment of gastric ulceration in equines, comprising an extract of Ficus glomerata. The composition preferably comprises at least one or more pharmaceutically acceptable excipient.

The feed supplement of the present invention is also useful in treating gastrointestinal problems, such as colic in animals, preferably in equines, more preferably in horses.

The feed supplement of the present invention may be advantageously used as a dietary supplement and as a functional food ingredient.

The feed supplement of the present invention may be used in the preparation of medicaments for the treatment of animal gastrointestinal problems, such as horse colic.

The feed supplement of the present invention may be advantageously incorporated in the ordinary diet of an equine such as a horse as a treatment for, or preventive measure against, colic and other gastrointestinal problems, including gastric ulceration.

Accordingly, the present invention provides an extract of Ficus glomerata for use in prevention or treatment colic in animals, preferably in equines, and more preferably in horses.

The present invention also provides a feed supplement for use in the treatment of colic in equines, comprising Ficus glomerata. The supplement preferably comprises at least one or more excipient suitable for equine supplement formulation.

The present invention provides a pharmaceutical composition for use in the treatment of colic in equines, comprising Ficus glomerata. The composition preferably comprises at least one or more pharmaceutically acceptable excipient.

The present invention also provides use of one or more part of Ficus glomerata or an extract of Ficus glomerata for preventing or treating gastric ulceration or colic in equines.

The present invention also provides use of one or more part of Ficus glomerata or an extract of Ficus glomerata for increasing the pH in the stomach of equines having colic or gastric ulceration.

The present invention also provides a method of preventing or treating gastric ulceration or colic in equines comprising administrating an equine in need of treatment a sufficient amount of an extract of Ficus glomerata.

The equine referred to in the present disclosure is preferably a horse.

An extract of the Ficus Glomerata is preferably obtained from the fruit (100% natural) of Ficus Glomerata. The extraction is preferably an aqueous based extraction.

The present invention also provides a process for obtaining an extract of Ficus Glomerata for treating gastric ulceration or colic in equines, the process comprising:

a) preparing an extract from one or more part of Ficus Glomerata using a solvent;

b) filtering the liquid extract; and

c) drying the extract to obtain a powder.

Any suitable solvent may be used in the extraction process. The solvent can be selected such that maximum amount of the material gets extracted from the parts Ficus Glomerata into the extract. Preferably, the solvent used in the extraction process of the present invention is water and/or ethanol, or any similar solvents. The extraction is preferably an aqueous based extraction.

The liquid extract ratio is preferably 4:1 (i.e. 4 parts solvent and 1 part extract of Ficus Glomerata). Preferably, the liquid extract ratio is 3:2.

The one or more part of Ficus glomerata for use in the method is preferably a fruit.

Any known methods of drying the liquid extract may be used. Suitable drying process is preferably by vaporation, lyophilization, and the like, which is carried out to remove the solvent from the liquid fraction to form a dry powder, dry pellet, dry granulate, paste, and the like. The powder formed is preferably a fine light brown powder. The moisture content of the powder may be NMT 8%.

The present invention also provides a method of producing an equine feed supplement, comprising mixing together an extract of Ficus glomerata and at least one or more additive or excipient.

The amount of extract of Ficus glomerata present in the supplement may be in range of about 0,01 to 99.99 weight percentage of the supplement.

The amount of extract of Ficus glomerata present in the supplement may be In the range of about 10 to 90 weight percentage of the supplement.

The amount of extract of Ficus glomerata present in the supplement may be in the range of about 20 to 90 weight percentage of the supplement.

The amount of extract of Ficus glomerata present in the supplement may be in the range of about 40 to 90 weight percentage of fhe supplement.

The present invention also provides a method of producing a pharmaceutical composition, comprising mixing together an extract of Ficus giomerafa and at least one or more pharmaceutically acceptable excipient

The amount of extract of Ficus glomerata present in the pharmaceutical composition may be in range of about 0.01 to 99.99 weight percentage of the composition.

The amount of extract of Ficus glomerata present in the pharmaceutical composition may be in the range of about 10 to 90 weight percentage of the supplement.

The amount of extract of Ficus glomerata present in the pharmaceutical composition may be in the range of about 20 to 90 weight percentage of the supplement.

The amount of extract of Ficus glomerata present in the pharmaceutical composition may be in the range of about 40 to 90 weight percentage of the supplement.

