AU2017100714A4

AU2017100714A4 - A Composition Containing Tea Tree Oil and Uses Therefor

Info

Publication number: AU2017100714A4
Application number: AU2017100714A
Authority: AU
Inventors: Gary Denning
Original assignee: Individual
Current assignee: Individual
Priority date: 2016-06-15
Filing date: 2017-06-14
Publication date: 2017-07-13
Anticipated expiration: 2025-06-14

Abstract

A chemical composition comprising eucalyptus oil, menthol liquid, phenol liquefied, tea tree oil and thymol which can be used as a topical ointment to deter bacterial and fungal infections of the type that previously were not considered to be treatable by natural products.

Description

ι 2017100714 14 Jun2017

A COMPOSITION CONTAINING TEA TREE OIL AND USES THEREFOR FIELD OF THE INVENTION

[0001] This invention is directed to a novel chemical composition and is particularly directed to a chemical composition comprising natural products including tea tree oil and which can be used as a topical ointment to deter bacterial and fungal infections of the type that previously were not considered to be treatable by natural products.

BACKGROUND

[0002] There is a number of bacterial and fungal infections which are potentially dangerous in the community and in hospitals.

[0003] One particular bacterium which is of concern is the gram positive bacteria Methycillin Resistant Staphylococcus Aureus which is otherwise known as Golden Staph or MRSA. These bacteria, if transferred to a wound, can cause infection and can prevent healing of the wound site as well as creating the possibility of boils. The bacteria are quite resistant to normal antibiotics and are treated by "last line" type drugs. Therefore, there would be a great advantage if another chemical composition could be developed that could treat this bacteria and especially if the chemical composition could comprise natural products.

[0004] Another type of bacteria which is of concern is the gram positive bacteria Vancomycin Resistant Enterococcus, also known as VRE. This bacteria normally lives in the intestines and some strains of the bacteria are becoming resistant to Vancomycin. Should this bacteria spread to a wound site and cause infection, a chronic or acute infected wound site can be the result. At this stage, there does not appear to be any topical agent currently available that can be used to treat this bacterium.

[0005] There is also a fungal infection caused by Trichophyton mentragrophytes. This is a fungi commonly found in "athlete's foot" or Tinea Corporis. The fungal infection can cause blisters containing a thin watery fluid. There would be a great advantage if it were possible to treat this fungal infection using a topical composition which can comprise natural products.

[0006] There are many types of natural products that are known to provide some relief from 2017100714 14 Jun2017 2 certain conditions. One such product is eucalyptus oil. A few Eucalyptus species produce a leaf oil ("eucalyptus oil") for which there is a world trade as a pharmaceutical product. Although some "mallees", with multiple stems, woody lignotubers, and the ability to regrow repeatedly after harvesting (particularly Eucalyptus polybractea, the blue mallee) are harvested for oil in eastern Australia, most of the world's production of eucalyptus oil comes from overseas plantations of E. globulus, Tasmanian bluegum, grown primarily as a source of wood. The pharmaceutically active component of eucalyptus oil is 1,8-cineole, which is a cyclic ether, chemically stable and unreactive, and with the ability to readily penetrate tissue, presumably the reason for its efficacy in various decongestants and pain relief products. Cineole is completely biodegradable and relatively non-toxic. It occurs in complex mixtures with numerous other terpenoid compounds in the leaf oils of many eucalypts, but to differing extents - about 60% in the case of bluegums, and up to 95% in some oil mallees.

[0007] Another known natural product is menthol liquid. This is a colourless liquid having a boiling point of over 200° Centigrade and is soluble in alcohol. The product is widely used as perfumes but also has some uses as a skin balm to reduce pain. The product has a molecular weight of 198.31 and is otherwise known as menthyl acetate or laevo-menthyl acetate.

[0008] Phenol is a known natural product, which in larger quantities is quite toxic but in smaller quantities has some pharmaceutical benefits.

