Cooling Composition and Method of Use

Abstract

A sprayable cooling composition comprising at least one refrigerant (DME) as well as at least one non-volatile antiseptic agent (cetrimide), wherein the cooling composition is capable of eliciting both a local refrigerant effect to a body surface area to which it is applied and providing antisepsis due to the non-volatile antiseptic agent remaining on the body surface area. The composition is useful for surgical and animal husbandry procedures, such as piglet castration.

Claims

1.-20. (canceled)

21. A sprayable cooling composition comprising at least one refrigerant as well as at least one non-volatile antiseptic agent, wherein the cooling composition is capable of eliciting both a local refrigerant effect to a body surface area to which it is applied and providing antisepsis due to the non-volatile antiseptic agent remaining on the body surface area.

22. The composition of claim 21, wherein the cooling composition comprises anywhere between approximately 20% (w/w) and approximately 80% (w/w) of said at least one refrigerant.

23. The composition of claim 21, wherein the cooling composition comprises anywhere between approximately 1% and approximately 5% weight/weight of said at least one non-volatile antiseptic agent.

24. The composition of claim 21, wherein the at least one refrigerant comprises one or more refrigerants selected from the group consisting of: a compressed gas; a liquefied hydrocarbon; a fluorinated hydrocarbon; an ether; and a hydrofluoroalkane.

25. The composition of claim 21, wherein the at least one refrigerant is dimethyl ether (DME).

26. The composition of claim 21, wherein the at least one non-volatile antiseptic agent is one or more antiseptic agents selected from the group consisting of: cetrimide; povidone-iodine; chlorhexidine; iodine; benzalkonium chloride; benzoic acid; nitrofurazone; benzoyl peroxide; hydrogen peroxide; hexachlorophene; phenol; resorcinol; cetylpyridinium chloride; chlorhexidine gluconate; and parachoroxylenol.

27. The composition of claim 21, wherein the at least one non-volatile antiseptic agent comprises at least one quaternary ammonium salt.

28. The composition of claim 27, wherein the at least one non-volatile antiseptic agent comprises cetrimide.

29. The composition of claim 21, wherein the cooling composition further comprises a colorant.

30. The composition of claim 21, wherein the cooling composition is formulated to be applied to the body surface in a form selected from the group consisting of: a spray; stream; mist; and foam.

31. The composition of claim 30, wherein the cooling composition is in the form of an aerosol spray.

32. The cooling composition of claim 21, comprising a formulation selected from the group consisting of: approximately 20-80% (w/w) butane and propane blend, and approximately 1.0-5.0% (w/w) cetrimide; approximately 20-80% (w/w) butane, propane and isobutane blend, and approximately 1.0-5.0% (w/w) cetrimide; approximately 50% (w/w) butane and propane blend, and approximately 3.5% (w/w) cetrimide; approximately 50% (w/w) butane, propane and isobutane blend, and approximately 3.5% (w/w) cetrimide; approximately 20%-80% (w/w) DME, and approximately 1.0-5.0% (w/w) cetrimide; approximately 30% (w/w) DME, and approximately 3.5% (w/w) cetrimide; approximately 50% (w/w) DME, and approximately 2.5% (w/w) cetrimide; approximately 30% (w/w) DME, and approximately 1.5% (w/w) cetrimide; approximately 70% (w/w) DME, and approximately 1.5% (w/w) cetrimide; and approximately 80% (w/w) DME, and approximately 1.0% (w/w) cetrimide.

33. A method of cooling and providing antisepsis to a body surface of a subject, comprising the step of applying the cooling composition of claim 21 to an area of the body surface requiring cooling and antisepsis.

34. The method of claim 33, wherein the cooling composition comprises a formulation selected from the group consisting of: approximately 20-80% (w/w) butane and propane blend, and approximately 1.0-5.0% (w/w) cetrimide; approximately 20-80% (w/w) butane, propane and isobutane blend, and approximately 1.0-5.0% (w/w) cetrimide; approximately 50% (w/w) butane and propane blend, and approximately 3.5% (w/w) cetrimide; approximately 50% (w/w) butane, propane and isobutane blend, and approximately 3.5% (w/w) cetrimide; approximately 20%-80% (w/w) DME, and approximately 1.0-5.0% (w/w) cetrimide; approximately 30% (w/w) DME, and approximately 3.5% (w/w) cetrimide; approximately 50% (w/w) DME, and approximately 2.5% (w/w) cetrimide; approximately 30% (w/w) DME, and approximately 1.5% (w/w) cetrimide; approximately 70% (w/w) DME, and approximately 1.5% (w/w) cetrimide; and approximately 80% (w/w) DME, and approximately 1.0% (w/w) cetrimide.

