BR102016030131B1 - STABLE SPARKLING COMPOSITION, USE AND SYSTEM THEREOF AND METHOD OF DISPENSING THE COMPOSITION - Google Patents

Abstract

STABLE SPARKLING COMPOSITION AND METHOD OF USE. The present invention relates to compositions, systems and methods of dispensing compositions for treating skin conditions, the compositions including an inorganic compound and having desirable viscosity, spreadability and foam drainage profiles.

Description

CROSS REFERENCE TO RELATED ORDERS

[001] The present application claims the benefit of US patent application No. 62/270889, filed on December 22, 2015, the complete description of which is incorporated herein, by reference, for multiple purposes.

FIELD OF INVENTION

[002] The present invention relates to skin treatment compositions, particularly skin treatment compositions for topical use for skin care, including the treatment of diaper rash in infants and young children. The invention includes compositions, application methods and applicators for dispensing such compositions.

BACKGROUND

[003] Diaper rash is a common problem that affects children and babies and young children. It is generally associated with an increase in bacteria on and in the diaper area in babies. Currently, the most popular and commonly used method for treating diaper rash is applying a thick cream that includes active components and includes a moisture barrier to the skin. These compositions are typically spread by hand to ensure coverage over the desired area at the appropriate thickness and sufficient coverage to treat the affected area. Other methods include using an applicator to contact the affected skin, releasing part of the composition and rubbing the skin with the applicator. These methods require contact of the affected skin with a device or with the user's skin or hand, which not only presents a risk of contamination, but may also cause additional pain or discomfort to the affected skin.

[004] Although effective, these methods require that the user's hand or fingers come into contact not only with the diaper rash cream itself, but also with the affected area of the baby's skin to spread the composition properly. Furthermore, these treatments tend to be very time-consuming and thus are difficult to spread accurately and adequately to the affected area of skin. There is a need to provide a composition that is effective, spreadable and easy to apply while remaining aesthetically pleasing.

[005] A stable viscous foaming composition was found containing oil-soluble inorganic compound such as zinc oxide and high levels of organic oils. The composition also optionally contains a foaming agent, a propellant, an emulsifier and a polymeric thickener.

SUMMARY

[006] In one embodiment, there is a composition that includes an ester; an oil; and a flake resin. The composition may also additionally include components such as an inorganic compound. The invention may also include a system including a composition, which includes an ester; an oil; a flake resin; a propellant; and an applicator having an outlet port that is oriented in a closed position and is opened by means of an opening action; where the composition is contained within the applicator.

[007] Other aspects of the invention relate to a method of dispensing a composition from an applicator, including the steps of: aligning an exit port of the applicator, to a target site, where the exit port is inclined at a closed position and is opened upon activation, the applicator including a propellant and a composition including: an ester; an oil; and a flake resin; and activating the exit port at the target site to open the exit port, thereby applying a desired amount of the composition to the target site.

BRIEF DESCRIPTION OF THE DRAWINGS

[008] Figure 1 is a side view of an exemplary applicator useful in the present invention.

[009] Figure 2 is a cross-sectional view of the applicator shown in Figure 1.

DETAILED DESCRIPTION

[0010] The present invention relates to and includes compositions, methods and devices for treating skin conditions, including, for example, diaper rash in infants and young children, as well as adults, such as individuals with incontinence. However, the products described in the present invention may be useful for treating various skin conditions that can be treated by applying the composition described herein. The compositions provided herein not only include components useful for actively treating and protecting the surface of the skin, but also include components useful for providing the desired viscosity and spreadability. Furthermore, the invention includes a system and apparatus for applying the desired composition. Additionally, the invention includes a method of treating diaper rash, or other skin conditions.

[0011] For use in the present invention, the term "diaper rash" refers to and includes contact dermatitis in the diaper region of a human person, such as the region that may be exposed to prolonged contact with feces and urine. Diaper rash generally refers to an inflammatory reaction located in the area of skin normally covered by the diaper, which can have many causes, including infections (fungal, bacterial or viral), frictional irritation, chemical allergies (perfumes, soaps), sweat, decomposed urine clogged sweat glands. Although referred to herein as "diaper rash", the region of skin to be treated includes regions that may not be adjacent to or covered by a diaper, and may include regions that experience skin irritation or other infections to be treated through the application of a composition described herein. The area of skin experiencing such infection or inflammatory reactions (including diaper rash) is referred to as the affected area and may include evidence of infection or inflammation or may have no visible symptoms. The affected area is an area of skin where treatment is required, including the individuals' diaper regions.

[0012] For use in the present invention, "apply topically" means to apply directly or spread onto the external skin, for example, by using the hands or with an applicator such as a tissue, bead applicator or by spraying.

