Stable emulsion for prevention of skin irritation and items using same.

(54) Title: STABLE EMULSION FOR THE PREVENTION OF SKIN IRRITATION AND ARTICLES CONTAINING THE EMULSION.

(54) Title: STABLE EMULSION FOR PREVENTION OF SKIN IRRITATION AND ITEMS USING SAME.

(57) Summary

An emulsion suitable for incorporation into wet wipes used to clean urine and fecal matter from the skin. The emulsion includes silicone oil and water-soluble zinc salt, such as zinc chloride and zinc sulfate. Phase separation is prevented with an emulsification system that includes a rubber mixture and a salt tolerant emulsifier. The gum blend includes at least one type of gum and propylene glycol alginate.

(57) Abstract

An emulsion suitable for incorporated into wet wipes used to clean uriñe and fecal matter from the skin. The emulsion includes silicone oil and water-soluble zinc salt such as zinc chloride and zinc sulfate. Phase separation is prevented with an emulsification system that includes a gum blend and salt-tolerant emulsifier. The gum blend is included at least one gum and propylene glycol alginate.

<img file="MX354116B_D0001.tif" />

PATENT TITLE No. 354116

<img file="MX354116B_D0002.tif" />

Owner (s): D micilio:

KIMBERLY-CLARK WORLDWIDE, INC.

2300 Winchester Road, Neenah, Wisconsin, 54956, USA

D nomination:

STABLE EMULSION FOR THE PREVENTION OF SKIN IRRITATION AND ARTICLES CONTAINING THE EMULSION.

Inventor (s)

CIP:

A61K8 / 8J

Classification;

CPC:

The patent of reference

<img file="MX354116B_D0003.tif" />

the * 1 ^ 8/37; A61K8 / 55; A61K8 / 062;

articles' articles

MX / a / 201¿ »4í864 pbfeí

Validity: See me

VtaUiien Date

Ex sheet

In accordance with the article from the date of prese

<img file="MX354116B_D0004.tif" />

3; A61K8 / 92

VERIC MU

Who subscribes to this title is (Official Gazette of the Federation 01/25/2006, 06/05 / 2009,06 / 61/2010, Regulations of the Mexican Institute of articles 1^or, 3^or, 4^or, 5^or fraction V subsection a), '1 12/27/1999, amended on 10/10/2002, 07/29/20 Deputy Generals, Coordinator, Departmental Directors and other subordinates of the Mexican Institute 08/04/2004 and 09/13/2004 2007).

mesto

A61K8 / 27; A61K8 / 34; A61K8 / 37;

JAN 't (| lEF&gt; ER; COREY THOMAS

W '

NntetiuKfional;

hey of the

Industrial.

carry over, counted to s.

the Industrial Property Law

Ί999, 01/26/2004, 06/16/2005, ha), 4^or and 12th sections I and III of (ΟβΤΓ5 / 07/2004. 28/07/2004 and 7/09/2007): exican of Industrial Property (DOF. Agreement that delegates powers to the Directors ales, Divisional Deputy Directors, Coordinators trial. (DOF 12/15/1999, amended on 02/04/2000, 07/29/2004,

This letter is signed with an advanced electronic signature (FIEL), based on articles 7 BIS 2 of the Industrial Property Law; 3 of its Regulations, and 1 fraction III, 2 fraction V, 26 BIS and 26 TER of the Agreement establishing the guidelines for the use of the Electronic Payment and Services Portal (PASE) of the Mexican Institute of Industrial Property, in the procedures indicated.

THE DIVISIONAL DIRECTOR OF PATENTS

NAHANNY CANAL REYES

<img file="MX354116B_D0005.tif" />

Original string:

NAHANNY MARISOL CANAL REYES | 00001000000403252793 | Administration Service

Tax | 1695 || MX / 2018/13353 | MX / a / 2014/015864 | Patent title PCT | 1027 | RGZ | Page (s) 2 | CaFGerrH / PgZeKR + idvUoxjl5zl =

Digital stamp:

Mt3QJ / PZ5OxlDnqB6IU7vJDCftBtGEK12u87RHYuYRpGoinUty7CKWhl2Bbqj9MiV2JyhH6tvbxnf + UeChYypqvB6m UoDcn6GJEZL nOrv1EDOLH4p6NepBuof1pv + + + 8G5DtiEbLNwjnEwR147QjX uZ8Uvk + Yj2kulsYBZqCVvZ1BgKHCxAw + E + hhKLVx11MbUcQgEoW6TgUk7df6Xr2rtMXqlgNbmtUNYyw / thZHoXIGIHcZTULuWZBG4IKjbJtBTLheyY + YK5Txw vNRwF / VrPU81 + foXhOYaR3BSg3WBIYNctChpD4l / pHhilfQCGEslvNeKu3PNrcfa31imflA == * Additional information on the back

Arenal No. 550, Floor 1, Pueblo Santa María Tepepan, Xochimilco, 16020, Mexico City.

(55) 53340700 www.gob.mx/impi

<img file="MX354116B_D0006.tif" />

MX / 2018/13353

Continuation of the Symb I d Cia ification

Classification: CIP: A61K8 / 55; A61K8 / 60; A61K8 / 73; A61K8 / 89; A61K8 / 92; A61Q19 / 00

CPC: A61K8 / 0208; A61K8 / 342; A61K8 / 416; A61K8 / 602; A61K8 / 733; A61K8 / 737;

A61K8 / 4973; A61Q19 / 00; A61K2800 / 75; A61K2800 / 594

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STABLE EMULSION FOR THE PREVENTION OF IRRITATION

SKIN AND ARTICLES CONTAINING THE EMULSION

FIELD OF THE INVENTION

The present disclosure generally relates to an emulsion formulation including a combination of a rubber mixture and a salt tolerant emulsifier, and articles containing the emulsion. The combination provides physical stability to an emulsion containing zinc salts and silicone oil. The formulation of the present description is useful for the prevention of rashes and can be applied to the skin with a wipe impregnated with the emulsion or in various other ways.

