Antimicrobial composition

Abstract

A composition comprising a solubiliser, at least one preservative, at least one liquid emollient and at least one antimicrobial agent, wherein the composition comprises thymol and carvacrol. The antimicrobial agent may comprise essential oils, active ingredients derived from essential oils or synthetic equivalents thereof and, optionally, additional antimicrobial compounds. The composition may comprise thymol, carvacrol, levulinic acid and lauric acid. The composition may be used for intra-anal douching and may be used to reduce the risk of the transmission of sexually transmitted diseases (STDs) and / or sexually transmitted infections (STIs). The composition may be essentially free of water and may be provided as a single unit dosage formulation. Alternatively, the composition may further comprise water and may be provided as a single unit dosage or multi-dosage formulation. Methods of making the composition that is essentially free of water and the composition further comprising water are also disclosed.

Description

[0001] ANTIMICROBIAL COMPOSITION

[0002] INTRODUCTION

[0003] The present invention relates to an antimicrobial composition and a method of making said composition. More particularly, the present invention relates to antimicrobial compositions comprising essential oils and / or active ingredients derived from essential oils (or their synthetic equivalents) as the antimicrobial agent.

[0004] Essential oils have gained recognition for their potent antimicrobial properties, making them valuable in various applications. Extracted from plants through distillation or cold pressing, these oils contain bioactive compounds such as terpenes and phenolics that exhibit antibacterial, antifungal, and antiviral properties. Their ability to inhibit the growth of microorganisms has been studied extensively, showing promise in fighting against pathogens responsible for infections. Incorporating essential oils into hygiene products, environmental disinfectants, and medical treatments offers a natural and potentially effective alternative to conventional antimicrobial agents.

[0005] STDs and STIs impact the health of millions of people around the world each year. The overall number of reported STDs and STIs has been on the rise since 2014 and shows no sign of slowing down, with infections disproportionately affecting young people under the age of 25, racial and ethnic minority groups, and homosexual or bisexual men.

[0006] STDs and STIs can have serious health consequences. People with STDs and STIs do not always experience symptoms, but if left untreated, some can increase the chances for HIV infection, or can cause chronic pelvic pain, pelvic inflammatory disease, infertility, severe pregnancy complications, newborn complications, and even infant death.

[0007] There is an ongoing focus on the development of products which are derived from a higher percentage of natural products. Additionally, there remains a stigma relating to the clinical or medical nature of products marketed to prevent or reduce the risk of STDs and STIs. From a separate perspective, resistance to conventional drugs in the treatment of STDs and STIs is rising and there is a global unmet need for alternative and improved agents for the treatment of STDs and STIs which are safe, effective, and non-toxic. It is therefore an aim of the present invention to solve at least one of the aforementioned problems. The inventors of the present invention have determined that a selection of essential oils and / or active ingredients derived from essential oils (or their synthetic equivalents) are particularly useful for preventing the transmission of sexually transmitted diseases (STDs) and / or sexually transmitted infections (STIs).

[0008] The selection of essential oils and / or active ingredients derived from essential oils (or their synthetic equivalents) may also demonstrate efficacy in a wider range of implications where minimising or preventing bacterial, viral, or fungal infection is relevant and / or desirable. For example, in use as a lip shield, laundry detergents or additives, surface cleansing wipes, or as a cleaning and / or sanitising spray.

[0009] DETAILED DESCRIPTION

[0010] The present invention focuses on transmitted STDs and STIs such as gonorrhoea, syphilis, herpes, etc. but is also effective in preventing or reducing the risk of transmission of other diseases and / or infections including those caused by bacteria, viruses and fungi. Further, the inventors of the present invention have determined that, when utilised appropriately, certain blends of essential oils and / or active ingredients derived from essential oil (or their synthetic equivalents) and / or additional antimicrobial agents offer a very effective, safe and non-toxic alternative to what is currently available in the market and the essential oils and / or active ingredients derived from essential oil (or their synthetic equivalents) are able to exert their antimicrobial properties before the pathogens can establish themselves in the human body.

[0011] Disclosed herein are compositions comprising a solubiliser, at least one preservative, at least one liquid emollient and at least one antimicrobial agent. Many antimicrobial agents may be used in such a composition including those listed below. The present invention also provides methods of making the compositions of the invention. For the avoidance of doubt, the scope of the invention is defined by the appended claims.