[0009] Tea tree oil is widely used on a variety of ailments. Most oils are made from the species “Melaleuca Altemifolia” which is considered by many users to be most therapeutic of the hundred and more varieties of tea tree plants. Many people use tea tree oil for athletes foot, cold and flu, oral thrush, cold sores & canker sores, tooth ache & gum infections, ringworm, Candida, head lice or louse, cleanser additive, gum problems, mosquito bites, bug repellent, cockroaches, deter fleas, mouth ulcers, herpes, cuts, abrasions, after shave, sunburn, anorectal or vaginal yeast infections, unwanted body odours, acne, toe nail infections, and many other uses.

Extraction [0010] Essential oil by steam or water distillation from leaves and twigs. 2017100714 14 Jun2017 3

Details of Oil [0011] A pale yellowy-green or water-white mobile liquid with a warm fresh, spicy-camphoraceous odour.

Aromatherapy Uses • SKIN CARE: Abscess, acne, athlete's foot, blisters, bums, cold sores, dandruff, herpes, insect bites, oily skin, rashes (nappy rash), spots, verrucae, warts, wounds. • RESPIRATORY SYSTEM: Asthma, bronchitis, catarrh, coughs, sinusitis, tuberculosis, whooping cough. • GENITO-URINARY SYSTEM: Thrush, vaginitis, cystitis, pruitis. • IMMUNE SYSTEM: Colds, fever, flu, infectious illnesses such as chicken pox.

Antiseptic / Bacterial Properties [0012] Treatment of cuts, burns, insect bites, infected splinters and all kinds of wounds, especially dirty wounds or wounds which contain puss. As an antiseptic, it is valuable for general skin care, spots, acne and blackheads etc. As a general disinfectant, it is especially useful for respiratory or genito-urinary tract infections i.e. bronchitis and sinusitis or cystitis.

Anti-fungal Properties [0013] Tea Tree is an effective treatment for ringworm, athlete’s foot and thrush (Candida). It has also been used to combat fungal diseases affecting animals, fish and plants.

Anti-viral Properties [0014] Viruses are the invading organisms responsible for most epidemic illnesses. As a powerful anti-viral agent, Tea Tree is effective in fighting many common infectious diseases such as measles, chicken pox, flu, cold and shingles, as well as other viral complaints i.e. cold sores, verrucae and warts. 4 2017100714 14 Jun2017

Immuno-stimulant Properties [0015] In this context, Tea Tree is of great value as a preventative remedy to help the body fight off all kinds of infection. This is especially important if the body is already in a weakened condition brought on by either stress, illness or the use of antibiotics or other drugs which have lowered the body's natural resistance levels. It can be helpful to those who need to build up their strength before a surgical operation or for those suffering from chronic or long standing debilitating illness.

[0016] Another known natural product which is used for therapeutic purposes is Thymol (thyme camphor). Thymol, or isopropyl-metacresol, C6H3CH3OHC3H7, is a crystalline phenol, obtained from the volatile oils of Thymus vulgaris, Linn. (N.O. Labiatae), Monarda punctata, Linn. (N.O. Labiatae), Carum copticum, Benth. and Hook. f. (N.O. Umbelliferae), and other plants. Thymol occurs in the form of large, colourless, transparent, rhombic prisms, having the characteristic, agreeable odour of thyme, and a spicy, burning, aromatic taste; it is not affected by light. Melting-point, 44° to 51°; boiling-point, 232°; specific gravity, 1.028. Solidifying point, 49° to 50°.

[0017] Thymol resembles phenol in its action, but owing to its insolubility in the fluids of the body it is absorbed much more slowly. It is also less irritant to wounds, while its germicidal action is greater than that of phenol, though less than that of naphthol. In alcoholic solution it penetrates the skin and produces local anaesthesia. It is used as an antiseptic lotion and mouth wash (1 in 1000), or and as an ointment (1 in 24 of soft paraffin, the thymol being dissolved with the aid of heat) for eczema, psoriasis, broken chilblains, parasitic skin affections, and burns. An ointment half this strength, perfumed with oil of lavender, is used to keep off gnats and mosquitoes. Thymol in oily solution (1 or 2 per cent) is applied to the respiratory passages by means of a spray in nasal catarrh. An alcoholic solution may be inhaled from hot water or from a dry inhaler in laryngitis and bronchial affections. It is given internally in large doses, to robust adults, 2 grams (30 grains) or more, repeated after two hours, to expel intestinal parasites, especially the miner’s worm, Ankylostomum duodenale. To children and delicate persons no more than 6 decigrams (10 grains) should be given. For its action as a vermifuge it should be administered in a cachet or capsule; alcohol or other solvent of thymol should be avoided, and a purgative dose of castor oil administered a few hours subsequently. In large doses, it may cause 5 2017100714 14 Jun2017 symptoms of collapse and renal irritation, if time be allowed for absorption. Thymol is used to medicate absorbent gauze and wool for use as surgical dressings.

