Formulation comprising urea

Abstract

The present invention relates to a new topical formulation with flame retardant properties. In particular, the present invention relates to the use of urea in a topical formulation as an additive for increasing the flame retardancy of the topical formulation.

Description

[0001] New Formulation

[0002] The present invention is directed to a new topical formulation comprising urea and its use in the treatment and prevention of skin conditions or the maintenance of healthy skin and / or hair.

[0003] Background

[0004] There are many topical compositions that are used daily by large sectors of the population. Many of these compositions are flammable when dried on bedding, clothing and other fabrics which is dangerous for all people but especially for the elderly or vulnerable.

[0005] Topical compositions such as hair products such as shampoos, conditioners, hair dye and other hair compositions, sun protection formulations, aftersun formulations, moisturisers, cleansers and other forms of cosmetics, medical topical compositions and emollients are just some of the compositions that are used regularly and which contain ingredients which make fabrics flammable. In particular, topical emollient compositions, such as skin moisturisers make fabrics typically highly flammable which can lead to serious accidents and even death.

[0006] Since 2019, the Medicines and Healthcare Products Regulatory Agency (MHRA) has required that many products, and in particular, emollients, carry a warning that the product increases the flammability of fabrics. However, accidents still occur.

[0007] In addition, many topical compositions contain oils and other components which adhere firmly to fabric. Many such compositions are not removed from fabric by ordinary washing, such as washing in a washing machine. This can lead to accidents when an apparently clean fabric, such as a piece of clothing, shows greater flammability than would be expected as it has residue of a topical composition, such as an emollient, on the surface.

[0008] Accordingly, the present invention is directed to providing a formulation that reduces the flammability of fabrics with the formulation dried on them in comparison to the typical emollient compositions on the market or reduces the flammability of fabrics with the formulation dried on them to a level of flammability similar to the fabric alone. The present invention is also directed to providing a composition that is removed from clothing by ordinary washing. Summary In particular, the present invention provides a use of urea in a topical formulation as an additive for increasing the flame retardancy of the topical formulation.

[0009] In other words, the topical formulation comprises the urea. In other words, the present invention provides a use of urea in a topical formulation to increase the flame retardancy of the topical formulation. In another aspect the present invention provides a use of urea in a topical formulation as an additive for the purpose of increasing the flame retardancy of the topical formulation. In another aspect the present invention provides a use of urea in a topical formulation for increasing the flame retardancy of the topical formulation.

[0010] Each aspect or embodiment as defined herein may be combined with any other aspect(s) or embodiment(s) unless clearly indicated to the contrary. In particular, any features indicated as being preferred or advantageous may be combined with any other feature indicated as being preferred or advantageous.

[0011] Urea is a known humectant and keratolytic. However, the inventor has surprisingly found that the inclusion of urea in a topical formulation can also increase the flame retardancy of the topical formulation. This is surprising observation may be highly advantageous in the drive to develop a topical formulation which reduces the risks outlined in the background section above, relating to the flammability of fabrics coated with the topical formulation.

[0012] It is important to note that the inventors have also found that, surprisingly, the mere inclusion of a known flame retarding additive in a topical formulation does not necessarily have the same flame retarding effect on the topical formulation. For example, fumed silica is a known flame retarding additive. However, it has been seen that the inclusion of fumed silica compared to the inclusion of urea in a similar topical formulation may not increase the flame retardancy of the topical formulation, at least to the same extent as the urea-containing formulation. Accordingly, the fact that a substance may be a known flame retardant in other applications does not guarantee its use as an additive for increasing the flame retardancy of the topical formulation.

[0013] The term “increased flame retardancy” as used herein may encompass that the topical formulation perse is less flammable when comprising the additive (i.e. urea) relative to before inclusion of the additive. However, the term “increased flame retardancy” may also encompass that the flammability of a fabric having the topical formulation comprising the additive (i.e. urea) applied thereto (and optionally dried thereon) is lower than the flammability of a fabric having the topical formulation without the additive (i.e. urea) applied thereto. This latter option is the preferred parameter for determining flame retardancy of the resulting topical formulation described herein. Even more preferably, the flammability of a fabric having the topical formulation comprising the additive (i.e. urea) applied thereto (and optionally dried thereon) is lower than the flammability of the fabric perse, i.e. without having a topical formulation applied thereto.

[0014] Without wishing to be bound by theory, it is thought that the urea may provide flame retarding capabilities to the topical formulation by, on burning of the topical formulation, forming a char through thermal decomposition and / or releasing large volumes of non-flammable / inter gases per mole of the urea.

[0015] Of course, the urea need not be present only for this purpose. The urea may have other uses or purposes within the topical formulation, for example as a humectant and / or keratolytic.

[0016] The urea may be included in the topical formulation in the form of urea crystals.

[0017] Preferably, the topical formulation is an emollient. Due to their ingredients and their mode of application in practice, emollients have been seen to present a particular flammability risk. It may therefore be particularly advantageous to increase the flame retardancy of an emollient. The topical formulation may also be one or more of a moisturiser, shampoo, conditioner, hair dye, sun cream, aftersun composition or medical composition, for example.

[0018] Preferably, the topical formulation comprises from 0.1 to 50 wt.% of the urea, preferably from 1 to 45 wt.% of the urea, more preferably from 5 to 40 wt.% of the urea, even more preferably from 10 to 30 wt.% of the urea, based on the total weight of the topical formulation comprising the urea. In other words, the present invention may encompass the use of from 0.1 to 50 wt.% urea in a topical formulation, based on the total weight of the topical formulation comprising the urea, as an additive for increasing the flame retardancy of the topical formulation. Such levels of urea may be particularly effective at increasing the flame retardancy of the topical formulation, while enabling the other components of the topical formulation to continue to fulfil their desired purpose within the topical formulation, and allow the topical formulation itself to fulfil its intended purpose.

[0019] Preferably, the topical formulation comprises a humectant other than urea, preferably wherein the humectant other than urea comprises one or more of glycerol, propylene glycol, butylene glycol, hexylene glycol, diglycerin, polyglycerin, sorbitol, mannitol, xylitol, erythritol, sodium lactate, potassium lactate, zinc lactate, magnesium lactate, sodium pyrrolidone carboxylic acid (PCA), potassium PCA, sodium gluconate, sodium citrate and a phosphate salt. Such humectants may increase skin hydration and soften skin feel.

[0020] Preferably, the topical formulation comprises from 1 to 20 wt.% of the humectant other than urea, preferably from 5 to 15 wt.% of the humectant other than urea, based on the total weight of the topical formulation comprising the urea. If the concentration of such humectants is too high, then they may act as a fuel for the flame. Accordingly, in some embodiments there may be a balance between the urea and further humectant in order to achieve the desired flame retardancy.

[0021] Preferably, the humectant other than urea comprises:

[0022] (i) one or more of glycerol, propylene glycol, butylene glycol, hexylene glycol, diglycerin, polyglycerin, sorbitol, mannitol, xylitol and erythritol, preferably glycerol, and / or (ii) one or more of sodium lactate, potassium lactate, zinc lactate, magnesium lactate, sodium pyrrolidone carboxylic acid (PCA), potassium PCA, sodium gluconate, sodium citrate and a phosphate salt, preferably sodium lactate. The list (ii) of further humectants may also act as buffering agents, for example. Pyrolysis of such compounds can result in residues, such as sodium carbonate residue, that may stabilise the char formed on burning.

[0023] Preferably:

[0024] the topical formulation comprises from 0.1 to 20 wt.% of the (i) one or more of glycerol, propylene glycol, butylene glycol, hexylene glycol, diglycerin, polyglycerin, sorbitol, mannitol, xylitol and erythritol, preferably from 1 to 15 wt.% of the (i) one or more of glycerol, propylene glycol, butylene glycol, hexylene glycol, diglycerin, polyglycerin, sorbitol, mannitol, xylitol and erythritol, more preferably from 2 to 10 wt.% of the (i) one or more of glycerol, propylene glycol, butylene glycol, hexylene glycol, diglycerin, polyglycerin, sorbitol, mannitol, xylitol and erythritol, based on the total weight of the topical formulation comprising the urea; and / or the topical formulation comprises from 0.1 to 15 wt.% of the (ii) one or more of sodium lactate, potassium lactate, zinc lactate, magnesium lactate, sodium pyrrolidone carboxylic acid (PCA), potassium PCA, sodium gluconate, sodium citrate and a phosphate salt, more preferably from 1 to 12 wt.% of the (ii) one or more of sodium lactate, potassium lactate, zinc lactate, magnesium lactate, sodium pyrrolidone carboxylic acid (PCA), potassium PCA, sodium gluconate, sodium citrate and a phosphate salt, even more preferably from 2 to 10 wt.% of the (ii) one or more of sodium lactate, potassium lactate, zinc lactate, magnesium lactate, sodium pyrrolidone carboxylic acid (PCA), potassium PCA, sodium gluconate, sodium citrate and a phosphate salt, based on the total weight of the topical formulation comprising the urea.

[0025] Preferably, the topical formulation comprises (i) one or more of glycerol, propylene glycol, butylene glycol, hexylene glycol, diglycerin, polyglycerin, sorbitol, mannitol, xylitol and erythritol, preferably glycerol, and

[0026] the content of the urea in the topical formulation, based on the total weight of the topical formulation comprising the urea, is greater than or equal to the content of the (i) one or more of glycerol, propylene glycol, butylene glycol, hexylene glycol, diglycerin, polyglycerin, sorbitol, mannitol, xylitol and erythritol in the topical formulation, based on the total weight of the topical formulation comprising the urea. More preferably, the content of the urea in the topical formulation, based on the total weight of the topical formulation comprising the urea, is at least twice, at least three times, at least four times, at least five times, at least six times, at least seven times, at least eight times, at least nine times or even at least ten times the content of the (i) one or more of glycerol, propylene glycol, butylene glycol, hexylene glycol, diglycerin, polyglycerin, sorbitol, mannitol, xylitol and erythritol in the topical formulation, based on the total weight of the topical formulation comprising the urea. Such ratios may increase the flame retardancy of the resulting topical formulation.

[0027] Preferably, the content of the urea in the topical formulation, based on the total weight of the topical formulation comprising the urea, is greater than or equal to the content of the (i) one or more of glycerol, propylene glycol, butylene glycol, hexylene glycol, diglycerin, polyglycerin, sorbitol, mannitol, xylitol and erythritol in the topical formulation, based on the total weight of the topical formulation comprising the urea; and wherein when the content of the (i) one or more of glycerol, propylene glycol, butylene glycol, hexylene glycol, diglycerin, polyglycerin, sorbitol, mannitol, xylitol and erythritol in the topical formulation, based on the total weight of the topical formulation comprising the urea, is from 5 to 10 wt.%, then the content of the urea in the topical formulation, based on the total weight of the topical formulation comprising the urea, is at least twice the content of the (i) one or more of glycerol, propylene glycol, butylene glycol, hexylene glycol, diglycerin, polyglycerin, sorbitol, mannitol, xylitol and erythritol in the topical formulation, based on the total weight of the topical formulation comprising the urea. It has been observed that when the content of the (i) further humectants in the topical formulation is from 5 to 10 wt.%, higher amounts of urea may be required to offset the flammability of the resulting topical formulation.

[0028] Preferably, the topical formulation comprises one or more of lactic acid, citric acid, glycolic acid, gluconic acid and ascorbic acid, preferably lactic acid. Such components may act as exfoliants and / or as buffering agents, for example.

[0029] Preferably, the topical formulation comprises from 0.1 to 2 wt.%, preferably from 0.5 to 1.5 wt.%, of the one or more of lactic acid, citric acid, glycolic acid, gluconic acid and ascorbic acid, based on the total weight of the topical formulation comprising the urea.

[0030] Preferably, the topical formulation comprises one or more of polyvinyl pyrrolidone (PVP), pullulan, hydroxypropyl methylcellulose (HPMC), hydroxyethylcellulose (HEC), carboxymethylcellulose (CMC), alginates and carrageenan, preferably PVP. Such components may act as film forming agents. Without wishing to be bound by theory, it is also thought that the inclusion of such components may assist in increasing the flame retardancy of the topical formulation, in combination with the urea, in particular when the topical formulation comprises polymers, such as by stabilising the resulting char.

[0031] Preferably, the topical formulation comprises from 0.1 to 5 wt.%, preferably from 0.2 to 2 wt.%, more preferably from 0.3 to 1 wt.%, of the one or more of polyvinyl pyrrolidone (PVP), pullulan, hydroxypropyl methylcellulose (HPMC), hydroxyethylcellulose (HEC), carboxymethylcellulose (CMC), alginates and carrageenan, based on the total weight of the topical formulation comprising the urea. The desired amount of such components may depend on the desired film strength for the particular product.

[0032] Preferably, the topical formulation comprises a thickening agent, preferably a polymeric thickening agent. Preferably, the thickening agent comprises one or more of polyacrylate crosspolymer-6 (such as Sepimax Zen), a carbomer, ammonium acryloyldimethyltaurate / VP copolymer, Pemulen TR, hydroxypropyl starch phosphate, xanthan gum, guar gum and biosaccharide gum-1, preferably polyacrylate crosspolymer-6. Without wishing to be bound by theory, it is thought that the presence of such a thickening agent, particularly a polymeric thickening agent, and more particularly polyacrylate crosspolymer-6, may act synergistically with the urea to improve the flame retardancy of the resulting topical formulation. In particular, while urea can be effective on its own, it can also have practical limitations: it can dust or wash away, it can decompose too early to be fully effective, and might leave behind only a weak, non-adherent char. However, when combined with polymers such as Sepimax Zen or PVP, its behaviour changes. The polymers can bind and anchor the urea to the substrate, keeping it in place and ensuring it contributes at the right stage of heating. In addition, under heat they can provide the carbon backbone for char. The result may be a stable, self-binding intumescent layer that may adhere well, remain durable, and offer protection under flame. This is a level of performance neither component may be able to deliver on its own. Without wishing to be bound by theory, it is also thought that this may be the case for the film forming agents discussed above.

