Emulsions for use in oral and cosmetic formulations

Abstract

Emulsions for oral and cosmetic formulations free from sorbitan polyoxyethylene ethers esterified with fatty acids, comprising: a) a hydropolyol phase b) an oil phase; c) emulsifying agents; d) at least one water-soluble polysaccharide of plant origin; e) at least one lipophilic or hydrophilic active agent or a plant extract; wherein said hydropolyol phase a) comprises at least water, a polyol and a base the emulsifying agents c) consist of c1) ascorbyl palmitate and c2) at least one sucrose ester of fatty acids These emulsions are characterized by having the dispersed phase consisting of micelles of average size comprised between 90 and 800 nm measured by Dynamic Light Scattering (DLS).

Description

Emulsions for use in oral and cosmetic formulationsDESCRIPTIONFIELD OF THE INVENTIONThe present invention relates to emulsions for oral and cosmetic use.STATE OF THE ARTEmulsions are colloidal fluid systems consisting of two or more liquids immiscible with each other, in which one phase is dispersed in the form of droplets in the other. The dispersed phase is called the internal or discontinuous phase, and the dispersing phase is called the external or continuous phase. Depending on the dispersing phase, emulsions are classified into: i) simple oil-in-water (O / W) emulsions, in which the dispersed phase, present in lower quantities, is the oily phase, or water-in-oil (W / O) emulsions in which the dispersed phase, present in lower quantities, is the aqueous phase; ii) complex or multiple emulsions in which an emulsion is in turn dispersed in a +dispersing phase (W / O / W, O / W / O).Emulsions are also classified according to the size of the dispersed droplets: > 1pm macroemulsions; 100 nm - 1pm nanoemulsions; < 100 nm microemulsions.In addition to the external phase and the internal phase, emulsions are characterized by the presence of emulsifiers, amphiphilic substances that are arranged between the phases, reducing the interfacial tension and stabilizing the system. One or more emulsifiers may be used in the preparation of emulsions.The stability of the emulsions depends on both the composition and the size of the drops present in the system. Macroemulsions and nanoemulsions are thermodynamically unstable and kinetically stable systems, while microemulsions are thermodynamically and kinetically stable systems. In accordance with Gibbs' law AG=y A A- AST, where y is the interfacial tension between the phases, AA is the variation of the area at the interface, T is the temperature and AS is the entropy of the system, a system is thermodynamically stable when the free energy (AG) assumes a negative value. In macroemulsions and nanoemulsions the free energy of the system is positive because the emulsification process leads to an increase in interfacial tension and surface contact and at the same time an increase in the entropy of the system. The same occurs in microemulsions, however the latter are characterized by a highercontent of emulsifiers, which greatly reduce the interfacial tension by compensating for the increase in entropy of the system and thus making the reaction favourable, which occurs with a limited energy input or spontaneously. The emulsions are kinetically stable, despite the thermodynamically most favourable state being phase separation, i.e. when the contact surface is minimal, because the activation energy required to pass from the emulsified system to the separated phases is significantly higher than the thermal energy of the system (kT). Thus, to produce an emulsion that is kinetically stable for a long period of time it is necessary to use an emulsifying and stabilizing system capable of creating a sufficiently high AG gradient to delay physical separation phenomena such as flocculation, sedimentation, creaming, Ostwald ripening and coalescence, which anticipate phase separation. The sedimentation and creaming phenomena depend mainly on the difference in density of the phases, while the other phenomena are caused by the liquid-liquid interface properties.In accordance with Stoke's law v=2r2(pd-pc)g / 9r|, wherein v is the sedimentation velocity, r is the radius of the dispersed droplets, p is the density of the discontinuous phase, pcis the density of the continuous phase, g is the gravitational constant and q is the viscosity of the continuous phase, reducing the difference in density between the phases and the radius of the dispersed phase droplets, and increasing the viscosity of the dispersing phase acts to hinder phase separation.Emulsions, both in the field of research and at an industrial level, can be made with high or low energy methods. High-energy methods favour the dispersion of the internal phase into the external phase, and the consequent reduction in droplet size, using tools that provide high energy to the system, such as high-pressure homogenizers, sonicators, colloid mills, microfluidic systems. Low-energy methods, on the other hand, focus more on controlling phenomena at the interface and depend heavily on the characteristics of the emulsifiers present in the system. In the low-energy methods, the emulsion is formed when a phase inversion occurs due to the change in composition or temperature of the system during emulsification. The best-known low-energy preparation processes are the EIP (emulsion investment point) and PIT (phase investment point) methods. In the former, the phase inversion is induced by the change of the composition, i.e. by the modification of the water / oil ratio; the emulsion is formed at room temperature by gradually adding the continuous phase to thediscontinuous phase; during dilution the phase inversion takes place with consequent formation of the emulsion. The emulsion in this case is due to the inversion of the spontaneous curvature of the emulsifier. In the latter, the emulsion is set at temperatures higher than the phase inversion temperature of the emulsifier; when the system is cooled to room temperature, phase inversion occurs with the formation of the emulsion. Ethoxylated surfactants are widely used in emulsions prepared by the PIT method, since their properties are strongly influenced by temperature.Emulsions are systems that are widely used in the pharmaceutical, food and cosmetic sectors due to their ability to incorporate hydrophilic and hydrophobic substances and the preparation of stable emulsions over time is extremely important in the process of developing finished products for the market.Other solutions known in the state of the art are listed below:EP 2512648 Bl describes a nanoemulsion characterized by an aqueous phase and an oily phase with drops with a diameter between 20-900 nm (para.

