EP3076944A1 - Lipid microcapsules preferably comprising a lipophilic active substance and composition containing same, method for the production thereof, and use of same in dermatology and in cosmetics - Google Patents

Abstract

The invention relates to lipid microcapsules preferably comprising at least one lipophilic active substance, more specifically a retinoid in a soluble form, to the pharmaceutical compositions comprising same, and to the method for the production thereof. The invention further relates to the composition for the use thereof in the treatment of dermatological pathologies.

Description

 FIELD OF THE INVENTION The present invention relates to lipid microcapsules having an oily internal phase and a non-polymeric envelope obtained from a lipophilic microcapsule having an internal oily phase and a non-polymeric envelope obtained from less a lipid compound selected from amphiphilic lipids.

 In particular, the invention relates to lipid microcapsules comprising at least one lipophilic active principle, said active ingredient being present in lubilized form in the oily heart of the microcapsules.

 The invention also relates to the primary emulsion composed of oily heart microcapsules dispersed in an aqueous phase and to the composition comprising, within an acceptable vehicle, the primary emulsion.

 The invention also relates to a process for preparing the primary emulsion and the composition comprising the lipid microcapsules. Finally, the invention relates to a pharmaceutical composition for its use in the treatment of dermatological conditions.

 Those skilled in the art are constantly confronted with difficulties of formulation of active ingredients, in particular lipophilic active principles having a pharmaceutical activity and / or a cosmetic activity, because of their solubility in a medium which may sometimes prove unfavorable. Moreover, once lubilized, the asset must be stable and the composition containing it.

The problem that the present invention proposes to solve here is therefore to design a physically and chemically stable composition capable of facilitating the formulation of the active ingredient while improving its protection as well as its stability within the composition in which it is present. is incorporated. Thus, the Applicant has surprisingly discovered that the use of particular lipid microcapsules for modifying the structure of the interface between the solubilizing medium of the active and the external phase had an impact on the attained content of active so lubilized and on its stability within a composition. In the present invention, the active ingredient is lubilized in the oily heart of lipid microcapsules.

 Numerous encapsulation techniques exist in the prior art that make it possible to obtain microcapsules.

 Microencapsulation is defined as the set of technologies that make it possible to obtain the preparation of individualized microparticles, consisting of a coating material containing an active material.

 The terminology "microcapsules" implies entities whose diameter is between 1 and 1000 μιη. The term nanocapsules is reserved for capsules whose size is less than one micron.

 The encapsulated material may be in the form of fine particles of split liquid, a liquid, or a gaseous compound. The microcapsule makes it possible to preserve the encapsulated substance in the form of a finely divided state, and to release it in the desired conditions.

 Microparticles obtained by microencapsulation can be presented under two different types of morphology:

 Microspheres which are particles consisting of a continuous macromolecular or lipidic network forming a matrix in which the active material is finely dispersed. The latter may be in the form of fine solid particles or droplets of solutions.

 Microcapsules which are reservoir particles consisting of a core of liquid or solid active material, surrounded by a continuous solid envelope of encapsulating material.

The different microencapsulation methods can be classified according to different criteria. Richard and Benoit, (Microencapsulation, 2000, Engineering Techniques, J2210, 1-20) propose four different ways to classify encapsulation methods:

 • The processes can be classified according to the use or not of organic solvent, some techniques such as complex coacervation using supercritical fluids,

• The nature of the dispersing medium can also serve as a basis for a classification: it can be liquid (interfacial polycondensation, coacervation), gaseous (spray drying, fluidized bed coating), or in the supercritical state (phase separation)

 • The family to which the compound used to obtain the capsule belongs can also make it possible to classify the encapsulation modes: preformed polymers (coacervation), lipids (spray-freezing), or monomers (interfacial polycondensation, polymerization in dispersed medium)

 • Finally, a final classification is based on the nature of the principle according to which microencapsulation is carried out: physicochemical processes are distinguished from chemical and mechanical processes.

The various methods of encapsulation are summarized in the table below according to the nature of the process (Finch and Bodmeier, 2005, Microencapsulation, Wiley-VCH verlag GmbH & Co, KGa, Weinheim, O. 1 002 / 14356007. al 6_575 ).