BACKGROUND OF THE INVENTION

Wet wipes have been used for years to conveniently cleanse the skin between diaper changes. Much progress has been made in creating wet wipe formulations. The formulations are available in the form of emulsions that serve as a vehicle for the application of active ingredients on the skin. The ingredients can be used to treat and / or prevent a diaper rash.

Diaper rash is a form of contact dermatitis that affects babies or people with incontinence, and occurs when absorbent clothing

Ref.:253325

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<img file="MX354116B_D0009.tif" />

IMPI

INSTtT'i '. MEXICAN. «I» OF THE Λ »™

INDvriTRlAL damp and / or stained do not change quickly. Due to the practical impossibility of attending quickly all the needs of one receive a high level of person, even those who care sometimes have a rash caused by the diaper.

Recently, it has come to be understood that the initial stages of some types of rash are the result of skin irritation produced by contact with digestive enzymes present in the faeces, particularly trypsin, chymotrypsin elastase. These enzymes are proteolytic enzymes that are produced in the gastrointestinal tract to digest food.

Similar conditions tend to produce skin irritation due to proteolytic enzymes present in the faeces in patients with colostomies. These patients would also benefit from improved treatments for the prevention of skin irritation due to fecal enzymes.

Silicone oil is a commonly used active ingredient that acts as a protective barrier for the skin and prevents diaper rash. While there are several methods of achieving stable silicone oil emulsions at concentrations consistent with its use as an over-the-counter drug, there are several disadvantages associated with these methods.

First of all, the

<img file="MX354116B_D0010.tif" />

emulsifier concentration required to successfully stabilize an emulsion containing silicone oil, e.g. ex. , dimethicone, can be so high that its cost can be prohibitive. Second, obtaining a low-viscosity aerosol solution can be difficult due to the high probability that silicone oil droplets will fuse, particularly at the high temperatures to which the solution may be exposed. Third, without proper modification of the water phase rheology, low-viscosity, low-solids emulsions tend to phase separate, particularly after a freeze-thaw cycle. This results in a non-uniform product that would not be effective.

Sometimes just a protective skin barrier is not enough to prevent a diaper rash, especially in the presence of stool. Accordingly, it is also desirable to inhibit skin irritants, such as proteolytic enzymes. One way to inhibit enzymes is to apply a water-soluble zinc salt to the skin. Zinc has long been known to soothe irritated skin / prevent skin irritation. However, zinc salts are not very compatible with silicone oils because when combined in an emulsion, the emulsion can separate into phases due to increased ionic strength.

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In view of the above, it is necessary to create an emulsion that contains silicone oil as an active ingredient and does not phase separate even in the presence of zinc salts. It is even more necessary to cost-effectively stabilize an emulsion containing silicone oil. It would be a further advantage if the emulsion were sprayable on a substrate during the manufacture of a wet wipe. Furthermore, there is a need to preserve the emulsion without causing phase separation, especially if the emulsion is to be applied to a substrate.

BRIEF DESCRIPTION OF THE INVENTION

Unexpectedly, it has been found that stable emulsions containing silicone oil and zinc salts can be formed by a salt tolerant emulsifier and a rubber mixture. In particular, the gum mixture contains one or more types of gums and propylene glycol alginate. One or more of the following types of gums may be suitable: xanthan gum, guar gum, gellan gum, acacia gum, cellulose gum, dehydroxantane gum, sclerotium gum, and garrotin gum. The emulsion is not only stable, but has a viscosity low enough to be sprayable in order to be applied to a wipe substrate.

Without theoretical restrictions, it is believed that alginate from

<img file="MX354116B_D0011.tif" />

MEXICAN INSTITUTE · / „&lt;&gt; · '* £ .rS **', OF. IA PRCNi-DAD Cjurtwe.VL »* · INDUSTRIAL propylene glycol in combination with one or more rubbers provides better freeze-thaw stability not only by increasing the density of the water phase, but also by imparting additional emulsification. Furthermore, the gums are also salt tolerant as opposed to typical rheology modifiers such as acrylates, carbomers, polyquaternium-37, etc.

An emulsion for the prevention of skin irritation; the emulsion comprises the following: a salt tolerant emulsifier;

a gum mixture comprising a type of gum and propylene glycol alginate, where the gum mixture is 0.01% to 0.5% by weight of the emulsion; 1% to 10% by weight of silicone oil; 90% to 98% by weight of water; and 0.2 0 to 10% by weight of water-soluble zinc salt. The emulsion can be applied to a substrate.

The advantages of the composition of the present description include, at least, the following: cost effectiveness due to lower concentrations of emulsifier, the possibility of being able to be applied to a substrate of wipes by spraying and physical stability.

DETAILED DESCRIPTION OF THE INVENTION

The present description is directed to an emulsion used for the prevention of skin irritation that includes, among other ingredients, an emulsifying system.

<img file="MX354116B_D0012.tif" />

INSTITUTO MÍXICAN- 'DF. LA * »» *&gt; industrial

<img file="MX354116B_D0013.tif" />

The emulsifying system is an emulsifier in combination with a mixture of propylene glycol gum and alginate.

Surprisingly, the emulsion with its emulsifying system remains physically stable when water soluble zinc salts and dimethicone (from about 1% to about 10% by weight) are combined in the emulsion.

Generally, the emulsion of the present disclosure contains a carrier medium, a barrier composition, an emulsifying system, and a stability enhancement system. Additional ingredients, eg, may be added to the emulsion. eg, fragrance, plant products, pH adjusting agents, buffers, preservatives, moisturizers, among others.