[0017] ), comprising ascorbyl palmitate, a base and one or more polyoxyethylene sorbitan esters (para.

[0018] ). The nanoemulsion is made by PIT preparation method by stirring the system with a mechanical stirrer (para.

[0057] ) and do not exceed 80°C in the heating of the phases (para.

[0059] ). This composition allows the delivery of melatonin and fatsoluble vitamins (para.

[0062] ).US 7393548 B2 discloses an oil-in-glycerin cosmetic or pharmaceutical emulsion having particles of average diameter lower than 1 micron, comprising at least one stabilizing emulsifier and at least one bioactive compound characterized by a hydrophobic moiety within its structure (column 1, lines 66-67; column 2, lines 1-4). The stabilizing emulsifier is selected from sucrose esters or cetearyl glucoside (column 7, lines 2-3). The preparation of the composition takes place by means of mechanical stirring (column 7, lines 41-45).WO 2022013184 describes an oil-in-glycerin food emulsion to be inserted in finished products in order to improve the sensory properties of the food (para. [Oil]). The oil of the composition is chosen from vegetable oils, preferably sunflower oil, and the presence of medium-chain triglycerides (MCT) is excluded (para.

[0022] ). The emulsion includes the presence of sucrose esters (para.

[0014] ) and any optional co-emulsifiers such as lecithin (para.

[0027] ). This emulsion is made with high-speed homogenizers (para.

