NZ740906A - A salve and methods of preparing and use thereof - Google Patents

Abstract

The present invention relates to a salve and methods of manufacturing and use thereof for use in treating a skin disease, disorder, condition or wound. The salve includes at least one oil, including fractionated coconut oil and a barrier forming agent comprising a wax, especially beeswax. The salve may include a further oil, such as olive oil. e may include a further oil, such as olive oil.

Description

A SALVE AND METHODS OF PREPARING AND USE THEREOF TECHNICAL FIELD The present invention relates to a salve and methods of preparing and use thereof.

BACKGROUND Barrier creams and other diaper or nappy rash creams are popular remedies in the treatment of diaper or nappy rash.

Generally, nappy rash or diaper dermatitis develops when skin is exposed to prolonged wetness, increased skin pH caused by urine and faeces and the resulting breakdown of the stratum corneum or outermost layer of the skin.

Barrier creams work by forming a barrier to block moisture from reaching the skin.

A problem with the use of such creams is that many such creams include petroleum- based products that may adversely affect a user. For example, petroleum-based chemicals have been found to adversely impact the nervous system and immune system of users after prolonged exposure.

Another problem with the use of such creams, including non-petroleum-based products, is that with the rapid rise in allergic diseases, many users exhibit allergic reactions to other cream ingredients, such as, e.g., artificial colourings and preservatives as well as other common allergens, such as soy, gluten and dairy-based ingredients, typically present in such creams.

SUMMARY OF INVENTION Embodiments of the present invention provide a salve and methods of preparing and use thereof, which may at least partially overcome at least one of the abovementioned problems or provide the consumer with a useful or commercial choice.

According to a first aspect of the present invention, there is provided a salve including: at least 50 %vol fractionated coconut oil; at least 10 %vol olive oil; and a barrier forming agent comprising a wax.

According to a second aspect of the present invention, there is provided a salve including at least one oil including fractionated coconut oil; and a barrier forming agent comprising a wax.

According to a third aspect of the present invention, there is provided a salve including: from 60% to 80%vol fractionated coconut oil; from 10 to 30%vol olive oil; and from % to 25%vol beeswax.

According to a fourth aspect of the present invention, there is provided a salve consisting of: fractionated coconut oil; olive oil; and beeswax.

According to a fifth aspect of the present invention, there is provided a salve consisting of: from 60% to 80%vol fractionated coconut oil; from 10 to 30%vol olive oil; and from 5% to 25%vol beeswax.

According to a sixth aspect of the present invention, there is provided a salve for use or when used for treating a skin disease, disorder or wound, said salve including: at least one oil comprising fractionated coconut oil; and a barrier forming agent comprising wax configured to form a barrier over a site of the skin disease, disorder or wound and promote and/or prolong contact of the at least one oil with the site of the skin disease, disorder or wound.

According to a seventh aspect of the present invention, there is provided a salve for use or when used for treating a skin disease, disorder or wound, said salve including: at least one oil comprising fractionated coconut oil; at least one essential oil having at least antiseptic and/or analgesic properties; and a barrier forming agent comprising a wax configured to form a barrier over a site of the skin disease, disorder or wound and promote and/or prolong contact of the at least one oil and the at least one essential oil with the site of the skin disease, disorder or wound.

Features of the first to seventh aspects of the present invention may be described as follows.

Advantageously, the present invention may provide a salve free of petroleum-based products, artificial colourings and preservatives as well as common allergens that can be used to treat a skin disease, disorder or wound. The therapeutic and low allergenic properties of the individual components of the salve may enable the salve to be used on the most sensitive of skins, including that of babies in the treatment of nappy rash. Moreover, the individual components of the salve together provide a synergistic effect that enhances the therapeutic properties of the components, especially compared to those components when used individually in the treatment of a skin disease, disorder or wound.

As indicated above, the salve may include at least one oil being fractionated coconut oil. The fractionated coconut oil is derived from whole coconut oil by a process of fractionation.

Whole coconut oil is an oil extracted from the kernel or meat of mature coconuts harvested from the coconut palm (Cocus nucifera). The coconut oil is typically extracted through either dry or wet processing.

Whole coconut oil generally has a high saturated fat content, typically about 91 wt% of total fat content. For example, whole coconut oil typically has a composition including: from about 0.2-0.8 wt% caproic acid (also known hexanoic acid; C6:0); from about 6-9 wt% caprylic acid (also known as octanoic acid; C8:0), from about 6-10 wt% decanoic acid (also known as capric acid; C10:0), from about 46-50 wt% lauric acid (also known as dodecanoic acid; C12:0); from about 17-19 wt% myristic acid (also known as tetradecanoic acid; C14:0); from about 8-10 wt% palmitic acid (also known as hexadecanoic acid; C16:0); from about 2-3 wt% stearic acid (also known as octadecanoic acid; C18:0); from about 12-19 wt% oleic acid (also known as (9Z)-Octadecenoic acid; 18:1 cis-9); and from about 1-2.5 wt% linoleic acid (also known as (9Z,12Z)-9,12-Octadecadienoic acid; C18:2).

Whole coconut oil has a melting point of about 24°C.

The fractionation process is a separation process in which the whole coconut oil is separated during a phase transition into fractions. Generally, the process involves fat splitting in which triglycerides in the whole coconut oil are split or hydrolysed into corresponding fatty acids and glycerine. The corresponding fatty acids are then separated into fractions based on differences in a specific property of the individual components. The corresponding fatty acids are typically fractionated by fractional crystallization or column fractionation by solubility at differing temperatures.