[0012] According to the present invention, the term “antimicrobial agent” refers to a therapeutic substance, used to prevent, treat, or reduce the risk of infections. The antimicrobial agents include antiseptics, antibiotics, antivirals, antifungals and antiparasitics. The present invention may combine one or more different types of antimicrobial agent. Combining more than one antimicrobial agent or type of antimicrobial agent may provide a synergistic antimicrobial effect, for example by acting on multiple mechanisms of action. The antimicrobial agent may prevent, treat, or reduce the risk of the transmission of STDs and STIs by dissolving the lipid coat of the bacteria I virus I fungus before it enters the body. The antimicrobial agent may also inhibit proteins that allow the bacteria I virus I fungus to enter the host cell. The antimicrobial agent may destabilise the Tat / TAR-RNA complex of HIV-1 virus, which is essential for HIV-1 replication. The antimicrobial agent may target the redox signalling pathway of the bacteria I virus I fungus and inhibit the late stages of their life cycle.

[0013] The compositions of the present invention comprise thymol and carvacrol. Carvacrol and its isomeric compound thymol are phenolic antimicrobial agents, best known as the aroma compounds of oregano and thyme, respectively. Both carvacrol and thymol exhibit antimicrobial effects by altering cell membrane permeability, such that leakage of bacterial nucleic acids and proteins results in cell death.

[0014] The composition may comprise a mixture of a natural extract, where the active ingredient is derived from an essential oil, and a synthetic equivalent of an active ingredient. For example, the relative amounts of a natural extract and a synthetic equivalent of a natural extract may be selected to provide a desired concentration of carvacrol and thymol.

[0015] Additional antimicrobial agents may also be included in the composition. The combination of carvacrol, thymol and the additional antimicrobial agents may assist in optimising the antimicrobial effect of the composition.

[0016] In some examples, the ratio of thymol to carvacrol in the composition is from about 1 :2 to about 8:1 , or from about 1:1 to about 7:1 , or from about 2:1 to about 6:1 , or from about 3:1 to about 5:1, or about 4:1. It has been determined that the specific ratio of thymol to carvacrol in the composition provides excellent antimicrobial activity whilst minimising the risk of adverse events.

[0017] In the context of the present invention, the antimicrobial agent may be provided as isolated compounds. For example, the antimicrobial agent may be provided separately as (i) carvacrol and (ii) thymol. In some examples, the carvacrol and / or thymol may be obtained from a natural extract. The natural extract may be standardised to contain a minimum percentage of antimicrobial agent. For example, carvacrol and thymol may be sourced from or present in the composition from an essential oil. The essential oil may be oregano oil (origanum vulgare). Oil of oregano naturally contains thymol and carvacrol. The antimicrobial agent may comprise an essential oil, an active ingredient derived from an essential oil or a synthetic equivalent thereof, or combinations thereof. Optionally, the antimicrobial agent may additionally comprise an additional antimicrobial compound.

[0018] The composition may comprise from about 0.25 wt% to about 60 wt% of antimicrobial agent. For example, the composition may comprise the antimicrobial agent in a proportion of about 0.25 wt% to about 55 wt%, about 20 wt% to about 50 wt%, about 25 wt% to about 40 wt% about 30 wt% to about 45 wt%, about 0.25 wt% to about 15 wt%, about 0.25 wt% to about 10 wt%, about 0.25 wt% to about 7 wt%, about 0.5 wt% to about 7 wt%, about 1 wt% to about 2 wt%, or about 2 wt% to about 7 wt%.

[0019] A combination of one or more essential oils may be used in the composition. Preferably, a combination of at least 7, at least 6, at least 5, at least 4, at least 3 or at least 2 essential oils is used in the composition. More preferably, a combination of at least 2 essential oils is used in the composition.

[0020] Essential oils suitable for use in the composition include thymus vulgaris, origanum vulgare, rosmarinum officinalis, cymbopogon citratus, melaleuca alternifolia, mentha pipertita, melissa officinalis, salvia officinalis, leptospermum scoparium, lavendula angustifolia, eucalyptus globulus, cinnamomum zeylanicum, eugenia caryophyllata, thymus mastichina, allium sativum and any combination thereof. Preferably, the essential oil is selected from melissa officinalis, mentha pipertita, thymus vulgaris, rosmarinum officinalis, cymbopogon citratus, origanum vulgare, leptospermum scoparium, lavendula angustifolia and combinations thereof. Most preferably, the essential oil is selected from thymus vulgaris, origanum vulgare or a combination thereof.

[0021] The composition may comprise from about 10 wt% to about 60 wt% of essential oil(s). For example, the composition may comprise the essential oil in a proportion of about 15 wt% to about 55 wt%, about 20 wt% to about 50 wt%, about 25 wt% to about 40 wt% or about 30 wt% to about 45 wt%.

[0022] If present, the synthetic equivalent may be a nature identical synthetic equivalent of an active ingredient derived from an essential oil. A combination of one or more active ingredients or their synthetic equivalents may be used in the composition. Preferably, a combination of at least 7, at least 6, at least 5, at least 4, at least 3 or at least 2 active ingredients or their synthetic equivalents is used in the composition. More preferably, a combination of at least 2 active ingredients or their synthetic equivalents is used in the composition.

