FR3048181A1 - OPAQUE HYDROALCOOLIC COMPOSITION - Google Patents

Abstract

The invention relates to a water-disinfecting hydroalcoholic composition comprising an aliphatic alcohol having 1 to 4 carbon atoms, an opacifying agent chosen from styrene / acrylate copolymers, a gelling agent and water, said composition being characterized in that the average particle size of the opacifying agent is between 400 nm and 500 nm and in that the viscosity of the composition is between 1500 mPa / s and 4000 mPa / s.

Description

The invention relates to a disinfecting hydroalcoholic composition and its use for the disinfection of the skin, especially the hands.

Hand disinfection is a well-known method for destroying pathogens such as bacteria or viruses that can become lodged on the hands.

Currently, there exists on the market a multitude of hydroalcoholic compositions allowing users to regularly disinfect their hands. These hydroalcoholic compositions are liquid and generally placed in a container that can contain from a few tens to several hundred milliliters of solution. In the vast majority of cases, the hydroalcoholic compositions are contained in transparent containers (generally spout flasks or topped with a pump) and are themselves transparent. The transparency of the container is advantageous because it allows the user to visually verify the amount of product remaining. Conversely, the transparency of hydroalcoholic compositions is not necessarily perceived positively by the general public. Indeed, this transparency is attached to a medical image and despite the reassuring aspect that this may have, some consumers, especially women, is hampered by this medical connotation.

It would be much more attractive, for at least this part of the non-medical public, to have a hydroalcoholic composition approaching the appearance of a care cream or a cosmetic cream so an opaque cream, while keeping of course the disinfecting effect for the skin of a conventional transparent hydroalcoholic composition. However, obtaining an opaque hydroalcoholic composition is not easy, especially when the opacity must remain uniform over time. Indeed, it would not be acceptable from the point of view of the user that an opaque hydroalcoholic composition is dehulled or decanted even partially or that a deposit appears in the container. It would not be acceptable either to stir the container prior to use to homogenize the hydroalcoholic composition.

It would be advantageous if such an opaque hydroalcoholic composition, in addition to having the appearance of a cream, a lotion or a cosmetic treatment, can also have a texture approaching it. The use of such an opaque hydroalcoholic composition would thus leave no visible residual deposit on the disinfected areas, especially the hands. In this way, the user would be pleased to apply the opaque hydroalcoholic composition to disinfect the skin in contrast to a conventional hydroalcoholic composition.

It would therefore be particularly advantageous to have an opaque hydroalcoholic composition as easy to use as a conventional transparent hydroalcoholic composition, more attractive to use, stable, and which is of course just as effective from a disinfectant point of view.

US Pat. No. 6,333,039 proposes an opaque hydroalcoholic composition, but the result obtained is not convincing from the point of view of the user. Indeed, this patent discloses a composition having a viscosity range ranging from 1000 to 65000 cps and preferably from 10000 to 65000 cps, or obtaining a liquid and opaque hydroalcoholic composition can not be satisfactory over the entire this range. Indeed, too high viscosity no longer allows sufficient application because the composition spreads too hard, or becomes solid when approaching the 65000 cps. In addition, at too low viscosities, a particular formulation must be developed in order to maintain the hydroalcoholic composition stable, that is to say without settling or phase shift. Finally, the preparation example gives no indication of the final viscosity of the composition.

There is therefore still a need for a hydroalcoholic composition having the visual appearance of a cream, a lotion or a cosmetic treatment, as easy to use as a conventional transparent hydroalcoholic composition and which is of course all as effective from a disinfectant point of view while being stable over time.

After much research, it is therefore the merit of the applicant to have found that the use of a particular opacifying agent allowed the development of such a hydroalcoholic composition.

The present invention thus relates to a hydroalcoholic disinfecting composition for the skin comprising: a C 1 -C 4 aliphatic alcohol, an opacifying agent chosen from styrene / acrylate copolymers, a gelling agent and water, said composition being characterized in that the average particle size of the opacifying agent is between 400 nm and 500 nm and in that the viscosity of the composition is between 1500 mPa / s and 4000 mPa / s. The C1-C4 aliphatic alcohol is used for its anti-pathogenic properties. Indeed, the alcohol has in particular its desiccant and denaturing action on proteins and enzymes, bactericidal, virucidal and fungicidal properties but without having a cleaning effect. In other words the aforementioned pathogens die, thus avoiding any spread to other people, but remain in contact with the skin.