The fractionated coconut oil of the present invention generally has a composition including caprylic acid (C8:0) and decanoic acid (C10:0), typically with a greater amount of caprylic acid to decanoic acid. In some embodiments, the fractionated coconut oil may have a composition including from about 50 wt% to about 60 wt% caprylic acid (C8:0) and from about 40 wt% to about 50 wt% decanoic acid (C10:0). In some particular embodiments, the fractionated coconut oil may have a composition including about 55 wt% caprylic acid (C8:0) and about 40 wt% decanoic acid (C10:0) with small amounts of caproic acid (C6:0) and lauric acid (C12:0). Fractionated coconut oil may only include medium chain fatty acids.

As a result, the fractionated coconut oil has a lower melting temperature than whole coconut oil and unlike whole coconut oil is liquid at room temperature. Fractionated coconut oil may also exhibit a lesser allergic response when administered topically to a subject than whole coconut oil.

Moreover, fractionated coconut oil has a longer shelf life than whole coconut oil.

For example, the fractionated coconut oil of the present invention has a shelf life of over five years. In contrast, whole coconut oil has a shelf life of up to six months. Fractionated coconut oil can be a natural emollient with hydrating properties that can help soften and soothe dry skin when applied. Fractionated coconut oil may synergistically increase the absorption rate of further oils (such as olive oil) and (for example) reduce the pore clogging characteristics of olive oil.

The salve may include at least 50%vol (or %wt) fractionated coconut oil. The salve may include less than 85%vol (or %wt) fractionated coconut oil. In other embodiments, the salve may include from 50% to 90%vol (or %wt) fractionated coconut oil; especially from 55% to 85%vol (or %wt), or from 60% to 80%vol (or %wt), or from 60 to 75%vol (or %wt) fractionated coconut oil; more especially from 63% to 74%vol (or %wt), or from 65% to 72%vol (or %wt), or from 67% to 71% vol (or %wt) fractionated coconut oil. The salve may include about 68% to 70%vol (or %wt) fractionated coconut oil.

In some embodiments, the salve may include at least one essential oil and the fractionated coconut oil may function as a carrier oil. In other embodiments and/or additionally, the fractionated coconut oil may provide therapeutic properties, such as, e.g., as an antiseptic. For example, caprylic acid, the major constituent in the fractionated coconut oil, may have antiseptic, antimicrobial, disinfectant and antibacterial properties.

In some embodiments, the salve may include more than one oil. For example, the salve may include at least two, at least three, at least four or at least five oils. Typically, in such embodiments, the salve may include a first oil being the fractionated coconut oil and at least one further oil. The further oil may be any suitable oil, preferably at least capable of functioning as a carrier oil and/or providing a desirable property. For example, the further oil may function as any one of a diluent, an excipient or base, a buffer, emollient; humectant, stabilising agent, a dispersing agent, a skin conditioning agent, a skin protectant, a skin penetration enhancer, a fragrance, a preservative, a textural modifier, and waterproofing agent.

Preferably, the further oil may function as an antiseptic agent and/or as a preservative (antioxidant).

The further oil may include one or more natural or synthetic oils, for example. The further oil may include vegetable oils, nut oils and seed oils, by way of example and not limitation. As used herein, the term “oil” or “further oil” does not include essential oils. In some embodiments, the further oil may not have been subjected to a hydrogenation process, and as such, the further oil is not hydrogenated (including partially hydrogenated).

Examples of the further oil include but are not limited to apricot oil, avocado oil, almond oil, babassu kernel oil, carrot seed oil, cashew oil, castor oil, cottonseed oil, corn oil, grape seed oil, hazelnut oil, linseed oil, macadamia oil, mongongo nut oil, olive oil, jojoba oil, palm oil, palm kernel oil, peanut oil, pecan oil, pine nut oil, pistachio oil, pumpkin seed oil, rapeseed oil, safflower oil, sesame oil, soybean oil, sunflower oil, vegetable oil, emu oil, blackcurrant seed oil, evening primrose oil, borage seed oil, walnut oil or any mixture thereof.

In some embodiments, the further oil may include avocado oil, apricot oil, peach oil or any combination thereof.

In other embodiments, the further oil may include olive oil, preferably virgin olive oil, more preferably extra virgin olive oil, most preferably organic extra virgin olive oil.

Generally, olive oil is obtained by crushing or pressing whole olives (the fruit of Olea europaea; family Oleaceae). The resulting paste is then malaxed to allow microscopic oil droplets to agglomerate. The oil is then separated from the watery matter and fruit pulp with the use of a press or centrifugation, and graded based upon its organoleptic qualities.

Olive oil typically is composed of mixed triglyceride esters of oleic acid (also known as (9Z)-Octadecenoic acid; C18:1 cis-9) and palmitic acid (also known as hexadecanoic acid; C16:0) and of other fatty acids, along with traces of squalene (up to about 0.7 wt%; also known as (6E,10E,14E,18E)-2,6,10,15,19,23-Hexamethyltetracosa- 2,6,10,14,18,22-hexaene) and sterols (about 0.2 wt% phytosterol and tocosterols).

In particular, olive oil is typically composed of mixed triglyceride esters of: from about 55 wt% to about 83 wt% oleic acid; from about 3.5 wt% to about 21 wt% linoleic acid (also known as (9Z,12Z)-9,12-Octadecadienoic acid; C18:2); from about 7.5 wt% to about 20 wt % palmitic acid (also known as hexadecanoic acid; C16:0); from about 0.5 wt% to about 5 wt% stearic acid; and from about 0 wt% to about 1.5 wt% α-linoleic acid (also known as (9Z,12Z,15Z)-9,12,15-Octadecatrienoic acid).