[0013] The compositions described here should be spread over the affected area of the skin and should have one or more desired characteristics described below, including a desired level of viscosity, desired spreadability and a desired level of foaming and duration. It is known to use a spray applicator to apply sunscreen containing zinc oxide, but in these products, the composition has a high water content of more than 70% water, resulting in a relatively low viscosity (e.g., about 500 to about 1,000 cps at room temperature) so that it is correctly sprayed. Additionally, these spray-on sunscreens include a smaller amount of zinc oxide (about 3 to 10%, usually about 6% by weight). The effect of these products is not to provide a therapeutic effect, but rather to apply a sunblock to the surface of the skin. The compositions of the present invention are effective for applying a high level of a skin treatment agent to the skin and allow it to be applied effectively and completely. In some aspects, the viscosity of the present compositions may be from about 5,000 cps to about 50,000 cps at room temperature (e.g., about 24 to 25 degrees C), and, in other aspects, the viscosity may be about 10,000 to about 40,000 cps at room temperature, or from about 10,000 to about 25,000 cps at room temperature. This viscosity level is measured before being dispensed from a dispensing apparatus such as an applicator that forms foam during dispensing of the composition.

[0014] Useful compositions of the present invention may include one or more of the following: active components, skin protectants, moisture barriers, spreading agents, viscosity modifiers, preservatives, emulsion stabilizers, humectants, emollients, emulsifiers and in some embodiments, include a propellant for dispensing a treatment composition from an applicator, such as an aerosol applicator. The compositions described in the present invention, when used to treat rashes or other similar skin conditions, may include a relatively high level of an inorganic component, as will be described below, where the inorganic component is suspended in the composition. For example, it may be desired that there be about 10% to about 15% by weight of an inorganic component dispersed in the composition.

[0015] The composition is also desirably fluid enough to be dispensed from an applicator, while also being viscous enough to be spread over the affected skin, without running off the skin after application. Desirable viscosity ranges are described below, but in general, the product must be capable of being dispensed through an applicator, spread over a region of the skin, and remaining on the skin for a desired period of time. It is desirable that the composition may be or include a water-in-oil emulsion.

[0016] Finally, the composition must foam to allow spreading and application to the skin and, as such, it may be desirable to include a foaming agent or foam stabilizer, so as to allow the product to foam and maintain the foam. for a desired period of time to apply to the target region of the skin. In some embodiments, the product forms a foamed product that is stable for at least about 30 seconds and can maintain foam for about two minutes after being dispensed from an applicator. These and other characteristics and properties will be described in more detail below.

Skin treatment compositions

[0017] The composition includes an oil base and desirably is a water-in-oil emulsion, which is designed to be applied directly to an affected area of skin, as described above. It is particularly desired that the composition is not an oil-in-water emulsion, but rather a water-in-oil emulsion. The use of oil in the composition is beneficial in sequestering the inorganic compound (such as zinc oxide), allowing for a smooth and even distribution of the inorganic compound during application. The composition includes an oily phase, an aqueous component, at least one inorganic compound, and optionally includes a foaming agent and/or a propellant.

[0018] The composition exhibits a flow-like behavior that has a desired level of viscosity, such that it is fluid and capable of being dispensed and applied directly to the affected skin. Furthermore, the composition is a foam when dispensed from the applicator, i.e., it has a plurality of small bubbles formed within the composition, wherein the bubbles are uniformly dispersed, in the desired manner, throughout the composition. The foam desirably has properties described in more detail below. The composition has an adequate viscosity to allow flow and spreading, but is not so low in viscosity as to flow away from the affected skin area. In desirable embodiments, the composition has a viscosity prior to dispensing through an applicator, of about 5,000 to about 50,000 cps at room temperature. More specifically, the composition has a viscosity of about 10,000 to about 25,000 cps at room temperature prior to dispensing from an applicator.

[0019] The composition, according to the invention, preferably comprises up to 60%, by weight, of an oil phase, in this case being water/oil emulsions. The oily phase, according to the invention, may be present in an amount of from about 10% to about 50% by weight of the composition. More desirably, the oily phase is present in an amount of from about 20% to about 50% by weight of the composition, and even more preferably from about 25% to about 40% by weight of the composition. .

[0020] The oily phase includes one or more oil compounds, including emollients used for the prevention or relief of skin dryness and for skin protection, as well as to solubilize inorganic compounds for the treatment of diaper rash described more fully. details below.

[0021] As used herein, the term "oils" means hydrophobic organic compounds that are liquids at room temperature and silicone-based materials. As used herein, the term "silicones" means chemically or physically cross-linked molecules comprising at least one siloxane repeat unit.

[0022] Examples of organic oils include various hydrocarbons (straight or branched chain alkanes or alkenes, ketone, diketone, primary or secondary alcohols, aldehydes, sterol esters, alkanoic acids, turpenes, monoesters), such as those that have a carbon chain length ranging from C6-C38, such as C6C18. Other organic oils include esters of fatty acids with low carbon number alcohols, for example with isopropanol, propylene glycol or glycerin or esters of fatty alcohols with low carbon number alkanoic acids or with fatty acids and polyol esters.

[0023] Specific non-limiting examples of oils include, without limitation, natural oils (e.g., olive oil, sunflower oil, soybean oil, peanut oil, rapeseed oil, almond oil, babassu oil , coconut oil, palm kernel oil, castor oil and the like), castor oil, mineral oil, petrolatum, vegetable oils (for example, triglycerides such as caprylic or capric triglyceride), esters of an alcohol ( glycerol or other than glycerol including diesters or other branched esters) and a fatty acid or fatty alcohol and various natural waxes including caité butter (Butirospermo parkii), lotus wax; beeswax, insect waxes, sperm whale oil, lanolin, vegetable waxes such as carnauba wax, jojoba oil, candelilla wax; waxes of mineral origin such as paraffin wax; and synthetic waxes such as cetyl palmitate, lauryl palmitate, cetostearyl stearate, and polyethylene wax.