[0033] Preferably, the topical formulation comprises from 0.5 to 4 wt.% of the thickening agent, preferably from 1 to 3 wt.% of the thickening agent, based on the total weight of the topical formulation comprising the urea.

[0034] Preferably, the topical formulation comprises one or more of phenoxyethanol, ethylhexylglycerin, caprylyl glycol, glyceryl caprylate, pentylene glycol, levulinic acid, anisic acid and benzyl alcohol, preferably phenoxyethanol and / or ethylhexylglycerin. Such components may act as preservatives.

[0035] Preferably, the topical formulation comprises from 0.1 to 5 wt.% of the one or more of phenoxyethanol, ethylhexylglycerin, caprylyl glycol, glyceryl caprylate, pentylene glycol, levulinic acid, anisic acid and benzyl alcohol, based on the total weight of the topical formulation comprising the urea. Preferably, the topical formulation comprises from 0.3 to 1 wt.% phenoxyethanol and / or from 0.1 to 4 wt.%, preferably from 1 to 3 wt.%, ethylhexylglycerin, based on the total weight of the topical formulation comprising the urea.

[0036] Preferably, the topical formulation comprises less than 1 wt.%, preferably less than 0.1 wt.%, more preferably less than 0.01 wt.%, even more preferably less than 0.001 wt.% oils, based on the total weight of the topical formulation comprising the urea, even more preferably wherein the topical formulation is free of oils. Oils may contribute to the flammability of the topical formulation. That being said, in some alternative embodiments, the topical formulation preferably comprises dimethicone, preferably from 1 to 20 wt.%, more preferably from 5 to 15 wt.% dimethicone, based on the total weight of the topical formulation comprising the urea. Dimethicone may act as an emollient. Despite dimethicone being an oil, the combination of urea and dimethicone has been seen to result in a topical formulation having good flame retardancy properties. Alternatively, the topical formulation may comprise greater than 15 wt.%, such as at least 20 wt.% castor oil, based on the total weight of the topical formulation comprising the urea, which has also been seen to provide a topical formulation having good flame retardancy properties.

[0037] Preferably, the topical formulation is water-based, preferably wherein the topical formulation comprises at least 30 wt.% water, at least 40 wt.% water, at least 50 wt.% water, at least 60 wt.% water, at least 70 wt.% water, at least 75 wt.% water or at least 80 wt.% water, based on the total weight of the topical formulation comprising the urea. The water is preferably purified water.

[0038] Preferably, the topical formulation is for use in the treatment or prevention of skin conditions. Preferably, the skin condition is eczema, dermatitis, psoriasis, elderly dry and itchy skin, ichthyosis, any other dry and / or itchy skin condition, preferably wherein the skin condition is eczema, dermatitis, psoriasis, elderly dry and itchy skin or ichthyosis. In some embodiments, the skin condition is preferably a rash or infection.

[0039] The topical formulation may suppress the flammability of a fabric compared to that of an untreated fabric when coated with the topical formulation four times at a weight of 12.5 mg / cm2.

[0040] Preferably, the topical formulation comprises, based on the total weight of the topical formulation comprising the urea:

[0041] from 5 to 15 wt.% urea, preferably from 8 to 12 wt.% urea, more preferably from 9 to 11 wt.% urea;

[0042] from 5 to 15 wt.% sodium lactate preferably from 8 to 12 wt.% sodium lactate, more preferably from 9 to 11 wt.% sodium lactate;

[0043] from 1 to 5 wt.% ethylhexylglycerin, preferably from 2 to 4 wt.% ethylhexylglycerin, more preferably from 2.5 to 3.5 wt.% ethylhexylglycerin; from 1 to 3 wt.% of a polymeric thickening agent, preferably from 1.5 to 2.5 wt.% of a polymeric thickening agent, preferably wherein the thickening agent comprises polyacrylate crosspolymer-6;

[0044] from 0.1 to 2 wt.% lactic acid, preferably from 0.5 to 1.5 wt.% lactic acid;

[0045] from 0.1 to 2 wt.% glycerol, preferably from 0.5 to 1.5 wt.% glycerol;

[0046] from 0.1 to 2 wt.% phenoxyethanol, preferably from 0.5 to 1.5 wt.% phenoxyethanol; and

[0047] from 0.1 to 1 wt.% polyvinyl pyrrolidone (PVP), preferably from 0.3 to 0.7 wt.% PVP.

[0048] Preferably, the topical formulation consists of, based on the total weight of the topical formulation comprising the urea:

[0049] from 5 to 15 wt.% urea, preferably from 8 to 12 wt.% urea, more preferably from 9 to 11 wt.% urea;

[0050] from 5 to 15 wt.% sodium lactate preferably from 8 to 12 wt.% sodium lactate, more preferably from 9 to 11 wt.% sodium lactate;

[0051] from 1 to 5 wt.% ethylhexylglycerin, preferably from 2 to 4 wt.% ethylhexylglycerin, more preferably from 2.5 to 3.5 wt.% ethylhexylglycerin;

[0052] from 1 to 3 wt.% of a polymeric thickening agent, preferably from 1.5 to 2.5 wt.% of a polymeric thickening agent, preferably wherein the thickening agent comprises polyacrylate crosspolymer-6;

[0053] from 0.1 to 2 wt.% lactic acid, preferably from 0.5 to 1.5 wt.% lactic acid;

[0054] from 0.1 to 2 wt.% glycerol, preferably from 0.5 to 1.5 wt.% glycerol;

[0055] from 0.1 to 2 wt.% phenoxyethanol, preferably from 0.5 to 1.5 wt.% phenoxyethanol;

[0056] from 0.1 to 1 wt.% polyvinyl pyrrolidone (PVP), preferably from 0.3 to 0.7 wt.% PVP; and

[0057] the balance water together with any unavoidable impurities.

[0058] In a further aspect, the present invention provides a topical formulation comprising, based on the total weight of the topical formulation:

[0059] from 5 to 15 wt.% urea, preferably from 8 to 12 wt.% urea, more preferably from 9 to 11 wt.% urea;

[0060] from 5 to 15 wt.% sodium lactate preferably from 8 to 12 wt.% sodium lactate, more preferably from 9 to 11 wt.% sodium lactate;

[0061] from 1 to 5 wt.% ethylhexylglycerin, preferably from 2 to 4 wt.% ethylhexylglycerin, more preferably from 2.5 to 3.5 wt.% ethylhexylglycerin; from 1 to 3 wt.% of a polymeric thickening agent, preferably from 1.5 to 2.5 wt.% of a polymeric thickening agent, preferably wherein the thickening agent comprises polyacrylate crosspolymer-6;

[0062] from 0.1 to 2 wt.% lactic acid, preferably from 0.5 to 1.5 wt.% lactic acid;

[0063] from 0.1 to 2 wt.% glycerol, preferably from 0.5 to 1.5 wt.% glycerol;

[0064] from 0.1 to 2 wt.% phenoxyethanol, preferably from 0.5 to 1.5 wt.% phenoxyethanol; and

[0065] from 0.1 to 1 wt.% polyvinyl pyrrolidone (PVP), preferably from 0.3 to 0.7 wt.% PVP.

[0066] The preferred features and advantages associated with the other aspect(s) described herein apply equally to this aspect of the invention.

[0067] Preferably, the topical formulation consists of the recited components, with the balance being water together with any unavoidable impurities.

[0068] In a further aspect, the present invention provides a process for preparing a topical formulation, the process comprising including urea in the formulation for the purpose of increasing the flame retardancy of the topical formulation. The preferred features and advantages associated with the other aspect(s) described herein apply equally to this aspect of the invention.

[0069] In a further aspect, the present invention is also directed to a fire retardant topical formulation comprising glycerol and urea in a ratio of from 1:1 to 1:30. Preferably, the topical formulation comprises glycerol and urea in a ratio of from 1:1 to 1:10, more preferably in a ratio of from 1:1 to 1:8, most preferably in a ratio of from 1:1 to 1:6. Unless otherwise specified herein, such a ratio (or ratios) may be, for example, a ratio by weight.

[0070] The formulation typically comprises glycerol in an amount of from 1 to 30% by weight. Preferably, the formulation comprises glycerol in an amount of from 1 to 20%, more preferably 1 to 10 %, more preferably 1 to 7.5%, more preferably 1 to 5 % by weight.

[0071] The formulation typically comprises urea in an amount of from 1 to 50% by weight.

[0072] Preferably, the formulation comprises urea in an amount of from 1 to 40%, more preferably 1 to 30 %, more preferably 1 to 25%, more preferably 1 to 15%, more preferably 5 to 10% by weight. The formulation also typically comprises further components. A typical formulation will also comprise one or more preservatives, humectants, barrier forming agents and stabilizing agents.

[0073] Typical preservatives include parabens, such as methylparaben ethylparaben propylparaben or butylparaben, alcohols and phenols, such as phenoxyethanol chlorobutanol or benzyl alcohol, organic acids and their salts, such as lactic acid, citric acid, sorbic acid, potassium sorbate, benzoic acid or sodium benzoate, formaldehyde releasing compounds, such as DMDM hydantoin imidazolidinyl urea, diazolidinyl urea or Quaternium-15, isothiazolinones, such as methylisothiazolinone (MIT) or methylchloroisothiazolinone (MCI), quaternary ammonium compounds, such as benzalkonium chloride or cetrimide, biguanides such as chlorhexidine (and its salts, e.g., Chlorhexidine Gluconate), or polyaminopropyl biguanide (PHMB), tocopherols, dehydroacetic acid, sodium dehydroacetate, caprylyl glycol, silver salts (e.g., silver sulfadiazine) or essential oils (e.g., tea tree oil, rosemary oil).

[0074] Typical humectants that can be used in the present formulation include glycerol, ethylhexylglycerin (EHG), hyaluronic acid, propylene glycol, sorbitol, butylene glycol, aloe vera, honey, sodium pea, panthenol (pro-vitamin B5), betaine, sodium hyaluronate, xylitol, citric Acid, saccharide isomerate, propanediol, trehalose, lactic acid, sodium lactate, Glycereth-7 and propylene carbonate.

[0075] In addition, the topical formulation may include lipids and oils such as, squalene, castor oil, liquid paraffin, white paraffin, polybutene, ceramides, sweet almond oil, avocado oil, calophyllum oil, ricin oil, olive oil, silicone oils such as dimethylopolysiloxane or cyclomethicone, oleyl alcohol, the oil of cereal germs such as the oil of wheat germ, isopropyl palmitate, octyl palmitate, isopropyl myristate, hexadecyl stearate, butyl stearate, decyl oleate, acetyl glycerides, the octanoates and benzoates of (C12-C15) alcohols, the octanoates and decanoates of alcohols and poly alcohols such as those of glycol and glyceryl, ricinoleates esters such as isopropyl adipate, hexyl laurate and octyl dodecanoate, dicaprylyl maleate, hydrogenated vegetable oil, phenyltrimethicone, jojoba oil, aloe vera extract, mineral oil having a viscosity in the range of 50 to 500 centipoise (cps), lanolin oil, coconut oil, cocoa butter, olive oil, almond oil, macadamia nut oil, aloe extracts such as aloe Vera lipoquinone, synthetic jojoba oils, natural Sonora jojoba oils, safflower oil, corn oil, liquid lanolin, cottonseed oil and peanut oil, cocoglyceride, which is a mixture of mono, di and triglycerides of coconut oil or caprylic / capric trigyceride, glyceryl dilaurate, hydrogenated lanolin, hydroxylated lanolin, acetylated lanolin, petrolatum, isopropyl lanolate, butyl myristate, cetyl myristate, myristyl myristate, myristyl lactate and cetyl alcohol. Other possible humectants and occulsives include pyrrolidine carboxylic acid, gelatin, and vitamins (vitamin A, vitamin C, vitamin B5). Preferably the humectant is glycerol and EHG.

[0076] Where the formulation comprises one or more further humectants, the ratio of urea to further humectants is at least 1:1, preferably at least 1.5:1, more preferably 2:1, more preferably 3:1. In another embodiment, the ratio of urea to all humectants including glycerol is at least 1:1, more preferably at least 2:1, more preferably at least 3:1, more preferably at least 4:1. The ratio of urea to all humectants including glycerol may be from 30:1 to 1:5, 30:1 to 1:2, more preferably from 10:1 to 1:1, more preferably from 5:1 to 1:1, more preferably from 3:1 to 1:1.

[0077] Where the formulation of the present invention comprises flammable components, the ratio of urea to all flammable components including, but not limited to, for example, glycerol, humectants, lipids, oils and alcohols is from 10:1 to 1:5, more preferably from 5:1 to 1:1, more preferably from 3:1 to 1:1 or 2:1 to 1:1. For example a fire retardant composition of the present invention may comprises urea and glycerol in a ratio of from 30:1 to 1:1 and the ratio of urea to all flammable components may be from 10:1 to 1:5. In a specific embodiment, the formulation further has a ratio of all urea to all humectant is from 30:1 to 1:2.