Olive oil also contains phenolics, such as esters of tyrosol, hydroxytyrosol, oleocanthal and oleuropein, having acidic properties that give extra-virgin olive oil its aroma and bitter, pungent taste. Olive oil is a source of at least 30 phenolic compounds, among which is elenolic acid, a marker for maturation of olives. Oleuropein, together with other closely related compounds such as 10-hydroxyoleuropein, ligstroside and 10-hydroxyligstroside, are tyrosol esters of elenolic acid.

The polyphenol content of olive oil has been attributed to the strong preservative properties (antioxidant) of olive oil.

In some embodiments, the salve may include at least one essential oil and the olive oil, like the fractionated coconut oil, may function as a carrier oil (diluent, carrier, dispersing agent and/or excipient).

In other embodiments and/or additionally, the olive oil may act as preservative or stabilizing agent prolonging the shelf life of the salve, for example. Olive oil may act as an antioxidant or an antibacterial. When both fractionated coconut oil and olive oil are present in the salve, it is believed that the salve has a superior shelf life than if each oil was used in isolation of the other.

Olive oil may also moisturise and hydrate skin. However, olive oil is very oily and if applied neat excess must be blotted off with a towel or cloth. Olive oil is heavy and is not easily absorbed into the skin, and it can cause blocked pores or trap bacteria. However, the absorption rate of olive oil may be synergistically enhanced when fractionated coconut oil and olive oil are mixed. The absorption rate of olive oil may be synergistically further enhanced by the presence of beeswax. When olive oil, beeswax and fractionated coconut oil are present in the salve, the resultant salve may be more absorbable, less likely to clog pores and feel greasy, whilst maintaining properties of the olive oil (such as antibacterial, moisturising and cancer reducing). The combination of olive oil, fractionated coconut oil and beeswax may reduce the volatility of olive oil, increase the shelf life of olive oil, and reduce the likelihood that the olive oil will cause an allergic response. When fractionated coconut oil and beeswax are present in the salve it is believed that the barrier properties of the salve are synergistically enhanced.

In yet other embodiments, the olive oil may act as an emollient, a skin conditioning agent and/or a skin protectant.

The salve may include at least 10%vol (or %wt) of the at least one further oil (especially the olive oil). The salve may include less than 30%vol (or %wt) of the at least one further oil (especially the olive oil). The salve may include from 10-30%vol (or %wt) of the at least one further oil (especially the olive oil), especially from 10-24%vol (or %wt), 12-22%vol (or %wt), 14-20%vol (or %wt), or 16-19%vol (or %wt) of the at least one further oil (especially the olive oil).

The ratio of the at least one further oil (especially the olive oil) : the fractionated coconut oil may be less than 40:60, especially from 30:70 to 10:90, most especially from 25:75 to 15:85, or about 20:80.

As indicated, the salve may include a barrier forming agent comprising wax. In some aspects, the salve may be formulated with any suitable wax capable of forming a barrier over a site of a skin disease, disorder or wound and promote and/or prolong contact of the at least one oil with the site of the skin disease, disorder or wound. Moreover, the wax may also allow diffusion of the at least one oil to the site of the skin disease, disorder, condition or wound.

The barrier forming agent comprising wax may provide a dual function by serving as a thickening agent to provide the salve with a desired consistency. For example, by functioning also as a thickening agent, the wax may adhere to the site of the skin disease, disorder, condition or wound rather than run-off.

The wax may preferably be impenetrable to water. For example, upon application, the salve containing the wax may form a substantially waterproof barrier to at least partially prevent the ingress of water to the site of the skin disease, disorder or wound.

The wax may generally be a solid at room temperature (about 25°C). The wax may have a melting temperature of at least 40° C.

The wax may be a natural wax or a synthetic wax.

The wax may include mono, di and tri esters of saturated C -C fatty acids with 18 40 C alcohols, and ester and alcohol derivatives of straight and branched chain fatty acids that 1-40 are solid at room temperature (e.g., cetyl and stearyl alcohol, glyceryl dilaurate and trihydroxystearin).

Suitable synthetic waxes may include, but are not limited to, Fisher-Tropsch waxes, microcrystalline waxes, ethylene glycol diesters, triglyceride waxes, ethylene/vinylacetate copolymers or any mixture thereof.

Suitable natural waxes may include, but are again not limited to, animal tallow, bayberry wax, beeswax, Chinese wax, lanolin, shellac wax, spermaceti, candelilla wax, carnauba wax, grapefruit wax, castor wax, Japan wax, tallow tree wax, ouricury wax, montan wax, orange peel wax, palm wax, rice bran wax, sumac wax, sunflower wax, soy wax or any mixture thereof.

In some embodiments, the wax may include carnauba wax, palm wax, lanolin or any combination thereof.

In other embodiments, the wax may be beeswax.

Beeswax is a natural wax produced by bees of the genus Apis. The wax is formed by worker bees, which secrete it from wax-producing glands. The newly secreted wax is initially glass-clear and colourless, becoming opaque after mastication and adulteration with pollen by hive worker bees. The wax progressively becomes more yellow or brown by incorporation of pollen oils and propolis. The bees use the beeswax to build honeycomb cells.

Beeswax has a melting point range of from about 62°C to about 64°C. If heated above 85°C, discolouration of the beeswax occurs.

Generally, beeswax is formed from a mixture of several compounds. Typically, beeswax is comprised of palmitate, palmitoleate and oleate esters of long-chain (30-32 carbons) aliphatic alcohols with a ratio of triacontanyl palmitate CH (CH ) O-CO-(CH ) CH to cerotic 3 2 29 2 14 3 acid CH (CH ) COOH, the two principal components, being 6:1. An approximate chemical 3 2 24 formula for beeswax is C H COOC H 31 30 61.