[0024] Other oils include, for example, esters such as isopropyl palmitate, isopropyl myristate, isononyl isononanoate (such as WICKENOL 151, available from Alzo Inc of Sayreville, NJ, USA), C12 to C15 alkyl benzoates (such as FINSOLV TN from Innospec Active Chemicals), pentaerythritol tetraoctanoate, dipropylene glycol dibenzoate, PPG-15 stearyl ether benzoate, 2-ethyl hexyl isostearate, alkyl isononanoate such as isotridecyl isononanoate, octyl dodecanol, isoeicosane, cocoate 2-ethyl hexyl, myristyl ether PPG-2-propionate, hydrogenated metathesis products of unsaturated triglycerides, and combinations thereof, and other hydrocarbons such as paraffin oil, squalane and squalene, and diethyl hexylcyclohexane. Other examples of oils include functional oils like vitamin E acetate.

[0025] Still other oils include, for example, silicone oils, such as dimethyl polysiloxanes (dimethicone), diethylpolysiloxanes and their mixed forms diphenylpolysiloxanes.

[0026] It has traditionally been believed that certain oil-based components, such as mineral oil and lanolin, are not suitable in foaming compositions. That is, such oil-based components were traditionally believed to disrupt bubble formation and therefore affect the foaming properties of the composition (described in more detail below). The present invention includes these components in a suitable foaming composition. In certain aspects, it is desirable to include a combination of a readily emulsifiable oil component and a non-readily emulsifiable oil component. A suitable readily emulsifiable component includes an ester, which offers a number of benefits. For example, esters are capable of solubilizing lipophilic cosmetic raw materials such as sunscreen agents and volatile silicones and have a high positive scattering coefficient, anti-sticking agents and anti-whitening properties.

[0027] Examples of components that are not readily emulsifiable include mineral oil and petrolatum, which is beneficial as it has a long wet touch duration and is capable of serving as a weak wetting agent for water-insoluble products. In combination, the present inventors have found that esters can be useful for imparting a dry lubricating sensation even in the presence of large amounts of mineral oil or petrolatum, and is a wetting agent and an auxiliary suspending agent for water-insoluble products.

[0028] The inorganic compound includes compounds suitable for treating diaper rash or other inflammation/infection or may include other agents, such as sunscreen agents, color cosmetic agents and other inorganic compounds suitable for application to human skin. The inorganic compound is desirably present in an amount of from about 5% to about 25%, and more particularly from about 10% to about 20%, and most desirably from about 13% to about 15%, by weight. of the final composition. The inorganic compounds may be suspended in the final composition and are desirably distributed in the composition in a substantially homogeneous form after being dispensed from a container. To obtain uniform dispersion in the composition, it is desirable to include an adequate content of oil to sequester and solubilize an inorganic compound and disperse it throughout the composition.

[0029] As described below, to dispense the composition in a suitable foaming form, it may be desirable to shake or otherwise shake a container with the composition to disperse the components therein, including inorganic compounds. The applicator is preferably an aerosol applicator and therefore one or more propellants are desired in the composition. It is desirable that the inorganic components are substantially homogeneously distributed in the composition as it is being dispensed from an applicator.

[0030] The inorganic compound may include, for example, skin protectants, such as zinc-based compounds, including, for example, zinc oxide or may include cationic zinc compounds. Other inorganic compounds include titanium dioxide, iron oxides, silicon oxides, or other metal oxides (e.g., transition metal, such as crystalline transition metal). These inorganic compounds are typically solid particles having a diameter of about 0.1 microns to about 10 microns. The inorganic compound is desirably present in an amount of from about 10% to about 20% by weight of the composition, and more desirably from about 10% to about 15% by weight of the composition. Optional sunscreen components may include, for example, compounds containing titanium. Suitable components may include those described in U.S. Patent Nos. 9,144,536 and 9,144,535, both of which are incorporated herein by reference in their entirety.

[0031] The compositions of the present invention are applied topically to human skin. Accordingly, the composition may also include cosmetically acceptable topical ingredients as known in the art for use in personal care with the water-in-oil emulsion type composition of the present invention. Examples of suitable additional active agents include: skin lightening agents, darkening agents, additional anti-aging agents, tropoelastin promoters, collagen promoters, anti-acne agents, shine controlling agents, antimicrobial agents such as anti-yeast agents, antifungal and antibacterial agents, anti-inflammatory agents, antiparasitic agents, external analgesics, sun filters, photoprotectors, antioxidants, keratolytic agents, detergents/surfactants, moisturizers, nutrients, vitamins, energy enhancers, antiperspirant agents, astringents, deodorants, hair removers, hair growth stimulating agents, hair growth retarding agents, firming agents, hydration accelerators, effectiveness accelerators, anti-calluses agents, skin conditioning agents, anti-cellulite agents, odor control agents, such as odor masking , or pH modifying agents and the like.