[0018] Notwithstanding that each of the above compounds have an array of therapeutic uses, one disadvantage with the compounds is that the compounds are not particularly effective against certain bacterial and fungal infections and simply increasing the concentration of the compounds can sometimes result in toxic side-effects, burning or other adverse consequences.

[0019] Therefore, there would be an advantage if it were possible to provide a composition containing tea tree oil as an ingredient in a particular range to provide a composition that can be effective against certain types of infections and particularly bacterial and fungal infections, and particularly topical infections, and where the composition can be relatively gentle and relatively safe in use.

[0020] It will be clearly understood that, if a prior art publication is referred to herein; this reference does not constitute an admission that the publication forms part of the common general knowledge in the art in Australia or in any other country.

OBJECT OF THE INVENTION

[0021] It is an object of the invention to provide a composition that can be at least partially effective against certain ailments which addresses or at least ameliorates the aforementioned disadvantages or provides a useful choice.

SUMMARY OF THE INVENTION

[0022] With the foregoing in view, in a first aspect of the present invention, there is provided a composition for treating a microbial infection, the composition comprising eucalyptus oil, menthol liquid, phenol liquefied, tea tree oil and thymol.

Suitably, the eucalyptus oil comprises between 1 -20% by weight of the composition. Preferably, the eucalyptus oil comprises between 2-10% by weight of the composition.

[0023] Suitably, the menthol liquid comprises between 1-20% by weight of the composition.

[0024] Suitably, the phenol comprises between 1 % or less by weight of the composition. 6 2017100714 14 Jun2017 [0025] Suitably, the tea tree oil comprises between 0.1-20% by weight of the composition, preferably comprises between 0.1-1% by weight of the composition, and most preferably 0.33% v/v.

[0026] Suitably, the thymol comprises between 0.01-10% by weight of the composition.

[0027] The composition may comprise a base. The base may comprise a wool fat base. The wool fat typically comprises a yellow viscous animal oil extracted from wool; a mixture of fatty acids and esters; used in some ointments and cosmetics. Other types of base products may be provided including oils, greases, and the like. The base may be present in an amount of between 20%-95% by weight and preferably between 40%-80% by weight. The base is preferably a wool fat base.

[0028] The composition may comprise further additives. The further additives may include oil. The oil may comprise paraffin oil. The paraffin oil may be present in an amount of between 20%-90%.

[0029] Other additives may comprise perfumes, stabilisers, emulsifiers, and the like.

[0030] The composition may be in the form of a cream, a liquid, a solid, and is preferably in the form of a topical ointment.

[0031] In another form, the invention resides in a method of treating an ailment in a human or animal, the method comprising applying an effective amount of a composition described above to the skin of the human or animal. The ailment is the result of a microbial infection. For the purposes of this specification the term “microbe” is defined as a living microoragnsim such as a bacterium, fungus or virus.

[0032] In another form, the invention resides in a method of treating a bacterial infection by applying an effective amount of the composition described above to the bacterial infection. The bacterial infection may comprise gram positive bacteria Methycillin Resistant Staphylococcus Aureus, and/or gram positive bacteria Vancomycin Resistant Enterococcus.

[0033] In another form, the invention resides in a method of treating a fungal infection by applying an effective amount of the composition described above to the fungal infection. The 7 2017100714 14 Jun2017 fungal infection may comprise a fungal infection caused by Trichophyton mentragrophytes, or Aspergillus Fumigatus.