The feed supplement of the present invention is preferably in the form of a powder, a suspension, a solution, a paste or a pellet.

The feed supplement of the present invention may further comprise at least one or more excipient used in an equine feed supplement, such as binders, carriers, stabilising agents, anticaking agents, emulsifiers, coloring agents, flavoring agents, dispersants, solubilizers, any other additives commonly used in feed supplements for animals, or combinations thereof.

The feed supplement ofthe present invention is preferably provided to equines, as part of their diet.

The feed supplement of the present invention is preferably orally administered, in the form of a tablet, a capsule, a gel, syrup, a solid form, a liquid, a powder, granules, a solution, a suspension, or other forms known to the person skilled in the art.

The feed supplement of the present invention may be provided to animals along with the main food of animals, such as alfalfa.

The feed supplement of the present invention may also be in the form of a food, such as, but not limited to, a food bar, a beverage, a food gel, a food supplement, a powder, syrup, or combinations thereof.

The feed supplement of the present invention is preferably injected parenteraily in the form of a sterile solution containing other solutes; for example, saline or glucose sufficient to make a solution isotonic.

Preferably, the feed supplement or the pharmaceutical composition of the present invention comprises at least one or more pharmaceutically acceptable excipient. Pharmaceutically acceptable excipient for use with the dosage forms include, but are not limited to, diluents, binders, disintegrants, solubilizers, extended release polymers, lubricants, preservatives, inorganic excipients, giidants, taste-masking excipients, flavorants, flavor enhancers, sweeteners, or combinations thereof.

The feed supplement of the present invention may be used either alone or in combination with other supplements, vitamins, minerals or additives for improving the general health and preventing/treating gastric ulceration or colic in animals, preferably in equines, and more preferably in horses.

The invention also provides a method of preventing and/or treating gastric ulceration in an equine, comprising administering to an equine, an effective amount of a feed supplement comprising an extract of Ficus glomerate.

The invention provides a method of preventing and/or treating gastric ulceration in an equine, comprising a regime of feeding the equine an effective amount of a feed supplement comprising an extract of Ficus glomerata on its own or in combination with other medications such as Omeprazole for an initial treatment period.

The invention provides a method of preventing and/or treating gastric ulceration in an equine, comprising a regimen of providing Omeprazole for an initial treatment period and followed by treatment with a feed supplement comprising an effective amount of an extract of Ficus glomerata.

In addition to Omeprazole, other known drugs such as H2 blockers (such as cimetidine, ranitidine), proton pump inhibitors, buffers (antacids) and protectants (sucralfate), Norodine, trimethoprim sulphonamide may be provided.

The invention provides a method of preventing and/or treating gastric ulceration in an equine, comprising a regime of feed supplement comprising an effective amount of an extract of Ficus glomerata as an initial treatment period followed by treatment with known drugs, such as Omeprazole, Norodine, trimethoprim sulphonamide, if required.

The effective amounts can be based on the treatment regime. For example the effective amounts per unit dosage can be decreased if the daily treatments are increased.

The effective amount of the extract of Ficus glomerata to be given to the animal depends upon the treatment which varies in accordance with the scale of the ulcers (Grades 1 to 4), other medications that are being given to the animal and the ongoing veterinary assessment.

Depending upon which stage the gastric ulceration is the amount of the extract of Ficus glomerata or feed supplement can be varied in treating the animal. For instance, in Grade 1 ulceration, a low amount of the extract is provided to the animal. For extreme conditions i.e. Grade 4, a very high amount of the extract of Ficus glomerata or feed supplement is given for treating the animal.

The effective amount of the extract of Ficus glomerata or feed supplement for use In the treatment of gastric ulceration in equines is preferably in the range of about 0.1g to about 1000g per day.

Preferably, the effective amount is in the range of about 0.1g to about 150g per day.

Preferably, the effective amount is in the range of about 150g to about 300g per day.

Preferably, the effective amount is in the range of about 3GQg to about 600g per day.

Preferably, the effective amount is in the range of about 600g to about 1GG0g per day.

For Grade 1 gastric ulceration the animal is preferably fed with 0.1g to 150g of the extract per day.

For Grade 2 gastric ulceration the animal is preferably fed with 150g to 300g of the extract per day.

For Grade 3 gastric ulceration the animal is preferably fed with 300g to 6G0g of the extract per day.