[0032] The cosmetically active agent may be present in a composition in any suitable amount, for example, when used, it may be present in an amount of from about 0.0001% to about 20% by weight of the composition, e.g. example, about 0.001% to about 10%, such as about 0.01% to about 5%. In certain modalities, in an amount of 0.1% to 5% and in other modalities from 1% to 2%.

[0033] The composition may include a foam booster in a suitable amount to assist in forming the desired level of foam and ultimately spreading and adhering to the skin. The foam reinforcer may include a resin, such as a siloxy silicate, including trimethyl siloxy silicate (commercially available as Dow Corning® MQ-1600 flake resin). Other silicates may be useful as foam reinforcers. Foam reinforcers may be present in an amount of from about 0.2% to about 1.0% by weight of the final composition. Most desirably, the film former is present in an amount of about 0.5% by weight of the final composition. The use of a flake resin such as the previously mentioned siloxy silicate has traditionally been used as an SPF booster and waterproof barrier in sunscreens, but the present inventors have surprisingly found that the use of such a flake resin acts as a foaming agent and optimizes the final formulation used in the present invention. Until the present invention, such flake resin was not known to provide a composition with foaming properties.

[0034] In embodiments that use a flake resin, it may be useful to include one or more esters to dissolve the flake resin. The weight ratio of flake resin to ester is about 1:2 to about 2:1. Suitable esters include, for example, esters of branched and/or branched, saturated and/or unsaturated alkanecarboxylic acids having a chain length of 3 to 30 carbon atoms and branched and/or unbranched, saturated and/or unsaturated alcohols having a chain length of 3 to 30 carbon atoms from the group of branched and/or unbranched, saturated and/or unsaturated aromatic carboxylic acid esters and alcohols having a chain length of 3 to 30 carbon atoms. Preferably, suitable esters are, but not limited to, isopropyl myristate, isopropyl palmitate, isopropyl stearate, isopropyl oleate, n-butyl stearate, n-hexyl laurate, n-decyl oleate, iso-octyl stearate, isononyl stearate, isononyl isononanoate, 2-ethylhexyl palmitate, 2-ethylhexyl laurate, 2-hexyldecyl stearate, 2-octyldodecyl palmitate, oleyl oleate, erucate oleyl, erucil oleate, erucil erucate and synthetic, semi-synthetic and natural mixtures of such esters, for example, jojoba oil, glycerides (specifically triglycerides) and alkyl benzoates. For example, C12 to 15 alkyl benzoate, caprylic/capric triglycerides, may be useful individually.

[0035] The composition may also include an aqueous component, such as water or another similar aqueous component. Water may be present in an amount of from about 5% to about 65% by weight of the composition. More desirably, water is present in an amount of from about 40% to about 60% by weight of the composition, and even more preferably from about 55% to 60% by weight of the composition.

[0036] The composition may include other components, including, for example, one or more skin conditioners, emollients, humectants, emulsifiers, thickeners and emulsion stabilizers, as desired. Suitable skin conditioners include, for example, hexanediol, caprylyl glycol, tropolone, oat grain extracts and cationic polymers, including polyquaternaries, cationic guar gum, and the like. Skin conditioners may be present in an amount of from about 0.1% to about 1.0% by weight of the composition. The quantity and selection of conditioners must be sufficient to impart additional attributes, such as shine and softness to the skin, that are suitable for use in this invention.

[0037] Suitable emollients include, for example, isopropyl palmitate, shea butter, mineral oil, lanolin, dicaprylyl carbonate, alkyl benzoates including C12 to 15 alkyl benzoate, petrolatum, hexyldecyl stearate and plant, walnut and vegetable oils such as macadamia nut oil, rice bran oil, grape seed oil, palm oil, evening primrose oil, hydrogenated peanut oil and avocado oil, pentylene glycol, caprylyl methicone, dicaprylyl carbonate and octyldodecyl neopentanoate or mixture thereof. When used, emollients may be present in an amount of from about 5% to about 20% by weight of the composition. The quantity and selection of the emollient must be sufficient to dissolve inorganic compounds while maintaining the stability of the composition. Additional emollients include compounds that help maintain the soft, smooth, and supple appearance of the skin (for example, by remaining on the surface of the skin or in the stratum corneum to act as a lubricant).

[0038] Suitable humectants include, for example, glycerin, sorbitol or trehalose (e.g., α,α-trehalose, β,β-trehalose, α,β-trehalose) or a salt or ester thereof (e.g., trehalose 6- phosphate). When used, humectants may be present in an amount of from about 1% to about 5% by weight of the composition. The quantity and selection of humectant must be sufficient to increase the water content of the upper layers of the skin (e.g. hygroscopic compounds).

[0039] Suitable emulsifiers include, for example, polyglyceryl-2-hydroxy stearate, polyglyceryl-3 diisosterate, glyceryl stearate, steareth-21 and polyacrylate-13/polyisobutene/polysorbate 20 or mixtures thereof. When used, emulsifiers may be present in an amount of from about 1% to about 10% by weight of the composition.