Carrier medium:

Ideally, water serves as a means of transporting silicone oil and zinc salts on the skin in an aesthetically pleasing manner and with a suitable viscosity, as discussed herein. In addition, the water helps to moisten the substrate of the wipes product, which incorporates the emulsion. Generally, the emulsions of the present disclosure include from about 90% by weight to about 98% by weight of water, which includes from about 92% by weight to about 97% by weight and about 94 % by weight to about 96% by weight.

Barrier composition:

a barrier composition that

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INDUSTrilÁl.

Emulsions include serves to protect the skin from digestive enzymes. The components of the barrier composition include silicone oils and water soluble zinc salts.

Silicone oil

The emulsions of the present disclosure include silicone oil, sometimes called polymerized dimethylsiloxane. Silicone oil is an active ingredient that works mainly as a skin protector, since it provides a barrier against humidity (urine, perspiration and general humidity) and, secondarily, as an emollient. Desirable silicone oils are those that impart a tactile impression of softness and smoothness, and that do not impart an excessive tactile perception of greasiness, oiliness, or coating when incorporated into the emulsion. Non-volatile silicone oils may be more desirable than volatile silicone oils. Non-volatile silicone oils tend to remain stable when exposed to the environment, tend to provide a long-lasting tactile impression, and tend to form a stable oil layer on the skin. Mixtures of silicone oils can be used. For example, volatile silicone oils can be combined with non-volatile silicone oils to impart desirable aesthetic properties as long as the emulsion contains enough silicone

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MEXICAN INSTITUTE $

FROM THE MOHHUrtb tNDUSTKIAL · »volatile eyno to provide a skin protective barrier layer that is effective for a given application.

In one aspect, the silicone oil is dimethicone (linear polydimethylsiloxane).

In this aspect of the disclosure, the emulsions of the present disclosure include from about 1% by weight to about 10% by weight of dimethicone, included from about 1% by weight to about 5% by weight, and included from about 1% by weight to about 3% by weight. Other examples of silicone oils that are suitable for use herein include dimethiconol, ethoxylated dimethicone (linear and pendular varieties), amodimethicone and its derivatives, cyclomethicone, alkyl substituted derivatives, such as stearyl dimethicone and behenyl dimethicone, phenyltrimethicone, and mixtures between these. Silicones are commercially available, for example, from the Dow Coming Company, in Midland, Mich. with the names XIAMETER PMX-200 silicone fluid (dimethicone), XIAMETER PMX-1184 silicone fluid (trisiloxane and dimethicone), DOW CORNING 1403 fluid (dimethicone and dimethiconol), DOW CORNING 1501 fluid (cyclopentasiloxane and dimethiconol), DOW CORNING fluid 593 (dimethicone and trimethylsiloxysilicate), DOW CORNING 2502 fluid (cetyldimethicone) and DOW CORNING 558 fluid (phenyltrimethicone).

<img file="MX354116B_D0014.tif" />

<img file="MX354116B_D0015.tif" />

MLXICANC INSTITUTE

Say LA PSOWÍDAD

INDUSTRIAL

Zinc salt ................

In one aspect of the present disclosure, desirable sources of zinc ions are zinc chloride and zinc sulfate. In other aspects of the present disclosure, sources of zinc ions include non-covalent zinc compounds, such as zinc acetate, zinc carbonate, zinc nitrate, zinc phosphate, zinc hydroxide, zinc fluoride, zinc bromide, zinc iodide, zinc sulphite, zinc citrate, zinc lactate, zinc salicylate, zinc gluconate, zinc glycinate, zinc glutamate, and zinc stearate. Zinc oxide, a covalent zinc compound, is specifically excluded.

Ideally, the zinc compounds, the salts, are from about 0.20% to about 10% by weight of the emulsion.

Emulsifying system:

In addition to the vehicle and the barrier composition, the emulsions of the present disclosure include an emulsifying system for forming oil-in-water emulsions. The emulsifying system is a synergistic combination of specific ingredients that stabilize other components of the formulation that would not otherwise mix stably. It is capable of demulsifying once the entire formulation has been applied to the skin and thus forms a film of silicone oil on top of the skin. The system

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MEXICAN INSTITUTE

OF PROPHETY _K '- - ,, - s

INDUSTRIAL E '—---¹ Emulsifier does not tend to re-emulsify once the emulsion is applied to the skin and exposed to urine or other body fluids. This prevents silicone oil from being removed when an assault occurs.

Specifically, the emulsifier system contains a select group of phosphate esters along with two additional components, (a) a salt tolerant emulsifier and (b) a gum mixture.

Salt tolerant emulsifier

A desirable phosphate ester based emulsifying agent is similar in structure to phospholipids found in the skin. Therefore, it is substantial and compatible with the natural lipids of the skin. Like phospholipids, dialkyl phosphate esters have surfactant characteristics that tend to promote the formation of double-layered or lamellar structures.

Phosphate ester based emulsifying agents are formed by reacting phosphoric acid or its derivatives with one or more fatty alcohols, such as cetearyl alcohol, cetyl alcohol, or behenyl alcohol, resulting in an anionic compound. Phosphate esters are well known for their ability to retain active ingredients of interest, such as sunscreens or, in the present invention, ingredients to protect the

As described herein, select "anionic phosphate ester emulsified" were compatible with the zinc salts, which cause dispersion of cationic zinc ions when dissolved in the emulsion.

Ideally, the phosphate ester linker is very stable at high and low pH, giving it extreme pH tolerance. The emulsion characteristic of the ester depends on the degree of neutralization of the free acid groups.

Phosphate ester is an emulsifier with a mid-range HLB that is used to achieve uniform, small-particle, low-viscosity dispersions. It produces stable and well dispersed systems, even in products that contain a relatively high load of pigments and oils. The phosphate ester maintains its uniformity over time and is much less sensitive to shear rate. Furthermore, it forms foam-free emulsions and can be easily incorporated in the oil phase. Phosphate esters are generally used as primary emulsifying agents for formulations with percentages by weight of 0.5% to 5%. Additionally, phosphate esters can also be incorporated at lower levels as co-emulsifiers. The phosphate ester is present in a desired amount of about 0.5% to about 3% by weight of the emulsion, and even more ideally about 0.75% to about

<img file="MX354116B_D0016.tif" />

2% by weight of the emulsion.