35. A surgical or animal husbandry procedure comprising the steps of: 1) applying the cooling composition of claim 21 to an area of a body's surface so as to provide a local refrigerant effect and antisepsis; and 2) carrying out a surgical step or step of an animal husbandry procedure.

36. The procedure of claim 35, wherein the cooling composition comprises a formulation selected from the group consisting of: approximately 20-80% (w/w) butane and propane blend, and approximately 1.0-5.0% (w/w) cetrimide; approximately 20-80% (w/w) butane, propane and isobutane blend, and approximately 1.0-5.0% (w/w) cetrimide; approximately 50% (w/w) butane and propane blend, and approximately 3.5% (w/w) cetrimide; approximately 50% (w/w) butane, propane and isobutane blend, and approximately 3.5% (w/w) cetrimide; approximately 20%-80% (w/w) DME, and approximately 1.0-5.0% (w/w) cetrimide; approximately 30% (w/w) DME, and approximately 3.5% (w/w) cetrimide; approximately 50% (w/w) DME, and approximately 2.5% (w/w) cetrimide; approximately 30% (w/w) DME, and approximately 1.5% (w/w) cetrimide; approximately 70% (w/w) DME, and approximately 1.5% (w/w) cetrimide; and approximately 80% (w/w) DME, and approximately 1.0% (w/w) cetrimide.

37. The procedure of claim 35, wherein the surgical or animal husbandry procedure is castration and the composition is applied to a scrotum of the subject so as to provide a local refrigerant effect and antisepsis.

38. The procedure of claim 35, comprising the steps of: 1) applying a sprayable cooling composition, comprising at least one refrigerant as well as at least one non-volatile antiseptic agent, wherein the cooling composition is capable of eliciting both a local refrigerant effect to a body surface area to which it is applied and providing antisepsis due to the non-volatile antiseptic agent remaining on the body surface area, to a scrotum of the subject so as to provide a local refrigerant effect and antisepsis; 2) making a surgical incision into the scrotum; 3) applying a topical local anaesthetic and/or vasoconstrictor within the scrotum; and 4) cutting and removing testicles of the subject via the surgical incision; and optionally 5) applying a topical local anaesthetic and/or vasoconstrictor within the scrotum.

39. The procedure of claim 37, wherein said subject is a piglet.

Description

DESCRIPTION OF THE FIGURES

[0067] FIGS. 1 and 2 show different types of aerosol cans and nozzle delivery systems, for delivering cooling compositions according to different embodiments of the present invention.

[0068] FIG. 3 shows a preferred aerosol can and nozzle delivery system for delivering a cooling composition for piglet castration. A topical anaesthetic spray called Tri-solfen (Bayer) that is also used for piglet castration is also shown.

[0069] FIGS. 4, 5 and 6 show different steps of a piglet castration procedure, wherein FIGS. 4 and 5 show application of the cooling composition as a white foam prior to scrotal incision, and FIG. 6 shows application of the anaesthetic/vasoconstrictor Tri-solfen (Bayer), according to an embodiment of the present invention.

DETAILED DESCRIPTION

[0070] The inventor has developed a cooling composition that is capable of both cooling and providing antisepsis to a body surface of a subject.

[0071] In a first embodiment, this is achieved by way of using a compressed refrigerant/propellant gas (eg. carbon dioxide or nitrogen) and a non-volatile antiseptic agent that remains on the skin or other body surface area.

[0072] In a second embodiment, this is achieved by way of using liquefied hydrocarbon as a refrigerant/propellant and a non-volatile antiseptic agent that remains on the skin or other body surface area.

[0073] In a third embodiment, this is achieved by way of using ether as a refrigerant/propellant and a non-volatile antiseptic agent that remains on the skin or other body surface area.

[0074] In a preferred embodiment, the cooling composition is delivered from a pressurised aerosol container as a fine mist, a metered spray delivering just the right amount, or foam.

Example 1Preparation of a Cooling Composition Utilising Carbon Dioxide as the Refrigerant and Propellant

[0075] An aerosol container is partially filled with the liquid antiseptic agent cetrimide (5% w/w cetrimide powder+approximately 95% w/w water as a solvent) and optionally up to 5% w/w colourant in the form of a blue organic dye. The container is then sealed and charged with a suitable amount of carbon dioxide until suitably pressurised. The carbon dioxide serves both as a refrigerant and propellant. The container's composition comprises 1.0% to 5% w/w cetrimide, (optionally dye), and carbon dioxide to balance.