[0023] In the instance of the antimicrobial agent comprising an essential oil or a suitable natural extract, said essential oil or natural extract will inherently comprise a certain concentration of carvacrol and / or thymol. Accordingly, it should be acknowledged that in such examples of compositions, the concentration of essential oil or natural extract may be different to that of the underlying carvacrol and / or thymol concentration in the composition. For example, if a composition comprises 50 wt% origanum vulgare, the underlying amount of carvacrol and thymol will inherently be less than 50 wt% in the composition due to the presence of additional components in origanum vulgare. In the instance where origanum vulgare is standardised to provide a minimum of 80 wt% carvacrol, for example, a composition comprising 50 wt% origanum vulgare would therefore comprise a minimum of 40 wt% (0.5 x 0.8 = 0.4) carvacrol.

[0024] If present, the active ingredients or their synthetic equivalents may be selected from the group comprising monoterpenes, sesquiterpenes, linalool, triterpenes, camphor, cineol, terpineol-4-01, citral, 3,7-dimethyl-2,6-octadienal, lemonal, L-menthol, menthone, methyl acetate, limonene, linalyl acetate, 1-8-cineole, a-thujone, b-thujone, borneol, viridiflora, cinnamaldehyde, eugenol and any combination thereof.

[0025] The composition may comprise from about 0.25 wt% to about 60 wt% of active ingredient(s) derived from an essential oil or synthetic equivalent(s) thereof. For example, the composition may comprise the active ingredient(s) derived from an essential oil or synthetic equivalent(s) thereof in a proportion of about 0.25 wt% to about 55 wt%, about 20 wt% to about 50 wt%, about 25 wt% to about 40 wt%, about 30 wt% to about 45 wt%, about 0.25 wt% to about 15 wt%, about 0.25 wt% to about 10 wt%, about 0.25 wt% to about 7 wt%, about 0.5 wt% to about 7 wt%, about 1 wt% to about 2 wt%, or about 2 wt% to about 7 wt%.

[0026] The antimicrobial agent may additionally comprise an additional antimicrobial compound. If present, the additional antimicrobial compound may be selected from levulinic acid, lauric acid, chlorhexidine digluconate, cetylpyridinium chloride, octenidine, alexidine, picloxydine, polyhexanide, bakuchiol and any combination thereof. Preferably, the additional antimicrobial compound is chlorhexidine digluconate or comprises levulinic acid and lauric acid.

[0027] Preferably, at least 1 or a combination of at least 7, at least 6, at least 5, at least 4, at least 3 or at least 2 additional antimicrobial compounds is used in the composition. More preferably, at least 1 or a combination of at least 2 additional antimicrobial compounds is used in the composition.

[0028] The composition may comprise from about 0.05 wt% to about 30 wt% of additional antimicrobial compounds. For example, the composition may comprise the additional antimicrobial compound in a proportion of about 0.05 wt% to about 25 wt%, about 0.05 wt% to about 20 wt%, about 0.05 wt% to about 30 wt% or about 0.05 wt% to about 20 wt%.

[0029] If present, the composition may comprise levulinic acid in a proportion of about 0.05 wt% to about 0.3 wt%, about 0.05 wt% to about 0.25 wt%, about 0.1 wt% to about 0.3 wt%, about 0.1 wt% to about 0.25 wt%, or about 0.15 wt% to about 0.25 wt%.

[0030] The antimicrobial agent of the present invention may comprise a combination of one or more essential oils, one or more active ingredient(s) derived from an essential oil or their synthetic equivalent(s) and one or more additional antimicrobial compounds. Alternatively, the antimicrobial agent of the present invention may comprise one or more essential oils and one or more active ingredient(s) derived from an essential oil or their synthetic equivalent(s) but no additional antimicrobial compounds; one or more active ingredient(s) derived from an essential oil or their synthetic equivalent(s) and one or more additional antimicrobial compounds but no essential oils; one or more essential oils and one or more additional antimicrobial compounds but no active ingredient(s) derived from an essential oil or their synthetic equivalent(s); one or more essential oils but no active ingredient(s) derived from an essential oil nor their synthetic equivalent(s) and no additional antimicrobial compounds; or one or more active ingredient(s) derived from an essential oil or their synthetic equivalent(s) but no essential oils and no additional antimicrobial compounds.

[0031] The combination of antimicrobial agents used and the amount of antimicrobial agents used in the composition provide an effective formulation to mitigate the risks of STDs and / or STIs and provide a safe formulation that is suitable for sensitive areas of skin and therefore is suitable for intra-anal use, peri-anal use, and vaginal use. The formulation is also suitable for use in mitigating the risks of other diseases and / or infections associated with less sensitive areas of skin and other areas of the body, such as lips, throat, feet, and other areas of human skin. In some examples, the compositions may be used as a cleaning and / or sanitising spray.