According to the present invention, the C 1 -C 4 aliphatic alcohol may be chosen from methanol, ethanol, propanol, isopropanol and butanol, and mixtures thereof. Preferably, the alcohol is selected from ethanol, isopropanol and mixtures thereof, more preferably from ethanol and a mixture of ethanol and isopropanol.

According to an advantageous variant of the invention, the C 1 -C 4 aliphatic alcohol is denatured alcohol, that is to say ethanol rendered unfit for food consumption. Advantageously, it is ethanol denatured with isopropanol and / or tert-butanol. The quantities of denaturing alcohol are, for example, for isopropanol, amounts ranging from 2% to 5%, preferably from 2% to 3%, even more preferentially from approximately 2.5%, and for tert-butanol, amounts ranging from from 0.1% to 0.3%. Quantities are expressed in volume concentration. In a preferred embodiment, the C 1 -C 4 aliphatic alcohol selected is denatured ethanol with about 2.5% (v / v) isopropanol. In another preferred embodiment, the C1-C4 aliphatic alcohol is isopropanol.

In general, an alcohol concentration of at least about 20% by weight relative to the total weight of the composition and more preferably about 50% by weight relative to the total weight of the composition, is sufficiently effective to provide the disinfectant activity. However, preferably the alcohol is present in the composition in amounts ranging from 60% to 80% by weight relative to the total weight of the composition, preferably in an amount ranging from 65% to 75% by weight relative to relative to the total weight of the composition, more preferably, the alcohol is present in an amount of about 70% by weight relative to the total weight of the composition. According to a preferred embodiment, the alcohol is the only disinfecting compound used in the present hydroalcoholic composition. However, according to another embodiment, the hydroalcoholic composition may contain other additional disinfectant or antimicrobial compounds such as, for example, triclosan (5-chloro-2 (2,4-dichlorophenoxy) phenol), chloroxylenol (4-chloro -3,5-xylenol), hexetidine (5-amino-1,3-bis (2-ethylhexyl) -5-methyl-hexahydropyrimidine) or the salts of chlorhexidine. Note that in the present application, conventionally the indefinite article "a" must be considered as a generic plural (meaning "at least one" or "one or more"), except when the context shows the opposite (1 or "Only one"). For example, when it is said above that the hydroalcoholic composition comprises a C 1 -C 4 aliphatic alcohol, it should be understood that the hydroalcoholic composition comprises one or more C 1 -C 4 aliphatic alcohols.

According to the present invention, the opacifying agent is specifically selected from styrene / acrylate copolymers having an average particle size of between 400 nm and 500 nm, preferably about 450 nm. Such a styrene / acrylate copolymer is, for example, sold by OMNOVA under the trade name LYTRON® 450.