For Grade 4 gastric ulceration, the animal is preferably fed with 6G0g to 100Gg or more of the extract per day.

The feed supplement for use in the invention is preferably fed to the animal in an amount sufficient to treat gastric ulcers.

The recommended dosage of the supplement of the present invention may be adjusted according to the grades of ulceration (0-4), weight of the animal being treated, medical history of the animal to be treated etc.

Preferably, the supplement of the present invention is given to equines at least once daily for treating gastric ulceration. Preferably, the supplement is given to the equine twice daily.

More preferably, the supplement is given to the equine thrice daily.

Preferably, the feed supplement of the present invention is given to the animal being treated, at least twice daily for a period of 1 to 8 weeks.

Preferably, the treatment with a feed supplement comprising an extract of Ficus glomerata is provided for a period of time of about 1 week to about 8 weeks. Preferably, the treatment with a feed supplement comprising an extract of Ficus glomerata is provided for a period of time of about 1 to 6 weeks. More preferably, the treatment with a feed supplement comprising an extract of Ficus glomerata is provided for a period of time of about 1 week to about 4 weeks.

Preferably, the treatment with Omeprazole is provided for an initial treatment period of time of about 1 week to about 6 weeks. Preferably, the treatment with Omeprazole is given for a period of time of about 1 week to about 4 weeks. More preferably, the treatment with Omeprazole is given for a period of time of about 1 week to about two weeks.

Typically, the supplement for use in the invention is fed to animals in an amount of from 0.1g to 1000g per kilogram of bodyweight per day.

For example, the recommended dosage of the feed supplement for a horse weighing around 500 kg having Grade 1 gastric ulceration is preferably 150g twice daily for the treatment phase of 1 to 8 weeks.

For example, the recommended dosage of the feed supplement for a horse weighing around 500 kg having Grade 2 gastric ulceration is preferably 150g - 300g twice daily for the treatment phase of 1 to 8 weeks.

For example, the recommended dosage of the feed supplement for a horse weighing around 500 kg having Grade 3 gastric ulceration is preferably 30Gg-600g twice daily for the treatment phase of 1 to 8 weeks.

For example, the recommended dosage of the feed supplement for a horse weighing around 500 kg having Grade 4 gastric ulceration is preferably 600g -1G00g twice daily for the treatment phase of 1 to 8 weeks.

The following example of the extraction process is provided for the purpose of illustrating the present invention and shall not be construed as being limitations on the scope of the invention.

Example 1

An extract of Ficus Glomerata was obtained by the following process.

Raw fruits of Ficus Glomerata were subjected to a standard Raw Material test, and if found to be up to the standards of the raw material, the raw fruits were washed three times with clean water before subjecting to the extraction process.

The washed raw fruits of Ficus Glomerata (approximately 100 kg) were macerated, and mixed with sufficient amount of water. The extraction with water was carried out twice. The extracted solution was then allowed to cool down.

The extracted solution after cooling was filtered, under low temperature using a High-velocity centrifugal machine to obtain a liquid extract having an extract ratio of 4:1 (water: Ficus glomerata extract).

The filtered solution was then concentrated using a vacuum system. This was followed by a standard Quality analysis and evaluation.

Subsequently, the concentrated solution was subjected to sterilization using an Ultra-high temperature processing (UHT).

The liquid extract, was then dried to yield a dry powder (approximately 25 kg).

The dry powder was then filtered using a standard 80 mesh screen to obtain a fine powder of the extract.

Clinical Trail I

The first clinical trial was undertaken by Dr Kirstie Pickles, a European College specialist in Internal Medicine.

Test 1:

A 9 year old Thoroughbred mare with a 2 year history of nervous behaviour, shying and bucking was presented by the owner for evaluation of her vision. The mare had previously been evaluated by several other veterinary surgeons and had been referred for orthopaedic evaluation with diagnoses of kissing spines and bone spavin. Vision was assessed to be normal however gastroscopy was advised due to the medical history of the mare.

Gastroscopy revealed grade 4 ulceration of the squamous and glandular mucosa consisting of extensive areas of merging ulcers with overlying diphtheritic membrane (Figs. 1-3). Due to the extensive nature of the lesions the horse was treated with combination therapy of omeprazole 4 mg/kg PO SID, trimethoprim sulphonamide 30 mg/kg PO BID and a supplement comprising an extract of Ficus glomerata at the recommended dose 150g per day.