In one aspect of the disclosure, a desired phosphate ester is available from Croda Inc. as

CRODAFOS CS20A.

Gemini Surfactants

Gemini surfactants are surfactants that contain multiple special classes of hydrophobic tails and multiple groups of hydrophilic heads within the same molecule. Gemini surfactants can be ten to one thousand times more active on the surface than conventional surfactants with similar but unique hydrophilic and hydrophobic groups on the molecule. Gemini surfactants can reduce skin irritation as well as work as emulsifiers.

Many Gemini surfactants were screened to create a stable emulsion containing dimethicone and clay, and surprisingly, the only Gemini surfactant that was found to work in an emulsion with 95.15% water was PEG15 ethylenedicocoamide disodium disulfate. In one aspect of the description, Gemini surfactant is mixed with behenyl alcohol, glyceryl stearate, and glyceryl stearate citrate, and is available in this form from Sasol North America, Inc. as CERALUTION H. Gemini surfactant is limited to the oil phase.

IMPI

MEXICAN INSTITUTE OF. Ι.Λ PK.Ct'IEUAO! N; IIISTHIAL

Gemini surfactants are considered to form networks of liquid crystalline lamellar gels in the oil phase causing very small oil droplet formation. The small droplet size and gel-like nature provide resistance against droplet coalescence, resulting in complete separation in the oil phase. Furthermore, Gemini surfactants have been shown to be non-HLB dependent for oil emulsification of typical ethoxylated fatty alcohols, ethoxylated fatty esters and other common non-Gemini emulsifiers.

Stability improvement system:

The stability enhancement system is a rubber blend that includes a single type of rubber or various types of rubber and propylene glycol alginate. A desirable gum mix is ​​made up of xanthan gum and guar gum. In certain applications, it may be advantageous to substitute xanthan gum and / or guar gum for gellan gum, acacia gum, cellulose gum, dehydroxantane gum, sclerotium gum, and locust bean gum.

Without theoretical restrictions, propylene glycol alginate is believed to improve freeze-thaw stability not only by increasing the density of the water phase, but also by imparting additional emulsification of silicone oil.

Ideally, the rubber blend is used in an amount of between about 0.01% to about 0.5% by weight of

<img file="MX354116B_D0017.tif" />

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MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY

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the emulsion.

Gums are rheology modifiers. Other classes of rheology modifiers, such as starches, can be used in combination with propylene glycol alginate, provided that a stable emulsion is achieved using less than 0.5% by weight of rheology modifiers and the viscosity of the formulation is less than 5000 cps, depending that obtained using a Brookfield DV-II viscometer with axis 5 at 6 rpm

Optional ingredients:

1) pH adjusting agent

The emulsions of the present disclosure may further include an agent for adjusting the pH. Agents are desirable for creating emulsions that have a pH equal to or close to that of human skin. Therefore, the pH will typically be adjusted as necessary so that the emulsion of the present disclosure has a pH of from 4 to 7 or, more preferably from 4.5 to 6.5. The pH can be adjusted by adding one or more agents to adjust the pH in an effective amount to provide the pH values ​​(effective amount). Agents that can be used to adjust the pH of the emulsions include organic and inorganic acids and bases. In one aspect of the present disclosure, a more desirable pH adjusting agent is malic acid.

<img file="MX354116B_D0019.tif" />

<img file="MX354116B_D0020.tif" />

INSTITUTO MEXICANO nn la lrohhuad industrial

For the most desirable emulsions of the present disclosure, the emulsion in the absence of a pH adjusting agent tends to be more basic than desired. Therefore, an acidic pH adjusting agent will typically be used to bring the emulsion to the desired pH. Acidic pH adjusting agents include organic acids, which are preferably relatively non-irritating. Acids include malic acid, citric acid, acetic acid, propionic acid, oxalic acid, glycolic acid, malonic acid, lactic acid, succinic acid, tartaric acid, aspartic acid, maleic acid, glutaric acid, glutamic acid, gluconic acid, sorbic acid. , benzoic acid, ascorbic acid, salicylic acid and mixtures of these.

The amount of the pH adjusting agent used depends on the equivalent weight of the pH adjusting agent and the desired pH. Typically, the pH adjusting agent is used in an amount of about 0.05% to about 0.5% by weight of the emulsion. The desirable emulsions of the present disclosure include from about 0.1% to about 0.5%, typically, from about 0.2% to about 0.3% of the pH adjusting agent.

2) Conservatives

Preservatives act in one or more ways to improve the shelf life of emulsions and the products that incorporate them. For example, the preservative can be an antimicrobial agent, an agent

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MLXICAN INSTITUTE · '

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INDUSTRIAL

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antibacterial, an antifungal agent, or a combination of these.

Antimicrobial agents herein include, but are not limited to, benzethonium chloride, benzisothiazolinone, benzoic acid, benzyl alcohol, 2-bromo-2-nitropropane-l, 3-diol, butylparaben, caprylylglycol, chlorhexidine digluconate, DMDM ​​hydantoin, diazolidinyl urea, dehydroacetic acid, ethylparaben, iodopropynyl butylcarbamate, methylchloroisothiazolinone, methylisothiazolinone, methyldibromo glutanitrile, methylparaben, pentylene glycol, phenethyl alcohol, phectxyethanol, propylparaben, polyamine propyl biguanide, quatemium-15, salicylic acid, sodium benzoate, sodium methyl paraben, sodium dehydroacetate, thymol, triclosan, and mixtures thereof.