[0032] The preservative used in the composition of the present invention may be selected from ethylhexylglycerin, phenoxyethanol, caprylyl glycol, propylene glycol, diazolidinyl urea, iodopropynyl butylcarbamate, benzyl alcohol, benzoic acid and any combination thereof. The preservative used in the composition of the present invention may be a combination of phenoxyethanol and ethylhexylglycerin. The preservative used in the composition of the present invention may be a combination of phenoxyethanol and caprylyl glycol. The preservative used in the composition of the present invention may be a combination of propylene glycol, diazolidinyl urea and iodopropynyl butylcarbamate. The preservative used in the composition of the present invention may be a combination of benzyl alcohol, benzoic acid and caprylyl glycol.

[0033] Preferably, the preservative is ethylhexylglycerin, phenoxyethanol, a combination of benzyl alcohol, benzoic acid and caprylyl glycol or any combination thereof. The preservative may help reduce the risk of microbial contamination of the product and may help ensure the product remains suitable and safe during shelf-life and the period of their use by consumers.

[0034] The composition may comprise from about 0.1 wt% to about 50 wt% of preservative. For example, the composition may comprise the preservative in a proportion of about 0.5 to 40 wt%, about 0.75 to 35 wt%, about 2 to 32 wt%, or about 5 to 30 wt%.

[0035] The liquid emollient used in the composition of the present invention may be selected from caprylyl glycol, triolein, vitamin E, sunflower seed oil, olive oil and any combination thereof. Preferably, the liquid emollient is caprylyl glycol, triolein, vitamin E or a combination thereof. The liquid emollient in the composition may act as a skin conditioning agent, can have soothing effects, and can reduce oxidative stress in skin. In some examples, the liquid emollient is provided by virtue of ingredients possessing inherent emollient properties. For example, PEG-40 hydrogenated castor oil (used as a solubiliser) may also serve as the emollient in the composition.

[0036] Preferably, algae oil is used as the source of triolein.

[0037] The composition may comprise from about 0.1 wt% to about 25 wt% of liquid emollient. For example, the composition may comprise the liquid emollient in a proportion of about 0.1 wt% to about 020 wt%, about 0.5 wt% to about 20 wt%, about 1 wt% to about 15 wt%, about 2 wt% to about 12 wt% or about 5 wt% to about 10 wt%.

[0038] The solubiliser used in the composition of the present invention may be a lipoamino acid. Preferably, when the solubliser is a lipoamino acid, the lipoamino acid is cocoyl proline. The solubiliser may be selected from PEG-40 hydrogenated castor oil, polyglyceryl-4 caprate, polyglyceryl-4 caprylate, polyglyceryl-4 succinate, polyglyceryl-3 caprate, polyglyceryl-3 caprylate, polyglyceryl-3 succinate, propylene glycol, PEG-7 glyceryl cocoate, lyceryl oleate citrate and any combination thereof. Preferably, the solubiliser is PEG-40 hydrogenated castor oil. The solubiliser ensures that the active ingredients are evenly dispersed, rendering them readily available for absorption by the skin.

[0039] The composition may comprise from about 0.5 wt% to about 45 wt% of solubiliser. For example, the composition may comprise the solubiliser in a proportion of about 0.5 wt% to about 40 wt%, about 1 wt% to about 30 wt%, about 3 wt% to about 20 wt%, about 5 wt% to about 35 wt% or about 10 wt% to about 30 wt%.

[0040] Compositions in accordance with the present invention have passed established tests for medical disinfectants and antiseptics including BS EN 14476 (the virucidal activity test), BS EN 13727 (the bactericidal test) and BS EN 13624 (the fungicidal test). Furthermore, compositions in accordance with the present invention have passed the tests listed above within a relatively short period of time such as less than 10 minutes, less than 5 minutes, less than 3 minutes, less than V / z minutes, or less than 1 minute. Hence, a user of the composition can be confident that, when used appropriately, the composition will prevent or reduce the risk of the transmission of transmitted STDs and STIs and other diseases and / or infections including those caused by bacteria, viruses and fungi.

[0041] Proprietary blend

[0042] The inventors have prepared a proprietary blend of the composition comprising a combination of essential oils, active ingredients derived from essential oils or synthetic equivalents thereof with a solubiliser, at least one preservative and at least one liquid emollient.

[0043] The composition may comprise additional antimicrobial agents.

[0044] The composition of the invention may comprise at least one antioxidant, at least one emulsifier, at least one surfactant or combinations thereof.

[0045] The antioxidant used in the composition of the invention may differ from or correspond to the same compound as that used as the liquid emollient. Hence, the antioxidant may be selected from triolein, vitamin E, citric acid, tocopherol, tartaric acid, lactic acid and any combination thereof. Preferably, the antioxidant comprises triolein, vitamin E, tocopherol or a selection thereof. The antioxidant may help protect skin cells from damage and aging and may improve skin texture and appearance. In some examples, the antioxidant may be a separate addition to the composition. In other examples, the antioxidant may be present by virtue of an ingredient possessing inherent antioxidant properties. Thymol and carvacrol possess inherent antioxidant properties.