[0078] The barrier forming agent may be selected from polyethylene glycol (peg), polyvinyl alcohol (pva), carbomer, hydroxyethylcellulose (hec), hydroxypropylcellulose (hpc), sodium carboxymethylcellulose (cmc), gellan gum, xanthan gum, gelatin, guar gum, alginate, chitosan, silicones (e.g., dimethicone, cyclopentasiloxane), acrylates copolymer, cetearyl alcohol, cetyl alcohol, stearic acid, lanolin, petrolatum, beeswax, microcrystalline wax, polyurethane. Preferably the barrier forming agent is polyvinyl pyrrolidone.

[0079] The stabiliizing agent may be a thickener selected from polyacrylate crosspolymer-6, xanthan gum, carbomer, hydroxyethylcellulose (HEB), sodium polyacrylate, hydroxypropyl guar (hpg), polyacrylamide, gellan gum, guar gum, polysaccharides (e.g., acacia gum, tara gum), alginate, cellulose gum, pectin, cetyl alcohol, stearyl alcohol, ceteareth-20, laponite, polyquaternium-7, crosslinked polyacrylate, PEG-150 pentaerythrityl tetrastearate, sodium CMC (carboxymethylcellulose). Preferably the stabilizing agent is polyacrylate crosspolymer-6. Other stabilizers include chelating agents, buffers, and anti-oxidants.

[0080] The formulation of the present invention typically comprises urea, glycerol, a barrier forming agent and a stabilizing agent. The formulation of the present invention may also comprise urea, glycerol, further humectant(s), a barrier forming agent and a stabilizing agent. In one embodiment, the formulation comprises from 1 to 40% urea, from 1 to 30% glycerol, from 1 to 50% further humectant(s), from 0.1 to 10% barrier forming agent and from 1 to 10% stabilizing agent. In another one embodiment, the formulation comprises from 1 to 30% urea, from 1 to 20% glycerol, from 1 to 15% further humectant(s), from 0.1 to 10% barrier forming agent and from 1 to 10% stabilizing agent. For example, the formulation may comprise from 5 to 10% urea, from 1 to 2% glycerol, from 5 to 15% further humectant(s), from 0.5 to 1% barrier forming agent and from 1 to 3% stabilizing agent.

[0081] The topical formulation of the present invention typically comprises urea, glycerol, phenoxyethanol, sodium lactate 60% solution, lactic acid, ethylhexylglycerin, polyacrylate crosspolymer-6 and polyvinylpyrrolidone. In a specific embodiment, the topical formulation of the present invention comprises 1% phenoxyethanol, 10% urea, 10% sodium lactate (60% solution), 1% lactic acid, 1% glycerol, 3% ethylhexylglycerin, 2% polyacrylate crosspolymer-6, 0.5% polyvinyl pyrrolidone and 71.5% water by weight.

[0082] In a specific embodiment, the topical formulation of the present invention comprises glycerol, 2% polyacrylate crosspolymer-6, 10% sodium lactate solution 60%, 1% phenoxyethanol, 1% lactic acid, 3% ethylhexylglycerin and 0.5% polyvinylpyrrolidone by weight. Preferably, the topical formulation comprises 1% glycerol.

[0083] The topical formulation of the present invention can be used safely on the skin and has the advantage that it is not as flammable as the typical commercial formulations. The topical formulation of the present invention may be a hair product such as shampoo, conditioner, hair dye, and other hair formulations, sun formulations, aftersun formulations, emollient, moisturisers, cleansers and other forms of cosmetics, deodorants or antiperspirants, scar treatment formulations, insect repellent creams or lotions, sunburn relief formulations, antiaging formulations, foot care formulations or medical compositions. In this context, a medical composition is a topical formulation that is formulated so as to provide a drug through the skin. For example, an antibiotic, antifungal or antiviral topical formulation, a topical formulation comprising a steroid or other anti-inflammatory or pain relief ingredients (such as NSAIDs, capsaicin etc) or antihistamine compounds or cooling agents (e.g. menthol), acne treatment formulations, wound healing formulations, foot treatment formulations, tattoo aftercare formulations, hand sanitizers (non-alcoholic), diaper rash formulations or stretch mark formulations.

[0084] The present invention is also directed to the topical formulation of the invention for use in the treatment or prevention of a skin condition. The skin condition may be eczema, dermatitis, psoriasis, elderly dry and itchy skin, ichthyosis, any other dry and itchy skin condition or any other dry skin conditions. The skin condition may also be a condition that is treated by a medical composition comprising a drug. For example, the condition may be a rash or skin infection which can be treated by an antibiotic or cortisone drug.

[0085] The formulations of the present invention have fire retardant properties. The formulations of the present invention show a reduced flammability when applied to fabric compared to commercially available topical formulations, such as E45 Cream, and can suppress the flammability of fabric to the level of an untreated fabric or can suppress the flammability of a fabric entirely. For example, formulations of the present invention can suppress the flammability of fabric to the level of an untreated fabric when coated onto the fabric at a weight of 12.5mg / cm2applied four times and then air dried before testing. Accordingly, the present invention is directed to the use of a formulation of the present invention as a fire retardant or fire resistant material. A fire resistant material is designed to withstand fire and high temperatures without catching fire or spreading flames. A fire retardant material is designed to slow down or prevent the spread of fire.

[0086] The present invention is also directed to the use of the formulation of the present invention on skin. For example, the topical formulation of the present invention may be an emollient or moisturiser and may be applied to the skin in order to hydrate and / or provide emolliency to the skin.

[0087] The formulations of the present invention provide highly hydrating and protective formulations for the management of dry skin conditions which may also be itchy. The hydration is effective and long-lasting. The formulations of the present invention restore, maintain and protect the skin’s natural barrier. The formulations reduce the symptoms of dry skin and itching. The formulations of the present invention are also particularly suited to use on sensitive skin. The present invention has the advantage that the topical formulation of the present invention is less flammable than existing commercial formulations and may show no or little flammability. For example, the topical formulation may retard the burning of a fabric such as cotton, polyester or silk.

[0088] The present invention also has the advantage that the topical formulation of the present invention can be removed from fabric by ordinary washing procedures such as hand washing or machine washing. Preferably the formulation can be removed by machine washing with detergent at 40°C, 30°C or with cold water. As the formulation is removed from fabric by washing, a residue of the formulation does not build up on a piece of clothing over time due to, for example, repeated use of the formulation on skin that is then in contact with a particular item of clothing.

[0089] The invention may also be described with reference to the following numbered clauses.

[0090] 1. A fire retardant topical formulation comprising glycerol and urea in a ratio of from 1:1 to 1:30, preferably from 1:1 to 1:10, more preferably from 1:1 to 1:6.

[0091] 2. A formulation according to clause 1, further comprising polyvinyl pyrrolidone.

[0092] 3. A formulation according to clause 1 or 2, wherein the formulation further comprises ethylhexylglycerin.

[0093] 4. A formulation according to any one of clauses 1 to 3, wherein the formulation comprises from 1 to 50% urea by weight.

[0094] 5. A formulation according to any one of clauses 1 to 4, wherein the formulation comprises from 1 to 30% glycerol by weight.

[0095] 6. A formulation according to clause 5, comprising from 1 to 10% glycerol by weight.

[0096] 7. A formulation according to any one of clauses 1 to 6, wherein the formulation comprises one or more further humectants.

[0097] 8. A formulation according any one of clauses 1 to 7, wherein the ratio of urea to further humectant is from 30:1 to 1:5, preferably 30:1 to 1:2, preferably 2:1 to 1:1. 9. A formulation according to any one of clauses 1 to 8, wherein the ratio of urea to further humectant is at least 1:1.

[0098] 10. A formulation according to any one of clauses 1 to 9, wherein the ratio of urea to glycerol and further humectants is from 30:1 to 1:5.

[0099] 11. A formulation according to any one of clauses 1 to 10, wherein the ratio of urea to glycerol and further humectants is at least 1:1.

[0100] 12. A formulation according to any one of clauses 1 to 11, wherein the ratio of urea to flammable components is from 10:1 to 1:5.

[0101] 13. A formulation according to any one of clauses 1 to 12, wherein the formulation further comprises a barrier forming agent and a stabilizing agent.

[0102] 14. A formulation according to any one of clauses 1 to 13, wherein the topical formulation further comprises 2% polyacrylate crosspolymer-6, 10% sodium lactate as a 60% solution, 1 % phenoxyethanol, 1% lactic acid, 3% ethylhexylglycerin and 0.5% polyvinylpyrrolidone by weight.

[0103] 15. A formulation according to any one of clauses 1 to 14, further comprising water.

[0104] 16. A formulation according to any one of clauses 1 to 15, which is a moisturiser, shampoo, conditioner, hair dye, sun cream, aftersun composition, emollient or medical composition.

[0105] 17. A formulation according to any one of clauses 1 to 16, which is an emollient.

[0106] 18. A formulation according to any one of clauses 1 to 17, wherein the formulation suppresses the flammability of a fabric to that of an untreated fabric when coated with the formulation four times at a weight of 12.5mg / cm2.

[0107] 19. A formulation according to any one of clauses 1 to 18, wherein the formulation is washable. 20. A formulation according to any one of clauses 1 to 19, wherein the formulation comprises 1% phenoxyethanol, 10% urea, 10% sodium lactate (60% solution), 1% lactic acid, 1% glycerol, 3% ethylhexylglycerin, 2% polyacrylate crosspolymer-6, 0.5% polyvinyl pyrrolidone and 71.5% water by weight.

[0108] 21. A fire retardant topical formulation comprising 1% glycerol, 2% polyacrylate crosspolymer-6, 10% sodium lactate solution 60%, 1 % phenoxyethanol, 1% lactic acid, 3% ethylhexylglycerin and 0.5% polyvinylpyrrolidone by weight.

[0109] 22. A fire retardant topical formulation as defined in any one of clauses 1 to 21, for use in the treatment or prevention of skin conditions.

[0110] 23. A formulation for use according to clause 22, wherein the skin condition is eczema, dermatitis, psoriasis, elderly dry and itchy skin, ichthyosis, any other dry and / or itchy skin condition.

[0111] 24. A formulation for use according to clause 23, wherein the skin condition is eczema, dermatitis, psoriasis, elderly dry and itchy skin or ichthyosis.

[0112] 25. A formulation for use according to clause 22, wherein the skin condition is a rash or infection.

[0113] 26. A formulation for use according to clause 22 or 25, wherein the formulation is an antibiotic, antifungal or antiviral topical formulation, a topical formulation comprising a steroid or other anti-inflammatory or pain relief ingredients (such as NSAIDs, capsaicin etc) or antihistamine compounds or cooling agents (e.g. menthol), acne treatment formulation, wound healing formulation, foot treatment formulation, tattoo aftercare formulation, hand sanitizer (non-alcoholic), diaper rash formulation or stretch mark formulation.

[0114] 27. Use of a fire retardant topical formulation as defined in any one of clauses 1 to 21 on skin or hair.

[0115] 28. Use according to clause 27 for maintaining healthy skin, mucous membranes or hair. 29. Use according to clause 27 wherein the topical formulation is a moisturiser, cleanser, deodorants or antiperspirant, scar treatment formulation, insect repellent formulation, sunburn relief formulation, anti-aging formulation or foot care formulation.

[0116] 30. Use according to clause 27 wherein the topical formulation is a shampoo, conditioner, hair dye or other hair formulation.

[0117] The invention may also be described with reference to the following numbered aspects.

[0118] 1. A topical formulation comprising urea and a humectant or the topical formulation of any of the other numbered aspects further comprising a humectant.

[0119] 2. A topical formulation comprising urea and glycerol or the topical formulation of any of the other numbered aspects further comprising glycerol.

[0120] 3. A topical formulation comprising urea and one or more of propylene glycol, butylene glycol, hexylene glycol, diglycerin, polyglycerin, sorbitol, mannitol, xylitol and erythritol or the topical formulation of any of the other numbered aspects further comprising one or more of propylene glycol, butylene glycol, hexylene glycol, diglycerin, polyglycerin, sorbitol, mannitol, xylitol and erythritol.

[0121] 4. A topical formulation comprising urea and sodium lactate or the topical formulation of any of the other numbered aspects further comprising sodium lactate.

[0122] 5. A topical formulation comprising urea and one or more of potassium lactate, zinc lactate, magnesium lactate, sodium pyrrolidone carboxylic acid (PCA), potassium PCA, sodium gluconate, sodium citrate and phosphate salts or the topical formulation of any of the other numbered aspects further comprising one or more of potassium lactate, zinc lactate, magnesium lactate, sodium pyrrolidone carboxylic acid (PCA), potassium PCA, sodium gluconate, sodium citrate and phosphate salts.

[0123] 6. A topical formulation comprising urea and an exfoliant or the topical formulation of any of the other numbered aspects further comprising an exfoliant. 7. A topical formulation comprising urea and a buffering agent or the topical formulation of any of the other numbered aspects further comprising a buffering agent.

[0124] 8. A topical formulation comprising urea and lactic acid or the topical formulation of any of the other numbered aspects further comprising lactic acid.

[0125] 9. A topical formulation comprising urea and one or more of citric acid, glycolic acid, gluconic acid and ascorbic acid or the topical formulation of any of the other numbered aspects further comprising one or more of citric acid, glycolic acid, gluconic acid and ascorbic acid.

