IT202000011056A1 - SANITIZING GEL WITH HIGH ANTI-INFECTIVE AND SKIN PROTECTIVE ACTIVITY - Google Patents

Description

DESCRIPTION

FIELD OF THE INVENTION

The present invention pertains to the field of skin sanitizing products. A new formulation of sanitizing gel is described, particularly effective against bacteria and viruses, suitable for repeated and prolonged applications over time.

STATE OF THE ART

Sanitizing products are widely used for cleaning and disinfecting parts of the skin, especially the hands, which are particularly exposed to contact with infectious agents present in the environment. These products can be formulated in various ways, e.g. as aqueous gels comprising at least one disinfectant agent in association with water and suitable gelling agents. The gel dilutes the disinfectant to the target concentration and forms a viscosity phase. medium-low which, compared to liquid formulations, maintains cohesion after application to the skin, does not drip or drip and d? time for the user to spread the formulation covering the entire affected area; after application, the gelled matrix forms a thin film on the skin which opposes the evaporation and/or dispersion of the antibacterial active substances, prolonging their effect; moreover, compared to creams and ointments, the use of the gel? preferred because after drying the product leaves no perceptible trace on the skin.

These products act on environmental infectants already? present on the body surface to be treated, inhibiting its growth and vitality; however, the effect can? also be preventive, in this case counteracting the adhesion and growth of new infectious agents that come into contact with the skin after applying the product. Like all sanitizing treatments, the effect is? transient and needs to be renewed over time with further product applications if long-lasting protection is desired; the disinfectant effect? moreover directed aspecifically against the organic material in general, therefore pu? involve the skin itself causing irritation, dryness, etc. These limitations were not normally perceived as a problem, as the sanitizing gel was normally used for short periods as an alternative to soap and water, protecting the user during those particular periods of activity, e.g. outdoor, during which he does not have the possibility? conventional hand washing. However, the constant growth of the population, its concentration in urban areas, the increased mobility? of people has significantly increased the close contacts between people and the possibility? transmission of old and new infectious diseases; consequently the use of body sanitizing products and above all their frequency of use by the single user, have gradually increased. The use more? frequent has aggravated the problem of? aggressiveness? of these products towards the skin; to reduce this impact ? possible to reduce the disinfectant concentration, but with an undesirable correlated loss of effectiveness; on the other hand ? It has also been proposed, with modest results, to add dermoprotective substances to the gel: however this is not? an easy way as these substances can reduce the effectiveness of the disinfectant, modify the rheology, stability? o organoleptic characteristics of the gel, e.g. leave annoying traces after application that stimulate the user to rub the hand, thus increasing? contacts with new and additional quantities? of infectious agents. Research ? therefore strongly engaged in the search for new and effective combinations of disinfectants, gelling agents and dermoprotective agents which allow to reconcile a significant disinfectant effect, an optimal gel rheology and a strong dermoprotective effect such as to allow prolonged and frequent use of the product, without cause damage to the affected skin surface. The need for products with these requirements? more and more heartfelt, in order to counteract and protect themselves from the growing spread of new diseases, especially those with high danger? and/or high rate of infection.

SUMMARY

The Applicant has now developed a new sanitizing formulation which optimally overcomes the aforementioned limitations, reconciling a strong activity? anti-infective with full respect for the physiology of the skin, thus avoiding? the consequences normally related to the continuous use of common sanitizing products, such as irritation, dryness, etc. The wording? in the form of aqueous gel and ? mainly characterized in that it contains an alcoholic disinfectant agent and a dermoprotective mixture comprising: (a) vitamin E or an ester thereof, (b) hyaluronic acid or a physiologically acceptable salt thereof and (c) one or more? polyol humectants, preferably selected from glycerin, pentylene glycol and/or propylene glycol. The aforementioned components have been shown to protect the skin in an intense and even synergistic way, without any prejudice to the activity? disinfectant and properties? of the gel: there? allows the repeated application of significant quantities/concentrations of disinfectant agent(s) over time without causing contact damage to the treated skin area.

DETAILED DESCRIPTION OF THE INVENTION

According to the present application, the term ?gel? identifies a homogeneously gelled fluid, comprising one or more? gelling agents; this gel has a viscosity? preferably medium or low dynamics, in particular between 30,000 and 100,000 mPa.

The term ?sanitizing gel? identifies a gel as defined above, which includes one or more? alcoholic disinfectant agents. For ?disinfectant agent? it means, as in the common sense, a substance capable of killing bacteria and/or viruses.