Type of Encapsulation Mode Range of Process Type Microparticle Product Sizes Obtained

Phase separation or 2 - 1200μιη Microcapsules coacervation (single or

 complex)

Processes Evaporation - extraction 0.5 - 200μιη Microcapsules physico-de so lvant Microspheres

 Extrusion / Spheronization 200 μιη Microspheres

While mechanical processes only make it possible to obtain microspheres, the microcapsules are generally obtained by physicochemical or chemical methods. These methods require the use of preformed coating agents such as polymers or monomers which in situ via a specific polymerization mechanism allow formation of the coating material.

 According to the present invention as defined hereinafter, the microcapsules and processes making it possible to obtain them have the advantage over the prior art of not containing a polymer, or of an organic solvent, and not to I had temperature cycles.

According to the invention, it is meant any solvent, considered unstable, ie having a boiling point strictly below 100 ° C. By analogy, any solvent having a boiling point greater than or equal to 100 ° C. will be considered non-vo latile according to the invention. In the case of the majority of microencapsulation applications, the active substances are initially maintained and protected in the microcapsule core for a defined period of time, and in a second time are either progressively released through the membrane according to a certain speed of release, are liberated massively at one time. In this case, the release is triggered by a method providing specific release.

 The problem which the present invention proposes to solve here is therefore to design a physically and chemically stable composition capable of containing at least one lipophilic active principle for the treatment of dermatological pathologies, said active ingredient being in solubilized form. The composition according to the invention has the objective of improving the formulation of the active ingredient while ensuring stability and ease of use and cosmetology acceptable for application to all areas of the body that can be affected by pathology.

 By physical stability according to the invention is meant a composition whose physical properties such as organoleptic characteristics, microcapsule size, pH and viscosity are stable over time and under different temperature conditions, 4 ° C, temperature ambient, 40 ° C.

 By chemical stability according to the invention is meant a composition capable of containing a chemically stable active ingredient over time and regardless of the temperature condition: 4 ° C, room temperature, 40 ° C.

 By ambient temperature is meant a temperature of between 15 and 25 ° C.

 According to the present invention, the lipophilic active principle is in a solubilized form in a stable composition.

Many lipophilic active agents often have difficulty in solubilization and stability, thus limiting the incorporation of these into the vehicles conventionally used, and making it difficult to obtain a stable composition.

 Moreover, the addition of soiling agent in the topical formulations often increases the irritating power of the formulations, while inducing instability of the composition and therefore does not present an ideal solution to the problem encountered.

 The composition according to the invention is therefore capable of containing, within the microcapsules, at least one active ingredient known to those skilled in the art for presenting problems of solubilization and stability. The active agents that can be used according to the invention may be in a nonlimiting manner:

 active substances that are difficult to grow and stable in highly aqueous media, such as plant extracts, and in particular Indigo Naturalis. Other active agents that can be used preferentially according to the invention are also the prostaglandin analogues.

By "prostaglandin analogs", non-limiting mention may be made of travoprost, latanoprost and tafluprost. Preferably, travoprost is used.

 the active agents exhibiting a pH-dependent degradation of the composition, such as corticosteroids, and in particular clobetasol and its esters, betamethasone and its esters, aclomethasome and its esters, which destabilize at pH> 5. Preferably, clobetasol propionate is used.

 Oxidation-sensitive assets, such as phenolic derivatives. By "phenol derivative", mention may be made, without limitation, of hydroquinone, rucino l or lucino l, resorcino l, 4-hydroxyaniso l, hydroquinone monoethyl ether and hydroquinone monobenzylether. Preferably, hydroquinone and rucinol are used.

By lipid microcapsules is meant a vesicular system of micrometric size that is to say greater than one micrometer consisting of a non-polymeric lipid envelope surrounding a liquid or semi-liquid oily heart at room temperature. By oily heart, or internal lipid phase is meant the internal phase of lipid microcapsules of micrometric size containing a lipophilic solvent immiscible with water.

 The present invention therefore relates to the formulation of lipid microcapsules of micrometric size that can improve the formulation and stability of the lipophilic active principles, in the treatment of cutaneous pathologies

 The oily heart of the lipid microcapsules of micrometric size of the present invention is lipophilic allowing the solubilization of hydrophobic active ingredients in greater quantity.

 The present invention is a system for implementing lipid microcapsules of micrometric size without the use of organic solvents vo latil often used for the formation of the envelope, thus limiting the risks of toxicity and intolerance and in particular irritation .