[0076] Pressing an actuator button opens a valve of the container such that pressurised carbon dioxide can force the (coloured) antiseptic agent up a dip tube of the container and through the valve. The cooling composition can be applied as an aerosol mist or foam depending on the final composition. A specially articulated spray nozzle can also be used, if required. See the figures for different spray nozzles that can be used.

Example 2Preparation of a Cooling Composition Utilising Liquified

[0077] Hydrocarbon as the Refrigerant and Propellant

[0078] An aerosol container is partially filled with the liquid antiseptic agent cetrimide (5% w/w cetrimide powder+approximately 95% w/w water as a solvent) and optionally up to 5% w/w colourant in the form of a blue organic dye. The container is then sealed and charged with hydrocarbon until suitably pressurised. The hydrocarbon serves both as a refrigerant and propellant. The container's composition comprises 1 to 5% w/w cetrimide, (optionally dye), and 50-75% w/w butane and propane blend or butane, propane and isobutane blend.

[0079] Pressing an actuator button opens a valve of the container such that pressurised hydrocarbon can force the (coloured) antiseptic agent up a dip tube of the container and through the valve. The cooling composition can be applied as an aerosol mist or foam depending on the final composition. A specially articulated spray nozzle can also be used, if required. See the figures for different spray nozzles that can be used.

Example 3Preparation of a Cooling Composition Utilising DME as the Refrigerant and Propellant

[0080] An aerosol container is partially filled with the liquid antiseptic agent cetrimide (5% weight/weight cetrimide powder+approximately 95% weight/weight water as a solvent) and optionally up to 5% weight/weight colourant in the form of a blue organic dye. The container is then sealed and charged with DME until suitably pressurised. DME serves both as a refrigerant and propellant. The container's composition comprises 1 to 5% w/w cetrimide, (optionally dye), and 20-80% w/w DME, preferably 1.5% cetrimide (30 ml of a 5% concentrate) and 70% DME (70 ml DME).

[0081] Pressing an actuator button opens a valve of the container such that pressurised DME can force the (coloured) antiseptic agent up a dip tube of the container and through the valve. The cooling composition can be applied as an aerosol mist or foam depending on the final composition. A specially articulated spray nozzle can also be used, if required. See the figures for different spray nozzles that can be used.

Example 4Preferred Cooling Composition Formulations

[0082] A 5% cetrimide solution was prepared by combining 5% w/w cetrimide powder with approximately 95% w/w water. A select quantity of the cetrimide solution was then combined with the refrigerant/propellant.

[0083] Preferred aerosol formulations are shown in Table 1 below.

TABLE-US-00002 TABLE 1 Preferred Aerosol Formulations Formulation Refrigerant/Propellant Antiseptic Dye (optional) No. (% w/w) (% w/w) (% w/w) 1 Butane and propane Cetrimide Blue organic dye blend 3.5 Quantity to suit 50 2 Butane, propane and Cetrimide Blue organic dye isobutane blend 3.5 Quantity to suit 50 3 DME Cetrimide Blue organic dye 30 3.5 Quantity to suit 4 DME Cetrimide Blue organic dye 50 2.5 Quantity to suit 5 DME Cetrimide Blue organic dye 30 1.5 Quantity to suit 6 DME Cetrimide Blue organic dye 70 1.5 Quantity to suit 7 DME Cetrimide Blue organic dye 80 1 (or 1.5) Quantity to suit

[0084] Pressing an actuator button opens a valve of the container such that pressurised propellant can force the (coloured) antiseptic agent up a dip tube of the container and through the valve. The cooling composition can be applied as an aerosol mist or foam depending on the final composition. A specially articulated spray nozzle can also be used, if required. See the figures for different spray nozzles that can be used.

Example 5Use of the Cooling Compositions

[0085] The cooling composition of the Examples is sprayed onto a (human or animal) subject's skin/hide for the required period of time so as to elicit cooling and hence a local anaesthetic effect. Although the refrigerant dissipates, the antiseptic agent remains on the skin/hide to provide prolonged antisepsis. Successful application of the cooling composition can be confirmed by way of it including the colourantif the antiseptic agent itself is not opaque/visible enough.

[0086] After applying the cooling composition, the animal or human can be subjected to surgery or an animal husbandry procedure, such as castration, dehorning or ear tagging. For example, the cooling composition can be used to cool the scrotum of an animal prior to incision.

[0087] The cooling composition of the Examples can be sprayed onto other different body surfaces in a similar manner, including surfaces of tissues or internal organs.