The beeswax may or may not be treated prior to being used to formulate the salve.

For example, in some embodiments, yellow beeswax, which is a crude product obtained directly from a hive, may be used. In other embodiments, white beeswax, which is bleached and/or filtered yellow beeswax, may be used. In yet other embodiments, beeswax absolute, which is yellow beeswax treated with alcohol, may be used. In some embodiments, cosmetic grade beeswax may be used, especially certified organic cosmetic grade beeswax.

The wax (especially beeswax) may act as a thickening agent and may form a barrier to the skin where it is applied, protecting the skin from environmental contaminants and sealing in skin moisture to reduce skin dryness. Beeswax can act as a humectant, attracting water which helps the salve maintain skin moisture over time. Beeswax also has anti-allergic properties, and may act as an anti-inflammatory, antibacterial and possess collagen forming properties. When mixed with acids (such as the capric/caprylic acid in fractionated coconut oil), beeswax may have a reduced water vapour permeability and result in a stronger barrier forming layer that is water attracting. This synergistic effect can enhance the moisture retaining and barrier forming properties of the beeswax and strengthen the therapeutic benefits of the salve. The use of a wax such as beeswax in the salve may allow the salve to remain on the skin where it is applied for a longer duration and therefore enhance the duration of therapeutic benefit of the salve (for example allowing the therapeutic benefits of the salve to continue for hours after initial application). The combination of beeswax and olive oil is also believed to act synergistically to provide a superior therapeutic effect in the treatment of, for example, diaper dermatitis, psoriasis and eczema. The use of beeswax may also eliminate the need for use of artificial preservatives.

In some embodiments, the barrier forming agent may further include one or more of the following: adhesives, thickening agents, gelling agents and/or viscosity increasing agents: acrylamides copolymer, agarose, amylopectin, calcium alginate, calcium carboxymethyl cellulose, carbomer, carboxymethyl chitin, castor oil derivatives, cellulose gum, cellulosic preparation, cetyl alcohol, cetostearyl alcohol, dextrin, gelatin, hydroxy cellulose, hydroxyethylcellulose, hydroxypropylcellulose, hydroxpropyl starch, inert sugar, magnesium alginate, methylcellulose, microcrystalline cellulose, pectin, PEG's, polyacrylic acid, polymethacrylic acid, polyvinyl alcohol, quaternium ammonium compound of bentonite or zinc stearate, sorbitol, PPG's, sodium acrylates copolymer, sodium carrageenan, xanthum gum, and yeast beta-glucan.

In some embodiments, the salve may include from 5% to 25%vol (or %wt) of the barrier forming agent (especially the wax or the beeswax), more especially from 8-17%vol (or %wt), from 10-16%vol (or %wt), from 11-15%vol (or %wt), from 12-14%vol (or %wt), or from 13-14%vol (or %wt) of the barrier forming agent (especially the wax or the beeswax).

In some embodiments, the salve may include at least one essential oil. The essential oil may have at least antiseptic and/or analgesic properties. In some embodiments, the at least one essential oil may also have anti-inflammatory properties, fragrant properties and/or emollient properties.

As used herein, an “essential oil” is a concentrated, hydrophobic liquid containing volatile aroma compounds from plants and does not include an oil or the further oil as earlier described. Essential oils are derived from various sections of plants. An essential oil is “essential” in the sense that it carries a distinctive scent, or essence of the plant. Essential oils are also known as volatile oils, ethereal oils or aetherolea, or simply as “oil of” the plant from which they are extracted.

Examples of essential oils include agar oil, ajwain oil, allspice, almond, angelica oil, anise oil, sasfoetida, balsam oil, basil, bay leaf, bayberry, bergamot oil, black pepper, buchu oil, birch, camphor, caraway, cardamom, carrot seed, cassia, cedarwood, celery, chamomile, calamus root, cinnamon, cistus, citronella oil, clary sage, clove, coffee, coriander, costmary oil, costus root, cranberry, cubeb, cumin, cypress, cypriol, curry leaf, davana oil, dill, elecampane, elemi, eucalyptus, eugenol, fennel, fenugreek, fir, frankincense, galangal, galbanum, geranium, ginger, goldenrod, grapefruit, henna, helichrysum, hops, horseradish, hyssop, Idaho tansy, jasmine, juniper, juniper berry, laurel, lavender, ledum oil, lemon oil, lemongrass, lime, Litsea cubea oil, mandarin, manuka, marjoram, melaleuca, melissa oil, mint, mountain savory, mugwort oil, mustard oil, myrrh, myrtle, neem tree oil, neroli, niaouli, nutmeg, onion, orange, oregano, orris oil, palo santo, palma rosa, parsley, parsley seed, patchouli, perilla, penny-royal, peppermint, petitgrain, pine, ravensara, red cedar, roman chamomile, rose, rosehip, rosemary, rosewood, rue, sage, sandalwood, sassafras, savour, schisandra, sea buckthorn, spearmint, spikenard, spruce, St. Johns wort, star anise, styrax, tagetes, tangerine, tarragon, tea tree, thyme, tolu balsam, tsuga, turmeric, valerian, vanilla, vetiver oil, western red cedar, wintergreen, witch hazel, wormwood, yarrow, ylang-ylang, zedoary or any combination thereof.

Essential oils having at least antiseptic and/or analgesic properties can include, but are not limited to, oil of bay, cinnamon, clove, thyme, lavender, myrrh, sandalwood, melaleuca, helichrysum (H. italicum), coriander or any combination thereof.