[0126] 10. A topical formulation comprising urea and a film forming agent or the topical formulation of any of the other numbered aspects further comprising a film forming agent.

[0127] 11. A topical formulation comprising urea and polyvinyl pyrrolidone (PVP; such as Povidone K29 / 32) or the topical formulation of any of the other numbered aspects further comprising polyvinyl pyrrolidone (such as Povidone K29 / 32).

[0128] 12. A topical formulation comprising urea and one or more of pullulan, hydroxypropyl methylcellulose (HPMC), hydroxyethylcellulose (HEC), carboxymethylcellulose (CMC), alginates and carrageenan or the topical formulation of any of the other numbered aspects further comprising one or more of pullulan, hydroxypropyl methylcellulose (HPMC), hydroxyethylcellulose (HEC), carboxymethylcellulose (CMC), alginates and carrageenan.

[0129] 13. A topical formulation comprising urea and a thickening agent, preferably an electrolyte-tolerant thickening agent, or the topical formulation of any of the other numbered aspects further comprising a thickening agent, preferably an electrolyte-tolerant thickening agent.

[0130] 14. A topical formulation comprising urea and polyacrylate crosspolymer-6 (such as Sepimax Zen) or the topical formulation of any of the other numbered aspects further comprising polyacrylate crosspolymer-6 (such as Sepimax Zen).

[0131] 15. A topical formulation comprising urea and one or more of a carbomer, ammonium acryloyldimethyltaurate / VP copolymer, Pemulen TR, hydroxypropyl starch phosphate, xanthan gum, guar gum and biosaccharide gum-1 or the topical formulation of any of the other numbered aspects further comprising one or more of a carbomer, ammonium acryloyldimethyltaurate / VP copolymer, Pemulen TR, hydroxypropyl starch phosphate, xanthan gum, guar gum and biosaccharide gum-1.

[0132] 16. A topical formulation comprising urea and a preservative or the topical formulation of any of the other numbered aspects further comprising a preservative.

[0133] 17. A topical formulation comprising urea and phenoxyethanol and / or ethylhexylglycerin or the topical formulation of any of the other numbered aspects further comprising henoxyethanol and / or ethylhexylglycerin.

[0134] 18. A topical formulation comprising urea and one or more of caprylyl glycol, glyceryl caprylate, pentylene glycol, levulinic acid, anisic acid and benzyl alcohol or the topical formulation of any of the other numbered aspects further comprising one or more of caprylyl glycol, glyceryl caprylate, pentylene glycol, levulinic acid, anisic acid and benzyl alcohol.

[0135] 19. A topical formulation according to any of numbered aspects 1 to 18, comprising water, preferably purified water.

[0136] In any of these numbered aspects, the components may be present in the preferred ratios described throughout the description. As will be appreciated, the preferred embodiments described throughout the description apply equally to these numbered aspects. As will also be appreciated, the advantages described herein in relation to each of the components of the above numbered clauses apply equally to these numbered aspects.

[0137] Brief description of the Figures

[0138] Figure 1 An in vivo corneometry study was carried out and the 24h skin hydration of samples N and O was compared to untreated skin on 20 female subjects with dry skin.

[0139] Figure 2 An ex vivo skin hydration study was also carried out and the results are shown in Figures 2A-2F.

[0140] Examples Example 1

[0141] Two formulations of the present invention were tested and compared to commercially available E45 cream.

[0142] The compositions of the formulations of the present invention are given below in Table 1.

[0143] Raw material Sample A % (w / w) Sample B % (w / w) Water Purified EP 76.30 71.30 Phenoxyethanol EP 1.00 1.00

[0144] Urea crystals EP 5.00 10.00 Sodium Lactate solution 10.00 10.00

[0145] 60%

[0146] Lactic Acid EP 1.00 1.00 Glycerol EP 1.00 1.00 Ethylhexylglycerin 3.00 3.00 Polyacrylate crosspolymer- 2.20 2.20

[0147] 6)

[0148] Polyvinylpyrrolidone EP 0.5 0.5

[0149]

[0150] Table 1

[0151] E45 cream was used as a positive control. Amongst other ingredients, it contains 14.5% (w / w) white soft paraffin, 12.6% (w / w) light liquid paraffin and 1% (w / w) anhydrous lanolin.

[0152] Fabrics for testing were purchased from John Lewis. Bandage for wet wrapping, and Clinifast® tubular bandage were purchased from medicaldressings.co.uk.

[0153] As fabrics may have different orientations of fibres when washed compared to new ones, some materials were washed the washing machines at 30°C using detergents and air-dried prior to the study being initiated as listed in the Table below. Different types of cotton fabrics have different thicknesses and orientations of fibres, which may also influence flammability behaviours and therefore different types of cotton fabrics were investigated as well. Non-coated fabrics served as the negative control. The list of fabrics used in this study are listed in Table 2.

[0154] No. Fabric composition

[0155] 1 100% cotton bed sheet

[0156] 2 100% cotton pyjamas

[0157] 3 100% cotton pyjamas (washed and dried) 4 95% cotton, 5% elastane

[0158] 5 55% cotton, 45% linen

[0159] 6 100% cotton sheets (washed and dried) 7 35% cotton, 65% polyester

[0160] 8 50% cotton, 50% modal

[0161] 9 94% polyester, 6% spandex

[0162] 10 100% cotton towel

[0163] 11 100% wool

[0164] 12 100% viscose

[0165] 13 100% rayon

[0166] 14 100% polyester

[0167] 15 100% acetate

[0168] 16 100% silk

[0169] 17 92% viscose, 5% elastane, 3% polyamide (Clinifast ® tubular bandage)

[0170]

[0171] Table 2

[0172] The fabrics tested were cut into uniform square (5 cm x 5cm) using scissors. Each replicate was put in a separate weighing boat. Each replicate was pierced at the corners on one side of the square with two paperclips (one per corner). The paperclips were used for hanging the fabrics to dry in the drying phase and on metal hooks during flammability testing. Each formulation was applied on one side of the fabric in order to mimic real-life situations where emollient is transferred from the skin to one side of the material. The target amount of formulation (12.5mg / cm2±5%) was transferred onto the fabric and spread evenly with a spatula, covering the edges of the fabric as well. The replicates were weighed before commencing the work on the first, second and fifth days of the experiment being the days of applying the formulation and the day of flammability testing.

[0173] The formulations were applied twice a day for two days, followed by two days of drying at room temperature. The replicates were burned on the fifth day of the experiment. Between applications and before commencing burning the replicates were dried out by hanging in a fume cupboard with a constant airflow of approximately 93.4m3 / hr, using the previously inserted paperclips.

[0174] The replicates were burned in a controlled environment. A specially built metal cage (height 80 cm, width 80 cm and length 50 cm) was position in a fume cupboard. The top side of the metal cage had a removable mesh including two metal hook. The metal hooks were used to hold the replicate in place during the test using the previously inserted paperclips.

[0175] After drying the replicates each replicate was placed vertically in the metal cage using the previously inserted paperclips and ignited using a handheld gas light. The handheld gas lighter was chosen to represent a fire course commonly used in a household. Each replicate was ignited at the bottom edge from the front side, the side coated with emollients, and was exposed to the ignition source for one second followed by a five second break. If the replicate did not ignite after the first time, the cycle was repeated up to a maximum of five times. If no ignition was observed after five attempts, the fabric was considered unable to be ignited.

[0176] The intensity of the flame produced is graded 1 to 5 in Table 4 as described below.

[0177] 5 Fabric ignited with significant burning and vigorous flame

[0178] 4 Fabric ignited with moderate flame with a slightly bigger flame than the control 3 Fabric ignited with a comparable flame to the control fabric

[0179] 2 Fabric ignited but after multiple attempts of ignition with a minor flame, smouldering or glowing which quickly faded / dissipated

[0180] 1 Fabric did not ignite No. Fabric composition Average Burn Time ±SD (s)

[0181] 1 100% cotton bed sheet 13.6 ± 1.0

[0182] 2 100% cotton pyjamas 15.1 ± 1.0

[0183] 3 100% cotton pyjamas (washed 16.0 ± 0.3

[0184] and dried)

[0185] 4 95% cotton, 5% elastane 18.8 ± 0.4

[0186] 5 55%cotton, 45% linen 20.1 ±3.6

[0187] 6 100% cotton sheets (washed 14.5 ± 1.3

[0188] and dried)

[0189] 7 35% cotton, 65% polyester 15.9± 4.1

[0190] 8 50% cotton, 50% modal 13.2± 0.3

[0191] 9 94% polyester, 6% spandex 13.3± 1.0

[0192] 10 100% cotton towel 43.6± 27.3

[0193] 11 100% wool N / A

[0194] 12 100% viscose 14.2± 0.6

[0195] 13 100% rayon 14 / 7± 2.1

[0196] 14 100% polyester 20.4± 6.1

[0197] 15 100% acetate 14.1± 1.6

[0198] 16 100% silk 6.4± 1.5

[0199] 17 92% viscose, 5% elastane, 3% 17.9± 1.8

[0200] polyamide (Clinifast ® tubular

[0201] bandage)

[0202]

[0203] Table 3

[0204] No. Fabric composition Flame produced Average Burn Time for each replicate ±SD (s)

[0205] 1 100% cotton bed sheet – A 2 22 N / A

[0206] 100% cotton bed sheet – B 2 22 N / A 100% cotton bed sheet – E45 555 17.1 ± 1.3

[0207] 2 100% cotton pyjamas – A 1 2 1 N / A

[0208] 100% cotton pyjamas – B 2 1 1 N / A

[0209]

[0210] 100% cotton pyjamas – E45 555 21.9 ± 1.7 100% cotton pyjamas (washed 2 1 1 N / A and dried) – A

[0211] 100% cotton pyjamas (washed 1 1 1 N / A and dried) – B

[0212] 100% cotton pyjamas (washed 555 22.1 ± 0.6 and dried) – E45

[0213] 95% cotton, 5% elastane – A 1 22 N / A 95% cotton, 5% elastane – B 1 1 1 N / A 95% cotton, 5% elastane – E45 555 24.7 ± 1.6 55% cotton, 45% linen – A 2 22 N / A 55% cotton, 45% linen – B 2 22 N / A 55% cotton, 45% linen – E45 555 21.5 ± 2.5 100% cotton sheets (washed and 1 1 1 N / A dried) – A

[0214] 100% cotton sheets (washed and 1 1 1 N / A dried) – B

[0215] 100% cotton sheets (washed and 555 19.6 ± 2.6 dried) – E45

[0216] 35% cotton, 65% polyester – A 1 22 N / A 35% cotton, 65% polyester – B 222 N / A 35% cotton, 65% polyester – E45 555 32.9 ± 1.0 50% cotton, 50% modal – A 1 1 N / A N / A 50% cotton, 50% modal – B 1 2 N / A N / A 50% cotton, 50% modal – E45 555 18.5 ± 1.2 94% polyester, 6% spandex – A 1 1 1 N / A 94% polyester, 6% spandex – B 1 1 1 N / A 94% polyester, 6% spandex – 555 12.0 ± 0.3 E45

[0217] 100% cotton towel – A 1 2 1 N / A 100% cotton towel – B 1 1 1 N / A

[0218]

[0219] 100% cotton towel – E45 555 67.0 ± 0.8 100% wool – A 1 1 1 N / A 100% wool – B 1 1 1 N / A 100% wool – E45 555 31.0 ± 3.8 100% viscose – A 22 2 N / A 100% viscose – B 1 1 1 N / A 100% viscose – E45 555 18.7 ± 1.4 100% rayon – A 2 22 N / A 100% rayon – B 2 22 N / A 100% rayon – E45 555 17.6 ± 2.5 100% polyester – A 344 25.2 ± 21.0 100% polyester – B 1 1 1 N / A 100% polyester – E45 555 17.5 ± 2.8 100% acetate – A 2 22 N / A 100% acetate – B 2 22 N / A 100% acetate – E45 555 16.8 ± 2.2 100% silk – A 1 22 N / A 100% silk – B 1 1 1 N / A 100% silk – E45 555 16.1 ± 3.1 92% viscose, 5% elastane, 3% 1 1 1 N / A polyamide (Clinifast ® tubular

[0220] bandage) – A

[0221] 92% viscose, 5% elastane, 3% 1 N / A N / A N / A polyamide (Clinifast ® tubular

[0222] bandage) – B

[0223] 92% viscose, 5% elastane, 3% 555 15.1 ± 1.0 polyamide (Clinifast ® tubular

[0224] bandage) – E45

[0225]

[0226] Table 4 The control replicates made from 100% cotton caught fire easily. Loose fabrics, such as sheets or pyjamas, burned more quickly compared to the thicker fabrics such as towel. Loose fabrics had larger flames and most of these replicates burned completely. Washing and drying of cotton pyjamas did not significantly affect the flammability behaviour. Natural fibres such as cotton and silk, ignited easily and the flames spread quickly. In contrast, some other natural fibres, such as wool, did not ignite as easily and in some cases not at all, as wool is typically more resistant to catching fire. However, synthetic fabrics and tubular bandages ignited easily, with the exception of the 100% polyester fabric. Once ignited, synthetic fabrics melted which poses an additional risk alongside the vigorous flames.

