GB2460105A

GB2460105A - Composition comprising alcohol and chlorhexidine, optionally in the form of a wipe, that is useful in preventing mastitis

Info

Publication number: GB2460105A
Application number: GB0807178A
Authority: GB
Inventors: Robert Bryce Sneddon Drysdale; Bruce Dolby
Original assignee: MATTHEW CLIVE DOBBS; ROBERT BRYCE SNEDDON DRYSBALE
Current assignee: MATTHEW CLIVE DOBBS; ROBERT BRYCE SNEDDON DRYSBALE
Priority date: 2008-04-18
Filing date: 2008-04-18
Publication date: 2009-11-25
Also published as: GB0807178D0

Abstract

A composition comprising a liquid alcohol component and a chlorhexidine component. The alcohol may be methanol, ethanol, methylated spirit, surgical spirit or a mixture of these. The chlorhexidine component may be the acetate, gluconate or hydrochloride salt. The composition preferably comprises a mixture of surgical spirit and 0.25 wt% chlorhexidine gluconate, based on the weight of surgical spirit. One or more conventional excipients may be included in the composition. The composition may be useful for prophylactic therapy, in particular prophylaxis of mastitis and other mammary infections, especially of cattle during their dry period. The composition may be used for cleansing teats prior to administration of antibacterial agents that are used to prevent mammary infections during the dry period. Antiseptic wipes may be prepared by impregnating a paper and/or textile material with the composition.

Description

COMPOSITION AND IMPREGNATED WIPES

FOR CLEANING ANIMAL TEATS

The present invention relates to a novel composition. In particular, the invention relates to a composition that can be employed for the cleaning of animal teats, especially bovine teats, as well as to wipes impregnated with the composition.

The invention is suitable for the economical prophylactic treatment of mastitis and other mammary infections, in particular in cattle during their dry period.

Background to the Invention

The control of mastitis and other mammary infections is of great economic importance to dairy farmers. Bacteria known to cause such infections include the gram-positive bacteria Staphylococcus aureus and Streptococcus agalactiae.

Mastitis is the most costly disease in the dairy industry, with the biggest loss arising from subclinical mastitis, when bacteria are already in the udder. These organisms destroy milk-secreting tissue and thus lower milk production. The milk from an infected cow is contaminated and cannot be marketed until the infection is eliminated and the antibiotic is absent from the milk (usually 3-5 days after the last treatment with the antibiotic). During the lactating period, mammary infections such as mastitis are typically treated by the intramammary administration of an antibacterial agent (antibiotic) in a suitable vehicle.

Cattle are also vulnerable to mammary infectibns during their dry period, i.e. prior to calving. Intramammary administration of an antibacterial agent in a suitable vehicle is also conventionally employed at the onset of the dry period to prevent such infections. However, the effectiveness of such prophylactic treatment is adversely affected by various factors.

The antibiotic composition is generally administered at the onset of the dry period using a sterile syringe-like tube incorporating a plunger. The end of the tube is inserted into the udder via the streak canal and the plunger is depressed in order to expel the antibiotic composition from the tube prior to its removal. The antibiotic composition then flows down the udder into the streak canal under the influence of gravity, forming a plug which remains in the udder for up to 60 days. However, some bacteria are nevertheless able to infuse the udder and remain there during this period, even in the presence of the antibiotic. Examples of such bacteria are gram-negative coliforms such as E. co/i, which have a narrow antibiotic spectrum or may be resistant to certain antibiotics. Furthermore, there is a substantial risk of bacterial infection during the first five days (or thereabouts) of the dry period, during which time the effectiveness of the antibiotic is increasing. Infection during this period may lead to toxic mastitis, which is usually fatal. It has been observed that poor (i.e. incorrectly aligned or incomplete) insertion of the tube increases the risk of early bacterial infection of the udder Therefore, it is very important that the teat end must be clean and sterile when the antibiotic is administered, in order to minimise the risk of introducing bacteria at that time. According to the currently recommended husbandry practice, this is achieved by firstly dipping the teats in a disinfectant solution (typically one based on iodine, such as the concentrate "Deosan lodip", available from DiverseyLever Ltd, Northampton), and then sterilising the teat by wiping it with a wipe impregnated with isopropyl alcohol (IPA). Unfortunately, the potential effectiveness of this procedure is frequently compromised by poor compliance and other factors.

The disinfectant teat dip is intended to eliminate bacteria on the entire teat. Correct administration therefore involves dipping the full length of each teat in the solution.