In one aspect of the description, benzoic acid is used with or without phenoxyethanol. These compounds are effective in preventing the growth of a wide variety of microbes and are effective against fungal growth. Protection against microbes and fungi tends to be particularly desirable when the wipe product contains a porous substrate, eg, non-woven substrates.

Ideally, wet wipes have a shelf life of at least two years under storage conditions of around 75 ° F and 50% relative humidity. Certain agents can be used to achieve the desired term, one of which is an antimicrobial agent.

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The antimicrobial agent can be used at an effective rate to provide the desired shelf life (storage stability, i.e. microorganisms do not grow to a significant degree) (herein, alternately referred to as amount effective). This includes demonstrating sufficient antimicrobial activity according to the United States Pharmacopeia test titled Microbial Test, Antimicrobial Conservative: Efficacy.

3) Other

The emulsion of the present description may optionally include other ingredients, e.g. ex. , fragrance; acids to soothe the skin, such as aloe, lavender, chamomile, green tea, marigold, etc .; skin moisturizers (moisturizers), such as glycerin, propylene glycol, betaine, and hydroxyethyl urea; or emollients other than those previously described; powders, among others.

Viscosity:

While the examples herein show a highly aqueous emulsion, it is noted that emulsions with lower levels of water and hence higher viscosities may be desired, especially when applied to the skin by means other than a wet wipe. For example, the emulsion can be formulated to be a lotion, a gel, or a paste. However, for application to the wipe substrates described herein, it is desirable to have a viscosity at 25 ° C of about 5000 centipoise (cP) or less or, in other applications, 4000 Brookfield viscometer

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MEXICAN INSTITUTE

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DV-II with axis 5 at 6 rpm

Examples:

Table 1: Stable, highly aqueous, low viscosity dimethicone emulsions.

Table 2: Effect of 0.9% zinc chloride on the stability of the emulsion.

Table 3: Effect of zinc chloride concentration on the stability of the emulsion stability.

Table 4: Effect of zinc sulfate concentration on the stability of the emulsion stability.

Table 1

<td colspan="12">Table 1</td>

<td>Tradename</td><td>INCI name</td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td>

<td>Part A</td><td></td><td>F1</td><td>F2</td><td>F3</td><td>F4</td><td>F5</td><td>F6</td><td>F7</td><td>F8</td><td>F9</td><td>F10</td>

<td>Aqua</td><td>Aqua</td><td> 95.15</td><td> 95.15</td><td> 95.15</td><td> 95.15</td><td> 95.15</td><td> 95.15</td><td> 95.15</td><td> 95.15</td><td> 94.15</td><td> 94.15</td>

<td>ARAGUM3173</td><td>Xanthan gum (and) guar gum (and) alginate propylene glycol</td><td> 0.50</td><td> 0.50</td><td> 0.50</td><td> 0.50</td><td> 0.50</td><td> 0.50</td><td> 0.50</td><td> 0.50</td><td> 0.50</td><td> 0.50</td>

<td>PARTEB</td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td>

<td>CETIOL868</td><td>Ethylhexyl stearate</td><td> 0.50</td><td> 0.50</td><td> 0.50</td><td> 0.50</td><td> 0.50</td><td> 0.50</td><td> 0.50</td><td> 0.50</td><td> 0.50</td><td> 050</td>

<td>CETIOLSN</td><td>Cetearyl ionsonanoate</td><td> 0.50</td><td> 0.50</td><td> 0.50</td><td> 0.50</td><td> 0.50</td><td> 0.50</td><td> 0.50</td><td> 0.50</td><td> 0.50</td><td> 0.50</td>

<td>DC 200, 100 CST</td><td>Dimethicone</td><td> 1.50</td><td> 1.50</td><td> 1.50</td><td> 1.50</td><td> 1.50</td><td> 1.50</td><td> 1.50</td><td> 1.50</td><td> 1.50</td><td> 1.50</td>

<td>MONTANOV 202</td><td>Arachidyl alcohol (and) behenyl alcohol (and) arachidyl glycoside</td><td> 1.00</td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td>

<td>MONTANOV 68</td><td>Cetearyl alcohol (and) glucoside cetearyl</td><td></td><td> 1.00</td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td>

<td>MONTANOV 82</td><td>Cetearyl alcohol (and) coconut glucoside</td><td></td><td></td><td> 1.00</td><td></td><td></td><td></td><td></td><td></td><td></td><td></td>

<td>MONTANOV S</td><td>Coconut glycoside (and) coconut alcohol</td><td> —</td><td> —</td><td> —</td><td> 1.00</td><td> —</td><td> —</td><td> —</td><td> —</td><td> —</td><td> —</td>

<img file="MX354116B_D0022.tif" />

<td>MONTANOV L</td><td>C14-22 alcohols (y) C12-20 alkyl qlucoside</td><td></td><td></td><td></td><td></td><td> 1.00</td><td></td><td></td><td></td><td> ““</td><td></td>

<td>OLIVEM1000</td><td>Forget it Cetearyl (and) sorbitan olive tree</td><td></td><td></td><td></td><td></td><td></td><td> 1.00</td><td></td><td></td><td></td><td></td>

<td>INCROQUAT BEHENYL TMS-50</td><td>Methosulfate behentrimo-nio (y) cetyl alcohol (y) butilengli-col</td><td></td><td></td><td></td><td></td><td></td><td></td><td> 1.00</td><td></td><td></td><td></td>

<td>PR0LIPID151</td><td>Stearic acid (and) behenyl alcohol (and) glyceryl stearate (and) stearyl alcohol (and) cetyl alcohol (and) palmitic acid (and) hydroxyethyl cetearamidopropildi mo-nlo (and) myristyl alcohol</td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td> 1.00</td><td></td><td></td>

<td>AMPHISOLA</td><td>Cetyl phosphate</td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td> 1.00</td><td></td>