[0227] The data also show that the fabrics burned and melted significantly less when coated with the samples of the present invention. All fabrics coated with samples A or B showed a significant reduction in the intensity of the flames and the ease with which the fabrics were ignited when compared to the control (untreated) fabrics. The fabrics treated with these formulations in most cases did not catch fire at all. For two types of fabric, 35% cotton with 65% polyester, and 100% polyester, when they did ignite, the flame was significantly smaller than the control flame for the same type of fabric. In some cases, the fire was spontaneously extinguished leaving the fabric undamaged.

[0228] The difference between the samples A and B was most noticeable in the case of the 100% polyester fabric, where the flame was completely absent in the replicates coated with Sample B whereas there was a small flame produced in replicates coated with Sample A.

[0229] The fabrics treated with E45 cream ignited easily due to the presence of oils in the formulation. The flames spread quickly and in a majority of cases were larger than the control, more vigorous and ferocious. In most cases, these replicates burned quickly and completely when ignited, with the burning time being longer or comparable compared to the control replicates of the same type of fabric. In one case, (50% cotton and 50% modal) the fabric treated with E45 cream burned for less time than the control but with a more vigorous flame. The burning was also followed by the appearance of dark smoke. This indicates that there is a risk that the larger flame and rapid spread of the flames do not leave enough time for emollient users to notice and extinguish the flame which can have major safety consequences. E45 Cream also increases the fire risk of the fabrics that are naturally more resistant to catching fire, for example, wool. Accordingly, it can be seen from the data above that the compositions of the present invention reduce the flammability of a range of emollient impregnated fabrics.

[0230] Example 2

[0231] Samples C to J were formulated as shown in Table 5 below and the flammability of 100% cotton sheet was assessed when coated with these samples using the same process as in Example 1. The results are also shown in Table 5.

[0232] As can be seen from the results in Table 5, all of the formulations of the present invention show a reduced flammability compared to untreated cotton. Accordingly, formulations containing a range of amounts of urea and glycerol result in a reduction in flammability of the emollient formulation.

[0233] In addition, the base formulation of Sample C also shows a low flammability in the absence of a urea component.

[0234] Raw Material Sample Sample Sample Sample Sample Sample Sample Sample C D E F G H I J

[0235] Urea crystals 2 20 1 20 30 30 30 EP

[0236] Glycerol EP 1 1 10 1 20 5 10 20

[0237] polyacrylate 2 2 2 2 2 2 2 2 crosspolymer-6

[0238] Sodium lactate 10 10 10 10 10 10 10 10 soln 60%

[0239] Phenoxyethan 1 1 1 1 1 1 1 1 ol EP

[0240] Lactic acid EP 1 1 1 1 1 1 1 1

[0241] Ethylhexylglyc 3 3 3 3 3 3 3 3 erin

[0242] Polyvinylpyrroli 0.5 0.5 0.5 0.5 0.5 0.5 0.5 0.5

[0243]

[0244] done EP Water Purified 81.5 79.5 52.5 80.5 42.5 47.5 42.5 32.5 EP

[0245] Flammability Struggli Struggli Struggli Struggli Struggli Struggli Struggli Struggli assessment ng to ng to ng to ng to ng to ng to ng to ng to comments ignite. ignite. ignite. ignite. ignite. ignite. ignite ignite.

[0246] Caught Bit of Two Difficult Tiny, Tiny, Tiny, fire at fire at sample to tiny bit tiny bit tiny bit the the s didn’t ignite. of the of of back of edge. ignite. Minimu glowing glowing glowing the Much The m at the

[0247] fabric better third glowing back

[0248] and than one

[0249] slowly plain had a

[0250] spread. cotton micro- glowing

[0251] better

[0252] than

[0253] plain

[0254] cotton.

[0255]

[0256] Table 5

[0257] Example 3

[0258] Sample K was evaluated against E45 Cream and untreated cotton sheets in order to assess the effect of washing fabric that had been coated with a formulation of the present invention.

[0259] Sample K has the following formulation.

[0260] Raw Material % w / w

[0261] Water Purified EP 87.05

[0262] Sorbitan Laurate EP 0.25

[0263] Urea EP 5.00

[0264] Permulen TR1 HSE 0.70

[0265] Glycerol EP 5.00

[0266] Trolamine EP 1.00

[0267] Phenoxyethanol 1.00

[0268]

[0269] Table 6

[0270] Replicates of 100% cotton sheets were prepared in the same way as in Example 1.

[0271] Approximately 310mg / 25cm2were applied to replicates for testing with a spatula. For each formulation three samples were used and had the formulation applied twice a day on one side of the fabric for two days, followed by two days drying as in Example 1.

[0272] Untreated replicates, replicates treated with the formulation of Sample K and replicates treated with E45 Cream were prepared.

[0273] After the drying phase was complete the samples were washed in a washing machine with detergent at 40C air-dried and tested for flammability. The flammability test was done under the same conditions as in Example 1.

[0274] Control (untreated cotton) replicates, washed and air-dried prior testing for flammability:

[0275] All three replicates ignited after the first attempt. Flames spread quickly and burned the replicates completely. Flames were large and vigorous. The average burning time of these replicates was 14.4 + / - 1.8 s.

[0276]

[0277] K, washed and air-dried prior testing for

[0278]

[0279] All three replicates ignited after the first attempt. Flames spread quickly and burned the replicates completely. Flames were large and vigorous. The average burning times of these replicates was 12.8 + / - 1.8 s.

[0280] treated with E45 cream, washed and air-dried prior testing for

[0281]

[0282] All three replicates ignited after the first attempt. Flames spread quickly and burned the replicates completely. Flames were large and more vigorous comparing to untreated control replicates. The average burning time of these replicates is 13.0 + / - 0.3 s.

[0283] When evaluating number of ignitions and burning times of replicates, it can be concluded that there were no significant differences between tested replicates. All replicates ignited after the first attempt and burned for a similar period. Simple visual assessment of flames indicated that the flames produced when replicates treated with the formulation of Sample K were ignited after being washed and air-dried, were not different compared to untreated control flames treated the same way. However, when replicates treated with E45 cream, washed and air-dried prior flammability testing, were ignited, produced flames were more vigorous compared to untreated control replicates.

[0284] The overall conclusion that can be drawn after analysing the flames, is that the formulation of Sample K can be easily removed from fabrics with laundering. In contrast, E45 cream is not completely removed from the cotton during washing, leaving residue that makes cotton fabric more flammable.

[0285] Example 4

[0286] Samples L and M were formulated as shown in Table 7 below and the flammability of 100% cotton sheet was assessed when coated with these samples using each of three treatment processes. Uncoated cotton sheet was used as a control. Pieces of 100% cotton sheet were prepared in the same way as in Example 1. One of the three treatments was then applied to the cotton sheet. Treatment a) was application three times daily for two consecutive days, followed by two-days drying out and then burning. Treatment b) was application twice daily for nine days, followed by three days drying out and then burning. Treatment c) was application twice daily for nine days, followed by washing in the washing machine at 40°C, quick drying in open and then burning. Each treatment was carried out on three replicates.

[0287] Raw Material Sample L Sample M

[0288] Water Purified EP 82.05 77.05

[0289] Sorbitan Laurate EP 0.25 0.25

[0290] Urea EP 10.00 15.00

[0291] Pemulen TR1 0.70 0.70

[0292] Glycerol EP 5.00 5.00

[0293] Trolamine EP 1.00 1.00

[0294] Phenoxyethanol 1.00 1.00

[0295]

[0296] Table 7 For treatment a) the three replicates of untreated cotton sheet ignited at first attempt and burned completely. Of the replicates coated with Sample L, the first replicate ignited at third attempt, the second replicate ignited at first attempt and the third replicate at fourth attempt; in all three cases the flames extinguished themselves and the fabric burned incompletely. Of the replicates coated with Sample M the first replicate ignited at sixth attempt, second replicate didn’t ignite even at the tenth attempt and the third replicate ignited at sixth attempt; in all three cases the flames extinguished themselves and the fabric burned incompletely.

[0297] For treatment b) all three replicates of untreated cotton sheet ignited at first attempt and burned completely. All three treated replicates treated with sample L did not ignite even after five attempts. All three treated replicates treated with sample M also didn’t ignite even after five attempts.

[0298] For treatment c) all the of the previous treated and untreated replication ignited at the first attempt and burned completely.

[0299] Accordingly, it was harder to ignite replicates coated with sample L or M using treatment a) and the replicates coated with sample M were harder to ignite. None of the treated replicates ignited after treatment b). As all treated replicates ignited at the first attempt after treatment c), this indicates that after a washing cycle at 40°C most of the applied formulation on the fabric has been removed.

[0300] Example 5

[0301] The flammability of two formulations of the present invention was compared with E45 Cream and Oilatum Cream. The major components of E45 Cream are described above. The major components of Oilatum Cream are 15 % white soft paraffin, 6 % light liquid paraffin, benzyl alcohol, cetostearyl alcohol, potassium sorbate, macrogol 1000 monostearate, glycerol, citric acid monohydrate, povidone (polyvinylpyrrolidone) and purified water.

[0302] The formulations of the present invention, samples N and O are given below in Table 8. Raw Material Sample N (New emollient Sample O (New emollient 1) 2)

[0303] Water Purified EP 76.50 71.50 Phenoxyethanol EP 1.00 1.00

[0304] Urea EP 5.00 10.00

[0305] Sodium Lactate Solution

[0306] 10.00 10.00

[0307] 60%

[0308] Glycerol EP 5.00 5.00

[0309] Ethylhexylglycerin 3.00 3.00

[0310] polyacrylate crosspolymer-6 1.00 1.00 Polyvinylpyrrolidone EP

[0311] 0.50 0.50

[0312]

[0313] Table 8

[0314] Each formulation was applied with both single and multiple application on both cotton and polycotton fabric. The results are shown in tables 9 and 10 below. Emollient 1 is E45 cream and Emollient 2 is Oilatum cream.

[0315] An indirect flame study was carried out to mimic the real-life use of heaters which provide an intensive heat but no naked flame. An adapted Federal Aviation Administration (FAA) test was used. The test was adapted to use an indirect flame. Table 9. Vertical flammability tests using an indirect ignition (results of ignition time, flame time, glow time, maximum flame height and width).

[0316] 1CO<- conor- fabric tests ' single irni-tl' m i l.b " i 1 Blank * \ w •.,: i;_ „> ' s *. n> > - -w. '> w. < i. '•■’.-. I - f »\y,e,'>r I i> nw»i >' -»'1 4..c-w -.’ j ' '4 *. 4 < c-,: •■ ei'.’nfu.r 1? -JJ 1.4 s w ", s.'S. > tc i w ' -. M t j 4-, S - S >.: •> <..4 -.\' 4> ', '. V e / ro.'< e sr 1 PC f'Od. ctll 3 i -c Noname * -1 > - *. i ’ cw 7ea iv'io vrt 7 / w\’ w r'i'. v 4 •. • Wo / tow Um »lme 'e G’ r l®W»? WWWdlWWW»IWWWBI®lwWlllWg|W4WS®®SWC®WTO 100% cotton fabric tests ’ - sequential 1 i l l 1 1 triple applications over 3 days (total 1 1 1 1; 3.75mi; i I I I 1 1 Blank4I 1. " ”: r<"..! r’,t: nw.',’i i. " s,..,, J- >.' ■rM. e-t.', l ' ■ ’.>. ". '. 4,.,..4; - -> X,4. '.,» - >, W 4 4. ' 'd’rt f”d 1 p. rw«3.1. d- - * *, - dowme done V ‘ee.'.'cw t'cior-t. ' p; (?<«>,. •m t.' / ; we 4 - •.e j' '.--’ >..• “e ■■■■ V-c c.- ' e-.- ‘.3 •><■<■ 52M / 48S4 polyester / cotton mix fabric 1 I I I I I I tests' single application (1.25mlJ 1 1 Blank11 <w; - w:,s. ' • _ c,s <• ■ v- s - w. 34 ' - 4.4 - 4 c.-j j,-.-.c.; 1 p. t ' v»<..v, ' -..>5 8:..’,4: rsw,’. « -;? w >-... 4; ',,. f-o ' t-.'t.’ f c'o.v r? c / : > c i. ie - ■ me-. 4 >, - ' o -. s - rs; > w’ w 4 > 411 '-Va rd’ ’ er!mem,, t h? 'j; -w, ‘.'n(crt.-,?, t.1 •.-..•.w tests ’ sequential triple applications over 1 i l l - - MV. -. -S 1 1 1; 1 1: Btanks\ > >: £rro ent 2 (• I -J * >. )»'. * ' -s ‘ <■... -.1 V P-’ <) ‘; K\ ’ S'G i f -3t ' a i ' C« * C \ ' 1 '. ’, ■■ •• ”'r ' ’,r? / C’' o* cr? 2 r i * 2 / * ’ ’*<' ^7' *. ' ’.. ru -,.,p '»,, 5

[0317]

[0318] 0

[0319] 5 Table 10. Vertical flammability tests using an indirect ignition (results of flame speed, temperature on ignition and temperatures at two heights).

[0320] m m

[0321] M

[0322] H

[0323]

[0324] In the indirect ignition testing, the fabrics coated with the formulation of the present invention did not ignite and thus no flame was observed. Due to high temperatures, limited glowing combustion was observed when exposed to the heat of the ignition source, which partially travelled up from the ignition source. As no flame measurements could be recorded, burn length and the char length were measured.

[0325] The burn length is defined as the damage of the textile strip due to combustion which includes areas of impartial and complete consumption, charring or embrittlement of the textile. This indicates areas of combustion, even without a flame. As expected, up to 20% of fabric was damaged in this way. During this time there were occasions of flashing, but these did not result in flame.