In some embodiments, the at least one essential oil may include any one of the above-mentioned essential oils or a mixture thereof. For example, in some embodiments, the salve may include more than one essential oil. The salve may include at least two, at least three, at least four, at least five, at least six, at least seven, at least eight, at least nine or at least essential oils, for example.

In some embodiments, the at least one essential oil may include myrrh. Myrrh is a natural gum or resin extracted from tree species of the genus Commiphora. Myrrh has both antiseptic and analgesic properties.

In other embodiments, the at least one essential oil may include lavender oil.

Lavender oil is an essential oil obtained by distillation of the flower spike of certain species of lavender. The main chemical components of lavender oil include monoterperneoids and sesquiterpenoids. Specifically, lavender oil generally includes linalool, linalyl acetate, lavandulyl acetate, terpinenol, lavandulol, 1,8-cineole and camphor.

Lavender oil has both antimicrobial (antiseptic) and anti-inflammatory properties.

The lavender oil may also advantageously provide the salve with a pleasant fragrance.

In one embodiment, the salve may include at least one essential oil selected from the group consisting of: myrrh essential oil, lavender essential oil, geranium essential oil, sandalwood essential oil, fennel essential oil, clary sage essential oil, basil essential oil, eucalyptus essential oil, tea tree essential oil, chamomile essential oil, and peppermint essential oil.

The salve may include less than 5%vol (or %wt) of the at least one essential oil, especially less than 4%vol (or %wt), or less than 3%vol (or %wt), or less than 2%vol (or %wt) of the at least one essential oil. The salve may include from 0.1% to 3%vol (or %wt) of the at least one essential oil, especially from 0.2% to 2%vol (or %wt) of the at least one essential oil.

The salve of the present invention may be a substantially non-aqueous composition free from petroleum-based components. The salve may preferably be formulated for topical administration, and may serve as a substitute for conventional petroleum-based products, such as petroleum jelly.

As indicated above, in some embodiments, the salve may include at least one oil, including fractionated coconut oil and a barrier forming agent comprising wax. The at least one oil and the barrier forming agent may be present in the salve at any suitable concentration such that the salve has a semisolid composition. Typically, a semisolid composition is characterised by high viscosity and a relatively firm consistency compared to a liquid. Advantageously, the semisolid composition of the salve of the present invention facilitates the salve in forming a barrier over a site of a skin disease, disorder or wound.

For example, in some embodiments, the salve may include at least one oil being fractionated coconut oil at a concentration of from about 80 wt % to about 90 wt % and the barrier forming agent being wax at a concentration of from about 10 wt % to about 20 wt %.

In other embodiments, the salve may include more than one oil. For example, the salve may include a first oil being fractionated coconut oil at a concentration of from about 55 wt % to about 80 wt %, a second oil at a concentration of from about 20 wt% to about 45 wt% and the barrier forming agent being wax at a concentration of from about 10 wt % to about 20 wt %. The second oil may preferably be olive oil, more preferably extra virgin olive oil.

In yet other embodiments, the salve may include at least one essential oil.

For example, in one such embodiment, the salve may include at least one oil being fractionated coconut oil at a concentration of from about 80 wt % to about 90 wt %, the barrier forming agent being wax at a concentration of from about 10 wt % to about 20 wt % and at least one essential oil at a concentration of from about 0.05 wt % to about 0.3 wt %.

In another such embodiment, the salve may include a first oil being fractionated coconut oil at a concentration of from about 55 wt % to about 80 wt %, a second oil at a concentration of from about 20 wt% to about 45 wt%, the barrier forming agent being wax at a concentration of from about 10 wt % to about 20 wt % and at least one essential oil at a concentration of from about 0.05 wt % to about 0.3 wt %.

In yet further embodiments, the salve may include more than one essential oil.

For example, in one such embodiment, the salve may include at least one oil being fractionated coconut oil at a concentration of from about 80 wt % to about 90 wt %, the barrier forming agent being wax at a concentration of from about 10 wt % to about 20 wt %, a first essential oil at a concentration of from about 0.05 wt % to about 0.3 wt % and second essential oil at a concentration of from about 0.05 wt % to about 0.3 wt %.

In another such embodiment, the salve may include a first oil being fractionated coconut oil at a concentration of from about 55 wt % to about 80 wt %, a second oil at a concentration of from about 20 wt% to about 45 wt%, the barrier forming agent being wax at a concentration of from about 10 wt % to about 20 wt %, a first essential oil at a concentration of from about 0.05 wt % to about 0.3 wt % and second essential oil at a concentration of from about 0.05 wt % to about 0.3 wt %.

In yet another such embodiment, the salve may include a first oil being fractionated coconut oil at a concentration of about 69.1 wt%, a second oil at a concentration of about 17.3 wt%, the barrier forming agent being wax at a concentration of about 13.3 wt%, a first essential oil at a concentration of about 0.1 wt% and a second essential oil at a concentration at a concentration of about 0.2 wt%.

In some embodiments, the salve contains all organic components, with the exception of fractionated coconut oil.

According to an eighth aspect of the present invention, there is provided a method of preparing a salve for use or when used for treating a skin disease, disorder, condition or wound, said method including: melting together components including a wax and at least one oil including fractionated coconut oil to obtain a liquid mixture; and pouring the liquid mixture into at least one cooling vessel for cooling at room temperature to obtain the salve.

According to a ninth aspect of the present invention, there is provided a method of preparing a salve for use or when used for treating a skin disease, disorder, condition or wound, said method including: melting together components including a wax and at least one oil including fractionated coconut oil to obtain a liquid mixture; mixing at least one essential oil having at least antiseptic and/or analgesic properties with the liquid mixture to obtain a heated composition; and pouring the heated composition into at least one cooling vessel for cooling at room temperature to obtain the salve.