[0040] Suitable thickeners include, for example, ammonium acrylolidimethyltaurate/vinylpyrrolidone copolymer, ammonium acrylolidimethyltaurate/vinylpyrrolidone copolymer and sodium polyacrylate. When used, thickeners may be present in an amount of about 0.1 to about 10. The amount and selection of thickener allows stabilization of the composition while maintaining the aesthetics of the composition and the feel of the skin.

[0041] Suitable emulsion stabilizers include, for example, magnesium sulfate and zinc stearate, among others. When used, emulsion stabilizers may be present in an amount of from about 1% to about 5% by weight of the composition.

[0042] The composition may be dispensed from an applicator and may include a propellant to assist in dispensing from an applicator. When present, the propellant may be present in an amount suitable to assist in releasing the product and may vary in amount capable of dispensing the composition. For example, the propellant may be present in an amount of from about 4% to about 10% or more desirably from about 6% to about 7%, by weight, of the composition. When the composition is not dispensed from an applicator requiring propellant, the propellant may be absent. Any propellant may be used, including those described in US Patent No. 8,821,841, the entire contents of which are incorporated herein by reference. Propellants that may be particularly desirable include, for example, propane, butane, isobutane, pentane, ethane, isopentane, pentane, methyl ether, difluoroethane, and combinations thereof. In one aspect, the propellant includes that available under the trade name Aeron-A-31 (commercially available from Dow Corning), which is a combination of propane, ethane, isopentane and pentane. When the viscosity of the composition is higher, the amount of propellant required to dispense the composition from the applicator may be greater (e.g., about 8% to about 10% by weight).

[0043] In one aspect, it was found that the composition including a combination of an oil, a flake resin and an ester providing viscosity, foaming and spreadability of the composition. Although the amounts of each may vary, in certain embodiments, it may be desired that the oil and ester be present in an amount of from about 50:50 (oil:ester) to about 25:75 (oil:ester), in weight.

Foaming properties

[0044] The compositions described here are preferably capable of forming a foamy composition when dispensed from the applicator. Although the compositions may be bubble-free or substantially bubble-free in the applicator and, not used, during dispensing the composition, they are desirably a foamed composition. This can be aided, for example, by agitation or shaking the applicator before dispensing the composition. When dispensed and applied to affected skin, the composition should have a foam profile suitable for a substantially uniform dispersion of small bubbles, being small enough in size to create a dense foam structure. It is desirable that the size of the bubbles within the foamed composition does not vary more than about 100% with respect to other bubbles within the foamed composition. In other words, the relative sizes of the bubbles formed in the foamed composition may be of substantially similar sizes to each other. It is desirable that the dispensed composition is at least substantially free of, if not completely free of, irregularly sized bubbles as described above. When the bubbles become too large and finally burst, this leaves undesirably large voids when no product is located. Visual inspection of the dispensed product can be helpful in assessing whether a foaming profile exists.

[0045] It is desirable that the foamed composition includes a plurality of bubbles in it and that the foam has a slow foam drainage time. That is, most of the bubbles in the foam should remain intact for at least about 30 seconds, or at least about 1 minute, or at least about 90 seconds, or at least about 2 minutes, or up to about 2 minutes. . It is further desired that the foam has a substantially uniform deflation throughout the dispensed composition, so that the composition has a foam drainage of approximately the same rate throughout the dispensed area.

[0046] As described above, it has surprisingly been found that the compositions described in the present invention can include water-in-oil compositions, including a relatively high oil content (and low water content), and include components such as oil mineral and/or lanolin, while still maintaining appropriate and sufficient bubble formation. The inventors have found that the use of a flake resin is useful in maintaining the formation of bubbles in the dispensed composition, allowing the foaming profile described above to be maintained. Flake resin may be used in combination with an ester component to dissolve the flake resin in the composition, and the composition may use an ester, an oil, and a flake resin in combination with each other to obtain a desirable profile.

Composition viscosity

[0047] The composition must have a desired viscosity to allow for proper dispensing from a container, while also maintaining viscosity after dispensing and application to the skin. It is desirable that the viscosity be high enough to hold the product on the skin and prevent run-off, but not so high as to prevent dispensing from a container, as described below. Suitable viscosities of the composition may be from about 10,000 cps to about 40,000 cps (at room temperature) prior to dispensing from the applicator. Although higher or lower viscosities may be appropriate in certain instances, for the treatment of diaper rash as described in the present invention, the viscosity range of 10,000 to 40,000 cps at room temperature is preferred.

Usage method

[0048] The compositions of the present invention described here can be used directly by applying the composition directly to the skin of the infected individual and specifically to the site on the affected skin of the individual. The composition is desirably substantially homogeneous at the time of application, therefore it may be useful to mix, shake, shake or otherwise mix the composition prior to application to the user's skin. This can be achieved, for example, by agitation or shaking the applicator (described below) enough to obtain a mixture of the components of the present invention. In embodiments where an applicator, such as described below, is not used, the product may be mixed or stirred to a desired level of mixing prior to application. In some embodiments, the composition may be contained in a tube and the mixture may be obtained by squeezing or massaging a tube sufficiently before dispensing the product. In still other embodiments, the composition is substantially homogeneous within the applicator and no mixing or stirring by the user is required.

[0049] Once the user is satisfied that the product is substantially homogeneous or mixed to a sufficient degree of mixing, the user can then apply the product directly to the individual's affected skin.