In practice this is not always achieved. However, even when correctly administered, the penetration of the teat dip solution is not optimal because the streak canal of the udder is closed during the dry period, and bacteria may live on the keratinized surface of the canal.

Furthermore, it is widely known that many farmers do not complete the procedure by using an IPA wipe. This is believed to be due to inconvenience of use: IPA is a flammable chemical and also highly volatile, so that it evaporates rapidly from any material on which it is absorbed. Consequently, IPA wipes are usually individually packaged, but these are inconvenient and time-consuming for the farmer to use.

Therefore, there is a need for a product suitable for cleansing teats prior to administration of antibacterial agents, which product is both effective at disinfecting the teat and convenient to use. Such a product should result in high user compliance, thereby reducing the incidence of mastitis and other mammary infections, particularly in cattle during their dry period.

Summary of the invention

According to a first aspect of the invention there is provided a composition comprising: a) A liquid alcohol component; and b) a chlorhexidine component.

According to a second aspect of the invention there is provided a composition as defined above for use in prophylactic therapy.

According to another aspect of the invention there is provided a composition as defined above for use in the prophylaxis of mastitis and other mammary infections, particularly in cattle during their dry period.

According to a further aspect of the invention there is provided the use of the said composition for the manufacture of a topical medicament for the prophylaxis of mastitis and other mammary infections, particularly in cattle during their dry period.

According to a still further aspect of the invention there is provided a method for the prophylaxis of mastitis and other mammary infections in mammals, particularly in cattle during their dry period, which comprises applying the said composition to the surface of a teat of the mammal, preferably by wiping said teat with an impregnated wipe of paper andlor textile material.

According to a yet further aspect of the invention there is provided an antiseptic wipe comprising paper and/or textile material impregnated with the said composition.

According to a yet still further aspect of the invention there is provided a method of manufacturing an antiseptic wipe, said method comprising impregnating a suitable portion of paper and/or textile material with the said composition.

According to a yet still further aspect of the invention there is provided a method of manufacturing the said composition comprising admixing the ingredients a) and b).

Detailed description of the invention

The compositions according to the invention comprise a liquid alcohol component and a chiorhexidine component. The compositions may consist only of the components a) and b) or additional components known to those skilled in the art (e.g. conventional excipients) may also be present, preferably in minor amounts only, for example less than 15 wt%, preferably less than 10 wt%, more preferably less than 5 wt%.

The alcohol component may include methanol, ethanol, methylated spirit or surgical spirit, or a mixture of any of these. Surgical spirit is most preferred. According to Martindale's Pharmacopoeia, a litre of Surgical Spirit BP has the following composition: 950 ml industrial methylated spirit, 25 ml castor oil, 20 ml diethyl phthalate and 5 ml methyl salicylate. Surgical spirit is known for its mild sterilizing and cleansing properties.

Chiorhexidine is a known bisbiguanide antiseptic and disinfectant effective against a wide range of bacteria, some fungi and some viruses. Chiorhexidine is generally used in the form of the acetate, gluconate or hydrochloride salt. Chlorhexidine gluconate is preferred for use in the present invention.

In preferred compositions of the invention, a minor amount of the chlorhexidine component is solvated in a major amount of the alcohol component. More preferably, the compositions comprise from 0.1 to 2.0 wt% of the chlorhexidine component, based on the weight of the alcohol component.

A most preferred composition of the invention comprises a mixture of surgical spirit and 0.25 wt% of chiorhexidine gluconate, based on the weight of surgical spirit.

The compositions of the invention are formed by mixing together the components a) and b). Any other components present may be mixed with one or both of components a) and b) prior to the admixing of components a) and b); or they may be mixed into components a) and b) after these two have been mixed. It may necessary to heat the mixture gently in order to obtain a homogeneous mixture.

As mentioned above, the compositions of the invention are especially suited for application to the teats of animals, especially cattle, in particular at the onset of their dry period. The compositions can be applied to the teats in any manner known in the art. for example by dipping the teat into a vessel containing the composition.