[0046] The composition may comprise from about 1.5 wt% to about 0.5 wt% of antioxidant. For example, the composition may comprise the antioxidant in a proportion of about 1 wt%.

[0047] The emulsifier may be selected from glyceryl oleate citrate, coco-glucoside, glyceryl oleate, polyglyceryl-4oleate, glyceryl olivate, hydrogenated rapeseed alcohol, lecithin, glyceryl stearate, cetearyl alcohol, cetyl PEG / PPG-10 / 1 dimethicone, lauryl PEG-9 polydimethylsiloxvethyl dimethicone, lauryl PEG-10 tris(trimethylsiloxy)silylethyl dimethicone and any combination thereof. The emulsifier used in the composition of the present invention may be a combination of coco-glucoside and glyceryl oleate. The emulsifier used in the composition of the present invention may be a combination of polyglyceryl-4oleate, glyceryl olivate and hydrogenated rapeseed alcohol. Preferably, the emulsifier is glyceryl oleate citrate. The emulsifier may help provide a homogenous mixture and may help prevent non- miscible liquids from separating.

[0048] The composition may comprise from about 5 wt% to about 20 wt% of emulsifier. For example, the composition may comprise the emulsifier in a proportion of about 5 wt% to about 15 wt%, about 5 wt% to about 10 wt%, about 10 wt% to about 20 wt%, about 10 wt% to about 15 wt% or about 7 wt% to about 13 wt%.

[0049] The surfactant may be selected from sodium laureth sulfate, decyl glucoside, sodium cocoyl glycinate, sodium coco sulfate, disodium cocoyl glutamate, sodium cocoyl glutamate, lauryl glucoside, lauric acid, and any combination thereof. Preferably, the surfactant is sodium laureth sulfate. The surfactant may act as a stabiliser and may help prevent non-miscible liquids from separating.

[0050] The composition may comprise from about 1 wt% to about 40 wt% of surfactant. For example, the composition may comprise the surfactant in a proportion of about 1 wt% to about 35 wt%, about 5 wt% to about 30 wt%, about 10 wt% to about 40 wt%, about 15 wt% to about 40 wt% or more preferably about 20 wt% to about 35 wt%.

[0051] The composition may further comprise a conditioning agent. Levulinic acid is a conditioning agent and possesses inherent antimicrobial properties. Levulinic acid may therefore be considered as an additional antimicrobial agent in the present invention. The composition may comprise the conditioning agent in a proportion of about 0.01 to 1 wt%, about 0.05 to 0.7 wt%, or about 0.1 to 0.4 wt%.

[0052] The composition may further comprise lauric acid. Lauric acid is a preservative and possesses inherent antimicrobial properties. Lauric acid may therefore be considered as an additional antimicrobial agent in the present invention. The composition may comprise from about 0.05 to about 0.3 wt%, about 0.1 to about 0.3 wt%, about 0.13 to about 0.25 wt%, or about 0.15 to about 0.25 wt% lauric acid.

[0053] The inventors of the present invention have determined that, when the composition comprises levulinic acid and lauric acid as additional antimicrobials, a lower concentration of carvacrol and / or thymol may be required for the composition to provide the desired level of antimicrobial effect.

[0054] The composition may be used for intra-anal douching. More particularly, the composition may be used for intra-anal douching prior to sexual intercourse, and the antimicrobial agent of the present invention may prevent bacteria, viruses, or fungus from entering the body or reduce the deleterious effects of bacteria, viruses, or fungus on humans. Therefore, the composition may be used to prevent or reduce the risk of transmission of STDs and / or STIs such as chlamydia, gonorrhea, hepatitis, herpes, HIV / AIDS, Human Papillomavirus (HPV), Mycoplasma genitalium (Mgen), syphilis, trichomoniasis, genital warts, and scabies.

[0055] Compositions in accordance with the present invention may provide protection against a range of pathogens such as chlamydia trachomatis, neisseria gonorrhoeae, hepatitis virus, herpes viruses, human immunodeficiency virus, human papilloma virus, mycoplasma genitalium, treponema pallidum, trichomonas vaginalis, sarcoptes scabiei, pseudomonas, staphylococcus epidermidis, dermatophytes, and malassezia. As compositions in accordance with the present invention have passed established tests for medical disinfectants and antiseptics including BS EN 14476 (the virucidal activity test), BS EN 13727 (the bactericidal test) and BS EN 13624 (the fungicidal test), the compositions provide efficacy against the viruses, bacteria, and fungi required for compliance with the aforementioned certifications.