[0048] ).Problems of the background artEmulsifiers belonging to the class sorbitan polyoxyethylene ethers esterified with fatty acids, better known as polysorbates, are commonly and widely used for the manufacture of emulsions in the pharmaceutical, nutraceutical and cosmetic fields. Polysorbates are amphipathic, non-ionic surfactants that reduce tension at the interface by favouring the formation of emulsions. They are effective in O / W emulsions already at low concentrations due to their high hydrophilic-lipophilic ratio (HLB) and low critical micelle concentration (CMC).However, from recent studies the use of polysorbates, even in reduced concentrations, seems to be harmful to the gastrointestinal tract since it causes inflammation, reduction of the intestinal barrier mucosa and bacterial translocation through the intestinal epithelium(Partridge et al., 2019)(Bancil et al., 2021). They are also not very suitable for cosmetic emulsions intended for sensitive skin since by altering skin permeability they expose sensitive skin more to harmful agents.Finally, the products in liquid form intended for oral intake, such as sprays and syrups, have low compliance by the final consumer due to the unpleasant taste of the polysorbate reminiscent of that of soap.For these reasons, the need is therefore felt to identify compositions capable of conveying active ingredients in the form of emulsions free of polysorbate. The formula must be pleasant for the final consumer and must be stable over time, so it must have an adequate emulsifying and stabilizing system to delay phase separation phenomena and the preparation method must provide sufficient energy to the system to correctly disperse the internal phase in the external phase.SUMMARY OF THE INVENTIONThe Applicant has now found that it is possible to overcome the aforementioned drawbacks with the emulsions for cosmetic use and for oral use that are the subjectmatter of the present invention.These emulsions, free from sorbitan polyoxyethylene ethers esterified with fatty acids, comprise: a) a hydropolyol phase b) an oil phase; c) emulsifying agents; d) at least one water-soluble polysaccharide of plant origin; e) at least one lipophilic or hydrophilic active agent or a plant extract; wherein said hydropolyol phase a) comprises at least water, a polyol and a base the emulsifying agents c) consist of cl) ascorbyl palmitate and c2) at least one sucrose ester of fatty acidsThese emulsions are characterized by having the dispersed phase consisting of micelles of weight average size comprised between 90 and 800 nm, preferably between 100 and 600 nm measured by Dynamic Light Scattering (DLS) according to the method described in ISO 22412:2017.Advantages of the inventionThe emulsion of the invention has the following technical advantages: it is free from emulsifiers belonging to the class of sorbitan polyoxyethylene ethers esterified with fatty acids it is prepared by heating a single phase and emulsification takes place by simple mechanical stirring or with high shear homogenizers it is pleasant from an organoleptic standpoint, if intended for oral intake.The present invention also offers the possibility of preparing nutraceutical compositions or formulations, food supplements, pharmaceutical and cosmetic formulations for conveying lipophilic active components with emulsifiers alternative to sorbitan polyoxyethylene ethers esterified with fatty acids, limiting the harmful impacts on the body and providing a product with greater compliance by the final consumer.DESCRIPTION OF THE FIGURESThe accompanying figures highlight the results obtained by conducting Example 6.Figure 1 is a photo of the emulsion A containing vitamin D3 according to the present invention.Figure 2 is a photo of the emulsion B corresponding to the emulsion A, deprived of only the vegetable polysaccharide d)Figure 3 is a photo of the emulsion C corresponding to the emulsion A in the absence of ascorbyl palmitate cl) and of the base present in the hydropolyol phase a);Figure 4 is a photo of the emulsion D) corresponding to the emulsion A without the sucrose esters.DETAILED DESCRIPTION OF THE INVENTIONFor the purposes of the present invention, the definition "comprising" does not exclude the presence of additional components or characteristics in addition to those clearly listed after such definition.The definitions "consisting of" and "composed of" exclude the presence of additional components and characteristics beyond those expressly listed after these definitions.For the purposes of the present invention, oral formulations or compositions are understood to mean food supplements or nutraceutical formulations and pharmaceutical compositions. Preferably they are food supplements or nutraceutical formulations.