The horse was re-evaluated six weeks following the initiation of therapy.

Result: Repeated gastroscopy showed that all ulcerated areas had healed fully (Figs. 4 and 5) apart from a couple of small, focal, reddened areas at the pylorus (Fig. 6). Given the extent of the lesions complete healing was unexpected as longer therapy is often required for grade 4 ulceration of the squamous and glandular mucosa in horses.

Test 2

A yearling thoroughbred horse with gastric ulceration was fed with the supplement of the present invention comprising an extract of Ficus glomerata. The ulcers in this horse had been resistant to standard treatment with omeprazole.

After 4 weeks of treatment at 75g of per day, the horse was re-gastroscoped.

Result: The veterinary surgeon reported that the ulcers had disappeared although there was still evidence of hyperkeratinisation.

Test 3

In addition to this, during the Autumn of 2009 between October and February (inclusive), thirty 2 year old racehorses in a single barn and under the same management were fed with between 10g to 300g of supplement comprising Ficus glomerata extract per day.

Result: At the end of the feeding period of 4 months the veterinary surgeon reported no evidence of any adverse effects. In addition, it was reported that the prevalence of colic was significantly lower in the barn of horses fed the Ficus glomerata extract compared with the barn next door which was on identical management, but without the supplement comprising

Ficus glomerata extract.

Clinical Trail II

The second trial was completed with Towcester Vets who gastrocoped horses with a history of current clinical signs suggestive of gastric ulcers. Depending on the severity and location of ulcers, horses were either assigned to treatment of omeprazole or treatment of omeprazole plus a supplement comprising Ficus glomerata (See Table 1). Whilst this is not a placebo controlled or blinded trial, the clinical findings support the fact that a supplement comprising an extract of Ficus glomerata has efficacy against gastric ulceration in horses.

The clinical findings support that a supplement comprising an extract of Ficus glomerata can be used for treating Grade 1 and Grade 2 gastric ulceration in horses. The clinical findings further support that a supplement comprising an extract of Ficus glomerata alone or in combination with known drugs such as omperazole has improved efficacy against gastric ulceration, especially in treating Grade 3 and Grade 4 gastric ulceration in horses.

TABLE I

Horse Name	Initial complaint	Gastroscopic findinas	T reatment Plan	Follow up aastroscopic findinas/Results	Follow up aastroscopic findinas/Results
Mac Thomson	Behavioural changes in stable and under saddle over the last month. Very unsettled.	Grade 2 gastric ulceration in mucosal fundus, focal grade 3. Also Grade 2/3 at pylorous.	One syringe of omeprazole (2800 mg)* once daily for 7 days; After 7 days 1/2 syringe of omeprazole once daily + gastric ulcer trial supplement comprising 150g daily Ficus glomerata extract	Improved clinically but still spooking on rides. Fundus ulcers completely resolved. Pylorous VMB Grade 1. Taper omeprazole and use 1.2 syringe when known stress anticipated.	Stomach clear
Harry	Progressive	Mucosal	omeprazole	Owner reports	Stomach clear.

Rednall	stopping when jumping, grumpy when girthed, abnormal spooky behaviour	fundus diffuse grade 1 and focal grade 2. Grade 2/3 areas at the lesser curvature. Pylorous has multiple Grade 3 and bleeding areas.	1 syringe (2800 mg)* daily for 1 week, followed by 2/3 of syringe of omeprazole for 2 weeks. Norodine 1 syringe** daily for 10 days. Additionally, Gastric ulcer trial supplement comprising 150g day Ficus glomerata extract	excellent clinical response. Much improved performance. Fundus and lesser curvature clear. Pylorous muffifocal Grade 1 ulcers with some focal grade. Very much improved. Plan: reduce omeprazole to 1/3 syringe daily and continue on ulcer trial suplement. Rescope in 1 month
Moggl Olivier	colic surgery 10months ago. Aggressive when tacked up. Reluctant to go forward. Kicks out in canter transitions.	Pinpoint grade I ulceration. Single Grade 1/2 ulcer at pylorous.	gastric ulcer supplement comprising 150g Ficus glomerata extract; Regastroscope in 4 weeks.	Stomach clear
Alfle Indge	history of bucking when ridden and spooky behaviour. Aggressive when ginned.	Muttifocal Grade 2 at lesser curvature. Grade 2 ulcers at pylorous with single focal Grade 3	gastric ulcer supplement comprising Ficus glomerata extract 50g daily only for initial 4 weeks then re- gastroscope	owner reports generally seen a behaviour improvement but had a bad week last week. Scope improvement. Ulcers at lesser curvature still present but resolving, much less associated inflammation. Pylorous now general grade 1 with focal grade 2. plan to extend ulcer