<td>CERALUTION H</td><td>Behenyl alcohol (and) glyceryl stearate (and) glyceryl stearate citrate (and) disodium ethylene glycol disulfate- coamide PEG-15</td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td> 2.00</td>

<td>PARTEO</td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td>

<td>PUROXS</td><td>Sodium benzoate</td><td> 0.45</td><td> 0.45</td><td> 0.45</td><td> 0.45</td><td> 0.45</td><td> 0.45</td><td> 0.45</td><td> 0.45</td><td> 0.45</td><td> 0.45</td>

<td>BRONIDOX 1160</td><td>Phenoxyet-nol</td><td> 0.40</td><td> 0.40</td><td> 0.40</td><td> 0.40</td><td> 0.40</td><td> 0.40</td><td> 0.40</td><td> 0.40</td><td> 0.40</td><td> 0.40</td>

Table 2

<td>Primary emulsifier</td><td>Stable in C / D</td><td>Stable at 50C; one week</td><td>Stable at 40C; 3 months</td>

<td>MONTANOV 202</td><td>No</td><td>Yes</td><td>No</td>

<td>MONTANOV 68</td><td>No</td><td>No</td><td>No</td>

<td>MONTANOV 82</td><td>Yes</td><td>No</td><td>No</td>

<td>MONTANOVS</td><td>Yes</td><td>No</td><td>No</td>

<td>MONTANOV L</td><td>No</td><td>No</td><td>No</td>

<td>OLIVEM 1000</td><td>No</td><td>No</td><td>N / C</td>

<td>INCROQUAT BEHENYL TMS-50</td><td>No</td><td>Yes</td><td>N / C</td>

<td>PROLIPID 151</td><td>No</td><td>No</td><td>No</td>

<td>AMPHISOLA</td><td>Yes</td><td>No</td><td>No</td>

<td>CERALUTION H</td><td>Yes</td><td>Yes</td><td>Yes</td>

<img file="MX354116B_D0023.tif" />

Table 3

<td></td><td colspan="8">Percentage by weight of added zinc chloride (%)</td>

<td></td><td> 0%</td><td> 0.42 %</td><td> 0.63 %</td><td> 0.83 %</td><td> 1.04%</td><td> 1.25%</td><td> 1.67%</td><td> 2.08%</td>

<td>Stable in freeze / thaw</td><td>No</td><td>No</td><td>No</td><td>No</td><td>No</td><td>No</td><td>No</td><td>No</td>

<td>Stable at 40 C (3 months)</td><td>Yes</td><td>Yes</td><td>Yes</td><td>Yes</td><td>Yes</td><td>Yes</td><td>Yes</td><td>No</td>

<td>Stable at 5 C (3 months)</td><td>Yes</td><td>Yes</td><td>Yes</td><td>Yes</td><td>Yes</td><td>Yes</td><td>Yes</td><td>Yes</td>

Table 4

<td></td><td>Percentage</td><td colspan="7">e by weight of added zinc sulfate (%)</td>

<td></td><td> 0%</td><td> 0.55%</td><td> 0.82%</td><td> 1.10%</td><td> 1.37%</td><td> 1.65%</td><td> 2.20 %</td><td> 2.75%</td>

<td>Stable in freeze / thaw</td><td>Yes</td><td>Yes</td><td>Yes</td><td>Yes</td><td>Yes</td><td>No</td><td>No</td><td>No</td>

<td>Stable at 40 C (3 months)</td><td>Yes</td><td>Yes</td><td>Yes</td><td>Yes</td><td>Yes</td><td>Yes</td><td>Yes</td><td>No</td>

<td>Stable at 5 C (3 months)</td><td>Yes</td><td>Yes</td><td>Yes</td><td>Yes</td><td>Yes</td><td>Yes</td><td>Yes</td><td>Yes</td>

Table 1 shows ten emulsions (F1-F10) that demonstrated adequate stability after freeze / thaw tests, according to the methods described herein. In general, the stability of the emulsion was evaluated for a minimum of four weeks at 50 ° C, three months at 40 ° C and 5 ° C. In Table 1 below, the three freeze / thaw cycles are shown. Three freeze / thaw cycles were applied to each emulsion at these two different temperatures.

INSTO'Π · 'MSXiCANu your AI (NDUmtAl.

In addition to the emulsifiers provided in the Tahl, additional emulsifiers were selected between% and% by weight alone or in combination with each other with the other ingredients that remained constant in the emulsion.

Emulsifiers that did not produce a stable emulsion include the following: Glyceryl Stearate, Stearate / Stearate

Glyceryl PEG-100, Sorbitan Sesquioleate, Sorbitan Olivate, Undecet-3, Methyl Glucose Sesquysterate PEG-20, Tridecet-3, Tridecet-12, Lauret-9, Behenoyl Stearic Acid, Olet-2, Olet-20, sorbitan laurate, sorbitan palmitate, sorbitan oleate, sorbitan trioleate, estearet-2, estearet-20, estearet-21, lauret-23,

Cll-15 paret-15, PPG-24-butet-27, high molecular weight polymers of ethylene oxide and propylene oxide, phosphate

PPG-5-cetet-10, phosphate olet-5, dioleyl phosphate, phosphate olet-

3, olet-10 phosphate, lauryl phosphate, tridecet-3 phosphate, tridecet-6 phosphate, decet6 phosphate, trilauret-4 phosphate, C20-22 alkyl phosphate, C20-22 alcohols, polyglyceryl-3 oleate, dimethicone PEG / PPG-20/6, bis-PEG / PPG-20/20 dimethicone, bis-PEG / PPG-16/16 PEG / PPG-16/16 dimethicone, bis-PEG / PPG-20/5 PEG / PPG dimethicone -20/5, dimethicone methoxy PEG / PPG-25/4, dimethicone bis-PEG / PPG-14/14 (and) dimethicone, methyl ether dimethicone PEG-11, butyl ether dimethicone PEG / PPG

20/22, polydimethylsiloxyethyl dimethicone lauryl PEG-9, dimethicone PEG-10, dimethicone disiloxane polyglyceryl-3,

<img file="MX354116B_D0024.tif" />

<img file="MX354116B_D0025.tif" />

polydimethylsiloxyethyl dimethicone

IMPI

INSTITUTE Μ '• ν'; ·⁴'·' 'IN. LA: ni »ust» íIa &lt;.