“Food supplements” are defined by the legislation of the sector (Directive 2002 / 46 / EC, implemented by Legislative Decree no. 169 of 21 May 2004) as: "foodstuffs the purpose of which is to supplement the normal diet and which are concentrated sources of nutrients, such as vitamins and minerals, or other substances with a nutritional or physiological effect, in particular, but not exclusively, amino acids, essential fatty acids, fibre and herbal extracts, both single- and multi-compound, in pre-dosed forms" .The adjective "nutraceutical" is a term composed of "nutrition" and "pharmaceutical", coined in 1989 by the American nutritionist and biochemist Stephen De Felice to indicate a food, or part of a food, whose function is beneficial on human health, including the prevention and treatment of disease. Nutraceuticals, also CS QA functional foods or pharmaceutical foods, are ‘drug foods’, i.e. healthy foods that combine the healing properties of natural active ingredients of proven and recognized effectiveness with nutritional components, selected due to characteristics like the high digestibility and hypoallergenicity (Treccani Encyclopedia).For the purposes of the present invention, active ingredient means an ingredient that performs a biological activity in oral formulations or a eudermic activity in the cosmetic field. The active ingredients may be lipophilic, hydrophilic or poorly soluble in the aqueous and oily phase.The particularly preferred lipophilic active ingredients of the subject emulsions that can be used in both oral and cosmetic formulations are fat-soluble vitamins such as vitamins D, E, K, and A.The other ingredients that are either hydrophilic, or poorly soluble in aqueous and oily phase or soluble in oily phase active to be preferably employed in oral formulations such as food supplements are for example melatonin, polyphenols, flavonoids, carotenoids, amino acids, palmitoylethanolamide, water-soluble vitamins, resveratrol, lipoic acid, caffeine, vegetable extracts.The vegetable extracts may also contain lipophilic and / or hydrophilic actives therein. Preferably, they are oily extracts of plants containing mostly lipophilic actives or they are solid extracts.For the purposes of the present invention, plant extracts are understood to mean marketed and non-marketed extracts, consisting of mixtures of phytochemicals, generally obtained by extraction processes from plant parts.Phytochemicals are precisely the substances contained in the same plant.This extraction is obtained using water as the extraction solvent, possibly in admixture with a water-miscible organic solvent, or supercritical carbon dioxide, the latter being particularly suitable for obtaining oily extracts.The hydropoliolic phase a) refers to a phase comprising water and at least one C2-C8 polyol, with at least 2 hydroxyl groups such as for example glycerin, propylene glycol, 1,3-propanediol, butylene glycol, pentylene glycol, 1,2-hexanediol, 1,2-heptanediol, caprylyl glycol and a base.Preferably, glycerin is used in both oral and cosmetic formulations.Polyol is preferably present in the aforementioned hydropolyol phase in an amount comprised between about 30 and 85%, preferably between about 45% and 85%, preferably between about 50% and 80%, preferably between about 55% and 75%, preferably between about 58% and 75% by weight on the total weight of the emulsion.The base contained in the hydropolyol phase a) may be a weak base or a strong base among those acceptable in oral and / or cosmetic formulations, it is preferably selected from sodium hydroxide, potassium hydroxide, calcium hydroxide, arginine. According to preferred embodiments, sodium hydroxide is used in cosmetic formulations, while arginine is preferably used in both oral and cosmetic formulations.For the purposes of the present invention, strong base