[0034] In another form, the invention resides in a method of treating a bacterial infection and/or fungal infection by breathing an effective amount of the composition described above in the form of a vapour.

[0035] In another form, the invention resides in a pharmaceutical composition comprising a pharmaceutical effective amount of the composition described above together with a pharmaceutical carrier. In this form the composition comprises pharmaceutical grade components.

[0036] An embodiment of the invention will now be described.

[0037] Any of the features described herein can be combined in any combination with any one or more of the other features described herein within the scope of the invention. The reference to any prior art in this specification is not, and should not be taken as an acknowledgement or any form of suggestion that the prior art forms part of the common general knowledge

BEST MODE

[0038] In an embodiment, the following ingredients are used (values are in v/v):

Eucalyptus oil 1-20%

Menthol liquid 1-20%

Phenol liquefied 80%w/w 0.01 -1 %

Tea tree organic certified oil (Mel. Altemifolia) 0.1-20% v/v Thymol raw material 1-20% [0039] The above ingredients were mixed together and stirred for approximately two minutes at room temperature. Then, a suitable amount of paraffin oil is added and the mixture is stirred for a further two minutes at room temperature. 2017100714 14 Jun2017 8 [0040] A suitable amount of wool fat raw material (solid) is heated in a container over moderate heat until liquefied. The mixture of the above ingredients together with the paraffin oil is added to the liquefied wool fat and stirred for approximately three minutes.

[0041] The mixture is then poured into ointment jars which can be 30 millilitres clear round jars. The mixture will provide approximately 12 jars of ointment.

Bacterial and Fungal Efficacy

Efficacy against MRSA (Golden Staph) [0042] A sample of the ointment was tested against golden staph. The test results are as follows:

Test Organism

Methycillin Resistant Staphylococcus aureus (B.111 Environmental Isolate)

Test Results

Challenge Organism Initial Inoculum (cfu) Recovery Count TSA 30°C / 72hrs (cfu per gram) Time ' 0' 48 hours 7 days 28 days Methycillin Resistant Staphylococcus aureus 5.5x10s 5.0x106 6.2x103 <10 <10 i i [0043] The British Pharmacopoeia requires that for an effective topical preparation, the initial bacterial challenge is reduced by a factor of not less than 100 within 48 hours and a factor of 1000 within seven days of the challenge and there is no increase thereafter. The above test shows that the ointment passes these requirements.

Efficacy against VRE

[0044] A sample of the ointment was tested against VRE. The results are as follows 9 2017100714 14 Jun2017

TEST ORGANISMS

Vancomycin Resistant Enterococci Environmental Isolate

TEST RESULTS

Time elapsed from challenge Vancomycin Resistant Enterococci (VRE) Initial Challenge 2.7x1 07 0 hours 4.7x105 48 hours 1.0x102 7 days <10 28 days <10 [0045] The British Pharmacopoeia requires that for an effective topical preparation, the initial bacterial challenge is reduced by a factor of not less than 100 within 48 hours and a factor of 1000 within seven days of the challenge and there is no increase thereafter. The above test shows that the ointment passes these requirements.

Efficacy against Fungal Infection.

[0046] A sample of the ointment was tested against a fungal infection. The results are as follows:

TEST ORGANISMS

Trichophyton mentragrophytes ACM 5068

TEST RESULTS

Time elapsed from challenge T. mentragrophytes Initial Challenge 1.4x105 0 hours 6.3x103 7 days <10 14 days <10 28 days 1---—-—— <10 [0047] The British Pharmacopoeia requires that for an effective topical preparation, the initial fungal challenge is reduced by a factor of not less than 100 within 48 hours and a factor of ίο 2017100714 14 Jun 2017 1000 within seven days of the challenge and there is no increase thereafter. The above test shows that the ointment passes these requirements.

TEST ORGANISM

AspargMus fymipatiK

TEST RESULTS

TfofretaeHd from chattenge AspfwgSttot nib Challenge ΰ train acOxio” 14 Days <ΐϋ 28 Days <10 < - Ll'^S than [004iij The British Pharmacopoeia requires that for an effective topical preparation, the initial fungal challenge Is reduced by a factor of not less than 100 within 4H hours and a factor of 1000 within seven days of the challenge and there is no increase thereafter. The above test shows that the ointment passes these requirements.