 According to the present invention, the composition comprises lipid microcapsules of micrometric size and not lipid microspheres. In contrast, lipid microspheres are matrix particles, i.e. the whole of the mass is solid at room temperature. When the microspheres contain a pharmaceutically acceptable active ingredient, it is finely dispersed or solubilized in the solid matrix. The lipid microcapsules of micrometric size according to the invention are particles whose core is composed of one or more fats liquid (s) or semi-liquid (s) at room temperature and is likely to contain the active ingredient in the form of lubilized, and whose envelope is lipidic and nonpolymeric in nature. Indeed, lipid microcapsules of micrometric size according to the invention do not require any polymer and therefore no in situ polymerization.

The Applicant has, surprisingly, discovered that compositions comprising at least one lipophilic active principle, in lubilized form in lipid microcapsules of micrometric size in a hydrophilic environment, do not require the use of polymer or solvent. organic vo latil, guarantee the stability of the active ingredient by encapsulating said active ingredient in microcapsules. The compositions according to the invention can also promote the cutaneous penetration of the active agent, which is useful in the treatment of cutaneous affections.

 The present invention therefore has for first obj and a lipid microcapsule of micrometric size containing an oily internal phase, a non-polymeric envelope obtained from at least one lipid compound selected from amphiphilic lipids.

 Preferably, the lipid microcapsule of micrometric size according to the invention contains at least one lipophilic active ingredient solubilized in the oily internal phase.

 In particular, the lipid microcapsules of micrometric size according to the invention preferably consist of:

 a non-polymeric envelope obtained from at least one lipid compound,

 at least one oily heart in which the lipophilic active agent is lubilized;

 at least one lipophilic active principle solubilized in said oily heart.

 The invention relates in particular to lipid microcapsules of micrometric size made without organic solvents vo latil.

 The present invention also relates to a primary emulsion composed of lipid microcapsules of micrometric size dispersed in an aqueous phase.

By primary emulsion is thus meant the lipid system composed of lipid microcapsules of micron size with a solid or semi-solid interface dispersed in a continuous aqueous phase, said microcapsules containing an oily heart capable of containing the lipophilic active principle in solubilized form. an envelope obtained from a lipid compound forming the semi-solid or solid interface between the oily internal phase and the continuous aqueous phase. This primary emulsion is therefore an oil-in-water type emulsion. Said primary oil-in-water emulsion according to the invention may be incorporated into a pharmaceutically acceptable vehicle, such as a gel, a solution or an emulsion such as a cream or a lotion.

 The present invention therefore also relates to a composition comprising the primary emulsion according to the invention.

 In particular, the present invention therefore also relates to a composition, in particular a pharmaceutical and / or a cosmetic composition, said composition comprising, within a pharmaceutically or cosmetically acceptable vehicle, the primary emulsion according to the invention.

 The present invention therefore relates to a pharmaceutical composition, said composition comprising, within a pharmaceutically acceptable vehicle, the primary emulsion composed of lipid microcapsules of micrometric size preferably consisting of:

 a non-polymeric envelope obtained from at least one lipid compound

 at least one oily heart in which the lipophilic active principle is solubilized;

 at least one lipophilic active principle.

 said lipid microcapsules of micrometric size being dispersed in an aqueous phase.

 By composition according to the invention is therefore meant the primary emulsion, incorporated in a pharmaceutically acceptable vehicle, such as an excipient or a mixture of excipients which can form a composition in the form of a gel, a solution or an emulsion such as a cream or a lotion that can be sprayable or not.

 The compositions according to the invention have the advantage of being chemically and physically stable.

 Lipid microcapsules of micrometric size according to the present invention means lipid microsystems whose size is preferably between 1 μιη and Ι ΟΟ μιη.

According to a preferred method of manufacture, 50% of the lipid microcapsules have at least an average size of between 1 and 80μηι and preferably between 1 and 50 μιη. In a particularly preferred embodiment, the microcapsules according to the invention have an average size of between 1 and 20 μπι.

 The lipid microcapsules of micrometric size are present in the composition according to the invention in an amount of between 0.1 and 30% by weight relative to the total weight of the composition, preferably between 0.5 and 20%, and more particularly between 1 and 10%.

 The microcapsules each consist of a liquid or semi-liquid core at room temperature, and an envelope obtained from at least one lipid compound.

 Preferably, the lipid microcapsules consist of a liquid or semi-liquid heart at room temperature containing at least one lipophilic active ingredient solubilized within the oily heart.