means a substance that dissociates completely in water producing hydroxide ions. Examples of strong bases are e.g. alkali and alkaline earth metal hydroxides.For the purposes of the present invention, a weak base is a chemical substance that, when dissolved in water, only partially dissociates producing hydroxide ions (according to the Arrhenius definition) or accepting protons (according to the definition ofBrpnsted)The base according to the present invention is preferably present in concentrations comprised between: 0, 01 and 1% by weight on the total weight of the emulsion.The oily phase b) of the emulsion preferably contains medium-chain fatty acid triglycerides, preferably caprylic / capric (C8-C10) triglyceride, vegetable oils and relative mixtures.The vegetable oil can be selected from the group consisting of: sunflower oil, corn oil, olive oil, hemp oil, amaranth oil, avocado oil, soy bean oil, and mixtures thereof.For the purposes of the present invention medium-chain triglycerides or medium-chain fatty acid triglycerides are meant triglycerides with two or three saturated fatty acids having 6 to 12 carbon atoms.They are generally found in palm kernel oil and coconut oil.The oily phase is preferably present in an amount comprised between about 0.01% and 7%, preferably between about 0.1% and 5%, preferably between about 0.1% and 4%, preferably between about 0.2% and 3% by weight on the total weight of the emulsion.The ascorbyl palmitate cl) present in the emulsion subject-matter of the present invention is an ester formed by the reaction of the primary alcoholic group of ascorbic acid and the carboxylic group of palmitic acid. It is a powerful antioxidant and is widely used in the nutraceutical, cosmetic and pharmaceutical sectors. The ascorbyl palmitate has an amphiphilic structure and is used as an emulsifier in the invention. The solubilization in water and the emulsifying action are favoured by the addition of a base that allows the salification of the enediol function.The ascorbyl palmitate is preferably present in an amount comprised between about 0.01% and 5%, preferably between about 0.02% and 4%, preferably between about 0.02% and 3%, preferably between about 0.03% and 2% by weight of the total weight of the emulsion.The sucrose esters of the fatty acids most commonly defined as sucresters c2) present in the emulsion according to the present invention are non-ionic surfactants characterized by a hydrophilic portion given by the presence of the sucrose and by a hydrophobic portion given by the presence of the fatty acids. They are commonly used in the nutraceutical, food, cosmetic and pharmaceutical industries.The sucrose esters of the fatty acids are preferably present in an amount comprised between about 0.01% and 4%, preferably between about 0.05% and 3%, preferably between about 0.1% and 2%, preferably between about 0.1% and 1% by weight on the total weight of the emulsion.By water-soluble polysaccharide of vegetable origin d) contained in the emulsion subject-matter of the invention is meant a hydrocolloid isolated from vegetable plants. Preferably the water soluble polysaccharide of plant origin is selected from plant exudate hydrocolloids and seed derived hydrocolloids. In a particularly preferred embodiment of the invention the polysaccharide of plant origin is selected from plant exudates and is preferably comprised in the group consisting of: gum Arabic and tragacanth gum and relatedmixtures.The polysaccharide of plant origin d) soluble in water, is preferably in a quantity comprised between about 0.1% and 10%, preferably between about 0.2% and 8%, preferably between about 0.5% and 6%, preferably between about 1% and 5% by weight of the total weight of the emulsion.The emulsions object of the present invention may contain excipients of conventional type such as preservatives in particular potassium sorbate and acidifiers, preferably citric acid, flavours such as for example honey flavouring.The invention also relates to a process for preparing emulsions by simple mechanical mixing or high shear homogenization, in contrast to the state of the art in which high pressure systems are needed to obtain dispersed phase dimensions below the micron, and provides for heating the hydropolyol phase only, allowing an optimization of construction