However, in a preferred embodiment the compositions are used to impregnate a material of paper and/or textile that is suitable for forming wipes. A particularly preferred wipe material is a thermally bonded, non-woven polypropylene viscous blend 23g/m2, which is a semi biodegradable material commercially available from StarChem Ltd. (Willenhall, West Midlands, GB). Most conveniently, the wipe material is obtained in the form of a roll that has been perforated so as to provide a suitable number of individual wipes of a suitable size, for example 200 mm x 200 mm squares. By way of example, a roll of 160 wipes would be sufficient to treat the teats of 40 cows. The roll is then impregnated with the composition of the invention, by exposing it to a metered amount of the composition under controlled conditions (e.g. in a sealed vessel), whereby the, composition is fully absorbed into the textile material. The impregnated roll can then be packaged in a sealed plastic dispenser of known type, for subsequent use.

In use, the husbandman applies the composition of the invention to substantially the entire outside surface of the teat immediately prior to administering the antibiotic composition via the streak canal, as described above. When the composition of the invention is applied by means of the wipes described above, a wipe is removed from the dispenser and then used to wipe (jreferably substantially the entire outside surface of) the teat, before being disposed of. Each wipe should be used to clean a single teat only, to avoid any bacterial or other contamination from one teat to another. The wipes of the invention are very easy to use in comparison with the existing recommended procedure (see above), are easily disposed of (for example, compared with the conventionally used iodine solutions) and are inexpensive.

Accordingly, a substantially higher degree and quality of compliance from users can be expected than occurs with the existing recommended procedure.

The following Example is provided in order to illustrate the invention, and should not be interpreted as limiting its scope.

EXAMPLE

To a vessel containing Surgical Spirit BP, 0.25 wt% of chiorhexidine gluconate was added. Precipitation of the chiorhexidine gluconate was observed. The mixture was therefore heated gently to a temperature of 24-30°C, whereupon the chiorhexidine gluconate was observed to dissolve. The composition was allowed to cool to room temperature. 475m1 of the cooled mixture was then added to a roll of 160 wipes made from a thermally bonded, non-woven polypropylene viscose blend of 23g/m2, in a closed vessel. After the mixture had been completely absorbed by the wipes (which may take up to 48 hours), the roll was placed in a robust plastic dispenser of known type, for example as available commercially from Neiman packaging (Derbyshire, GB).

Claims

CLAIMS: 1. A composition comprising: (a) a liquid alcohol component; and (b) a chiorhexidine component.
2. A composition as claimed in claim 1 consisting of components (a) and (b) in combination with one or more conventional excipients.
3. A composition as claimed in claim 2 wherein the amount of said excipients is less than 15 wt%.
4. A composition as claimed in any preceding claim, wherein the liquid alcohol component (a) comprises methanol, ethanol, methylated spirit, surgical spirit, or a mixture of any of these.
5. A composition as claimed in claim 4 wherein the liquid alcohol component (a) is surgical spirit.
6. A composition as claimed in any preceding claim, wherein the chlorhexidine component (b) is in the form of the acetate, gluconate or hydrochloride salt.
7. A composition as claimed in claim 6 wherein component (b) is chiorhexidine gluconate.
8. A composition as claimed in any preceding claim comprising from 0.1 to 2.0 wt% of the chiorhexidine component, based on the weight of the alcohol component.
9. A composition as claimed in claim 8 comprising a mixture of surgical spirit and 0.25 wt% of chiorhexidine gluconate, based on the weight of surgical spirit.
10. A composition as claimed in any preceding claim for use in prophylactic therapy.
11. A composition as claimed in any one of claims 1 to 9 for use in the prophylaxis of mastitis and other mammary infections.
12. A composition as claimed in any one of claims 1 to 9 for use in the prophylaxis of mastitis and other mammary infections of cattle during their dry period.
13. Use of a composition as claimed in any one of claims 1 to 9 for the manufacture of a topical medicament for the prophylaxis of mastitis and other mammary infections, particularly in cattle during their dry period.
14. Use of a composition as claimed in any one of claims I to 9 for the manufacture of a topical medicament for the prophylaxis of mastitis and other mammary infections of cattle during their dry period.
An antiseptic wipe comprising paper andlor textile material impregnated with a composition as claimed in any one of claims 1 to 9.
16. A method of manufacturing an antiseptic wipe, said method comprising impregnating a suitable portion of paper andlor textile material with a composition as claimed in any one of claims I to 9.
17. A method of manufacturing a composition as claimed in claim 1, said method comprising admixing: (a) a liquid alcohol component; and (b) a chlorhexidine component.
18. A composition according to claim 1, substantially as herein described with reference to the Example.
19. A method of manufacturing a composition according to claim 1, the method being substantially as herein described with reference to the Example.
20. A method of manufacturing an antiseptic wipe, the method being substantially as herein described with reference to the Example.