[0056] The composition of the present invention may be essentially free of water to provide a first formulation. In the context of this invention, “essentially free of water” is defined as a composition comprising less than 1.5 wt% water, optionally less than 1 wt% water, less than 0.75 wt% water, or a composition without water.

[0057] The first formulation may be provided as a single unit dosage formulation. A single unit dose may comprise from about 5 ml to about 10 ml of the first formulation, optionally from about 6 ml to about 9 ml, from about 6.5 ml to about 8 ml or from about 6.5 ml to about 7 ml.

[0058] The single unit dosage formulation may be a suppository, a soft capsule, a sachet, a pellet or a pod. The soft capsule or pod may comprise a water-soluble film. The water-soluble film may comprise pea protein, polyvinyl alcohol or seaweed. Preferably, the water-soluble film comprises pea protein.

[0059] The first formulation may be diluted in water prior to use. A single unit dose of the first formulation may be diluted in 100-230 ml water. Preferably, a single dose of the first formulation is diluted in about 140 ml water.

[0060] The first formulation, as a single unit dosage formulation, may provide the user with a convenient way of preparing the diluted composition, to be used for douching. The user simply has to drop the formulation in the appropriate volume of water, followed by shaking to prepare a homogenous solution that is ready to use.

[0061] According to another aspect of the present invention, the composition may further comprise water to provide a second formulation. The second formulation may comprise from about 10 wt% to about 50 wt% water. For example, the second formulation may comprise from about 15 wt% to about 40 wt% water, from about 20 wt% to about 30 wt% water or about 25 wt% water.

[0062] The second formulation may be provided as a single unit dosage formulation or a multidosage formulation. A single unit dose may comprise from about 5 ml to about 10 ml of the second formulation, optionally from about 6 ml to about 9 ml, from about 6.5 ml to about 8 ml or from about 6.5 ml to about 7 ml.

[0063] The second formulation may be diluted in water prior to use. A single dose of the second formulation may be diluted in 100-230 ml water. Preferably, a single dose of the second formulation is diluted in about 140 ml water. The multi-dosage formulation may comprise a dosing system where a specific volume corresponds to a single dose. This ensures precise and convenient measurement when diluting the second formulation to prepare a ready to use solution. The second formulation may be dispensed using a calibrated syringe or pipette, which may be used to facilitate accurate measurement.

[0064] The second formulation may be impregnated onto a wipe, or provided as a throat spray, a rim spray, a buccal spray, a pharyngeal spray, a laundry spray, a nasal inhaler, a surface spray, a foot spray, or a sanitiser gel.

[0065] The second formulation may be used in at least one of the following applications: household detergents, cleaning wipes, sanitisation wipes, laundry detergents, laundry spray, industrial detergents or medical disinfectants.

[0066] The second formulation may be provided as a single unit dosage formulation. The single unit dosage formulation may be a suppository, a soft capsule, a sachet, a vial, an ampoule or a pellet. The ampoules may be Blow-Fill-Seal (BFS) ampoules.

[0067] In other examples, the first and / or second formulation may be used (i) for intra-anal douching, (ii) for intra-vaginal douching, or (iii) as a lip shield.

[0068] In some examples, in particular those which pertain to the second formulation, any suitable flavouring may be incorporated into the composition. For example, peach or cherry flavour may be used. Essential oils are known for their pungent smell and taste. Accordingly, the applicant has determined that a suitable flavouring may be used to reduce or prevent any negative sensory associations or experiences with the compositions of the present invention. This is particularly advantageous in embodiments of the present invention which relate to lip shields, throat sprays, rim sprays, or as a lubricant, as composition taste is enhanced.

[0069] The flavourings may possess fragrant properties, such that the flavourings may also provide anti-odour properties. The flavourings may therefore mask or limit negative scents. This may be particularly useful when the composition is used, for example, as a foot spray, or as a throat spray. In some examples, the compositions may comprise a dedicated fragrance. The suitable choice and amount of fragrance may be selected to provide a composition with a positive sensory experience. The compositions may comprise about 0.1 to 5 wt% flavouring, about 0.2 to 4 wt% flavouring, about 0.3 to 3 wt% flavouring, about 0.4 to 2.5 wt% flavouring, or about 0.5 to 1.5 wt% flavouring.

[0070] The first and second compositions and the relative amounts of components may be adapted depending on the particular use case upon which the composition is to be used. For example, when the composition is intended to be used as a suppository, the composition is likely to be oil-based with minimal or no surfactant. In all examples, the compositions may be modified, adapted, or optimised to provide at least one of the following: regulatory compliance, legal compliance, a suitable sensory experience, ease of application, suitable durability and preservation of the composition and its components, suitable antimicrobial efficacy, adequate safety, practical and logistical efficiency, and suitable user experience.