The average particle size is advantageously determined by dynamic light scattering (in English: dynamic light scattering). It is in fact the choice of a styrene / acrylate copolymer as defined above which makes it possible to obtain an opaque hydroalcoholic composition having the appearance of a cream, a lotion or a cosmetic treatment which does not does not suffer from problems of settling or phase shift and which remains just as effective as a conventional hydroalcoholic composition. When the average particle size is less than 450 nm, the composition does not remain stable and is out of phase and when it is greater than 500 nm, the composition has a rough feel and visible residues remain on the skin after application. The opacifying agent is advantageously used in effective amounts to obtain a fully opaque hydroalcoholic composition. Thus, the opacifying agent is preferably present in amounts ranging from 0.2% to 0.8%, preferably in amounts ranging from 0.2% to 0.4% by weight relative to the weight of the composition. and more preferably, the opacifying agent is present in an amount of about 0.35% by weight based on the weight of the composition. This range of amount of the opacifying agent is particularly advantageous because below 0.2% by weight of opacifying agent, the hydroalcoholic composition may not be totally opaque and beyond 0.8% the viscosity may be destabilized and thus cause a rough effect on the skin. The gelling agent contained in the hydroalcoholic composition according to the invention makes it possible to adjust the viscosity of the composition. It is preferably chosen from acrylic polymers, polyacrylamides, carbomers, xanthan gums, pectins, polyethylene glycol, polyvinyl alcohols and modified starches. Preferentially, the gelling agent is chosen from acrylic polymers, polyacrylamides and carbomers. Also preferably, the gelling agent is an acrylic polymer such as Carbopol® Ultrez 20 sold by the company Lubrizol. The gelling agent is advantageously present in amounts ranging from 0.05% to 0.5% by weight relative to the weight of the composition. Preferably, the gelling agent is present in an amount of about 0.2% by weight relative to the weight of the composition in order to adjust the viscosity of the hydroalcoholic composition between 1500 mPa / s and 4500 mPa / s, preferably between 1500 mPa / s or 1600 mPa / s and 3000 mPa / s, preferably still between 1500 mPa / s or 1600 mPa / s and 2500 mPa / s and more preferably to about 2000 mPa / s. The viscosity of the hydroalcoholic composition according to the invention is determined using a Brookfield viscometer whose rotational speed is set at 30 rpm.

This particular viscosity is essential because, in combination with the opacifying agent having an average particle size of about 450 nm, it makes it possible to obtain an opaque hydro-alcoholic composition which is, above all, stable over time, which consequently does not decant or not even after several weeks without use.

Indeed, above 4500 mPa / s the viscosity obtained limits the use of the hydroalcoholic composition because the latter being too pasty, the application and even spreading on the skin becomes difficult or impossible and the presence of a Residual deposit on the skin is visible. Tests conducted by the Applicant have shown that below 1500 mPa / s the hydroalcoholic composition was not viscous enough to allow uniform application and spreading and lost its stability by the appearance of a phase shift, which is particularly disadvantageous.

It is thus the merit of the Applicant to have, from the fruit of numerous investigations, combined in optimal proportions a particular opacifying agent having an average particle size of 400 nm to 500 nm, preferably of approximately 450 nm with an agent gelling agent in order to obtain an optimum viscosity allowing the opaque hydroalcoholic bearing composition to the disadvantages mentioned above.

The term "stable" or "stable over time" within the present application means that for a use temperature generally between 5 ° C and 35 ° C, the hydroalcoholic composition does not overheat, does not decant and that it is therefore not necessary to homogenize it to use it. Thus, when the composition according to the invention is for example packaged in a transparent bottle it keeps, even after a prolonged period without use, a uniform, homogeneous appearance and no deposit is visible on the bottle.

The stability of the composition according to the present invention has been validated by accelerated aging and cold resistance tests. Thus, even after being stored for 6 months at 40 ° C or 4 ° C, no decantation or phase shift was observed.

The hydroalcoholic composition may also comprise one or more adjuvants well known to those skilled in the art making it possible to make said composition easily formable or aesthetically acceptable, such as, for example, emollients, co-emollients, preservatives, pH adjusters or agents. neutralizers, soothing and / or healing substances, lubricating agents, lubricity agents, perfumes or dyes.

The effective amounts generally used for these adjuvants are those known to those skilled in the art, namely advantageously amounts less than 1% by weight relative to the total weight of the hydroalcoholic composition, preferably in amounts of between about 0.01%. and 0.5% and more preferably in amounts of between about 0.01% and 0.3% by weight relative to the total weight of the composition.

Thus, advantageously the hydroalcoholic composition comprises an emollient. Emollients are often used to impart a feeling of softness to the skin's surface without measurably affecting the level of hydration and / or lipid barrier. The emollients is advantageously chosen from vegetable triglycerides, such as avocado oil, olive oil, sunflower seed oil, esters of organic acids such as sorbitan oleate, myristate isopropyl, glyceryl oleate, preferentially from the group comprising isopropyl myristate, vegetable triglycerides and glyceride oleate, and more preferably, the emollient used in the present hydroalcoholic composition is the myristate of isopropyl. The emollient is advantageously present in an amount of between about 0.05% and 1% by weight of the composition, preferably in an amount of between about 0.05% and 0.5%, more preferably in an amount between about 0.05% and 0.2% and in particular, the emollient is present in an amount of about 0.12% by weight relative to the total weight of the composition.