[0050] It is preferable to use an aerosol applicator including the composition therein to release the composition. Aerosol foam applicators, which are devices suitable for foaming compositions (mechanical, hydraulic, etc.), including those for industrial applications. Preferred foam applicators are spray containers. It has been found that the compositions are particularly suitable for spraying from mechanical foam applicators. In order to obtain good foaming, the aqueous phases and the oily phases are preferably mixed mechanically, preferably by simple stirring, before foaming. As noted above, the composition cannot be foamed while contained in the applicator, but after shaking or shaking the applicator and dispensing the composition therefrom, the composition is foamed. Typical aerosol applicators are useful in the present invention and are known to those skilled in the art. Such a suitable aerosol applicator is described in U.S. Patent No. 6,946,139, the contents of which are incorporated herein by reference in their entirety. The invention described herein includes a system, which includes a composition as described above and the applicator described in the present invention.

[0051] Any dispensing container for holding the formulation described herein and dispensing the formulation can be used in the present invention. Without limitation, a useful applicator includes an aerosol applicator seen in Figure 1. Figure 1 shows applicator 10 and Figure 2 shows a cross section of the same applicator 10. As can be seen in the Figures, applicator 10 is defined by a outer side wall 30, which may be of any shape, including a cylindrical configuration as seen in the Figures. The outer side wall 30 may be rounded, square, bulbous, or any other desired shape or configuration. The side wall 30 may be made of any desired material, but is preferably a material that has a high degree of strength, such as metals or polymeric materials, including steel, aluminum or other materials suitable for containing and dispensing materials under pressure. The side wall 30 may be of any thickness, desirably having a thickness that increases its strength to a desired level so that it does not expand or contract during use. During use, the user can shake the container to mix the components, and can create a foam inside the container. Therefore, the outer sidewall 30 must be strong enough to prevent noticeable or undesirable levels of expansion or contraction.

[0052] The applicator 10 is defined at its ends by a bottom surface 40 and a top surface 50, which are joined to the outer side wall 30 in a fluid-tight configuration. The side wall 30, the bottom surface 40 and the top surface 50 collectively define an open interior 20, in which the formulation to be dispensed is housed. The open interior 20 may be any desired shape or size and in some embodiments may be in the shape of the outer side wall 30, the upper surface 50, and the lower surface 40.

[0053] The upper surface 50 may include a dispensing head 60, which may form a part of the upper surface 50. The dispensing head 60 includes a dispensing opening 70, which is in fluid communication with a lumen 80, the lumen terminating in a distal opening 90. The distal opening 90 may be located within the open interior 20, to allow fluid components within the open interior 20 to enter the lumen 80 during use.

[0054] The dispensing head 60 also includes a valve 100, which may have any configuration to allow a user to manipulate the dispensing head 60. The lumen 80 may be angled in a closed configuration so that fluid cannot pass through of lumen 80 without force acting thereon through an opening action, such as by opening valve 100. In one embodiment, valve 100 includes a finger receiving portion to allow a user to push a finger therein, moving lumen 80 so that that creates an open passage from the distal opening 90 to the dispensing opening 70. Any valve configuration 100 may be used, including those described in US Patent No. 6,627,178, the entire contents of which are incorporated herein by reference. The receiving portion of the finger may be located adjacent to the dispensing opening 70.

[0055] For applicators of the type described in Figures 1 to 2, the user will invert the applicator 10, so that the dispensing opening 70 is facing downwards, and may be at or near the target location, such as the region of a baby's diaper. Other configurations, including those described in the aforementioned US Patent No. 6,627,178, may be used, including spray applicators or an applicator that includes a hose or other conduit disposed within the open interior 20 of the applicator.

[0056] In use, the user will pick up the applicator and may shake or shake the applicator to fully mix the components in it for use. Once the composition has been shaken or shaken sufficiently (e.g., from about 1 second to about 5 seconds or about 10 seconds of shaking), it can be dispensed onto the affected area of skin. The user has the dispensing opening 70 of the applicator 10 on or near the affected skin area, desirably without making contact with the skin and the applicator. Therefore, in one method of use, the composition is administered without contacting the target skin with an applicator component 10. In previous attempts, for example, in U.S. patent No. 6,803,045, an applicator is used to Dispense the product by contacting the applicator with the target skin. Desirably, in the present embodiment, there is no contact of the target skin with the applicator 10 or any component of the applicator 10.

[0057] Once the applicator 10 is aligned or directed to the target location, the user opens the valve by an opening or activating action (e.g., squeezing a finger trigger), so as to open the valve, which allows the composition therein to be forced under pressure through the lumen and dispensing opening 70 of the port. The composition will be dispensed at a desired speed, governed and guided by the amount and type of propellant within the applicator. The composition is applied to the affected skin in the amount desired by the user and with the desired coverage on the skin. In desirable embodiments, the composition is applied to completely cover the target region or affected area of the skin.