The term ?aqueous gel? identifies a gel as defined above, comprising water for at least 18% by weight of the total composition.

All the percentages indicated herein, unless otherwise indicated, are to be understood as percentages by weight on the total weight of the composition.

The term ?dermoprotective mixture? identifies and defines the set of components (a) ? (c), namely vitamin E or an ester thereof, hyaluronic acid or a salt thereof and a polyol humectant; the term, ?mixture? indicates the mere co-presence of each of the aforementioned components within the gel, without necessarily requiring that they themselves are separately mixed / pre-mixed with each other. Therefore, during the preparation of the gel, they can be added indifferently in separate form or pre-mixed with each other, to the remaining components of the gel. Said components (a) ? (c) they can be indifferently present within the gel in any form, e.g. dissolved, suspended, emulsified, etc. According to the invention, the components (a) ? (c) are always co-present; however there? does not limit the mixtures to? being tri-components, as each of them can? also be represented by pi? compounds belonging to the same class.

Vitamin E or its ester? the first component of the dermoprotective mixture. The term ?Vitamin E? includes all forms in which said vitamin ? present in nature or as a synthetic derivative: it therefore indifferently includes tocopherols, tocotrienols, their mixtures, their isoforms ?, ?, ?, ? determined based on the number and position of the methyl groups on the chromanol ring. Particularly preferred for the purposes of the invention are alpha-tocopherol and its esters, in particular those selected from the group comprising acetate, n-propionate and linoleate, with maximum preference for ?-tocopheryl acetate. Within the present dermoprotective mixture, vitamin E or its ester exerts a useful antioxidant effect that prevents inflammation, advantageously associated with its liposolubility, which favors its absorption by the skin.

Hyaluronic acid, the second component of the mixture, is a well-known glucosaminoglycan of natural origin: pu? be used in any form, salified or not, and any molecular weight (herein understood as weighted molecular weight or weight average molecular weight). Among the possible salts, ? Sodium salt preferred. Among the molecular weights, those between 20 and 1000 KDa are preferred. Hyaluronic acid exerts an activity dermotrophic and dermoriparativa, promoting among other things the synthesis of collagen, a protein essential to the functionality? of the skin.

The third component of the dermoprotective mixture? a polyol humectant: this? a well known class of products including for example glycerin, glyceryl triacetate, sorbitol, xylitol, maltitol, glycols such as e.g. propylene glycol and pentylene glycol, polymeric polyols such as e.g. polydextrose, etc. and mixtures thereof. As a component of the dermoprotective blend, the humectant ensures adequate hydration, among other things by stimulating skin elasticity. and the breathable function of the skin.

Has the Applicant specifically evaluated the quantities? of the components (a), (b) and (c), both between them within the dermoprotective mixture and in absolute respect to the gel, in order to ensure an adequate protective effect against the activity? dermoaggressive of the disinfectant compounds present in the gel. Therefore, within the dermoprotective mixture, the above components preferably vary within the following percentages by weight, calculated with respect to the total weight of (a)+(b)+(c): (a) = 30?75%, (b ) = 0.5?2.5%, (c) = 24-70%.

Alternatively or in addition, when evaluated with respect to the disinfectant gel as a whole, the aforementioned components preferably vary within the following percentages by weight, calculated with respect to the total weight of the gel:

(a) : 0.5-5%, plus? preferably 1-4%, even more? preferably 3 ? 0.5%;

(b) : 0.05?0.5%, pi? preferably 0.07-0.3%, even more? preferably about 0.1%;

(c) : 0.5?5%, plus? preferably 0.7-2.5%, even more? preferably 0.8-2.0%

The composition of the sanitizing gel of the invention further comprises the disinfectant agent, the gelling agent, possible co-gelling agents, possible pH regulators, and an adequate quantity of water useful for forming the aqueous gel.

L? "disinfecting agent", understood within the meaning of the present invention, can be a single disinfectant agent or a combination of more? disinfectant agents. This agent? an alkanol selected from the group comprising ethanol, isopropanol and mixtures thereof. The alcoholic disinfectant agent can? be present preferably in quantity? by weight between 50 and 80%, pi? preferably between 65 and 75% by weight of the composition. When more? disinfectant agents are used in combination, the above percentages refer to the total number of disinfectants used.