<img file="MX354116B_D0026.tif" />

PEG-8 lauryl dimethicone, sodium stearate, sucrose laurate, sucrose myristate, sucrose stearate, and methyl glucose sesquystearate. Unexpectedly, the use of PEG-15 ethylenedicocoamide disodium disulfate as the only Gemini surfactant in a 94.15% water system produced a stable emulsion.

In general, the procedure for making emulsions is as follows:

one. Heat the water phase of the formulation to 75 ° C while slowly adding the rubber mixture.

2. Combine the materials from the oil phase of the formulation and heat to 75 ° C under constant mixing conditions.

3. Add the oil phase to the water phase and homogenize the mixture at a speed of 5000 to 7000 rpm for five minutes using a SILVERSON homogenizer, available from Silverson Machines, Inc.

Four. Cool the mixture to 35 ° C under constant mixing conditions.

5. Add conservators, if desired.

6. Adjust the pH to a value of 4.5 +/- 0.5 using an acid.

7.

<img file="MX354116B_D0027.tif" />

INSTITUI O MEXICANO W:

DE LA rROPlEOAD V · - · -.b

INDUSTRIAL · ~ χ &lt;; ίΛ Homogenize the mixture again - during - two mimitos at a speed of 2000 to 3000 rpm.

Further testing demonstrated that one way to achieve a stable low-viscosity formulation by three freeze-thaw cycles at elevated temperatures is by using a combination of one or more types of gums and propylene glycol alginate. This combination is present in a concentration greater than 0.05%, so that the total sum of these components does not exceed 0.50% of the weight of the finished formulation. Additional water phase rheology modifiers that were evaluated alone or in combination with other rheology modifiers, but did not produce a stable emulsion, include the following: Citrus aurantium sinensis fiber (orange), acacia seyal gum octenylsuccinate, behenoxy dimethicone PEG10, bentonite, diestearet-75 IPDI, galactoarabine gums (gellan gum, guar gum, cellulose gum, and acacia gum) not in combination with propylene glycol alginate, hydroxyethyl cellulose, hydroxypropyl starch phosphate, laponite XLS, aluminum magnesium silicate, microcrystalline cellulose, montmorillonite, diesterate PEG-150, diisoestearate PEG-175, PEG-20 methyl glucose sesquystearate, polyacrylate crospolymer-6, modified potato starch, propylene glycol alginate, sodium alginate, sodium aluminum silicate, sodium carboxymethyl cellulose, aluminum silicate and

IMPIOUS

MEXICAN INSTITUTE

FROM THE INDUSTRIAL FkOHEPAD magnesium tromethamine and xanthan gum. ______________

F1-F10 emulsions included 0.9% by weight zinc chloride to determine if the previously stable base would remain stable for 3 freeze / thaw cycles and 50 ° C for a minimum of 2 weeks. As shown in Table 2 below, only the formulation containing Ceralution H with a combination of xanthan gum, guar gum, and propylene glycol alginate remained stable upon exposure to the stability conditions mentioned above. It is public knowledge that ionic materials can adversely affect the stability provided by low-viscosity polysaccharide materials for aerosol emulsions (see US Patent No. 6,831,107).

A subsequent dosing study using zinc chloride or zinc sulfate with Formulation 10 showed that a significant amount of zinc could be added to the formulation and remain stable. The results of this study are shown in Tables 3 and 4.

As shown in Tables 3 and 4, the zinc sulfate emulsions had superior freeze / thaw stability performance compared to zinc chloride solutions. After three months at 40 ° C, the viscosity of all the mentioned emulsions

<img file="MX354116B_D0028.tif" />

<img file="MX354116B_D0029.tif" />

<img file="MX354116B_D0030.tif" />

previously remained between

1000 and 5000 centipoise, as measured using a Brookfield viscometer (RV with axis 5,

rpm), available from Brookfield Engineering Laboratories.

Similar stability results were obtained with emulsions containing 1% CRODAFOS CS20A, available from Croda Inc.

Wipes substrates and emulsion addition levels

As used herein, the term "substrate" means any suitable material to carry the emulsion of the present description. Suitable substrates include any material that does not block the deposition of desirable emulsion components on the skin or cause skin irritation.

Examples of suitable substrates include, but are not limited to, woven or nonwoven webbing, spunbonded fabric, meltblown fabric, knit fabric, wet laid fabric, mesh, needled webbing, synthetic fibers. and natural fibers. It should be understood that these suitable substrates are not mutually exclusive and can be used in combination.

The choice of substrate fibers depends on, for example, the cost of the fiber and the desired properties. For example, suitable fibrous materials may include, but are not limited to, synthetic fibers, such as those derived from polyolefins, polyesters, polyamides, polyacrylics, polyethylene, combination may use jute, wool, bonded,

IMPIOUS

MEXICAN INSTITUTE t&gt; £ PROPERTY \ INDUSTRIAL polypropylene, polyvinyl, etc., alone or in one with the other. Similarly, there are also natural fibers, such as cotton, linen, hemp, wood pulp, such as viscose rayon, modified cellulosic fibers, etc .; cellulosic fibers and cuproammoniacal rayon, or as cellulose acetate.

Mixtures of one or more of the fibers listed above can also be used, if desired.