[0058] The user can apply one layer of the composition to the affected area of the skin or can apply more than one layer. Additionally, the user can apply the composition only to the affected area of skin or it can be applied to the affected area and healthy (unaffected) areas of the skin. Once applied, the composition can be allowed to set and spread through the force of gravity, or a user can spread the composition with a hand or finger or with a spreading tool. When the product rests on the surface of the skin, the foaming product will begin to undergo foam drainage, described below, where bubbles within the foaming composition begin to burst and the composition becomes substantially flat and therefore substantially free of visible bubbles. . Proper foam drainage is understood by those skilled in the art, and although complete freedom from bubbles is desired, it is understood that the term "substantially free from visible bubbles" allows for a minimum amount of visible bubbles in the compacted product. It is desired that at least about 99% of the bubbles formed during the initial dispensing of the product be ruptured, with about 1% or less of the initial bubbles remaining. The foam draining process can be from about 30 seconds to about 90 minutes or about 2 minutes. The foam structure, when discharged from the pressurized container, is ruptured as the propellant is released from the foam body. Gas propellants create high volumes of vigorous and relatively long-lived bubbles in the composition when discharged. Such compositions are distinct in the sense that the foam formed by the compositions is fluid and easily spreadable when applied and rubbed into the skin and imparts a pleasant cooling sensation.

[0059] Once a sufficient amount of the composition is applied to the surface of the skin, the user can apply the garment or diaper to the region of the skin or allow the composition to sit uninterruptedly for a desired period of time. It is desirable that the composition completely covers the affected skin region, so as to allow the inorganic compound of the composition to come into contact with the affected skin region. In the case of diaper rash, the inorganic compound may be a zinc-containing compound, such as zinc oxide, which can treat the skin and protect the skin from additional irritation and discomfort. In other embodiments, the composition may include other treatment agents, such as humectants, sunscreens, cleansing agents, and the like, which perform their own desired tasks on the surface of the skin.

[0060] The container may include a composition sufficient to permit multiple uses and may include sufficient composition to be dispensed at least 5 times or at least 15 times or at least 25 times to sufficiently treat an affected region of the skin with each use. When the user releases the trigger, the valve on the applicator is closed and therefore the composition remains inside the applicator until the user opens the valve again. It is desired that the inside of the applicator is sufficiently tight to allow the product to have the desired shelf life. The composition is advantageously stable over a typical commercial shelf life despite the higher amount of oil and the lower amount of emulsifiers. Little, preferably no, phase separation occurs in the composition over four weeks, eight weeks, six months, twelve months, eighteen months, or twenty-four months.

[0061] The present invention further comprises a method of improving the barrier function and hydration of the skin by topical application to the skin in need of improving the barrier function and hydration of the skin of the composition of the invention. The method comprises, for example, the topical application of the composition to the skin in need of improving the skin's barrier function and hydration. Such topical application can be to any skin that needs treatment on the body.

[0062] In some embodiments, the invention may include the base formulation, without an active or other component such as an inorganic compound. That is, the base formulation may include, for example, a combination of flake resin, ester and oil as described above and in the amounts and/or ratios described above. The base formulation can provide a foamable structure for a composition, such as a cleansing cream, a humectant or lotion, a sunscreen, or other uses including the foamable structure. The foamable structure described herein may include other components, for example, a cleaning component or a humectant component or a sunscreen component.

Examples

[0063] A series of different samples were prepared and tested for, among other properties, consistency, foaming, applicability, spreadability, effectiveness and viscosity. As will be described below, the inventors found that certain components were ineffective in preparing a suitable foaming composition and it was surprisingly found that the use of a flake resin in combination with certain oils allowed adequate foaming, viscosity and spreadability.

[0064] Checks were made by visual inspection, looking for small bubbles evenly spread in the dispensed product, where the bubbles were maintained in the composition for at least about 30 seconds after dispensing. Viscosity was measured for the composition prior to dispensing from the applicator at room temperature.

[0065] Each example discussed here was prepared by a conventional emulsion mixing process. For example, the aqueous phase and the oil phase were first prepared, then subsequently mixed to create emulsions containing various combinations of ingredients listed in the tables below.

[0066] AV formulations below were prepared, and the viscosity of each formulation was measured using a Brookfield RVDV-II+Pro Viscometer at room temperature according to the procedure described below. Once prepared, the formulation was placed in a 4 oz graduated jar, which was then placed in temperature stability/stability chambers (VWR Scientific Products model 1545 at 40°C and 50°C, respectively, GE number model GDSCOKCXMRWW at 4°C) and a top of a laboratory bench at room temperature (approximately 25°C). After the stability time interval was reached (e.g., 4 weeks), viscosity was measured as described below. Visual inspection of the formulation before dispensing from an aerosol container and after dispensing is conducted. Table 1 - Examples A to E

[0067] Examples A to E were prepared in the method described above with the components presented in Table 1. Example A was considered unstable in freezing temperature (FT) conditions, for example -5 °C to 0 °C, additionally, the formulation was unstable due to phase separation, and its viscosity was not measurable. Example B had a viscosity greater than 40,000 cps, which was considered to be very high. Example C was unstable. Example D was too viscous, with a viscosity that was too high and thus not measurable. Example E was unstable under FT conditions, so its viscosity was not measured. Table 2 - Examples F to K