 The prior art (US Pat. No. 8,057,823, FR 2,805,761 and WO201 1/036234) discloses lipid capsules containing phosphatidylcho lines, but these are of nanometric size and require, for their preparation, the systematic presence of at least a hydrophilic nonionic co-surfactant derived oxyethylenated fatty alcohols and fatty acids.

 Unlike the prior art, the present invention relates to lipid microcapsules of micrometric size containing exclusively phosphatidylcho lines without any other additional lipophilic or hydrophilic co-surfactant.

 The envelope encapsulating the oily liquid or semiliquid heart at room temperature is preferably composed of a rigid material at room temperature, non-polymeric and whose transition temperature or melting is high. To be rigid at room temperature, the transition or melting temperature must be greater than 35 ° C, preferably greater than 40 ° C and ideally greater than 45 ° C.

In the microcapsules according to the invention, the envelope consists of at least one lipid compound of amphiphilic type. Preferably, the envelope consists of a single lipid compound, advantageously chosen from amphiphilic lipids. More preferably, the lipid compound is selected from the family of phospholipids, and more specifically, phosphatidylcho lines or lecithins. Phosphatidylcho lines or lecithins show good compatibility with the skin with a very low irritating potential.

 As usable lecithins, there may be mentioned in particular soy or egg lecithins, natural or synthetic or derived. The first type of lecithin is phosphatidylcholine (PC). There are other types of lecithin including phosphatidylglycerol, phosphatidylinositol, sphingomyelin and phosphatidylethanolamine.

 Among the lecithins having a transition temperature greater than 35 ° C., mention may be made more particularly of dipalmitoylphosphatidylcholine (DPPC), phosphatidylcholine distearoyl (DSPC), phosphatidylcholine dibehenyl (DBPC), palmitoylstearoyl phosphatidylcholine (PSPC). palmitoyl-behenyl phosphatidylcholine (PSPC), stearoyl-behenyl phosphatidylcholine (SBPC), as well as all saturated lecithins with long chains of fatty acids and their derivatives.

 The lecithins especially used in the present invention are soluble at room temperature, which favors the formation of a semi-solid interface around the liquid or semi-liquid core. This formulation allows the encapsulation of the active ingredient solubilized in the oily heart.

The lipid microcapsules of micrometric size according to the invention more particularly contain a semi-solid or solid interface between the internal phase and the aqueous continuous phase, thanks to the use as a single lipid compound of a preferably hydrogenated lecithin. More particularly, the hydrogenated lecithin used according to the invention has a high percentage of saturated phosphatidylcholine. By high percentage is meant an amount greater than 85% hydrogenated phosphatidylcho line (or saturated) relative to the total weight of lecithin.

 As lecithin preferentially used according to the invention, mention may be made of certain hydrogenated lecithins with a content of hydrogenated phosphatidylcho line greater than 85%, such as, for example, Lipoid® grade P 100-3, Phospholipon® grade 90H sold by Lipoid, Epikuron® grade 200 SH marketed by Cargill, or Emulmetik® 950 sold by Lucas Meyer. Preferably, the lecithin used as the sole lipid compound is Phospholipon® 90H for which the content of hydrogenated phosphatidylcho line is greater than 90%>, whose transition temperature is about 54 ° C.

 The lipid compound surrounding the liquid or semiliquid heart as defined above is present in an amount of between 0.01 and 10% by weight, preferably between 0.05 and 5% by weight, and more preferably between 0.1 and 1. % by weight relative to the total weight of the composition.

 The lipid compound, especially hydrogenated lecithin, according to the invention alone allows the encapsulation of the active agent, which avoids the contact of this active agent with the aqueous phase, and thus ensures chemical stability. In particular, the lipid microcapsule, and in particular the envelope, is free of any co-surfactant, in particular lipophilic or hydrophilic co-surfactant.

 Lipid microcapsules of micrometric size are in particular free of organic solvent vo latil.

 In particular, lipid microcapsules of micrometric size are free of polymer.

 By "active" is meant in the sense of the present invention a compound having a pharmaceutical activity and / or a cosmetic activity.

For the purposes of the present invention, the term "lipophilic" means a compound which is soluble in a liquid or semi-liquid fatty substance at ambient temperature or in a range of temperatures between 25 and 90 ° C. In other words, a lipophilic substance is liposo luble.