[0071] The method for making the first composition according to the present invention comprises (a) heating the solubiliser until it reaches a temperature of 30 - 60 °C; (b) stirring the heated solubiliser and mixing it with the antimicrobial agent(s), liquid emollient(s), preservative(s), optional antioxidant(s), optional emulsifier(s), optional surfactant(s) and optional conditioning agent(s) to form a homogenous mixture; and (c) allowing the mixture formed in step (b) to cool to room temperature with stirring.

[0072] The method for making the second composition according to the present invention comprises (a) heating the solubiliser until it reaches a temperature of 30 - 60 °C; (b) stirring the heated solubiliser and mixing it with the antimicrobial agent(s), liquid emollient(s), preservative(s), optional antioxidant(s), optional emulsifier(s), optional flavouring(s) and optional conditioning agent(s) to form a homogenous mixture; (c) adding the optional surfactant(s) and heating the mixture with stirring until it reaches a temperature of 60 - 80 °C; and (d) allowing the mixture formed in step (c) to cool to room temperature with stirring.

[0073] Optionally, in the method for making the first or second composition the solubiliser is heated until it reaches a temperature of 45 - 55 °C, such as about 50 °C. Heating the solubiliser may result in it melting and becoming clear.

[0074] Heating the surfactant(s) with the mixture formed in step (c) the method for making the second composition may result in it melting and becoming clear. Optionally, the solubiliser is heated until it reaches a temperature of 75 - 75 °C, such as about 70 °C. Heating the solubiliser may result in it becoming clear. Examples

[0075] Example 1 Detailed composition of a first formulation

[0076] Example 2 Detailed composition of a first formulation

[0077] Example 3 Detailed composition of a first formulation Example 4 Detailed composition of a first formulation

[0078] Example 5 Detailed composition of a second formulation (for dilution with water)

[0079] Example 6 Detailed composition of a first formulation. Example 7 Detailed composition of a second formulation.

Claims

CLAIMS1. A composition comprising a solubiliser, at least one preservative, at least one liquid emollient and at least one antimicrobial agent, wherein the composition comprises thymol and carvacrol.

2. A composition according to claim 1 wherein the at least one antimicrobial agent comprises at least one of an essential oil or an active ingredient derived from an essential oil or a synthetic equivalent thereof.

3. A composition according to claim 2 wherein the essential oil is selected from the group comprising thymus vulgaris, origanum vulgare, rosmarinum officinalis, cymbopogon citratus, melaleuca alternifolia, mentha pipertita, melissa officinalis, salvia officinalis, leptospermum scoparium, lavendula angustifolia, eucalyptus globulus, cinnamomum zeylanicum, eugenia caryophyllata, thymus mastichina, allium sativum and any combination thereof.

4. A composition according to claim 2 or 3 wherein the active ingredient derived from an essential oil or a synthetic equivalent thereof comprises thymol, carvacrol or combinations of thymol and carvacrol, and additionally comprises an active ingredient selected from the group comprising monoterpenes, sesquiterpenes, linalool, triterpenes, camphor, cineol, terpineol-4-01, citral, 3,7-dimethyl-2,6-octadienal, lemonal, L-menthol, menthone, methyl acetate, limonene, linalyl acetate, 1-8-cineole, a-thujone, b-thujone, borneol, viridiflora, cinnamaldehyde, eugenol and any combination thereof.

5. A composition according to any of claims 2 to 4, wherein the antimicrobial agent additionally comprises an antimicrobial compound, and the antimicrobial compound is selected from the group comprising levulinic acid, lauric acid, chlorhexidine digluconate, cetylpyridinium chloride, octenidine, alexidine, picloxydine, polyhexanide, allium sativum, bakuchiol and any combination thereof.

6. A composition according to any preceding claim, wherein the composition comprises levulinic acid and lauric acid.

7. A composition according to any preceding claim wherein the ratio of thymol to carvacrol is from 1 :2 to 8: 1 , optionally from about 2: 1 to about 6: 1.

8. A composition according to any preceding claim wherein the composition comprises from 0.25 wt% to 15 wt% of antimicrobial agent.

9. A composition according to any preceding claim wherein the preservative is selected from the group comprising ethylhexylglycerin, phenoxyethanol, caprylyl glycol, propylene glycol, diazolidinyl urea, iodopropynyl butylcarbamate, benzyl alcohol, benzoic acid and any combination thereof.

10. A composition according to any preceding claim wherein the composition comprises from 0.1 wt% to 50 wt% of preservative.

11. A composition according to any preceding claim wherein the liquid emollient is selected from the group comprising caprylyl glycol, triolein, vitamin E, sunflower seed oil, olive oil and any combination thereof.

12. A composition according to any preceding claim wherein the composition comprises from 0.1 wt% to 25 wt% of liquid emollient.