As used herein, the term "nonwoven fabric" refers to a fabric having a structure of individual fibers or filaments interposed randomly and / or unidirectionally, similar to a mat.

Nonwoven fabrics can be manufactured from a number of processes including, but not limited to, air-laying processes, wet-laying processes, hydrolysis processes, carding, and bonding of staple fiber and spinning of the solution. Suitable nonwoven fabrics include, but are not limited to, spunbonded fabrics, meltblown fabrics, wet laid fabrics, and combinations thereof.

As used herein, the term "spunbonded fabric" refers to a continuous band of fibers and / or filaments with an extrusion diameter of a molten thermoplastic material or coextrusion of more than one molten thermoplastic material in

INWTUTO M.6XICANO **;, j

0 £ THE fkOHEDAD

INDUSTRIAL - Filament shape from a series of fine capillaries, -generally circular, in a row, and the diameter of the extruded filaments is then rapidly reduced, for example, by eductive or non-eductive fluid extraction, or other spunbonding mechanisms (ligation by spinning) well known. The production of spunbonded nonwoven webs is well known and is described in patents as pat. from the USA USA de Appel, et al. No. 4,340,563 to Appel et al .; the pat. from the USA USA No. 3,692,618 to Dorschner et al .; the pat. from the USA USA Kinney Nos. 3,338,992 and 3,341,394; the pat. from the USA USA

No. 3,276,944 to Levy; the pat. from the USA USA Petersen No. 3,502,538; the pat. from the USA USA Hartman's 3,502,763; the pat.

from the USA USA No. 3,542,615 to Dobo et al .; and the pat. Canadian

Harmon No. 803,714.

As used herein, the term meltblown fabrics refers to a fabric composed of fibers that are formed by extrusion of a molten thermoplastic material by a series of fine, generally circular capillaries, in matrix in the form of threads or filaments under a current high-speed gas (eg, air) that attenuates the filaments of the molten thermoplastic material to reduce their diameters, possibly to the diameter of the microfiber. Consequently, the meltblown fibers are carried by a high-speed gas stream and deposited on a collection surface to form a continuous band. ²⁸ IMPIí *

MEXICAN INSTITUTE / DE LA PROCEDA »&lt;INDUSTRIA !. * of finely distributed meltblown fibers * 4 · »·. ·· —-Ε · ί meltblown process is well known and is described in various patents, such as pat. from the USA USA No. 3,849,241 to Butin, et al.

As used herein, the term microfibers means small diameter fibers with an average diameter of not more than 100 microns, for example, with a diameter of from about 0.5 microns to about 50 microns. More specifically, microfibers can also have an average diameter of from about 1 micron to about 20 microns. Microfibers with an average diameter of about 3 microns or less are commonly referred to as ultrathin microfibers.

As used herein, the term wet-laid fabrics refers to fabrics formed by a process, such as a papermaking process, where the fibers dispersed in a liquid medium are deposited on a screen, such that the Liquid medium flows through the screen and leaves a cloth on the screen surface. Fiber binding agents can be applied to the fibers in the liquid medium or after being deposited on the screen. Wet laid fabrics may contain natural and / or synthetic fibers.

As used herein, the term fabrics

<img file="MX354116B_D0031.tif" />

spunlaced (hydroligadas) refers to a continuous band of material consisting of a mixture of synthetics, where the fibers are subjected at high speed, entangling the fibers, natural fibers and jets of water to achieve a mechanical bond. Ideally, natural fibers are wood pulp fibers, and synthetic fibers are polyester fibers.

As used herein, the terms "needle-punched" and "stitched" refer to a continuous web of material consisting of one or more fibrous materials, where the fibers are attached to needles that entangle the fibers to achieve mechanical entanglement without the need for adhesives or chemical additives.

As used herein, the term woven fabric refers to a fabric that contains a structure of fibers, filaments, or yarns, which are methodically arranged in an interconnected manner. Woven fabrics typically contain interconnected fibers in the warp and weft direction. The warp direction corresponds to the length of the fabric, while the weft direction corresponds to the width of the fabric. Woven fabrics can be manufactured on a number of looms, including but not limited to shuttle looms, weft sprayer looms, projectile looms, air jet looms, and water jet looms.

<img file="MX354116B_D0032.tif" />

The composition of the formulation Ha la. The present disclosure amount of can be incorporated into the base coat in an addition of from about 50% (by weight of the base coat) to about 800% (by weight of the base coat). More specifically, those incorporated into the base coat at about 200% (by weight of the formulations can amount of base coat addition) to about 600% (by weight of the base coat) or about 300% (by base coat weight) to about 600% (by base coat weight). The addition amounts of the formulation may vary depending on the composition of the base coat.

Experimental methods:

STABILITY TEST

The objective of this test is to demonstrate the stability of the formulation after exposure to possible freezing conditions, such as during shipment or storage. The test is performed by freezing the composition at 20 ° C. Once frozen, the emulsion is allowed to thaw completely at room temperature. This freeze-thaw cycle is performed three times in total. The test results are determined by visual inspection of the emulsion for phase separation.

By entering elements of this description or

<img file="MX354116B_D0033.tif" />

<img file="MX354116B_D0034.tif" />

MEXICAN INSTITUTE OF the! INDUSTRIAL KOWEDAD a (s) preferred modality (s!) Of, ..— understands that the articles a, the and the (s) indicate that there are one or more elements . It is understood that the terms comprise (n), include (n) and have (n) are inclusive and indicate that there may be more additional items than the items listed.

In view of what is detailed above, it should be noted that the various objectives of the description are achieved and other advantageous results are achieved.

Since various changes may be made to the formulations detailed above without departing from the scope of the disclosure, it is understood that all the subject matter included in the foregoing description will be construed as illustrative and not limiting.

It is noted that in relation to this date, the best method known by the applicant to put the aforementioned invention into practice is the one that is clear from the present description of the invention.

,. «As above it