 Preferably, the lipophilic active principle is chosen from plant extracts, prostaglandin analogs, corticosteroids and phenol derivatives.

 According to one embodiment, the active ingredient is chosen from plant extracts, in particular Indigo Naturalis.

 According to one embodiment, the active principle is chosen from prostaglandin analogues, in particular travoprost, latanoprost and tafluprost and more preferably travoprost.

 According to one embodiment, the active ingredient is chosen from corticosteroids, in particular clobetasol propionate.

 According to one embodiment, the active ingredient is chosen from phenol derivatives, preferably hydroquinone, rucino l or lucino l, resorcino l, 4-hydroxyaniso l, hydroquinone monoethyl ether and hydroquinone monobenzylether. . More preferably, according to this embodiment, the active ingredient is selected from hydroquinone and rucinol.

 Preferably, the active ingredient is chosen from indigo naturalis, travoprost, clobetasol propionate, hydroquinone and rucinol.

 According to one embodiment, the lipophilic active ingredient has a cosmetic activity and can be chosen in particular from moisturizing active agents and sunscreens.

 The lipophilic active principle present in the microcapsules according to the present invention is different from an irritating active ingredient.

 The composition according to the invention comprises between 0.001 and 10% of at least one lipophilic active ingredient by weight relative to the total weight of the composition, preferably from 0.005 to 5% of an active ingredient by weight relative to the total weight of the composition.

The lipophilic active principle is thus solubilized in the core of the lipid microcapsules of micrometric size according to the invention. Said core, or oily internal phase, comprises at least one liquid or semi-liquid fatty substance at ambient temperature. The composition of the internal phase is therefore essential for the stability of the active ingredient. The oily internal phase must of course be likely to be compatible with the asset to be solubilized and solubilizing the asset.

 By solubilizing phase of the active is meant a phase in which the active ingredient is stable and has a solubility allowing its use at the active concentration in the final composition.

 By stability of the active principle in the oily phase is meant in the sense of the invention that the active ingredient is chemically stable over time and regardless of the temperature condition: 4 ° C, room temperature, 40 ° C.

 The stability of the active ingredient in the oily phase is evaluated in particular by liquid chromatography coupled to a UV detector (HPLC-UV).

 For the purposes of the present invention, the term "liquid or semi-liquid fatty substance at ambient temperature" means an oily solvent.

 By oily solvent is meant any material immiscible with water at room temperature.

 More particularly, the oily solvent may be a vegetable, mineral, animal or synthetic oil.

 Among the vegetable oils, mention may be made, without limitation, of olive oil, almond oil, palm oil, soya oil, sesame oil, canola oil, cottonseed oil, corn oil, safflower oil, castor oil or sunflower oil.

 Among the mineral oils, mention may be made, without limitation, of paraffin oils of different viscosities, for example those sold by Exxon Mobil, Marcol 152®, Marcol 82® and Primol 352®.

Among the oils of animal origin, non-limiting mention may be made of lanolin, squalene, cod liver oil and squalane sold by Laserson under the trade name Cosbiol®. Among the synthetic oils, non-limiting mention may be made of triglycerides, fatty acid esters, fatty alcohols, polyethylene glycol ethers, the corresponding fatty alcohols and esters, polyethylene glycol ethers, amides or the like. glycols.

 In a preferred embodiment according to the invention, the oily solvent constituting the oily internal phase does not comprise fatty acids which are not esterified or polyethoxylated.

 More particularly, the oily solvent may be a mineral oil, a triglyceride, a fatty acid ester, a carboxylic acid ester, a fatty alcohol, a volatile or non-volatile silicone, or a polyethylene glycol ether.

 Among the mineral oils, there may be mentioned, without limitation, paraffin oil.

Among the oils containing triglycerides and include without limitation, the octanoic acid triglycerides or triglycerides of caprylic / capric acids such as those sold by Stéarineries Dubois or those sold under the name Miglyol ^® 810, 812 , and 818 by the company Sasol.

 Among the fatty acid esters, mention may be made, without limitation, of diisopropyl adipate, such as the commercial product Crodamol® DA sold by Croda or Schercemol DIA Ester® sold by Lubrizol, or cetearyl isononanoate sold under the name Cetiol SN® by BASF.