L? "gelling agent", understood within the meaning of the present invention, can be a single gelling agent or a combination of more? gelling agents. The gelling agent? generally chosen among the hydroxyalkyl celluloses. Among the hydroxyalkylcelluloses, hydroxyethylcellulose, hydroxypropylcellulose and hydroxypropylmethylcellulose are particularly preferred. The gelling agent? preferably present in quantity? by weight between 0.2 and 2% on the weight of the composition, plus? preferably between 0.5 and 1.5%. When more? gelling agents are used in combination, the above percentages refer to the total number of gelling agents used.

The ?pH regulator? intended within the meaning of the present invention, pu? be a single pH regulator or a combination of pi? pH regulators. The pH regulator ? a compound of acidic or basic nature capable of bringing the pH of the composition back within a range of safety standards for topical application; e.g. when ? Basic correction required, favorite adjuster or corrector? an alkanolamine such as e.g. triethanolamine; when instead ? request an acid correction, the preferred regulator ? an organic acid such as citric acid or lactic acid. The pH regulator can? be used in quantity? suitable for reaching the target pH, for example between 0.01 and 0.3%. When more? pH regulators are used in combination, the above percentages refer to the total number of pH regulators used.

A particularly preferred composition of the gel according to the present invention ? the following:

Alpha-tocopheryl acetate 2.5-3.5%

Hyaluronic acid 0.05-1.5%

Glycerol 1.0-2.0%

Ethanol 68.0-75.0%

Hydroxyethylcellulose 0.8-1.2%

Lactic acid 0.02-0.04%

Water: to taste at 100.0%

The invention also includes a process for preparing the aforementioned sanitizing gel. In its most significant sense in general, it provides for the step of formulating, together with an alcoholic disinfectant agent, a gelling agent and water, a dermoprotective mixture comprising vitamin E or an ester thereof, hyaluronic acid or a pharmaceutically acceptable salt thereof and a polyol humectant as defined above. As indicated above, the term ?dermoprotective mixture? indicates the mere co-presence of each of the components (a), (b), (c) within the gel, without necessarily requiring that they themselves are separately mixed/pre-mixed with each other. Therefore, during the preparation of the gel, they can be added indifferently in separate form or pre-mixed with each other, to the remaining components of the gel. Pi? in general, all the ingredients of the gel can be added at the same time or separately and, in the latter case, in any sequence.

The invention also includes the sanitizing gel as described above for use in therapy and, more specifically, for use in a skin disinfection method, in particular for eliminating and/or preventing bacterial and/or viral contamination of the skin, with reference preferably but not exclusively to the skin of the hands. The invention also includes the use of a sanitizing gel as described above in the preparation of a medicament for use in skin disinfection, in particular to eliminate and/or prevent bacterial and/or viral contamination of the skin, with preferred but not exclusive reference to the skin of the hands. The invention also includes a method for eliminating and/or preventing bacterial and/or viral contamination of the skin, with reference, preferably but not exclusively, to the skin of the hands, comprising applying the sanitizing gel as described above to the affected skin area of a patient who needs it.

The invention is now described in detail and without limitation by means of the following experimental examples.

EXPERIMENTAL PART

The following compositions have been made in accordance with the present invention. The percentages of the ingredients are expressed by weight on the weight of the final formulation.

Example 1

Alpha-tocopheryl acetate: 3.0%

Hyaluronic acid: 0.1%

Glycerol: 1.0%

Ethanol: 71.5%

Hydroxyethylcellulose 1.0%

Aqua: 23.4%

Example 2

Alpha-tocopheryl acetate: 3.0%

Hyaluronic acid: 0.1%

Glycerol: 2.0%

Ethanol: 68.6%

Isopropanol 2.9%

Hydroxyethylcellulose 0.8%

Aqua: 22.6%

Example 3

Alpha-tocopheryl acetate: 3.0%

Hyaluronic acid: 0.1%

Pentylene glycol: 1.88%

Ethanol: 75.0%

Hydroxypropylcellulose 0.8%

Aqua: 19.2%

Citric acid: 0.02%

Example 4

Alpha-tocopheryl acetate: 3.0% Hyaluronic acid: 0.1% Glycerol: 2.0% Ethanol: 68.6% Isopropanol 2.9% Hydroxypropyl methylcellulose 0.8% Aqua: 22.6% Example 5