[0326] The char length above the burn length indicated the length of where the fabric is undergoing pyrolysis (thermal decomposition) and heating of the material to produce vapours, but these are usually very lean in concentration within air to even support glowing combustion. Up to 12% of fabric was affected by charring.

[0327] In contrast, the marketed emollients tested reached a fire point i.e. a flame was produced. The flames were large and ferocious with significant increase in flame temperatures observed. The burn lengths and char lengths could not be measured as all fabric was damaged by flames.

[0328] A direct flame test was also undertaken for these samples in order to mimic a real-life situation of a house fire. The Federal Aviation Administration (FAA) standard was used. The results are presented in Tables 11 and 12 and the statistical significance of the results is shown in Table 13.

[0329] The direct tests involve a flame held onto the surface of the fabrics for 3 seconds and then turned off to assess if the burn continues on the fabrics. ANOVA (Analysis of Variance) post-hoc Tukey tests have been used to compare the test results of the blank control fabrics burning behaviour to the two known and inventive emollients. Table 11. Vertical flammability tests using direct ignition (results of flame time, glow time, maximum flame height, flame width and initial flame speed).

[0330] 5

[0331] : DIRECT IGNITIOM TESTI HG (3seccmcfc flame on wrface of strip and then remowd>; i mean mass ©fdned; mean flame times, man maxtmum ' mean maxmum mean flame speed ' i; emotert / g; $; ^ ftamehesght / m® flame wrdth / mm< 100% coton fabric tests ’ single ': i < 4!',!' lat 0”11 ' < ' < < B.a-'i ' i -'.i,' Z1■>&; •. •’,?’ > •■'• - D I.; -.

[0332] ■tf-'it ’ < Af.on. i-i; ’ o ’? s • i. \ is. -. - M- '.4; -.. ’.s • c >.: t ri.' i <<-? £n:o''f”t? (Af:onv-> / - » ■>> s - s i.-.a. - c e. t 1 u'Sl I’tnCvlt J)? -,.4’ i S ' •:7S.’ -;£> <»,.. •_; - jt-. o-,. s: - > i:y.< ii Jij.?;-.! ■. I-. I co-0,.-t 2. f i ruta t.’l C l-.?? o t. 4 cs..4 4;.« 4 > •■,s— 4..;-.- t t.-o.’ -., CIS.;, s..

[0333] 100% coton fabric tests’ - ' ' ' i ' ’sequential triple applications over 3 ' < '; i days (total 3.75ml) ’ - '

[0334] .i tiM i^oSzeni 1 iknown) ->si?.. <. -.-v ■ '. o- t;. o, 14.. c. s s - '.’ „e. -, =, > t m i n.t.' iKnou -' i: = '•; ss s -.. a 4-...4 - -.. -' '.'M- eTO.f i.t i ^. rw. Kt i '.;sj ’ i\'n i i- 4 - s > •’■■i -r >t1,, s >. >;.r * s4 <.-1■=4 -.c U~.-lc?:s; 1 - c:.-; - ■.1 •.'c« r-'o; ent.’ ji’i fifo. K.ct?’ s.h• 47,45: ■ o4 -.71.’4’-..’f c;4 •? j- <

[0335] 52% / 48% polyester / coton mix fabric' ' < i 'tests’ single application (1.25ml) i i i < ' ' ' ' Blank1'. ' -:. e < » 4.<.. -. 4 <. -s. -, 4. - -j;-,

[0336] > U'O. •..•! >..-44 -:9 4 -. 4 „ 3 • -’. -;4 =. il t-..:s...... tmo; act / (V'o.v.'f / ,’45 ' ’.’ ew.’ S '- 1- ’ r.:.".1u--=44 -; i -4,;..-.sje:c: < ’.'i.i en'c f.-'t I rfuauct 1) i'-'..- s. ■ <7 4 - 43. s0: -,. 3^:',.4 <.;c 'zcA- e-i'w' ent J i i'z r-ojuit li 0. i-s. -'4 -• •; s 4.-S f.7 i?' - ss -: s:?. r c c '9 >:4 s > S.'cf4,i- -iV'tei ‘Wti"' -n> < fabr.r ' tests’ sequential triple applications i i ' < ewr. <tat.il ’. 7 > 'V., ' ' B. O'-l ' ' tooiwtll fxno.v-; '. x'; X •. - 1 ’.tx - if s tt s i4i 4 •,. s s >4 1 •. ’> -. •. <.4... i..; -, > j Fmo.‘:‘.w>t 2 Iknoim]. 4s.’ • <• -’- •. i:. > -3. • s. 1 >. < t-!o e-f 1 (J. 11 j <v r;.. <i.1.4 <.r:. 4 •>.- •.. < *• < n-”r>,. { nt? (O; fK’wrt.’;, r’i tk i- r - - n'. -.',’ i4i?.<;» • -.???: x: r s

[0337] - n=3 as only S test samples burnt the foH length <rf strip * n=l as only 1 test sample burnt the fail length of the strtp

[0338]

[0339] Table 12. Vertical flammability tests using direct ignition (results of flame speed (total length), temperatures at two heights, burn and char length.

[0340] piHECT IGNITION TESTING (3 seconds flame on surface of strip and then removed)

[0341] : mean f lame speed mean max. temperature; mean max. temperature::

[0342] , i,:; Burn length / mm: Char length / mm; (0-300mm| / ms * measured (180mm! / C > measured (400mm) / C:.

[0343] 100% cotton fabric tests8single ace! cit ot’ s i S'ni:::: i: 5‘ciA > s.'.s;4(s=.i; eje;45 >: fmo.'to.t l A JO.vnl 07519 * C.'?6 4 M ehT r A- iu-.-i: j e'>?? f\no.w / ? w? * c i.t f 1 i ’.'C»v erio.l erit 1 <31 WCUuCt 1,' C r 3 7to ‘. i j:.' tie • 8-. i ltr. 1 1.6 1.t>3 » • 5? 1 'Se ’ '•> \t 4 - 4’-i r err'iW.' e''t 2 (Pi D'eo-ict?! C?;s.':: • Hi..7 ■> i J' S -,'S •> 1 it e.-> 7S s < io 100% coton fabric tests ° - i; sequential triple applications over 3 i: Pays (total 3,75ml)::.

[0344] i'>'o" erto (toowra - m-w i.-_,-• > ssi - ^s u,.. na sii Emollient 2 (known / •: C584 •? re?:.:c i‘.- •=■-'? - 1; ihto ” 4 - 4, i5- > r;e.v emo -.ent j (Di;>'OUurt n I.'. Sir r? CC'.^ < 4;• 1 » n: u i: fh'-i r>'-o„.ent 2 ■.n -is ’ ill.4- 1 ti n;.t? v.

[0345] S2% / 48% polyester / coton mix fabric::::: tests’ single application (1.25ml):::: i 6’jnt ■: t 7" 1,« n •> S’C - 'S C-'-l ■.,! * 3' ' i i-nol. ert l (k>\m nl 2 2673 • 2 C J' ■ 356 r 4*5.8=2 558: 44. Shi: tmo'> ent 2 ano.vi'l C,w * c 4-.) >;i.- ",6'.i Sil r SC. Sbi: 'te.\ emc.<'.c.'.t ll 2C_,;S.c cee 3-.ss. V r ii un 4i? - f.4’ i: At”,v etno.'..er:t 2 (Oi 1519: C m <7 >'h> m - 13 -i: 52% / 48% polyester / coton mix fabric:::: ri ots '' s^uufct, a1tr i:r!» applicat.on::;: ov^i 5 da*,? (total 3.75ml:: i: S'r.nt:..: Pro'ient J (Ancnvi:1i csca - c ct.'s K ’ s es nito 'ii i in...i [ £mo,„e-it 2 ^ '.v.’.ni o c is.i - t c.'c i:; j-„ 5ic:f4 '6%> -3-: it ■ y -: I.'CA ert 1 f. XPt 0A,e; s;: Ch t 3;;.c: ’.'C.v e-'TOM'Cj.’ / rM proo.ict.'l C:'«s r I 237.'. > -.. 3'. 5C’ - 29 1 452 r i-t:

[0346] i'- j 2

[0347]

[0348] » 2 Table 13. ANOVA comparisons of test results of fabrics contaminated with emollient compared to the blank (control fabrics).

[0349] Vertical ffatwnabHfty tests- direct flawte ignition - comparisons to blank controls (ANOVA)

[0350]

[0351] i i New EMI i New EMZ; Known EMI: Known EMI After flame time 100J.- cotton ■ angle application \ recucen,. 'crecb.od. re similar;: st similar:Cto re-i - ti.ireaponcat.on rcreasedu: cs reuocear;s uwlar rm' s.-iiiat.yre re S2% / 4Rre polyester cotton - s ng,e apnlsat. O'' similar -ere re sim-lar-f.re - vMr similarity.re 1 t / .c'e application.r, creased x increased,:s similar - o:s similar.r; re Glowing time i i:

[0352] IMS cotton - single application increased -p.re increased c c.re simdar u ■ tt similar ere m - tr o'eooo'.r jtcn i similar..- re similar - - re:simrar.. re similar 52:.' / 4S\’ pe.y ester • cotton - s, ng’e ctto. coton similar...re s mhar - -,-s similar x ■ re s:m-larcre • triple application \ umiat c ■ '« i similar x o cs increase re-::«■ similar x < re Maximum flame height 100\ cotta- - > rrej.e one, icatior: \ reduced r cs reduced,;. - re increasers 't-: re increased -c t re - tr.p'eorn'ra’.or: similar <■;.re reduced '.: re increased y? re increased c-: re 52'i,-48-x polyester / cotton - s.jgie aool.cat.on \ ‘imilar y re s niiiary tos increased ic.•.cs. increased -c c.re.

[0353] r triple application \ simi'arx-y rs simitar c r re mcreaseo o ' cs i-creased y: re Maximum flame width i(W~- ce*tr>" sn-gv non cat on sirn'ai x c;s sim.lar r rrr mcrewedretore* increased s: it - triple application \ similar,c:.re reduced re increased c: tt increased x c re 52e- / 48-. nc.'yester / ccttc- s.ng'e apoKabon simi'art. -s similar s increajeo c..s i-creaseu. r' t- triple apptcation \ similar x-t '« i similar > X»PSJ I increased;j»«o,os} 1 increased traps} Flame speed {0-180mm)

[0354] IOC. v.ntton S'ltc'e uoo / cot.oo similar y - m mmilar ■- increased,r ':si-creawd r c ts - t’.ple app'-cation c.nvar i.::t s m lar increased s?.'S sot'’ 52‘"t / 4SJ.:polyester / cctton • single appucat.cn s-m>lar yy;s similar;s increased u: ti similar r c:s: - triple application i similar e c.s reduceo r cs mcieored n- ’.t mcreased r t:s Flame speed (0- 300mm)

[0355] 100's cotton • s.ngie application \ smiilar.: cs \A(n-i;' increased e t c increased. c 't - tuple application similar.re,m UACi increaser ’t re mcreaseo r. es 52:re4S\ polyester, -cotton - smaie aooncat.oo. similar,f>; c> similar cs increased c. re Similar v o re i - triple application \ similar (po.os) i reduced 1 increased fcno.os| i increased fc><o.osj Max. temperature (180mm) / ’C 1005s cotton ■ single application Icv.er i t re lowerfc re s.nnlar.re rewfarcw<

[0356] - tr.o'e arjoi.cat.o'! 1 similarc-?,re lower ic: re s.mifarc:.re 'mi'si c; '1S2re,48re polyester / cotton ■ single ajpmCtton sim<!ar.' < 5 SimilarE< re smnlai <c.re s.miiat - re - rnDrecre'-cut.-jr:;re re -i.iar:; re - -oar re.. re la-.; re Max. temperature (400mm) / ’c 1 i i ’C0% cotton • single aool.cotion lower y: re ’ NA m=l)' higher «>.- ire mgheric s.re’

[0357] - ti'oieaooccatiorikgner n:. n i NACmgherc:.re h:gheriC: re 52-'s, '48-' polyester -cotton - smg e apuication similar,s-.’ re srnilar-c-.’re simtiatlf•;.re rem<ar>0.re trpleor'olnot.on \ similar.-.'.re i s.m<iar c • 'c*~.g»'eriE:? re h<g>'.r>r >r. re ■' n=re (only 3 tests burnt •'a<f way; onto Tukey ana Siaaz post not test carried out ' n=l (only 1 test burnt fuliy)

[0358]

[0359] 'to 'all k-re-t- burn,; It was notable that test burns with the two commercial emollients were turbulent. With the formulations of the present invention (samples N and O), the flame speed was generally slower in all the direct ignition tests compared to the known emollients on both types of fabrics.

[0360] 100% cotton

[0361] The statistical analysis demonstrated that the flame speed of both samples N and O were similar to the blank (p>0.05) with both single applications and the triple application. In contrast, the known commercial emollients showed an accelerated flame speed (p<0.05). It is worth noting that for sample N, only 3 tests burnt the full length of the test strips and for sample O only one test burnt the full length of the test strips.

[0362] For sample O with a single application flame time, flame height and max T at 180mm were all statistically better than untreated material. For triple application sample O showed a statistically significant reduced flame time, flame height and width and max T at 180mm.