[0068] Example F had a viscosity of 13,000 cps and was considered to be stable. Example G was unstable after 4 weeks of training. Example H was found to be stable in less than 1 week. Example I was unstable at 8 weeks. Example J was considered to be too "flowable", therefore having inadequate viscosity. In contrast, example K was considered to have too high viscosity; It was found to have a viscosity of 41,000 cps after 4 weeks which was undesirable even though its initial viscosity was about 27,000 cps. Table 3 - Examples L to Q

[0069] Examples L and Q were considered unstable at the time of manufacturing the samples. Example M was unstable within 2 weeks at a temperature of 50°C. Example N was considered to be very thin like water and was not a true emulsion. Example O was found to be stable and had a viscosity of 10,000 cps. Example P did not achieve the desired foaming profile. Table 4 - Examples R to V

[0070] Example R had a viscosity too high to be measured after 4 weeks, which was undesirable although its initial viscosity was about 25,000 cps. Example S was found to have a viscosity of 120,000 cps after 4 weeks, which was undesirable even with its initial viscosity of about 21,000 cps. In contrast, Example T was considered to be stable at a viscosity of 14,000 cps. Example U was found to be stable with a desirable viscosity of 10,000 cps. Example V was found to be stable also with a desirable viscosity of 10,000 cps.

[0071] From the previously mentioned examples, it was found that Compositions T, U and V have adequate viscosity levels and were stable for a desired period of time, for example, at least 4 weeks, or at least 8 weeks . Examples T and U included phenoxyethanol as well, while example V was free of trimethyl siloxy silicate, but contained trimethyl siloxy silicate, while Example V contained trimethyl siloxy silicate, but was free of phenoxyethanol. Compositions containing an ester (e.g., C12 to 15 alkyl benzoate), a non-readily emulsifiable oil (e.g., mineral oil), and a flake resin (e.g., trimethyl siloxy silicate) have been found to provide levels of improved viscosity, foaming, foam drainage and stability.

Claims (14)

1. Composition, characterized by the fact that it comprises: a. an ester, wherein said ester is C12-15 alkyl benzoate; B. an oil, said oil being a mineral oil; w. a flake resin, wherein said flake resin is trimethylsiloxysilicate; and d. an inorganic compound, wherein said inorganic compound is zinc oxide. 2. Composition according to claim 1, characterized by the fact that the weight ratio of flake resin to ester is 1:2 to 2:1. 3. Composition according to claim 1 or 2, characterized by the fact that the viscosity of said composition is 10,000 to 40,000 cps at 25°C. 4. Composition according to claim 1 or 2, characterized by the fact that said composition is capable of being foamed upon dispensing from a container, thus forming a foamed composition and said foamed composition having foam drainage time between 30 seconds and 2 minutes. 5. Method of dispensing a composition from an applicator, characterized by the fact that it comprises the steps of: a. aligning an exit port of said applicator at a target site, wherein said exit port is tilted in a closed position and is opened upon activation, the applicator including therein a propellant and a composition comprising: i. an ester, wherein said ester is C12-15 alkyl benzoate; ii. an oil, said oil being a mineral oil; iii. a flake resin, wherein said flake resin is trimethylsiloxysilicate; and iv. an inorganic compound, wherein said inorganic compound is zinc oxide; B. activating said exit port at said target site to open said exit port, thereby applying a desired amount of said composition at said target site. 6. Method according to claim 5, characterized by the fact that said composition is foamed upon dispensing by said applicator, thus forming a foamed composition, and wherein said foamed composition has a foam drainage time between 30 seconds and 2 minutes. 7. Method according to claim 5, characterized by the fact that the weight ratio of flake resin to ester is 1:2 to 2:1. 8. Method according to claim 5 or 7, characterized by the fact that the viscosity of said composition is 10,000 to 40,000 cps at 25 ° C. 9. Method, according to claim 5 or 7, characterized by the fact that said propellant is present in said applicator in an amount of 6% to 8%, by weight, of the contents of the applicator. 10. System, characterized by the fact that it comprises: a. a composition comprising: i. an ester, wherein said ester is C12-15 alkyl benzoate; ii. an oil, said oil being a mineral oil; iii. a flake resin, wherein said flake resin is trimethylsiloxysilicate; iv. an inorganic compound, wherein said inorganic compound is zinc oxide; v. a propellant; and b. an applicator having an outlet port that is tilted into a closed position and is opened by means of an opening action; wherein said composition is contained within said applicator. 11. Use of a composition as defined in claim 1, characterized by the fact that it is for the manufacture of a product for the treatment of contact dermatitis, comprising: a. aligning an exit port of an applicator at a target site on the surface of human skin, the target site having a treatable skin condition, the applicator including therein a propellant and the composition as defined in claim 1; B. activating said exit port at said target site, thereby applying a desired amount of said composition to said target site; and c. allowing said composition to be spread on said target site, thereby treating said skin condition. 12. Use according to claim 11, characterized by the fact that said composition is foamed upon dispensing by said applicator, thus forming a foamed composition, and wherein said foamed composition has a foam drainage time between 30 seconds and 2 minutes. 13. Use according to claim 11, characterized in that the weight ratio of flake resin to ester is 1:2 to 2:1. 14. Use according to claim 11 or 13, characterized by the fact that the viscosity of said composition is 10,000 to 40,000 cps at 25°C.