13. A composition according to any preceding claim wherein the solubiliser is a lipoamino acid, optionally wherein the lipoamino acid is cocoyl proline.

14. A composition according to any preceding claim wherein the solubiliser is selected from the group comprising PEG-40 hydrogenated castor oil, polyglyceryl-4-caprate, polyglyceryl-4 caprylate, polyglyceryl-4 succinate, polyglyceryl-3 caprate, polyglyceryl-3 caprylate, polyglyceryl-3 succinate, propylene glycol, PEG-7 glyceryl cocoate, lyceryl oleate citrate and any combination thereof.

15. A composition according to any preceding claim wherein the composition comprises from 0.5 wt% to 45 wt% of solubiliser.

16. A composition according to any preceding claim wherein the composition further comprises at least one antioxidant, at least one emulsifier, at least one surfactant or combinations thereof.

17. A composition according to claim 16 wherein the at least one antioxidant is selected from the group comprising citric acid, tocopherol, tartaric acid, lactic acid and any combinationthereof, and optionally wherein the composition comprises from 1.5 wt% to 0.5 wt% of antioxidant.

18. A composition according to claim 16, wherein the at least one emulsifier is selected from the group comprising glyceryl oleate citrate, coco-glucoside, glyceryl oleate, polyglyceryl-4 oleate, glyceryl olivate, hydrogenated rapeseed alcohol, lecithin, glyceryl stearate, cetearyl alcohol, cetyl PEG / PPG-10 / 1 dimethicone, lauryl PEG-9 polydimethylsiloxvethyl dimethicone, lauryl PEG-10 tris(trimethylsiloxy)silylethyl dimethicone and any combination thereof, and optionally wherein the composition comprises from 5 wt% to 20 wt% of emulsifier.

19. A composition according to claim 16, wherein the surfactant is selected from the group comprising sodium laureth sulfate, decyl glucoside, sodium cocoyl glycinate, sodium coco sulfate, disodium cocoyl glutamate, sodium cocoyl glutamate, lauryl glucoside and any combination thereof, and optionally wherein the composition comprises from 1 wt% to 40 wt% of surfactant.

20. A composition according to any preceding claim, wherein the composition is used (i) for intra-anal douching, (ii) for intra-vaginal douching, or (iii) as a lip shield.

21. A composition according to any preceding claim, wherein the composition is used to reduce the risk of the transmission of sexually transmitted diseases (STDs) and / or sexually transmitted infections (STIs).

22. A composition according to any preceding claim, wherein the composition is essentially free of water.

23. A composition according to any preceding claim, wherein the composition is provided as a single unit dosage formulation.

24. A composition according to claim 23, wherein the single unit dosage formulation is a suppository, a soft capsule, a sachet, a pellet or a pod.

25. A composition according to claim 24, wherein the soft capsule or pod comprises a water- soluble film.

26. A composition according to any one of claims 22 to 25, wherein the composition is diluted in water prior to use.

27. A method of making a composition according to any one of claims 22 to 26 wherein the method comprises:(a) heating the solubiliser until it reaches a temperature of 30 - 60 °C;(b) stirring the heated solubiliser and mixing the heated solubiliser with the antimicrobial agent(s), liquid emollient(s), preservative(s), optional antioxidant(s) and optional emulsifier(s) to form a homogenous mixture; and(c) allowing the mixture formed in step (b) to cool to room temperature with stirring.

28. A composition according to any one of claims 1 to 21 wherein the composition further comprises water.

29. A composition according to claim 28 wherein the composition is provided as a single unit dosage formulation or a multi-dosage formulation.

30. A composition according to claim 29, wherein the composition is provided in a multidosage formulation and wherein a specific volume represents one dose.

31. A composition according to any one of claims 28 to 30, wherein the composition is impregnated onto a wipe or provided as a throat spray, a rim spray, a buccal spray, a pharyngeal spray, a laundry spray or a surface spray.

32. A composition according to any one of claims 28 to 31 , wherein the composition is used in at least one of the following applications: household detergents, laundry detergents, industrial detergents and medical disinfectants33. A composition according to any one of claims 29 to 32, wherein the single unit dosage formulation is a suppository, a soft capsule, a sachet or a pellet.

34. A composition according to claim 33 wherein the composition is diluted in water prior to use.

35. A method of making a composition according to any one of claims 28 to 34, wherein the method comprises:(a) heating the solubiliser until it reaches a temperature of 30 - 60 °C;(b) stirring the heated solubiliser and mixing the heated solubiliser with the antimicrobial agent(s), liquid emollient(s), preservative(s), optional antioxidant(s) and optional emulsifier(s) to form a homogenous mixture;(c) adding the optional surfactants and heating the mixture with stirring until it reaches a temperature of 60 - 80 °C; and(d) allowing the mixture formed in step (c) to cool to room temperature with stirring.

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