[0363] 52% / 48% polyester / cotton

[0364] For single and triple applications, the flame speeds for sample N were similar to the blank fabric (p>0.05). For the single application of sample O, the flame speed was similar to the blank (p>0.05). However, with the triple applications, there was a statistically significantly decrease in speed compared to the blank (p<0.05), indicating suppression of the flame velocity. The known emollient EM1 had significant increase in flame speeds with both single and triple application compared to the blended fabric blank (p<0.05). Known EM2 with a single application was similar to the blank’s flame speed (p>0.05) and with triple application showed an increase in flame speed in comparison to the blank (p<0.05).

[0365] Skin performance data was also evaluated for these samples and are shown in Table 14. User evaluations were undertaken for samples N and O by 118 and 120 subjects aged 50 years or over with or over with dry and itchy skin in elderly, a history of eczema / psoriasis / dermatitis and other dry skin conditions, using the formulation once daily for 28 days and assessing the formulations on Day 1, Day 7, Day 14 and Day 28.1 xn Frifi

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[0375] ; r

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[0384]

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[0404]

[0405] il Bi *8iiB * A.. - -I. M ' - a l, i Table 14

[0406] The result of the evaluation was that the formulations provided long-lasting moisturisation, long-lasting itch relief and other cosmetic attributes. There was a high response rate of over 80%.

[0407] An in vivo corneometry study was also carried out and the 24h skin hydration of samples N and O was compared to untreated skin on 20 female subjects with dry skin. Both inventive formulations provided significant hydration. The results are shown in Figure 1 (sample O top line, sample N middle line, untreated bottom line).

[0408] An ex vivo skin hydration study was also carried out and the results are shown in Figures 2A-2F. Figure 2A shows a comparison of sample N (top line at 24 hours), Aproderm (second from top line at 24 hours), Epimax (third from top line at 24 hours) and nil treatment (bottom line at 24 hours). Figure 2B shows a comparison of sample O (top line at 24 hours), Epimax (second from top line at 24 hours), Aproderm (third from top line at 24 hours) and nil treatment (bottom line at 24 hours). Figure 2C shows a comparison of sample N (top line at 24 hours), E45 (second from top line at 24 hours), Cetraban (third from top line at 24 hours) and nil treatment (bottom line at 24 hours). Figure 2D shows a comparison of sample O (top line at 24 hours), Cetraban (second from top line at 24 hours), E45 (third from top line at 24 hours) and nil treatment (bottom line at 24 hours). Figure E shows a comparison of sample N (top line at 24 hours), Zerobase (second from top line at 24 hours), Epimax (third from top line at 24 hours) and nil treatment (bottom line at 24 hours). Figure F shows a comparison of sample O (top line at 24 hours), Epimax (second from top line at 24 hours), Zerobase (third from top line at 24 hours) and nil treatment (bottom line at 24 hours).

[0409] A cosmetic test of skin irritation on sensitive skin was also carried out. Skin irritation on atopic skin was assessed on 27 healthy male and female subjects with stop and self-assessed sensitive skin. The subjects tested four consecutive 23-hour applications. The total score was closer to the negative control than the positive control.

[0410] Example 6 Samples P to Z and AA to GG were formulated as shown in Table 15 below and the flammability of 100% cotton sheet was assessed when coated with these samples using the same process as in Example 1. The results are also shown in Table 15.

[0411] Raw Material Sample P Sampl Sample Sample Sam Sampl Sampl Sampl e Q R S pie T e U e V e W Squalene 15 5

[0412] Liquid Paraffin 15 5

[0413] Caprylic / Capric 15 5 triglycerides

[0414] Dimethicone 15 5 Urea crystals EP 30 30 30 30 30 30 30 30

[0415] Glycerol EP 1 1 1 1 1 1 1 1

[0416] polyacrylate 2 2 2 2 2 2 2 2 crosspolymer-6

[0417] Sodium lactate 10 10 10 10 10 10 10 10 soln 60%

[0418] Phenoxyethanol 1 1 1 1 1 1 1 1 EP

[0419] Lactic acid EP 1 1 1 1 1 1 1 1

[0420] Ethylhexylglyceri 3 3 3 3 3 3 3 3 n

[0421] Polyvinylpyrrolid 0.5 0.5 0.5 0.5 0.5 0.5 0.5 0.5 one EP

[0422] Water Purified 36.5 36.5 36.5 36.5 46.5 46.5 46.5 36.5 EP

[0423] Flammability No No Flame No No No No No assessment burning burnin tried to burning. burni burnin burnin burnin comments was g- establis ng. g- g- g- establishe h itself Micro d. but was glowin unable g- to.

[0424] Howeve

[0425]

[0426] r, no burning

[0427] was

[0428] establis

[0429] hed at

[0430]

[0431] all.

[0432] Raw Material Sample Sample Sample Sample AA Sampl Sampl Sample DD X Y Z e BB e CC

[0433] Silica

[0434] Liquid Paraffin 15 15 15 Isopropyl 15

[0435] myristate (IPM)

[0436] Castor Oil 15

[0437] Silicone 20 20

[0438] Elastomer

[0439] Urea crystals EP 30 30 10 10 10

[0440] Glycerol EP 1 1 1 1 1 1 1

[0441] polyacrylate 2 2 1 1 5 2 5 crosspolymer-6

[0442] Sodium lactate 10 10 10 10 10 10 10 soln 60%

[0443] Phenoxyethanol 1 1 1 1 1 1 1

[0444] EP

[0445] Lactic acid EP 1 1 1 1 1 1 1

[0446] Ethylhexylglyceri 3 3 3 3 3 3 3 n

[0447] Polyvinylpyrrolid 0.5 0.5 0.5 0.5 0.5 0.5 0.5 one EP

[0448] Water Purified 36.5 36.5 52.5 62.5 53.5 56.5 63.5 EP

[0449] Flammability No No No First Tiny No Massive assessment burning. burning. burning. replicate flame. burnin flame comments The had a tiny Exting g- edge flame, uished

[0450] had a looks like itself

[0451] tiny bit some prompt

[0452]

[0453] burning at _! X: _ of the back of glowing. the fabric.

[0454] The second replicate had a tiny, tiny flame. The third sample had a proper

[0455]

[0456] flame. Raw Material Sample Sample Sample GG

[0457] EE FF

[0458] Silica 5 5 5

[0459] Liquid Paraffin 15

[0460] Caprylic / Capric

[0461] triglycerides

[0462] Dimethicone 15

[0463] Urea crystals EP

[0464] Glycerol EP 1 1 1

[0465] polyacrylate

[0466] crosspolymer-6

[0467] Sodium lactate 10 10 10

[0468] soln 60%

[0469] Phenoxyethanol 1 1 1

[0470] EP

[0471] Lactic acid EP 1 1 1

[0472] Ethylhexylglycerin 3 3 3

[0473] Polyvinylpyrrolido 0.5 0.5 0.5

[0474] ne EP

[0475] Water Purified EP 63.5 63.5 78.5

[0476] Flammability Massive Massive Two samples caught fire

[0477] assessment flame flame easily. Flame properly

[0478] comments formed, similar if not

[0479] slightly bigger than

[0480] untreated control. The

[0481] third replicate struggled

[0482] to catch fire but the

[0483] fabric did burn all the

[0484]

[0485] way through.

[0486] Table 15

[0487] As can be seen from Table 15, Samples P to Z and AA to CC are samples of the present invention and Samples DD to GG are comparative samples. The formulations of the present invention showed extremely little or no burning when tested for flammability in the same manner as in Example 1. It can therefore be seen that the combination of urea and glycerol in a formulation as required by the present invention results in a formulation, in this case an emollient, that resists burning even when further flammable components such as squalene, liquid paraffin, caprylic / capric triglycerides, dimethicone, IPM, castor oil or silicone elastomer are added to the formulation. Samples P, Q, R and S all contained 15% of a further flammable component and samples BB, CC and DD each contained 15% liquid paraffin and only 10% urea in samples BB and CC.

[0488] Despite Samples EE-FF comprising silica, a known flame retarding additive, each sample caught fire.

[0489] Example 7

[0490] Samples HH to YY were formulated as shown in Table 16-18 below and the flammability of 100% cotton sheet was assessed when coated with these samples using the same process as in Example 1. The results are also shown in Tables 16-18.

[0491] Raw material HH II JJ KK LL MM

[0492] (wt.%)

[0493] Squalene 5.00

[0494] Liquid paraffin 5.00

[0495] Caprylic / Capric 5.00

[0496] triglycerides

[0497] Dimethicone 5.00

[0498] IPM 5.00

[0499] Castor oil 5.00

[0500] Urea crystals 1.00 1.00 1.00 1.00 1.00 1.00

[0501] Glycerol 1.00 1.00 1.00 1.00 1.00 1.00 Polyacrylate 2.00 2.00 2.00 2.00 2.00 2.00 crosspolymer-6

[0502] Sodium lactate soln 10.00 10.00 10.00 10.00 10.00 10.00

[0503] 60%

[0504] Phenoxyethanol 1.00 1.00 1.00 1.00 1.00 1.00

[0505] Lactic acid 1.00 1.00 1.00 1.00 1.00 1.00 Ethylhexylglycerin 3.00 3.00 3.00 3.00 3.00 3.00 Polyvinylpyrrolidone 0.50 0.50 0.50 0.50 0.50 0.50

[0506]

[0507] Water Purified 75.5 75.5 75.5 75.5 75.5 75.5 Flammability Massive Massive Massive No Massive Massive assessment burning.

[0508] comments flame. flame. flame. flame. flame.

[0509]

[0510] Table 16

[0511] Raw material NN OO PP QQ RR SS (wt.%)

[0512] Squalene 15.00

[0513] Liquid paraffin 15.00

[0514] Caprylic / Capric 15.00

[0515] triglycerides

[0516] Dimethicone 15.00

[0517] IPM 15.00 Castor oil 15.00 Urea crystals 1.00 1.00 1.00 1.00 1.00 1.00 Glycerol 1.00 1.00 1.00 1.00 1.00 1.00 Polyacrylate 2.00 2.00 2.00 2.00 2.00 2.00 crosspolymer-6

[0518] Sodium lactate soln 10.00 10.00 10.00 10.00 10.00 10.00 60%

[0519] Phenoxyethanol 1.00 1.00 1.00 1.00 1.00 1.00 Lactic acid 1.00 1.00 1.00 1.00 1.00 1.00 Ethylhexylglycerin 3.00 3.00 3.00 3.00 3.00 3.00 Polyvinylpyrrolidone 0.50 0.50 0.50 0.50 0.50 0.50 Water Purified 65.5 65.5 65.5 65.5 65.5 65.5 Flammability Massive Massive Massive No Massive Massive assessment burning.

[0520] comments flame. flame. flame. flame. flame.

[0521]

[0522] Table 17

[0523] Raw material TT UU VV WW XX YY

[0524] (wt.%)

[0525] Squalene 20.00

[0526] Liquid paraffin 20.00

[0527] Caprylic / Capric 20.00

[0528] triglycerides

[0529] Dimethicone 20.00

[0530] IPM 20.00

[0531] Castor oil 20.00

[0532] Urea crystals 1.00 1.00 1.00 1.00 1.00 1.00 Glycerol 1.00 1.00 1.00 1.00 1.00 1.00 Polyacrylate 2.00 2.00 2.00 2.00 2.00 2.00 crosspolymer-6

[0533] Sodium lactate soln 10.00 10.00 10.00 10.00 10.00 10.00

[0534] 60%

[0535] Phenoxyethanol 1.00 1.00 1.00 1.00 1.00 1.00

[0536] Lactic acid 1.00 1.00 1.00 1.00 1.00 1.00 Ethylhexylglycerin 3.00 3.00 3.00 3.00 3.00 3.00 Polyvinylpyrrolidone 0.50 0.50 0.50 0.50 0.50 0.50

[0537] Water Purified 56.5 56.5 56.5 56.5 56.5 56.5 Flammability Massive Massive Massive No Massive No assessment burning. burning. comments flame. flame. flame. flame.

[0538]

[0539] Table 18

[0540] As can be seen from Tables 16-18, the samples comprising most oils caught fire, though those containing dimethicone or 20 wt.% castor oil did not.

[0541] Example 8 Samples were prepared comprising urea crystals and glycerol, in amounts shown in Table 20 (wt.%), and the additional components of Table 19 (wt.%). The flammability of 100% cotton sheet was assessed when coated with these samples using the same process as in Example 1. The results are shown in Table 20.

[0542] Polyacrylate 2.00

[0543] crosspolymer-6

[0544] Sodium lactate soln 10.00

[0545] 60%

[0546] Phenoxyethanol 1.00

[0547] Lactic acid 1.00

[0548] Ethylhexylglycerin 3.00

[0549] Polyvinylpyrrolidone 0.50

[0550] Water Purified Balance

[0551]

[0552] Table 19

[0553] Urea Glycerol Flame retarding?

[0554] 25% 0 Yes

[0555] 20% 5% Yes

[0556] 5% 1% Yes

[0557] 2% 1% Yes

[0558] 1% 1% Yes

[0559] 20% 10% Yes

[0560] 20% 20% Yes

[0561] 30% 5% Yes

[0562] 30% 10% Yes

[0563] 30% 20% Yes

[0564]

[0565] Table 20 The foregoing detailed description has been provided by way of explanation and illustration, and is not intended to limit the scope of the appended claims. Many variations in the presently preferred embodiments illustrated herein will be apparent to one of ordinary skill in the art and remain within the scope of the appended claims and their equivalents.