In addition to a first emollient, it is particularly advantageous to use another emollient-effect compound such as, for example, a PEG-4 triglyceric caprylic / capric ester. The quantities used of this second emollient-effect compound are between about 0.05% and 1% by weight of the composition, preferably in an amount of between about 0.05% and 0.5%, more preferably in an amount of between about 0.05% and 0.2% and in particular, the emollient is present in an amount of about 0.14% by weight relative to the total weight of the composition. When used together, the isopropylmyristate and a PEG-4 triglyceric caprylic / capric ester thus make it possible to limit the slightly drying and abrasive effects that can result from the use of an opacifying agent.

The present invention may further comprise a pH adjuster to obtain a pH within a desirable range, generally at a pH of about 5 to 6. An example of a suitable pH adjuster is especially 2-aminoisobutanol , aminomethylpropanol or triethanolamine. Preferably, the pH adjusting agent is 2-aminoisobutanol.

This pH adjuster is generally added in an effective amount for modifying the pH of the composition for the desired pH range, that is to say in a quantity advantageously between 0.05% and 0.4% by weight. of the total composition, preferably in an amount of between 0.05% to 0.2% and even more preferably, the pH adjuster is present in an amount of about 0.07% by weight relative to the total weight of the composition.

The hydroalcoholic composition according to the invention may further comprise an adjuvant with or without moisturizing, soothing and / or healing properties. Examples include glycerin, hydrolysed proteins, cucumber juice, mineral oils, tocophenol, alphabisabolol, Aloe Barbadensis.

Preferably, these adjuvants, if they are used, are present in effective amounts advantageously between about 0.02% and 0.5% by weight relative to the total weight of the hydroalcoholic composition. Preferably, the hydroalcoholic composition comprises alphabisabolol and / or Aloe Barbadensis (aloe vera), in particular an aqueous extract of Aloe Barbadensis juice, in quantities of approximately 0.24%, , 12%.

The hydroalcoholic composition may also include a preservative to prevent microbial deterioration. By way of example, the preservative is advantageously chosen from iodopropynyl butylcarbamate, imidazolidinyl urea, methylchloroisothiazolinone and methylisothiazolinone, as well as the additional disinfecting compounds mentioned above, such as triclosan (5-chloro-2 (2,4-dichlorophenoxy) phenol), chloroxylenol (4-chloro-3,5-xylenol), hexetidine (5-amino-1,3-bis (2-ethylhexyl) -5-methyl-hexahydropyrimidine) or the salts of chlorhexidine. The preserving agent is preferably present in amounts of less than 0.2% by weight relative to the total weight of the hydroalcoholic composition.

The hydroalcoholic composition may also include a lubricating agent that generally facilitates the creation of a soft, smooth feel on the hands. An example of a lubricating agent useful in the present invention is methylpropanediol, propylene glycol or butylene glycol and preferably the lubricating agent is methylpropanediol. The lubricating agent is preferably present in amounts of less than 0.2% and preferably in an amount of about 0.06%.

Finally, it will be noted that the hydroalcoholic composition according to the present invention comprises water in sufficient quantity for the preparation (q.s.p) and preferentially, demineralised water. The water will act as a vehicle allowing a uniform distribution of the hydroalcoholic composition on the skin.

The hydroalcoholic composition according to the invention is therefore particularly suitable for disinfecting the skin and especially for disinfecting the skin of the hands.

Another object of the invention is therefore the use of the hydroalcoholic composition as described above for the disinfection of the skin, especially the hands. For this application, an effective amount of the composition according to the invention is advantageously applied to the skin, especially the hands, and spreads it uniformly. The invention will be better understood with the aid of the examples which follow, which are intended to be illustrative and not limiting. EXAMPLE 1 Preparation of a hydroalcoholic composition according to the invention

The first step in the preparation of the hydroalcoholic composition is to bring the demineralized water into contact with the gelling agent (Carbopol Ultrez 20 - Lubrizol) for about 45 minutes. This first contacting step is essential because it allows the hydration of the gelling agent before the addition of the alcohol.