Example 6Use of a Cooling Composition on Skin

[0088] Cooling composition, eg. 50% (w/w) DME and 2.5% (w/w) cetrimide supplied in an approximately 100 mL pressure-pack, was applied directly to skin of a subject. See FIG. 4. Spray application was from approximately 8 cm (nozzle to skin surface). Application was over approximately forty (40) seconds in three equal bursts, each of 3 seconds with a ten (10) second delay between applications.

[0089] A (subcutaneous) skin temperature equal to or below 10 degrees Celsius was achieved following the third spray application. This temperature was retained for approximately 10 seconds, thereby allowing adequate time for skin incision or other procedure.

Example 7Use of a Cooling Composition for Piglet Castration

[0090] Cooling composition, eg. 50% (w/w) DME and 2.5% (w/w) cetrimide, supplied in an approximately 100 mL pressure-pack (see FIG. 3), was applied directly to scrotal skin of 3 to 7-day old piglets (see FIG. 4). Spray application was from approximately 8 cm (nozzle to skin surface). Application was over approximately forty (40) seconds in three equal bursts, each of 3 seconds with a ten (10) second delay between applications.

[0091] Subcutaneous (directly under the scrotal skin) temperature was monitored using a temperature probe. A skin temperature equal to or below 10 degrees Celsius was achieved following the third spray application. This temperature was retained for approximately 10 seconds, thereby allowing adequate time for skin incision. Subsequent incision of the skin within this 10 second timeframe appeared to result in less discomfort to the animal as reflected by vocalisation and body responses.

Example 8Use of a Cooling Composition for Piglet Castration

[0092] Piglets of appropriate age were selected and, once restrained, cooling composition (50% (w/w) DME and 2.5% (w/w) cetrimide) as shown in FIG. 3 was sprayed directly over the body area where an incision for castration was to be made. See FIGS. 5 and 6. Because the chilling factor reduced any pain transmitted through nerve endings, the impact of the incision was less as far as the pain response was concerned. After waiting two or three seconds, a single incision was made over the middle of the scrotum. A spray-on topical anaesthetic known as Tri-solfen was then sprayed into the area and its local anaesthetic was given 20 seconds to work. See FIG. 6. The Tri-solfen anaesthetic was used in this area because it had contact with the blood vessels and nerves that are associated with the testicle. Following that, two further incisions were made to remove the testicles through the incision site. After cutting and removing the testicles, the Tri-solfen anaesthetic spray was applied to both provide further anaesthesia and constrict blood vessels by way of Tri-solfen's vasoconstrictor/adrenaline.

[0093] The treated piglets did not kick or squeal during the procedure, and once the procedure was over they typically returned to suckle from their mother.

[0094] Cooling down the actual tactile nature of cetrimide led to proper skin and nerve desensitization, compared with just using a basic vapocoolant.

Example 9Particularly Preferred Aerosol Formulations

[0095] A particularly preferred formulation has a very high percentage of DME, so as to deliver super-chilled cetrimide. A preferred formulation is 70% (w/w) DME and 1.5% (w/w) cetrimide. The formulation could contain as much as 80% DME, provided that the cetrimide (eg. 1 to 2%) can still be dispensed from a pressurised can.

[0096] Advantages of the present invention as exemplified include:

[0097] The cooling composition can be easily applied to a subject, such as an animal.

[0098] The cooling composition can be easily applied to a large number of animals in a short period of time.

[0099] Pain relief can be provided without injection or other invasive technique.

[0100] Successful application of the cooling composition can be identified by way of the colourant (if present).

[0101] The cooling composition can be applied in a metered dose and different dosages can result in different degrees of body surface cooling.

[0102] A single application can provide both pain relief and ongoing antisepsis.

[0103] The inclusion of cetrimide led to proper skin and nerve desensitization.

[0104] A high percentage of DME can deliver super-chilled cetrimide, so as to improve or prolong the numbing effect.

[0105] In the present specification (and claims), the word comprising and its derivatives including comprises and comprise include each of the stated integers but does not exclude the inclusion of one or more further integers.

[0106] Reference throughout this specification to one embodiment or an embodiment means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment of the present invention. Thus, the appearance of the phrases in one embodiment or in an embodiment in various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more combinations.

[0107] In compliance with the statute, the invention has been described in language more or less specific to structural or methodical features. It is to be understood that the invention is not limited to specific features shown or described since the means herein described comprises preferred forms of putting the invention into effect. The invention is, therefore, claimed in any of its forms or modifications within the proper scope of the appended claims (if any) appropriately interpreted by those skilled in the art.