Among the carboxylic acid esters, non-limiting mention may be made of alkyl benzoate (C _12-15 ), such as the commercial product Crodamol® AB sold by Croda, or the propylene glycol caprylate sold under the name Capryol. 90® by the company Gattefossé.

 Among the fatty alcohols, non-limiting mention may be made of octyl dodecanol or octyl dodecanol octanoate.

Among the ethers of polyethylene glycols, mention may be made, without limitation, of the PPG-15 stearyl ether sold under the name Arlamol PS11E-LQ by the company Croda. Among the volatile and non-volatile silicones, mention may be made of dimethicones and cyclomethicones, such as those sold by Dow Corning under the trade name Q7-9120 silicone fluid® and ST-Cyclomethicone 5-NF®.

In a preferred embodiment according to the invention, the solvents used in the oily internal phase are alkyl benzoate (C _12-15 ), propylene glycol caprylate or caprylic / capric acid triglycerides.

 In another preferred embodiment according to the invention, in the presence of an active ingredient, the preferred oily internal solvent phase of the active ingredient is diisopropyl adipate or PPG-15-stearyl ether.

 More particularly, the oily solvent may be a vegetable oil, a triglyceride, a fatty acid ester, fatty alcohols, or polyethylene glycol ethers.

 In a preferred embodiment according to the invention, the oily solvent constituting the oily internal phase does not comprise fatty acids which are not esterified or polyethoxylated.

 In particular, those skilled in the art will choose the oily solvent (s) adapted according to the lipophilic active agent capable of being solubilized.

 According to a preferred embodiment, the preferred oily solvents for solubilizing Indigo Naturalis are olive oil or triglycerides of caprylic / capric acids.

 In a preferred embodiment, the preferred oily solvent for solubilizing Travoprost is PPG-15 stearyl ether.

 In a preferred embodiment, the preferred oily solvents for solubilizing Clobetasol propionate are Apricot kerneil oil PEG-6 esters, PPG-15 stearyl ether or caprylic / capric acid triglycerides.

According to a preferred embodiment, the preferred oily solvents for solubilizing hydroquinone are diisopropyl adipate, PPG-15 stearyl ether. In a preferred embodiment, the preferred oily solvents for solubilizing rucino are diisopropyl adipate, PPG-stearyl ether or caprylic / capric acid triglycerides.

 According to one embodiment, the lipid microcapsules contain:

 an oily internal phase comprising at least one liquid or semi-liquid fatty substance at ambient temperature chosen from a vegetable oil, a triglyceride, a fatty acid ester, fatty alcohols, or polyethylene glycol ethers,

 a non-polymeric envelope obtained from at least one lipid compound,

 at least one active ingredient chosen from indigo naturalis, travoprost, clobetasol propionate, hydroquinone and rucino l; said active ingredient being solubilized in the oily internal phase.

 Likewise, the oily internal phase may also contain one or more non-oily co-solvents or other nonvolatile organic co-solvents.

 In a preferred embodiment according to the invention, the internal phase does not require any solvents / cosolvent of alcoholic type to solubilize the active ingredient. The blends of solvents selected according to the invention are sufficient to obtain the required solubility and stability of the active ingredient within the microcapsules without resorting to any alcoholic solvent.

 In addition to this oily solvent (s), the internal phase may also include one or more liquid or semi-liquid fatty substances at room temperature unsolubilizing asset.

 By non-solubilising fatty substance of the active ingredient is meant a compound for which the active ingredient does not exhibit a solubility allowing its use at the active concentration in the final composition.

In the oily internal phase, the solvent will be present in an amount of between 50 and 99.997% by weight relative to the total weight of the internal phase; preferably in an amount of between 70 and 99.997% by weight relative to the total weight of the internal phase, preferably between 95 and 99.997%). In the oily internal phase, the optional fatty substance or cosolvent is present in an amount of between 0 and 50% by weight relative to the total weight of the internal phase; preferably in an amount of between 0.1 and 25% by weight relative to the total weight of the internal phase, preferably between 0.5 and 10% by weight.

 In addition to the oily solvent (s) and the non-solubilizing fatty substance (s) of the active ingredient, the internal phase may also comprise one or more compounds such as, for example, antioxidants or preservatives.

 In the primary emulsion according to the invention, the oily internal phase of the microcapsules is present in an amount of between 0.1 and 50% by weight relative to the total weight of the primary emulsion, preferably in an amount of between 0.5 and 35%. by weight relative to the total weight of the primary emulsion.