times and costs. The preparation process comprises the following steps:Preparing the hydropolyol phase, dissolving in water the base, the ascorbyl palmitate, the polyol, the sucrose esters with fatty acids, the at least one polysaccharide of plant origin and, when required, the poorly soluble active ingredient in the aqueous or oily phase;Heating the phase obtained in the previous step at a temperature comprised between 60 and 80°C;Separately mixing the oily phase and, when required, the lipophilic active ingredient at room temperature and / or the oily extract;Combining the oily phase with the hydropolyol phase and mixing the system with a high- shear homogeniser for a few minutes;Cooling the system under mixing until reaching a temperature below 30°C, optionally adding thermolabile ingredients such as flavourings and when present at least one hydrophilic active ingredient, and / or a non-oily plant extract. EXAMPLESBelow the Applicant reports examples of the invention, merely for illustrative and nonlimiting purposes.Example 1 - Liquid emulsion containing vitamin D3Preparation method: a. Dissolve L- Arginine in the amount of Water indicated in the table; b. Heat the aqueous phase obtained from a. to 60°C; c. Add to Ascorbyl Palmitate the aqueous phase obtained from b.; d. Add Vegetable Glycerin to the aqueous phase obtained from c. and heat the hydropolyol system to 75°C; e. Add Sucrester to the hydropolyol phase obtained from d.; f. Add Gum Arabic to the hydropolyol phase obtained from e.;g. Separately mix at room temperature Medium-Chain Triglycerides and Vitamin D3; h. Combine the oily phase obtained from g. to the hydropolyol phase obtained from f. and mix the system with a high shear homogeniser for a few minutes; i. Cool the system under mixing until a temperature of less than 30°C is reached; j. Add Potassium Sorbate to the phase obtained from i.; k. Add Citric acid to the phase obtained from j.; l. Add Honey Aroma and Lemon Aroma to the step obtained from k. . Example 2 - Liquid emulsion containing melatoninPreparation method: a. Dissolve the L- Arginine in the amount of Water indicated in table; b. Heat the aqueous phase obtained from a. to 60°C; c. Add Ascorbyl Palmitate to the aqueous phase obtained from b.; d. Add Vegetable Glycerin to the aqueous phase obtained from c. heat the hydropolyol system to 75°C; e. Add Sucrester to the hydropolyol phase obtained from d.;f. Add Melatonin to the hydropolyol phase obtained from e.; g. Add to the hydropolyol phase obtained from f. Gum Arabica; h. Separately prepare Medium Chain Triglycerides at room temperature; i. Combine the oily phase obtained from h. with the hydropolyol phase obtained from g. and mix the system with a high-shear homogeniser for a few minutes; j. Cool the system under mixing until a temperature of less than 30°C is reached; k. Add Potassium Sorbate to the phase obtained from j.; l. Add Citric acid to the step obtained from k.; m. Add Honey Aroma and Lemon Aroma to the phase obtained from 1..Example 3 - Liquid emulsion containing vitamin D3 and vitamin K2Sucrester 0.2857Gum Arabic 3.0296Preparation method: a. Dissolve the L- Arginine in the amount of Water indicated in table; b. Heat the aqueous phase obtained from a. to 60°C; c. Add Ascorbyl Palmitate to the aqueous phase obtained from b.; d. Add Vegetable Glycerin to the aqueous phase obtained from c. and heat the hydropolyol system to 75°C; e. Add Sucrester to the hydropolyol phase obtained from d.;f. Add Gum Arabic to the hydropolyol phase obtained from e.; g. Separately mixing Medium Chain Triglycerides, Vitamin D3 and Vitamin K2 at room temperature; h. Combine the oily phase obtained from g. to the hydropolyol phase obtained from f. and mix the system with a high shear homogeniser for a few minutes; i. Cool the system under mixing until a temperature of less than 30°C is reached; j. Add Potassium Sorbate to the phase obtained from i.; k. Add Citric acid to the phase obtained from j.. Example 4 - Emulsion containing melatonin and Passiflora Incarnata L.a. Dissolve in the amount of Water indicated in the L- Arginine table; b. Heat the aqueous phase obtained from a. to 60°C; c. Add to the aqueous phase obtained from b. Ascorbyl Palmitate; d. Add to the aqueous phase obtained from c. Vegetable Glycerin and heat the