Claims

CLAIMS1. Use of urea in a topical formulation as an additive for increasing the flame retardancy of the topical formulation.

2. The use of claim 1, wherein the topical formulation is an emollient.

3. The use of claim 1 or claim 2, wherein the topical formulation comprises from 0.1 to 50 wt.% of the urea, preferably from 1 to 45 wt.% of the urea, more preferably from 5 to 40 wt.% of the urea, even more preferably from 10 to 30 wt.% of the urea, based on the total weight of the topical formulation comprising the urea.

4. The use of any preceding claim, wherein the topical formulation comprises a humectant other than urea, preferably wherein the humectant other than urea comprises one or more of glycerol, propylene glycol, butylene glycol, hexylene glycol, diglycerin, polyglycerin, sorbitol, mannitol, xylitol, erythritol, sodium lactate, potassium lactate, zinc lactate, magnesium lactate, sodium pyrrolidone carboxylic acid (PCA), potassium PCA, sodium gluconate, sodium citrate and a phosphate salt.

5. The use of claim 4, wherein the topical formulation comprises from 1 to 20 wt.% of the humectant other than urea, preferably from 5 to 15 wt.% of the humectant other than urea, based on the total weight of the topical formulation comprising the urea.

6. The use of claim 4 or 5, wherein the humectant other than urea comprises:(i) one or more of glycerol, propylene glycol, butylene glycol, hexylene glycol, diglycerin, polyglycerin, sorbitol, mannitol, xylitol and erythritol, preferably glycerol, and / or (ii) one or more of sodium lactate, potassium lactate, zinc lactate, magnesium lactate, sodium pyrrolidone carboxylic acid (PCA), potassium PCA, sodium gluconate, sodium citrate and a phosphate salt, preferably sodium lactate.

7. The use of claim 6, wherein:the topical formulation comprises from 0.1 to 20 wt.% of the (i) one or more of glycerol, propylene glycol, butylene glycol, hexylene glycol, diglycerin, polyglycerin, sorbitol, mannitol, xylitol and erythritol, preferably from 1 to 15 wt.% of the (i) one or more of glycerol, propylene glycol, butylene glycol, hexylene glycol, diglycerin, polyglycerin,sorbitol, mannitol, xylitol and erythritol, more preferably from 2 to 10 wt.% of the (i) one or more of glycerol, propylene glycol, butylene glycol, hexylene glycol, diglycerin, polyglycerin, sorbitol, mannitol, xylitol and erythritol, based on the total weight of the topical formulation comprising the urea; and / orthe topical formulation comprises from 0.1 to 15 wt.% of the (ii) one or more of sodium lactate, potassium lactate, zinc lactate, magnesium lactate, sodium pyrrolidone carboxylic acid (PCA), potassium PCA, sodium gluconate, sodium citrate and a phosphate salt, more preferably from 1 to 12 wt.% of the (ii) one or more of sodium lactate, potassium lactate, zinc lactate, magnesium lactate, sodium pyrrolidone carboxylic acid (PCA), potassium PCA, sodium gluconate, sodium citrate and a phosphate salt, even more preferably from 2 to 10 wt.% of the (ii) one or more of sodium lactate, potassium lactate, zinc lactate, magnesium lactate, sodium pyrrolidone carboxylic acid (PCA), potassium PCA, sodium gluconate, sodium citrate and a phosphate salt, based on the total weight of the topical formulation comprising the urea.

8. The use of claim 6 or claim 7, wherein the topical formulation comprises (i) one or more of glycerol, propylene glycol, butylene glycol, hexylene glycol, diglycerin, polyglycerin, sorbitol, mannitol, xylitol and erythritol, preferably glycerol, andthe content of the urea in the topical formulation, based on the total weight of the topical formulation comprising the urea, is greater than or equal to the content of the (i) one or more of glycerol, propylene glycol, butylene glycol, hexylene glycol, diglycerin, polyglycerin, sorbitol, mannitol, xylitol and erythritol in the topical formulation, based on the total weight of the topical formulation comprising the urea.

9. The use of claim 8, wherein the content of the urea in the topical formulation, based on the total weight of the topical formulation comprising the urea, is greater than or equal to the content of the (i) one or more of glycerol, propylene glycol, butylene glycol, hexylene glycol, diglycerin, polyglycerin, sorbitol, mannitol, xylitol and erythritol in the topical formulation, based on the total weight of the topical formulation comprising the urea; and wherein when the content of the (i) one or more of glycerol, propylene glycol, butylene glycol, hexylene glycol, diglycerin, polyglycerin, sorbitol, mannitol, xylitol and erythritol in the topical formulation, based on the total weight of the topical formulation comprising the urea, is from 5 to 10 wt.%, then the content of the urea in the topical formulation, based on the total weight of the topical formulation comprising the urea, is at least twice the content of the (i) one or more of glycerol, propylene glycol, butylene glycol, hexylene glycol,diglycerin, polyglycerin, sorbitol, mannitol, xylitol and erythritol in the topical formulation, based on the total weight of the topical formulation comprising the urea.

10. The use of any preceding claim, wherein the topical formulation comprises one or more of lactic acid, citric acid, glycolic acid, gluconic acid and ascorbic acid, preferably lactic acid.

11. The use of claim 10, wherein the topical formulation comprises from 0.1 to 2 wt.%, preferably from 0.5 to 1.5 wt.%, of the one or more of lactic acid, citric acid, glycolic acid, gluconic acid and ascorbic acid, based on the total weight of the topical formulation comprising the urea.

12. The use of any preceding claim, wherein the topical formulation comprises one or more of polyvinyl pyrrolidone (PVP), pullulan, hydroxypropyl methylcellulose (HPMC), hydroxyethylcellulose (HEC), carboxymethylcellulose (CMC), alginates and carrageenan, preferably PVP.

13. The use of claim 12, wherein the topical formulation comprises from 0.1 to 5 wt.%, preferably from 0.2 to 2 wt.%, more preferably from 0.3 to 1 wt.%, of the one or more of polyvinyl pyrrolidone (PVP), pullulan, hydroxypropyl methylcellulose (HPMC), hydroxyethylcellulose (HEC), carboxymethylcellulose (CMC), alginates and carrageenan, based on the total weight of the topical formulation comprising the urea.

14. The use of any preceding claim, wherein the topical formulation comprises a thickening agent, preferably a polymeric thickening agent.

15. The use of claim 14, wherein the thickening agent comprises one or more of polyacrylate crosspolymer-6 (such as Sepimax Zen), a carbomer, ammonium acryloyldimethyltaurate / VP copolymer, Pemulen TR, hydroxypropyl starch phosphate, xanthan gum, guar gum and biosaccharide gum-1, preferably polyacrylate crosspolymer-6.

16. The use of claim 14 or claim 15, wherein the topical formulation comprises from 0.5 to 4 wt.% of the thickening agent, preferably from 1 to 3 wt.% of the thickening agent, based on the total weight of the topical formulation comprising the urea.

17. The use of any preceding claim, wherein the topical formulation comprises one or more of phenoxyethanol, ethylhexylglycerin, caprylyl glycol, glyceryl caprylate, pentylene glycol, levulinic acid, anisic acid and benzyl alcohol, preferably phenoxyethanol and / or ethylhexylglycerin.

18. The use of claim 17, wherein the topical formulation comprises from 0.1 to 5 wt.% of the one or more of phenoxyethanol, ethylhexylglycerin, caprylyl glycol, glyceryl caprylate, pentylene glycol, levulinic acid, anisic acid and benzyl alcohol, based on the total weight of the topical formulation comprising the urea.

19. The use of claim 18, wherein the topical formulation comprises from 0.3 to 1 wt.% phenoxyethanol and / or from 0.1 to 4 wt.%, preferably from 1 to 3 wt.%, ethylhexylglycerin, based on the total weight of the topical formulation comprising the urea.

20. The use of any preceding claim, wherein the topical formulation comprises less than 1 wt.%, preferably less than 0.1 wt.%, more preferably less than 0.01 wt.%, even more preferably less than 0.001 wt.% oils, based on the total weight of the topical formulation comprising the urea, even more preferably wherein the topical formulation is free of oils.

21. The use of any of claims 1 to 19, wherein the topical formulation comprises dimethicone, preferably from 1 to 20 wt.%, more preferably from 5 to 15 wt.% dimethicone, based on the total weight of the topical formulation comprising the urea.

22. The use of any preceding claim, wherein the topical formulation is water-based, preferably wherein the topical formulation comprises at least 30 wt.% water, at least 40 wt.% water, at least 50 wt.% water, at least 60 wt.% water, at least 70 wt.% water, at least 75 wt.% water or at least 80 wt.% water, based on the total weight of the topical formulation comprising the urea.

23. The use of any preceding claim, wherein the topical formulation is for use in the treatment or prevention of skin conditions.

24. The use of claim 23, wherein the skin condition is eczema, dermatitis, psoriasis, elderly dry and itchy skin, ichthyosis, any other dry and / or itchy skin condition, preferably wherein the skin condition is eczema, dermatitis, psoriasis, elderly dry and itchy skin or ichthyosis.

25. The use of claim 24, wherein the skin condition is a rash or infection.

26. The use of any preceding claim, wherein the topical formulation suppresses the flammability of a fabric compared to that of an untreated fabric when coated with the topical formulation four times at a weight of 12.5 mg / cm2.

27. The use of any preceding claim, wherein the topical formulation comprises, based on the total weight of the topical formulation comprising the urea:from 5 to 15 wt.% urea, preferably from 8 to 12 wt.% urea, more preferably from 9 to 11 wt.% urea;from 5 to 15 wt.% sodium lactate preferably from 8 to 12 wt.% sodium lactate, more preferably from 9 to 11 wt.% sodium lactate;from 1 to 5 wt.% ethylhexylglycerin, preferably from 2 to 4 wt.% ethylhexylglycerin, more preferably from 2.5 to 3.5 wt.% ethylhexylglycerin;from 1 to 3 wt.% of a polymeric thickening agent, preferably from 1.5 to 2.5 wt.% of a polymeric thickening agent, preferably wherein the thickening agent comprises polyacrylate crosspolymer-6;from 0.1 to 2 wt.% lactic acid, preferably from 0.5 to 1.5 wt.% lactic acid;from 0.1 to 2 wt.% glycerol, preferably from 0.5 to 1.5 wt.% glycerol;from 0.1 to 2 wt.% phenoxyethanol, preferably from 0.5 to 1.5 wt.% phenoxyethanol; andfrom 0.1 to 1 wt.% polyvinyl pyrrolidone (PVP), preferably from 0.3 to 0.7 wt.% PVP.

28. The use of claim 27, wherein the topical formulation consists of, based on the total weight of the topical formulation comprising the urea:from 5 to 15 wt.% urea, preferably from 8 to 12 wt.% urea, more preferably from 9 to 11 wt.% urea;from 5 to 15 wt.% sodium lactate preferably from 8 to 12 wt.% sodium lactate, more preferably from 9 to 11 wt.% sodium lactate;from 1 to 5 wt.% ethylhexylglycerin, preferably from 2 to 4 wt.% ethylhexylglycerin, more preferably from 2.5 to 3.5 wt.% ethylhexylglycerin;from 1 to 3 wt.% of a polymeric thickening agent, preferably from 1.5 to 2.5 wt.% of a polymeric thickening agent, preferably wherein the thickening agent comprises polyacrylate crosspolymer-6;from 0.1 to 2 wt.% lactic acid, preferably from 0.5 to 1.5 wt.% lactic acid;from 0.1 to 2 wt.% glycerol, preferably from 0.5 to 1.5 wt.% glycerol;from 0.1 to 2 wt.% phenoxyethanol, preferably from 0.5 to 1.5 wt.% phenoxyethanol;from 0.1 to 1 wt.% polyvinyl pyrrolidone (PVP), preferably from 0.3 to 0.7 wt.% PVP; andthe balance water together with any unavoidable impurities.

29. A topical formulation comprising, based on the total weight of the topical formulation:from 5 to 15 wt.% urea, preferably from 8 to 12 wt.% urea, more preferably from 9 to 11 wt.% urea;from 5 to 15 wt.% sodium lactate preferably from 8 to 12 wt.% sodium lactate, more preferably from 9 to 11 wt.% sodium lactate;from 1 to 5 wt.% ethylhexylglycerin, preferably from 2 to 4 wt.% ethylhexylglycerin, more preferably from 2.5 to 3.5 wt.% ethylhexylglycerin;from 1 to 3 wt.% of a polymeric thickening agent, preferably from 1.5 to 2.5 wt.% of a polymeric thickening agent, preferably wherein the thickening agent comprises polyacrylate crosspolymer-6;from 0.1 to 2 wt.% lactic acid, preferably from 0.5 to 1.5 wt.% lactic acid;from 0.1 to 2 wt.% glycerol, preferably from 0.5 to 1.5 wt.% glycerol;from 0.1 to 2 wt.% phenoxyethanol, preferably from 0.5 to 1.5 wt.% phenoxyethanol; andfrom 0.1 to 1 wt.% polyvinyl pyrrolidone (PVP), preferably from 0.3 to 0.7 wt.% PVP.

30. The topical formulation of claim 29, wherein the topical formulation consists of the recited components, with the balance being water together with any unavoidable impurities.

31. A process for preparing a topical formulation, the process comprising including urea in the formulation for the purpose of increasing the flame retardancy of the topical formulation.

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