According to a tenth aspect of the present invention, there is provided a method of preparing the salve of any one of the first to seventh aspects, said method including: melting together the at least one oil and the barrier forming agent comprising a wax to obtain a liquid mixture; and cooling the liquid mixture prepare the salve.

According to an eleventh aspect of the present invention, there is provided a method of preparing a salve, said method including mixing at least one essential oil with the salve of any one of the first to seventh aspects.

The method of the eighth to eleventh aspects may include one or more features or characteristics of the salve as hereinbefore described.

The melting may typically include heating the components to a temperature greater than the melting temperature of the wax. For example, the temperature for melting can be from about 62°C to about 85°C, preferably from 62°C to about 80°C.

The melting may typically be carried out until the wax and the at least one oil form the liquid mixture, preferably a substantially homogenous liquid mixture.

In some embodiments, the method may further include mixing a desired amount of the at least one essential oil into the liquid mixture to obtain the heated composition, preferably again a substantially homogenous heated composition.

The pouring of some aspects may typically include pouring the liquid mixture or the heated composition into at least one cooling vessel, preferably being a glass container.

Once poured, the liquid mixture or the heated composition may be allowed to cool until the semisolid composition of the salve is obtained.

According to a twelfth aspect of the present invention, there is provided a salve for use or when used for treating a skin disease, disorder, condition or wound when prepared by the method of any one of the eighth to eleventh aspects.

According to a thirteenth aspect of the present invention, there is provided a method of treating a skin disease, disorder, condition or wound, said method including: applying an effective amount of the salve of any one of the first to seventh or twelfth aspects to a site of the skin disease, disorder, condition or wound; or applying an effective amount of the salve of any one of the first to seventh or twelfth aspects of the invention to a subject.

According to a fourteenth aspect of the present invention, there is provided use of the salve of any one of the first to seventh aspects in the manufacture of a medicament for treating a skin disease, disorder, condition or wound.

The method of the thirteenth aspect or the use of the fourteenth aspect may include one or more features or characteristics of the salve as hereinbefore described.

The applying may generally include topically applying the salve to the skin disease, disorder, condition or wound, preferably such that the salve at least partially covers the skin disease, disorder, condition or wound, more preferably such that the salve forms a barrier over the skin disease, disorder, condition or wound.

The skin disease, disorder, condition or wound may include any adverse cutaneous condition of a human or animal.

For example, the skin disease or disorder may include skin infections, skin neoplasms (including cancers), skin lesions, allergies, poisoning or autoimmunity.

Generally, the skin disease or disorder may include dermatitis (including atopic dermatitis, contact dermatitis, eczema, pustular dermatitis), seborrheic dermatitis, erythemas, inflammatory-related (including psoriasis and rosacea), and infection-related (including bacterial, fungal, yeast, virus and/or parasite). Typically, the skin disease, disorder or wound may include diaper dermatitis, skin inflammation, chapped or dry skin, skin infections, irritated skin, and wound healing.

The skin condition may include chapped or dry skin, irritated skin, aged skin and the like.

The skin wound may be understood to include a minor cut, a minor ulcer, a scratch, a sting, a burn (including thermal or radiation burns) or an abrasion, but excluding a significant open wound such as a laceration, a surgical incision, a major ulcer, a major abrasion or major burn.

As used herein, the term “treating”, “treatment”, “treat”, “treated” and like words refers to prophylaxis and/or therapy, particularly wherein the object is to prevent or slow down (lessen) or ameliorate an undesired physiological change or disorder. Alleviation can occur prior to signs or symptoms of disease appearing, as well as after their appearance. Thus the terms “treating”, “treatment”, “treat”, “treated” and like words include “preventing”, “prevent”, “prevented”, “prevention” and like words of a disease or disorder. Additionally, “treating”, “treatment”, “treat”, “treated” and like words does not require complete alleviation of signs or symptoms, does not require a cure, and specifically includes protocols which have only a marginal effect on the individual.

An “effective amount” of the salve of the invention means an amount necessary to at least partly attain a desired response, or to delay the onset or progression of the disease or disorder being treated. The amount may vary depending on factors such as: the health and physical condition of the individual to whom the salve is administered. It is expected that the “effective amount” will fall within a broad range that can be determined through routine trials.

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.

BRIEF DESCRIPTION OF DRAWINGS Preferred features, embodiments and variations of the invention may be discerned from the following Detailed Description which provides sufficient information for those skilled in the art to perform the invention. The Detailed Description is not to be regarded as limiting the scope of the preceding Summary of Invention in any way. The Detailed Description will make reference to the following drawings: Figure 1 is a flowchart of a method for preparing a salve for use in treating a skin disease, disorder or wound according to an embodiment of the present invention; and Figure 2 is a flowchart of another method for preparing a salve for use in treating a skin disease, disorder or wound according to another embodiment of the present invention.

DETAILED DESCRIPTION Salve 1 In a first example, the salve includes an oil being fractionated coconut oil (82 wt%) and a barrier forming agent being beeswax (18 wt%).

Salve 2 In a second example, the salve includes a first oil being fractionated coconut oil (about 69.1 vol%), a second oil being organic extra virgin olive oil (17.3 vol%), a first essential oil being certified pure therapeutic grade myrrh oil (0.1 vol%), a second essential oil being certified pure therapeutic grade lavender oil (0.2 vol%) and a barrier forming agent being organic beeswax (13.3 vol%). In this embodiment, a 903.25 mL salve included: 624 mL fractionated coconut oil, 156 mL organic extra virgin olive oil, 1.3 mL certified pure therapeutic grade myrrh oil, 1.95 mL certified pure therapeutic grade lavender oil and 120 mL organic beeswax.