hydropolyol system to 75°C; e. Add to the hydropolyol phase obtained from d. Sucrester; f. Add to the hydropolyol phase obtained from e. Melatonin; g. Add to the hydropolyol phase obtained from f. Gum Arabica;h. Separately prepare Medium Chain Triglycerides at room temperature; i. Combine the oily phase obtained from h. with the hydropolyol phase obtained from g. and mix the system with a high-shear homogeniser for a few minutes; j. Cool the system under mixing until a temperature of less than 30°C is reached; k. Add Dry extract of Passiflora Incarnata L to the phase obtained from i.. l. Add Potassium Sorbate to the phase obtained from j.; m. Add Citric acid to the step obtained from k.;Example 5 - Particle size analysis The particle size of the emulsions of the invention was analysed by Dynamic Light Scattering (DLS), a non-invasive technique that, by exploiting the phenomenon of light scattering, measures the speed of diffusion of the drops and determines their size.The formulations reported in Examples 1, 2, 3 and 4 were tested.Polydispersity Active component Peak size Z-average indexExample Vitamin D3 0.207 156 nm 128 nm1Example Melatonin 0.277 126 nm 125 nm2Example Vitamins D3 and K2 0.192 169 nm 136 nm3Example Melatonin and Passiflora 0.199 143 nm 116.7 nmThe emulsions of the invention are moderately poly disperse, with size distribution represented by a single peak respectively at 156 nm, 126 nm, 169 nm and 143 nm and weighted average diameter, expressed by Z-average value, at 128 nm, 125 nm, 136 nm and 116 nm (Tab. 1). This demonstrates the effectiveness of the composition and method of preparation in making nanometric emulsions in the absence of polyoxyethylene sorbitan esters.Example 6 - Comparison of liquid emulsions containing vitamin D3In order to evaluate the uniqueness of the following invention, preparations free of individual ingredients characterizing the composition were made, demonstrating that only the combination of the components of the preparation allows the emulsion to be obtained. The comparison is made visually and by DLS analysis.Emulsion A: inventionEmulsion B: invention without polysaccharide of plant originEmulsion C: invention without palmitate and baseEmulsion D: invention without sucrose fatty acid estersPreparation method: a. Where provided, dissolve the L- Arginine in the amount of Water indicated in table; b. Heat the aqueous phase obtained from a. to 60°C; c. If required, add Ascorbyl Palmitate to the aqueous phase obtained from b.;d. Add Vegetable Glycerin to the aqueous phase obtained from c. and heat the hydropolyol system to 75°C; e. If provided, add Sucrester to the hydropolyol phase obtained from d.; f. Where it is planned, add Gum Arabica to the hydropolyol phase obtained from e.; g. Separately mix at room temperature Medium-Chain Triglycerides and Vitamin D3; h. Combine the oily phase obtained from g. to the hydropolyol phase obtained from f. and mix the system with a high shear homogeniser for a few minutes; i. Cool the system under mixing until a temperature of less than 30°C is reached; j. If provided, add Potassium Sorbate to the phase obtained from i.; k. If provided, add Citric acid to the phase obtained from j.;The Emulsion A object of the present invention appears light yellow, is moderately polydisperse with polydispersity index equal to 0.289 and dimensional distribution represented by a single peak at 236 nm and weighted average diameter at 210 nm (Fig. 1, Tab. 2). Emulsion B, free of gum arabic, is visually superimposable on Emulsion A (Fig.2), however it is more polydisperse with a polydispersity index of 0.415 and the size distribution has two peaks at 138 nm and 456 nm respectively (Tab. 2). Emulsion C, free of ascorbyl palmitate and arginine, has an evident creaming phenomenon that manifests itself in the hours following preparation (Fig. 3). Emulsion D, free of sucrose esters of fatty acids, is not formed at the end of the manufacturing process, presenting surface layered oil drops (Fig. 4).PolydispersityPeak size Z-average indexEmulsion A 0.289 236 nm 210 nmEmulsion B 0.415 138 nm (peak 1)456 nm (peak 2)Table 2Example 7 Stability testsStability tests of the formula of example 1 were conducted at 25±2°C - 60%±5%°RH at To =6 and T5-5 months the results are shown in the following table 3.Table 3