				trial supplement comprising 50g Ficus glomerata extract
Zeus Farren	History of poor weight gain and anxious when ridden. Improved with charcoal based food	Focal Grade 1 ulceration to mucosal Fundus_ Multiple grade 3 ulcers at pylorous.	Gastric ulcer trial supplement comprising Ficus glomerata extract 50g for 1 month then rescope	Fundus ulceration resolved. Pylorus improved - now grade 2. Advise ideally continue Gastric ulcer supplement comprising Ficus glomerata extract 50g	Owner reports significantly improved behavior. No further gastroscopy.
Tom Deverall		Stomach clear.
Bella Goate		Stomach clear.
Bugsy Mu stow	Crib bites. Progressive worsening of objecting to leg being applied. Plants himself and bucks during flatwork. Objects to girth being done up	Generalised Grade 2 ulceration in pyloric region.	Supplement comprising Ficus glomerata extract 150g only. Rescope in 3-4 weeks. Introduce omeprazole if poor response.	Owner reports performance has improved different horse. Grade 1 ulceration at pylorus. Focal inflamed hyperaemic areas resolved. Advise to continue ulcer trial.
Ruby Rose McFarland	been resistant in work Squamous mucous and difficult on the NAD. Small focal Grade	Squamous mucous NAD. Small focal Grade 1 pyloric ulcer.	Start Ulcer trial supplement containing Ficus Glomerata extract 150g daily.	Owner reports excellent clinical response. Stomach clear but with small signs of inflammation. Plan: Continue Gastric ulcer supplement.

* The syringe used for administrating omeprazole is a 7 ml syringe containing 7.57 g of oral paste of omeprazole. Each gram of oral paste contains 370 mg of omeprazole.

** Each syringe of Norodine contains 45g of oral paste containing: Trimethoprim 5.80% w/w Sulfadiazine 28.83% w/w

It will be understood that the invention is not limited to the specific details as herein described, which are given by way of example only, and that various alternations and modifications may be made without departing from the scope of the invention as defined in the appended claims.

Claims

CLAIMS:

1. An equine feed supplement for preventing or treating gastric ulceration in equines comprising an extract of Ficus glomerata and at least one or more excipient suitable for equine supplement formulation.
2. An equine feed supplement according to claim 1 further comprising alfalfa.
3. An equine feed supplement according to claim 1 wherein the supplement is in the form of a powder, a suspension, a solution, a paste or a pellet.
4. An equine feed supplement according to claim 1 wherein the one or more excipient is selected from the group comprising: binders, carriers, stabilising agents, anticaking agents, emulsifiers, coloring agents, flavoring agents, dispersants, solubilizers, any other additives commonly used in feed supplements for animals, and combinations thereof.
5. An equine feed supplement according to claim 1 wherein the supplement is in the form of a food, a food bar, a beverage, a food gel, a food supplement, a powder, syrup, and combinations thereof.
6. An equine feed supplement according to claim 1 wherein the supplement is in the form of a tablet, a capsule, a gel, syrup, a solid form, a liquid, a powder, granules, a solution, a suspension, a parental dosage form and combinations thereof.
7. An equine feed supplement according to claim 1 further comprising other supplements, vitamins, minerals, additives or combination thereof.
8. An equine feed supplement according to claim 1 wherein the extract of Ficus glomerata is present in an amount of about 0.01 to 99.99 weight percentage of the supplement.
9. An equine feed supplement according to claim 1 wherein the supplement is provided to equines, as part of their diet.
10. A pharmaceutical composition for preventing or treating gastric ulceration in equines comprising an extract of Ficus glomerata and at least one or more pharmaceutically acceptable excipient.

5
11. A pharmaceutical composition according to claim 10 wherein the pharmaceutically acceptable excipient is selected from the group comprising: diluents, binders, disintegrants, solubilizers, extended release polymers, lubricants, preservatives, inorganic excipients, giidants, taste-masking excipients, fiavorants, flavor enhancers, sweeteners, and combinations thereof.
12. A pharmaceutical composition according to claim 10 or 11, wherein the composition is in the form of a tablet, a capsule, a gel, syrup, a solid form, a liquid, a powder, granules, a solution, a suspension, a parental dosage form and combinations thereof.

