Drug – bio-affecting and body treating compositions – Plant material or plant extract of undetermined constitution... – Containing or obtained from a tree having matured height of...
Reexamination Certificate
2001-01-23
2003-07-22
Lankford, Jr., Leon B. (Department: 1651)
Drug, bio-affecting and body treating compositions
Plant material or plant extract of undetermined constitution...
Containing or obtained from a tree having matured height of...
C424S725000, C424S742000, C424S746000
Reexamination Certificate
active
06596325
ABSTRACT:
The present invention relates to a composition for the treatment of hooves in (one- and/or two-) hoofed animals and a method for the treatment of hoofed animals.
The invention is also directed to a new and improved method for treating white line disease and hoof thrush in horses or in other equine animals susceptible to hoof thrush and white line disease and for treating hoof rot in sheep, goat and cattle. By “equine animals” is meant a horse, donkey, mule, burro or zebra. However, the preferred animal is a horse. Hereinafter, the term “horse” encompasses all equine animals.
White line disease in horses is a disease that has not been very well documented. White line disease can cause severe discomfort for the horse and, if not well groomed, the horse will become cripple or lame.
The white line is generally considered to be that section of the hoof where the farrier places the nails when shoeing the horse. The white line disease is an affection of the stratum internum, which is the inside part of the hoof. The disease will cause a disruption of the white line, other than the disruption caused by normal influences from the outside such as small stones, sand and the like. The disruptions caused by such normal influences are usually superficial and will disappear upon regular trimming of the hoof. The white line disease generally tends to spread out more and deeper into the hoof. If the disease spreads out at proximal distance a void will form. The void will be surrounded by the horn of the stratum lamellatum on one side and the stratum internum or medium on the other side. This situation is commonly known as “hollow wall”. The hoof then becomes brittle. The horse will experience considerable discomfort from this situation. The generally used remedy to limit the damage is regular and extensive trimming of the hooves. However, in many cases this does not solve the problem of white line disease.
By hoof thrush is meant a disease in horses of the hoof and frog tissue caused by a variety of pathogenic micro-organisms. By hoof rot is meant an analogous disease of the hoof in sheep, goats and cattle. The diagnostic signs of thrush disease or hoof rot include a strong unpleasant odour and discharge from the frog tissue. A veterinarian of ordinary skill can readily determine whether a horse exhibits a thrush infection or white line disease or whether a sheep, goat or cow exhibits a hoof rot infection.
A schematic drawing of the hoof is given in FIG.
1
.
In an article in the “Tijdschrift voor Diergeneeskunde, 1995, 120, 18, pp 526-529”, white line disease has been investigated in a population of horses in the Netherlands. A mycological investigation of the hoof material was carried out. It was found that
Scopulariopsis brevicaulis
was detected in 60% of the animals with an abnormal white line or with hollow wall or with seedy toe. The reported remedy against white line disease, hollow wall or seedy toe is based on the conventional treatment which is the extensive trimming of the hooves and removal of affected material. Other remedies or treatments are not given or suggested.
From WO89/07385 it is known that hoof thrush in horses and hoof rot in other animals is primarily caused by an anaerobic bacterium,
Spherophorus necrophorus
. The application describes a remedy based on the use of metronidazole (1-(2-hydroxyethyl)-2-methyl-5-nitroimidazole) in various forms and treatments.
It has now been found that a composition comprising a curing agent and a fungicide is very effective in the treatment of white line disease, hoof thrush and hoof rot. The invention thus relates to a composition for the topical treatment of hooves of one- and/or two-hoofed animals comprising a curing agent and a fungicide.
The curing agent in the composition is in general an agent which has a antiseptic and/or disinfecting effect. The curing agent, or caring agent, can also have other characteristics which can attribute to the well being of hooves. The active components in the curing agent are selected from the group consisting of bay leaf oil, medicinal turpentine oil, tea tree oil, lavender oil, bergamot oil, eucalyptus oil, pine oil, rosemary oil or mixtures and combinations thereof, preferably bay leaf oil, medicinal turpentine oil and/or tea tree oil or mixtures and combinations thereof. The curing agent is present in an amount up to 30 wt. %, preferably from 5 to 25 wt. %, more preferably from 10 to 20 wt. %. The fungicide in the composition can be any suitable fungicide as long as it is active against the fungus that is found in white line disease, hoof thrush or hoof rot. Preferably the fungicide expresses activity towards
Scopulariopsis brevicaulis
. The fungicide is selected preferably from the group consisting of enilconazole, clotrimazole, miconazole, sulconazole, econazole, oxiconazole, tioconazole, thiabendazole, naftifine, terbinafine, tolnaftate, itraconazole or mixtures and combinations thereof, preferably enilconazole, clotrimazole, miconazole or mixtures and combinations thereof. The fungicide is present in an amount up to 20 wt. %, preferably from 5 to 15 wt. %, more preferably from 7 to 12 wt. %. In a preferred embodiment the invention encompasses a composition for the topical treatment of hooves comprising
preferably
Curing agent
up to 30
wt. %
5-25
wt. %
Fungicide
up to 20
wt. %
5-15
wt. %
Emulgator
up to 50
wt. %
20-30
wt. %
solvent/diluent
to 100
wt. %
to 100
wt. %
In different embodiments, such as an ointment, the composition may additionally comprise compounds such as a cetylester or like compounds. For use as a conditioner a basis composition can be prepared which can subsequently be diluted to a concentration that is suitable for application to the hoof. Alternatively the composition can be in the form of a gel. The previously described afflictions of hooves are also influenced by the presence of bacteria. If the hoof suffers from these afflictions, bacteria may enter the damaged areas and cause further infections. This will not only cause additional discomfort, but also have a detrimental influence on the healing process in general. To avoid this, it is possible and desirable to have a bactericide present in the composition according to the invention. The bactericide is preferably selected from the group consisting of chloroxylenols, triclosan, chlorhexidine, octopyrox or mixtures and combinations thereof, preferably triclosan and/or chloroxylenols or mixtures and combinations thereof. The fungicide is present in an amount up to 20 wt. %, preferably from 5 to 15 wt. %, more preferably from 7 to 12 wt. %. The composition can be provided in any suitable form such as a solution, emulsion, powder, ointment, spray, gel etcetera. The composition can be further brought in a suitable form by the addition of diluents, carriers, excipients, adjuvants, emulgators, dyes, colorants, perfumes and the like. The composition can also be mixed with known products for grooming or tending of hooves.
The present invention also relates to a method for treating white line disease, hoof thrush (in a horse) or hoof rot (in a sheep, goat or cow) comprising topically administering a therapeutically effective amount of the composition in a carrier directly on a thrush or hoof rot infected area for a treatment period effective to cure the thrush or hoof rot infection.
The present invention encompasses a method for the topical administration of the composition in the form of a solution or in the form of a gel, salve or ointment at and/or near the area affected by white line disease or the thrush or hoof rot infected area.
For topical administration in the form of a solution, the active drug component of the present invention, in liquid, powdered or lyophilised form may be combined with a suitable pharmaceutical diluent or carrier (collectively referred to herein as “carrier” materials) such as water, saline, aqueous buffers, and the like. The method of application of the composition in the form of a solution may be by pouring, squirting, flushing or sponging the solution on the thrush or hoof rot infected area.
Davis Ruth A.
Hoffmann & Baron , LLP
Lankford , Jr. Leon B.
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