After the contacting is complete, denatured ethanol with 2.5% isopropanol is added before the mixture is mixed for about 240 minutes and then allowed to stand for about 15 minutes.

Then the triglyceric caprylic / capric ester PEG-4, alpha bisabolol, methylpropanediol are mixed with the composition. Then the aqueous extract of Aloe Barbadensis juice, isopropyl myristate and a perfume are added.

The following steps consist in adding the opacifying agent Lytron 450 (OMNOVA solution), to mix the whole so as to obtain a homogeneous composition and then to observe a rest time of about 15 minutes.

Finally, the last compound added is the AMP Ultra PC 2000 pH adjuster. The whole is then mixed and allowed to stand for about 15 minutes. The preparation of the hydroalcoholic composition is then complete. All the quantities and compounds used for the preparation according to Example 1 is presented in Table 1 below:

Table 1

The hydroalcoholic composition obtained is opaque and has a viscosity of about 2000 mPa / s at 20 ° C. ± 1 ° C., thus presenting a visual appearance of a lotion or cream. When applied on the hands it has a pleasant and soft touch and leaves no visible deposit after spreading. The apparatus used for viscosity measurement is a BROOKFIELD LVF viscometer. The rotational speed is set at 30 rpm and the measurements are carried out after stabilization of the hydroalcoholic composition for 30 minutes at 20 ° C. ± 1 ° C. using a thermostatic bath (measurement protocol applied for all examples). EXAMPLE 2: Stability study

A stability study of the composition of Example 1 was re-evaluated in order to verify the physico-chemical parameters as well as the dosages of active principle (ethanol).

A first batch of a hydroalcoholic composition according to Example 1 was stored at 40 ° C for 6 months (accelerated aging) while a second batch was stored at 4 ° C for 6 months (cold resistance).

An identical packaging was used for the storage of the two batches, namely a 300 mL polyethylene terephthalate (PET) bottle surmounted by a pump as can be found on the market.

Ethanol dosages, measurements of physicochemical parameters such as pH, density, refractive index, viscosity but also the appearance of batches, were measured and analyzed after a period of 1 month. , 3 months, 4 months, 5 months and 6 months.

First batch (accelerated aging):

For this test, the composition of Example 1 was stored for 6 months at a temperature of 40 ° C. The results show that all the physicochemical parameters are maintained within the standard deviation over the entire duration of the study.

Regarding the dosage of the active ingredient, measurements of the percentage of ethanol (w / w) also show that the concentration remains in the standard deviation over the entire duration of the study.

The composition according to the present invention is therefore stable after a storage period of 6 months at 40 ° C thus validating a maximum period of use of 36 months after the date of manufacture. The overall results are summarized in Table 2 below:

Table 2

Second batch (cold resistance):

For this test, the composition of Example 1 was stored for 6 months at a temperature of 4 ° C. The results also show that all physicochemical parameters are maintained within the standard deviation over the entire duration of the study, as are measurements of the percentage of ethanol (w / w).

The results of the stability study thus validate the objective of the present invention to obtain an opaque composition which does not decay and do not overheat and which therefore remains stable over time. The overall results are summarized in Table 3 below:

Table 3

EXAMPLE 3 Stability vs. Viscosity

In order to determine the viscosities which make it possible to obtain stable compositions according to the invention, eight compositions (Cl to C8) were formulated following the procedure of Example 1 with the same ingredients and by varying the amount of gelling agent. The stability (presence or absence of phase shift) was then evaluated at 20 ° C and 40 ° C after 3 months of storage. The results are shown in Table 4 below:

Table 4

The results show that compositions C6 to C8 do not show phase shift and remain stable. The results thus show that the stability of the hydroalcoholic compositions containing Lytron 450 as opacifying agent is dependent on the viscosity. Compositions C1 to C5 have viscosities that are too low and are therefore not stable.