Salve 3 In a third example, the salve includes a first oil being fractionated coconut oil (625 mL, about 68.6 vol%), a second oil being organic olive oil (156 mL, about 17.1 vol%), a first essential oil being myrrh essential oil (3.25 mL, 0.4 vol%), a second essential oil being lavender essential oil (3.25mL, about 0.4 vol%), a third essential oil being geranium essential oil (2.6mL, about 0.3vol%), a fourth essential oil being sandalwood essential oil (1.3mL, about 0.1vol%) and a barrier forming agent being beeswax (120 mL, about 13.2 vol%).

Salve 4 In a fourth example, the salve includes a first oil being fractionated coconut oil (625 mL, about 68.3 vol%), a second oil being organic olive oil (156 mL, about 17.0 vol%), a first essential oil being fennel essential oil (4.55 mL, 0.5 vol%), a second essential oil being clary sage essential oil (3.55mL, about 0.4 vol%), a third essential oil being geranium essential oil (3.25mL, about 0.4vol%), a fourth essential oil being basil essential oil (3.25mL, about 0.4vol%) and a barrier forming agent being beeswax (120 mL, about 13.1 vol%). This salve may be suitable for use on mothers who are sensitive to gluten or wheat and may assist in increasing milk supply for nursing mothers.

Salve 5 In a fifth example, the salve includes a first oil being fractionated coconut oil (625 mL, about 69.4 vol%), a second oil being organic olive oil (156 mL, about 17.3 vol%), and a barrier forming agent being beeswax (120 mL, about 13.3 vol%).

This salve may form a base substance for mixing with essential oils, for example to increase their surface area of application, or for diluting the essential oil to decrease their volatility or risk of an allergic response. For example, one combination of essential oils that may be added to the base substance is: eucalyptus, lavender, tea tree, chamomile, sandalwood and peppermint.

Ingredients in the Salve In salves 1-5 the fractionated coconut oil was purchased from N-essentials Pty Ltd (Moorabbin, Victoria, Australia). The olive oil was a certified organic olive oil (especially organic extra virgin olive oil), which can be purchased from a major supermarket such as Coles™. The beeswax was cosmetic certified organic beeswax from Bee Happy™ Apiaries (Avon Valley, Western Australia). The essential oils were purchased from doTERRA™ (Utah, USA).

Preparation of the Salves Figure 1 shows a method (100) of preparing a salve according to an embodiment of the present invention. Referring to Figure 1, Salve 1 was prepared by a method (100) which includes at step 110 of melting together the wax and fractionated coconut oil to obtain a homogenous liquid mixture. As an initial step, the fractionated coconut oil is added to a container containing the beeswax. The container is then placed in a water bath having a temperature of from about 62°C to about 80°C. The container is heated until the beeswax is entirely melted and the homogenous liquid mixture of the fractionated coconut oil and beeswax is obtained. Intermittent mixing may be required to ensure the components homogenously mix.

At step 120, the container containing the liquid mixture is removed from the water bath and the liquid mixture is poured into a desired number of cooling vessels. Once filled, each cooling vessel is sealed and placed in a dry cool location for cooling at room temperature.

When the liquid mixture cools to room temperature, it will have a semisolid consistency of the salve.

Figure 2 shows another method (200) of preparing the salve according to another embodiment of the present invention. Referring to Figure 2, Salve 2 was prepared by a method (200) which includes at step 210 melting together the wax and fractionated coconut oil to obtain a homogenous liquid mixture. The fractionated coconut oil is added to a container containing the beeswax. The container is then placed in a water bath having a temperature of from about 62°C to about 80°C. The container is heated until the beeswax is entirely melted and the homogenous liquid mixture of the fractionated coconut oil and beeswax is obtained.

Intermittent mixing may be required to ensure the components homogenously mix.

At step 220, the first and second essential oils are added and mixed into the container containing the homogenous liquid mixture to obtain a heated composition. The essential oils can be mixed into the homogenous liquid mixture with a stirring rod or can be mixed together on an orbital shaker. At step 230, the container containing the heated composition is removed from the water bath or orbital shaker and the heated composition is poured into a desired number of cooling vessels. Once filled, each cooling vessel is sealed and placed in a dry cool location for cooling at room temperature. When the liquid mixture cools to room temperature, it will have a semisolid consistency of the salve.

Salves 3-5 were made in a similar manner to that described above for Salves 1 and 2. In particular, the beeswax, fractionated coconut oil and olive oil are mixed together at a temperature high enough to melt the wax. This may be achieved by placing the oils and the beeswax together in a glass beaker and then heating the beaker in a water bath to approximately 62 °C (no higher than 80 °C, as beeswax can be discoloured at temperatures above 85 °C).

Through this process the oil and beeswax become liquid and mix together.

Subsequently any essential oils can be added before the mixture is poured into storage containers and set aside to cool at room temperature to form the salve. At room temperature the product has a semi-solid consistency.

Product Development The inventor particularly sought a low allergen salve. In various embodiments, the salve may act as an antioxidant, antibacterial, antiseptic and/or an anti-inflammatory (and preferably may have all of these properties). The salve may be moisturising and readily absorbed when applied to the skin.

Fractionated coconut oil, olive oil and organic beeswax were selected as core ingredients. Many different combinations of these core ingredients were tested to determine the optimum combination of ingredients and their relative amounts. Salves prepared in this step were assessed for their consistency, appearance, texture, stability (both at room temperature and at temperatures up to 50 °C), and fragrance.