Alpha-tocopheryl linoleate: 3.0%

Hyaluronic acid: 0.1%

Glycerol: 1.0%

Ethanol: 71.5%

Hydroxyethylcellulose 1.0%

Aqua: 23.4% Example 6

Alpha-tocopheryl n-propionate: 3.0% Hyaluronic acid: 0.1% Pentylene glycol: 2.0% Ethanol: 75.0% Hydroxypropylcellulose 0.8% Aqua: 19.07% Lactic acid: 0.03% Example 7

Alpha-tocopheryl acetate: 2.5%

Hyaluronic acid: 0.2%

Glycerol: 1.5%

Ethanol: 71.5%

Hydroxyethylcellulose 1.0%

Aqua: 23.3%

Example 8

Alpha-tocopheryl acetate: 3.0%

Hyaluronic acid: 0.1%

Glycerol: 2.0%

Ethanol: 71.5%

Hydroxyethylcellulose 0.8%

Aqua: 22.57%

Lactic acid: 0.03% In experimental tests on volunteers, the sanitizing gel in accordance with the aforementioned examples showed a significant antibacterial and antiviral effect. The tolerability of the product ? been demonstrated through tests on volunteers without any obvious damage to the skin being detectable, even after frequent and continuous use.

Claims (16)

1. Aqueous sanitizing gel containing a dermoprotective mixture based on (a) vitamin E or an ester thereof, (b) hyaluronic acid or a physiologically acceptable salt thereof and (c) a polyol humectant, in association with water, an alcoholic disinfectant agent and a gelling agent. 2. Gel according to claim 1, wherein said vitamin E ? present in one or more forms selected from tocopherols, tocotrienols, their isoforms ?, ?, ?, ?, and their esters. 3. Gel according to claims 1-2, wherein said hyaluronic acid has a molecular weight ranging from 20 to 1000 KDa. 4. Gel according to claims 1-3, wherein said polyol humectant ? selected from glycerin, glyceryl triacetate, sorbitol, xylitol, maltitol, glycols, polymeric polyols, or mixtures thereof. 5. Gel according to claims 1-4, wherein said component (a) ? a vitamin E ester selected from the group consisting of alpha-tocopheryl acetate, alpha-tocopheryl linoleate and alpha-tocopheryl n-propionate, and/or hyaluronic acid ? present as its sodium salt, and/or the polyol humectant ? selected from glycerin, propylene glycol, pentylene glycol or mixtures thereof. 6. Gel according to claims 1-5, comprising the following quantities of components (a), (b) and (c), by weight on the weight of the gel: (a) 0.5-5.0%, (b) 0.05?0.5%, (c) 0, 5?5.0%. 7. Gel according to claim 6, wherein said component (a) is alpha-tocopheryl acetate and ? contained in a quantity? of 2.5-3.5% by weight on the total weight of the gel. 8. Gel according to claims 1-7, wherein the alcoholic disinfectant agent is selected from ethanol, isopropanol and mixtures thereof. 9. Gel according to claims 1-8, wherein the disinfectant agent is present in quantity? by weight between 50% and 80%, pi? preferably between 65% and 75% by weight on the weight of the gel. 10. Gel according to claims 1-9, wherein the gelling agent is a hydroxyalkyl cellulose. 11. Gel according to claims 1-10, wherein the gelling agent is? present in quantity? by weight between 0.2 and 2.0%, preferably between 0.5 and 1.5%, based on the weight of the composition. 12. Gel according to claim 10 or 11, wherein said hydroxyalkylcellulose ? selected from the group consisting of hydroxyethylcellulose, hydroxypropylcellulose and hydroxypropylmethylcellulose. 13. Gel according to any one of claims 1-12, further comprising a pH regulator, preferably selected from citric acid and lactic acid. 14. Gel according to any one of claims 1-13, having the following composition: Alpha-tocopheryl acetate: 2.5-3.5% Hyaluronic acid: 0.05-1.5% Glycerol: 1.0-2.0% Ethanol: 68.0-75.0% Hydroxyethylcellulose 0.8-1.2% Lactic acid 0.02-0.04% Water: to taste at 100.0% 15. Process for the preparation of the sanitizing gel according to claims 1-14, comprising formulating, together with said alcoholic disinfectant agent, said gelling agent and water, a dermoprotective mixture comprising vitamin E or an ester thereof, hyaluronic acid or a salt thereof physiologically acceptable, and a humectant polyol. 16. Gel according to claims 1-14, for use in a skin disinfection method.