[0049] The composition has demonstrated activity against some of the worst type of bacterial and hi n gal infections. The composition is made primarily of natural ingredients and is a safe gentle and effective treatment for wounds and especially wounds infected wiLh the bacterial infections and fungal infections described above.

[0050] Surprisingly, the composition has demonstrated activity against these relatively aggressive bacterial and fungal infections without requiring excessively large quantities of each ingredient. Therefore, while not wishing to be hound by theory, there appears to he a surprisingly an unexpected advantage in having the combination of ingredients and the combination of ingredients in a particular range.

[0051J Thus preferred embodiments have a number of advantages over the prior art including: [0052] In the present specification and claims (if any), the word ’comprising’ and its derivatives including "comprises1 anti "comprise’ include each of the stated integers but does not exclude the inclusion of one or more further integers. 2017100714 14 Jun2017 11 [0053] 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.

[0054] 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 appropriately interpreted by those skilled in the art.

Claims

CLAIMS:

1. A composition, the composition comprising eucalyptus oil, menthol liquid, phenol liquefied, tea tree oil and thymol.
2. The composition according to claim 1, wherein the eucalyptus oil comprises between 1-20% by weight of the composition.
3. The composition according to claim 2, wherein the eucalyptus oil comprises between 2-10% by weight of the composition.
4. The composition according to any of the preceding claims, wherein the menthol liquid comprises between 1-20% by weight of the composition.
5. The composition according to any of the preceding claims, wherein the phenol comprises between 1% or less by weight of the composition.
6. The composition according to any of the preceding claims, wherein the tea tree oil comprises between 0.1-20% by weight of the composition,
7. The composition according to claim 6, wherein the tea tree oil comprises 0.1-1% by weight of the composition.
8. The composition according to claim 6 or claim 7, wherein the tea tree oil comprises 0.33% by weight of the composition.
9. The composition according to any of the preceding claims, wherein the thymol comprises between 0.01-10% by weight of the composition.
10. The composition according to any of the preceding claims, wherein the composition comprises a base.
11. The composition according to claim 10, wherein the composition comprises a wool fat base.
12. The composition according to claim 11, wherein the wool fat is present in an amount of between 20%-95% by weight of the composition.
13. The composition according to claim 12, wherein the wool fat is present in an amount of between 40%-80% by weight of the composition.
14. The composition according to any of the preceding claims, wherein the composition comprises at least one further additive selected from the group consisting of: an oil; perfume; stabilizer; or emulsifier.
15. The composition according to claim 14, wherein the oil is paraffin oil.
16. The composition according to claim 15, wherein the paraffin oil is present in an amount of between 20%-90%.
17. The composition according to any of the preceding claims wherein the composition is in the form of a cream, a liquid, a solid, or a topical ointment.
18. The composition according to claim 17 wherein the composition is in the form of a topical ointment.
19. A method of treating an ailment in a human or animal, the method comprising applying an effective amount of a composition according to claim 1, to the skin of the human or animal.
20. A method of treating a bacterial infection by applying an effective amount of the composition according to claim 1, to the bacterial infection.
21. The method of treating a bacterial infection as claimed in claim 20, wherein the bacterial infection is caused by a bacterium selected from the group consisting of: a gram positive Methycillin resistant bacteria, a drug resistant Staphylococcus Aureus bacteria, and/or a gram positive Vancomycin resistant Enterococcus bacteria.
22. A method of treating a fungal infection by applying an effective amount of the composition according to claim 1, to the fungal infection.
23. The method of treating a fungal infection as claimed in claim 22, wherein the fungal infection is caused by Trichophyton mentragrophytes or Aspergillus Fumigatus.
24. A method of treating a bacterial infection and/or fungal infection by breathing an effective amount of the composition according to claim lin the form of a vapour.
25. A pharmaceutical composition comprising a pharmaceutical effective amount of the composition according to claim 1, together with a pharmaceutical carrier.