Beeswax acts as a thickening agent and forms a barrier to the skin where it is applied. Consequently, beeswax was used in the salves.

Different combinations of olive oil and fractionated coconut oil were tested. It was found that fractionated coconut oil and beeswax alone produced a very smooth salve that was readily absorbed into the skin and was low allergy.

However, olive oil and beeswax alone provided a salve that was too oily when applied to the skin and did not readily absorb into the skin. It was also not as smooth in consistency when compared to other salves trialled. Whilst possessing substantial therapeutic benefits, this mixture was more likely to cause an allergic response due to the volatile nature of olive oil. It also had a strong smell of olive oil.

Salves with about 13% beeswax and 90:10, 80:20, 70:30, 60:40 and 50:50 fractionated coconut oil : olive oil were prepared. It was found that the salve with an 80:20 ratio of fractionated coconut oil : olive oil provided the optimum attributes of good consistency, texture, excellent therapeutic benefits (and very low allergy), aroma and stability at temperatures up to 50 °C.

The salves were compared to other products and tested for effectiveness for treating and preventing nappy rash, dermatitis and skin healing (and they were effective). The other products tested include petroleum based creams, zinc based creams and other organic creams for nappy rash.

Essential oils were added to examine their effectiveness as a salve for use as a nappy rash, dermatitis dry skin treatment. It was found that the salve had its own therapeutic benefits without requiring the addition of essential oils.

In the present specification and claims (if any), 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.

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.

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.

ADVANTAGES OF THE INVENTION In one or more of the preferred embodiments of the invention, the salve: - Is a low allergen.

- Can act as a topical antioxidant, antibacterial, antiseptic and anti-inflammatory.

- When applied to the skin can be moisturising and readily absorbed.

- Provides a natural low allergen barrier to external contaminants, whilst also maintaining the natural function of the skin.

- Can act as a barrier cream (to reduce skin sensitivity to allergens and allergen exposure to the skin), that does not clog skin pores.

- Can be used for wound healing.

- Can be used for dermatitis (particularly diaper area dermatitis), atopic dermatitis, eczema, rosacea, psoriasis, thermal and radiation burns and other types of skin inflammation.

- Can reduce skin sensitivity to allergens.

- Can be used for children, toddlers or babies that have multiple allergies.

- Advantageously is free of gluten, dairy, soy, eggs, nuts, petroleum, water, artificial colours, artificial preservatives, and artificial fragrances.

- Is made entirely from natural products that work in synergy to produce a range of skin benefits.

- Can be used on virtually all skin types (including very sensitive skin), and has a very low likelihood to cause an allergic response whilst also having natural healing properties.

- Is smooth in texture and is easy to apply to the skin. It is readily absorbed by the skin creating a breathable skin barrier to protect and heal hours after the salve is applied.

- Is self-preserving and therefore requires no preservatives and naturally has a long shelf life before going rancid.

- May slow the rate of evaporation of essential oils.

- May assist in normalising the skin.

Claims (22)

1. A salve including: at least 50 %vol fractionated coconut oil; at least 10 %vol olive oil; and a barrier forming agent comprising a wax.

2. A salve including: at least one oil including fractionated coconut oil; and a barrier forming agent comprising a wax.

3. The salve of claim 2, wherein the at least one oil further includes olive oil.

4. The salve of claim 1 or claim 3, wherein the salve includes from 10 to 30%vol olive oil.

5. The salve of claim 2 or claim 3, wherein the salve includes at least 50%vol fractionated coconut oil.

6. The salve of any one of claims 1 to 5, wherein the wax is beeswax.

7. The salve of claim 6, wherein the salve includes from 5% to 25%vol beeswax.

8. The salve of claim 6, wherein the salve includes from 8% to 17%vol beeswax.

9. The salve of any one of claims 1 to 8, wherein the salve includes from 60% to 80%vol fractionated coconut oil.

10. The salve of any one of claims 1 to 9, wherein the salve further includes at least one essential oil.

11. The salve of claim 10, wherein the at least one essential oil has at least analgesic and/or antiseptic properties.

12. A salve including: from 60% to 80%vol fractionated coconut oil; from 10 to 30%vol olive oil; and from 5% to 25%vol beeswax.

13. A salve consisting of: fractionated coconut oil; olive oil; and beeswax.

14. A salve consisting of: from 60% to 80%vol fractionated coconut oil; from 10 to 30%vol olive oil; and from 5% to 25%vol beeswax.

15. A salve for use for treating a skin disease, disorder or wound, said salve including: at least one oil comprising fractionated coconut oil; and a barrier forming agent comprising wax configured to form a barrier over a site of the skin disease, disorder or wound and promote and/or prolong contact of the at least one oil with the site of the skin disease, disorder or wound.

16. The salve of claim 15, wherein the salve includes from 55 %wt to 80%wt of the fractionated coconut oil.

17. The salve of claim 15 or claim 16, wherein the salve includes from 10%wt to 20%wt of the wax.

18. The salve of any one of claims 15 to 17, wherein the wax is beeswax.

19. The salve of any one of claims 15 to 18, wherein the at least one oil further comprises olive oil.

20. Use of the salve of any one of claims 1 to 19 in the manufacture of a medicament for the treatment of a skin disease, disorder, condition or wound.

21. A method of preparing the salve of any one of claims 1 to 19, said method including: melting together the at least one oil and the barrier forming agent comprising a wax to obtain a liquid mixture; and cooling the liquid mixture prepare the salve.

22. A method of preparing a salve, said method including: mixing at least one essential oil with the salve of any one of claims 1 to 9 or 12 to 19.