15
13. A feed supplement for use in the prevention or treatment of gastric ulceration or colic in equines, comprising an extract of Ficus glomerata.
14. A feed supplement for use according to claim 13 or 14 further comprising at least one excipient selected from the group comprising: binders, carriers, stabilising agents,

20 anticaking agents, emulsifiers, coloring agents, flavoring agents, dispersants, solubilizers, any other additives commonly used in feed supplements for animals, and combinations thereof,
15. A feed supplement for use according to claim 13, or 14, wherein the supplement is

25 effective for at least once daily administration.
16. A feed supplement for use according to claim 13, 14, or 15, wherein the supplement is effective for at least twice daily administration.

30
17. A feed supplement for use according to any one of claims 13, 14, or 15, wherein the extract of Ficus glomerata is present in an amount sufficient to treat gastric ulceration in equines.
18. A feed supplement for use according to any one of claims 13 to 17 wherein the

35 amount of the supplement administered to the equine is in the range of about 0.1g to about1000g per day.
19. A feed supplement for use according to any one of claims 13 to 18 wherein the supplement is administered to the equine for a period of at least about 1 to 8 weeks.
20. A feed supplement according to any one of claims 1 to 9 and 13 to 19, wherein the

5 equine is a horse.
21. A pharmaceutical composition for use in the prevention or treatment of gastric ulceration or colic in equines, comprising an extract of Ficus glomerata.

10
22. A pharmaceutical composition for use according to claim 21, further comprising at least one pharmaceutically acceptable excipient selected from the group comprising diluents, binders, disintegrants, solubilizers, extended release polymers, lubricants, preservatives, inorganic excipients, glidants, taste-masking excipients, flavorants, flavor enhancers, sweeteners, and combinations thereof,
23. A pharmaceutical composition according to any one of claims 10 to 12 and 21 to 22, wherein the equine is a horse,

23. An extract of Ficus glomerata for use in preventing and/or treating gastric ulceration

20 or colic in equines.
24. An extract of Ficus glomerata according to claim 23 wherein the equine is a horse.
25. An extract of the Ficus glomerata according to claim 23 or 24 wherein the extract is

25 obtained from the fruit (100% natural) of Ficus glomerata.
26. A process for obtaining an extract of Ficus glomerata for treating gastric ulceration or colic in equines, the process comprising:

a) preparing an extract from one or more part of Ficus Glomerata using a

30 solvent;

b) filtering the liquid extract; and

c) drying the extract to obtain a powder.
27. A method according to claim 26 wherein the solvent is water and/or ethanol.
28. A method according to claim 26 wherein the part of Ficus glomerata is a fruit.
29. A method of producing an equine feed supplement for preventing or treating gastric ulceration in equines, comprising mixing together an extract of Ficus Giomerata and at least one or more additive or excipient.

5 30. A method of making a pharmaceutical composition for preventing or treating gastric ulceration in equines, comprising mixing together an extract of Ficus Giomerata and at least one or more pharmaceutically acceptable excipient.

31. A method of preventing or treating gastric ulceration in equines comprising

10 administrating to an equine in need of treatment an effective amount of an extract of

Ficus giomerata.

32. A method according to claim 31, wherein the gastric ulceration is Grade 0-4.

15 33. A method according to claim 31 or 32, wherein the effective amount of the extract of

Ficus giomerata is in the range of about 0.1g to about 1000g per day.

34. A method according to claim 31, 32 or 33, wherein the extract is administered to the equine at least once or twice daily.

35. A method according to claim 31, 32, 33 or 34, wherein the extract is administered to the equine for a period of at least about 1 to 8 weeks.

36. Use of one or more part of Ficus giomerata perse, or an extract of Ficus giomerata

25 for preventing or treating gastric ulceration or colic in equines.

37. Use of one or more part of Ficus giomerata perse, or an extract of Ficus giomerata for increasing the pH in the stomach of equines having colic or gastric ulceration.
30 38. Use of one or more part of Ficus giomerata according to claim 36 or 37, wherein the part of Ficus giomerata is a fruit.

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Application No: GB 1622123.6 Examiner: Mr Brendan Donohoe