In addition, a sensory study carried out on the compositions C1 to C8 showed that for the compositions C1 to C5 the viscosities obtained did not make it possible to obtain uniform apphcation because the compositions were too liquid. In contrast, C6-C8 compositions were sufficiently viscous to allow uniform and homogeneous application without leaving residual deposits visible on the skin. Compositions C6 to C8 have in addition the visual appearance of a lotion of a cream or a cosmetic care and have when applying on the hands a pleasant and soft touch. EXAMPLE 4 Stability as a function of the opacifying agent

In order to compare the effects of the opacifying agent on stability, two additional compositions (C9 and C10) were formulated by replacing the opacifying agent according to the present invention either with a styrene / acrylate copolymer having an average particle size of 180. nm (Lytron 180) or with titanium dioxide which is an opacifier conventionally used in commercial water-alcoholic compositions. The results are shown in Table 5 below:

Table 5

The results show that the composition formulated based on Lytron 180 has a phase shift at 40 ° C while the composition formulated with titanium dioxide has a phase shift at both 20 ° C and 40 ° C. The opacifying agent therefore has an influence on the stability of the compositions obtained and the compositions according to the invention, formulated with an opacifying agent having a particle size of 450 nm, are therefore particularly stable.

A sensory study has made it possible to demonstrate a more pleasant feel, a facilitated application and a lack of visible residues when using a hydroalcoholic composition according to the present invention (C6) with respect to the use of a composition. formulated with other opacifying agents such as Lytron 180 or titanium dioxide (C9 and CIO).

Claims (13)

A water-disinfecting hydroalcoholic composition comprising: an aliphatic alcohol having 1 to 4 carbon atoms, an opacifying agent chosen from styrene / acrylate copolymers, a gelling agent, water, said composition being characterized in that the size The average particle size of the opacifying agent is between 400 nm and 500 nm and in that the viscosity of the composition is between 1500 mPa / s and 4000 mPa / s. 2. Composition according to claim 1, characterized in that the average particle size of the opacifying agent is about 450 nm. 3. Composition according to claim 1, characterized in that the viscosity of the composition is between 1500 mPa / s and 2500 mPa / s. 4. Composition according to any one of claims 1 to 3, characterized in that the alcohol is present in amounts ranging from 60% to 85% by weight relative to the total weight of the composition, preferably in an amount ranging from 70% to 80% by weight relative to the total weight of the composition, more preferably the alcohol is present in an amount of about 70% by weight relative to the total weight of the composition. 5. Composition according to any one of claims 1 to 4, characterized in that the alcohol is ethanol, especially denatured ethanol, or isopropanol. 6. Composition according to any one of claims 1 to 5, characterized in that the opacifying agent is present in amounts ranging from 0.2% to 0.8% by weight relative to the weight of the composition, preferably in amounts ranging from 0.2% to 0.4% by weight relative to the weight of the composition, and more preferably in an amount of about 0.35% by weight relative to the weight of the composition. 7. Composition according to any one of claims 1 to 6, characterized in that the gelling agent is present in amounts ranging from 0.1% to 0.5% by weight relative to the weight of the composition, preferably in an amount of about 0.2% by weight relative to the total weight of the composition. 8. Composition according to any one of claims 1 and 7, characterized in that the gelling agent is a polyacrylic polymer. 9. Composition according to any one of claims 1 to 8, characterized in that it further comprises an adjuvant selected from emollients, co-emollients, preservatives, pH adjusters or neutralizing agents, soothing substances and / or healing, lubricating agents, lubricity agents, perfumes or dyes. 10. Composition according to claim 9, characterized in that it comprises an emollient and in particular isopropyl myristate. 11. Composition according to claim 9, characterized in that it comprises a soothing and / or healing substance, in particular of alphabisabolol and / or aloe barbadensis. 12. Composition according to claim 9 characterized in that it comprises a lubricating agent and in particular methylpropanediol. 13. hydroalcoholic composition according to any one of the preceding claims for use in disinfecting the skin and preferably for the disinfection of hands.