Claims

CLAIMS1. Emulsions for oral and cosmetic formulations free from sorbitan polyoxyethylene ethers esterified with fatty acids, comprising: a) a hydropolyol phase b) an oil phase; c) emulsifying agents; d) at least one water-soluble polysaccharide of plant origin; e) at least one lipophilic or hydrophilic active agent or a plant extract; wherein said hydropolyol phase a) comprises at least water, a polyol and a base the emulsifying agents c) consist of cl) ascorbyl palmitate and c2) at least one sucrose ester of fatty acids wherein the emulsion has the dispersed phase consisting of micelles of weight average size comprised between 90 and 800 nm, preferably between 100 and 600 nm measured by Dynamic Light Scattering (DLS).

2. Emulsions according to claim 1, wherein the lipophilic active ingredient is at least one fat-soluble vitamin preferably selected from vitamin D, E, vitamin K, and vitamin A.

3. Emulsions according to claim 1 or 2, wherein the hydrophilic or lipophilic or poorly soluble active ingredient in oily or aqueous phase is selected from melatonin, polyphenols, flavonoids, carotenoids, amino acids, palmitoylethanolamide, water- soluble vitamins, resveratrol, lipoic acid, caffeine, plant extracts.

4. Emulsion according to any one of claims 1-3, wherein the hydropolyol phase comprises water, and at least one C2-C8 polyol, with at least 2 hydroxyl groups selected from glycerin, propylene glycol, 1,3-propanediol, butylene glycol, pentylene glycol, 1,2-hexanediol, 1,2-heptanediol, caprylyl glycol and a base, preferably glycerin.

5. Emulsions according to any one of claims 1- 4, wherein in step a) the polyol is present in an amount comprised between about 30 and 85%, preferably between about 45% and 85%, preferably between about 50% and 80%, preferably between about 55% and 75%, preferably between about 58% and 75% by weight on the total weight of the emulsion.

6. Emulsions according to any one of claims 1-5, wherein the base is selected from a weak or strong base acceptable in oral and / or cosmetic formulations.

7. Emulsions according to claim 6, wherein the weak base is arginine.

8. Emulsions according to claim 6 for cosmetic formulations, wherein the strong base is selected from sodium hydroxide, potassium hydroxide, calcium hydroxide, preferably it is sodium hydroxide and when present, the weak base is arginine.

9. Emulsions according to any one of claims 1-8, wherein the oily phase contains medium-chain fatty acid triglycerides, preferably caprylic / capric (C8-C10) triglyceride, vegetable oils and relative mixtures.

10. Emulsions according to claim 9, wherein the vegetable oil is selected from the group consisting of: sunflower oil, corn oil, olive oil, hemp oil, amaranth oil, avocado oil, soy bean oil, and mixtures thereof.

11. Emulsions according to any one of claims 1-10, wherein said oily phase is present in an amount comprised between about 0.01 % and 7 % , preferably between about 0.1% and 5%, preferably between about 0.1% and 4%, preferably between about 0.2% and 3% by weight on the total weight of the emulsion.

12. Emulsion according to any one of claims 1-11, wherein the ascorbyl palmitate cl) is preferably in an amount comprised between about 0.01% and 5%, preferably between about 0.02% and 4%, preferably between about 0.02% and 3%, preferably between about 0.03% and 2% by weight on the total weight of the emulsion.

13. Emulsion according to any one of claims 1-12, wherein the sucrose esters c2) with fatty acids are present in an amount comprised between about 0.01% and 4%, preferably between about 0.05% and 3%, preferably between about 0.1% and 2%, preferably between about 0.1% and 1% by weight on the total weight of the emulsion.

14. Emulsion according to any one of claims 1-13, wherein the polysaccharide of vegetable origin is a hydrocolloid isolated from vegetable plants and is preferably comprised in the group consisting of gum arabic and tragacanth gum and relative mixtures.

15. Emulsion according to any one of claims 1-14, containing the polysaccharide of plant origin d) in concentrations comprised between about 0.1% and 10%, preferably between about 0.2% and 8%, preferably between about 0.5% and 6%, preferably between about 1% and 5% by weight on the total weight of the emulsion.

16. Process for preparing emulsions according to any one of claims 1-15 comprising the following steps: preparing the hydropolyol phase, dissolving in water the base, the ascorbyl palmitate, the polyol, the sucrose esters with fatty acids, the at least one polysaccharide of plant origin and, when required, the poorly soluble active ingredient in the aqueous or oily phase;Heating the hydropolyol phase to a temperature comprised between 60°C and 80°C;Separately mixing the oily phase and, when required, the lipophilic active ingredient at room temperature and / or the oily extract, when present;Combining the oily phase with the hydropolyol phase and mixing the system with a high- shear homogeniser for a few minutes;Cooling the system under mixing until reaching a temperature below 30°C, optionally adding thermolabile ingredients such as flavourings and when present at least one hydrophilic active ingredient, and / or a non-oily plant extract.

17. Compositions selected from pharmaceutical compositions, nutraceutical compositions, food supplements and cosmetic compositions comprising the emulsions according to any one of claims 1-16.

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