 In the primary emulsion according to the invention, the ratio between the internal oily phase and the amount of hydrogenated lecithin is between 5 to 10 to 1.

 Preferably, this ratio in the emulsion is between 6 to 8 for 1 and preferably 7 to 1.

 Moreover, the ratio between the water and the internal oily phase is between 1.25 to 5 to 1. Preferably, this ratio between the water and the internal oily phase is between 2 to 4 for 1 and preferentially 2 to 3 to 1.

 In the primary emulsion, the microcapsules are dispersed in an aqueous phase. The continuous aqueous phase comprises water. This water can be demineralised water, floral water, or natural thermal or mineral water,

 The water may be present in a content of between 55 and 95% by weight relative to the total weight of the composition, preferably between 60 and 95% by weight.

The subject of the present invention is therefore a composition, in particular a pharmaceutical or a cosmetic composition, said composition comprising the primary emulsion containing the lipid microcapsules of micrometric size defined above in the text of the present invention in a pharmaceutically or cosmetically acceptable vehicle, such as a gel, solution or emulsion such as a cream or lotion.

 When the pharmaceutically or cosmetically acceptable vehicle is a gel, the primary emulsion is dispersed in an aqueous phase which comprises at least one gelling agent.

 This gelling agent may be a cellulose derivative chosen from semi-synthetic cellulosic gelling agents.

 The gelling agent may also be chosen from natural gums, in particular xanthan gum (known for example under the name Satiaxane and sold by Cargill), starch and its derivatives, polyacrylic acid polymers which have been crosslinked as carbomers such as Carbopol 980, Carbopol Ultrez 10 and among their alkylated derivatives such as copolymers of acrylates / C 10-30 alkyl acrylates such as Carbopol ETD2020, Pemulen TR I, Pemulen TR2, carboxyvinyl polymers, polyvinyl pyrrolidones and their derivatives, polyvinyl alcohols.

 The gelling agent may also be chosen from emulsifying polymers such as S epigel 305 consisting of a polyacrylamide / isoparaffin C 13 -C 14 / laureth-7 mixture, or Simulgel® 600PHA or Sepineo® P600, namely the sodium acryloyldimethyltaurate copolymer / isohexadecane / polysorbate 80. These two products being marketed by the company Seppic.

 When the pharmaceutically or cosmetically acceptable vehicle is a solution, the primary emulsion is dispersed in a vehicle composed of an aqueous phase.

 By aqueous phase which constitutes the pharmaceutically acceptable vehicle is meant any aqueous phase as defined above in the present invention.

When the pharmaceutically or cosmetically acceptable vehicle is a cream or a lotion, the primary emulsion is dispersed in a vehicle composed of an aqueous phase and a fatty phase comprising or not at least one surfactant or emulsifier. In the case of pharmaceutical or cosmetic vehicles in the form of a cream or a lotion, the composition according to the invention therefore comprises a fatty phase. This fatty phase may comprise, for example, vegetable, mineral, animal or synthetic oils, silicone oils, and mixtures thereof.

 Preferably, when the vehicle of the composition according to the invention is a cream or a lotion, the emulsion is in the form of an oil-in-water (O / W) emulsion. This emulsion may not comprise or comprise at least one emulsifying agent.

 The cream or the lotion according to the invention also comprises an aqueous phase.

 By aqueous phase which constitutes the pharmaceutically or cosmetically acceptable vehicle, alone or within an emulsion, is meant any aqueous phase as defined previously in the present invention.

 The composition according to the invention may also contain, within the primary emulsion or the pharmaceutically acceptable vehicle, one or more additives or combinations of additives, such as:

 - preservatives;

 - propenetrating agents;

 stabilizing agents;

 - humectants;

 humidity regulating agents;

 pH regulating agents;

 osmotic pressure modifying agents;

 chelating agents;

 UV-A and UV-B filters;

 - and antioxidants.

Of course, those skilled in the art will take care to choose the ingredients of the pharmaceutically or cosmetically acceptable vehicle and in particular, the aqueous phases, the fatty phases, the emulsifiers and the optional compound (s) to be added to these compositions, in such a way that the advantageous properties intrinsically attached to the present invention are not or substantially unaffected by the choice of ingredients.

 The composition according to the invention thus comprises, in a pharmaceutically or cosmetically acceptable vehicle, by weight relative to the total weight of the composition, compound microcapsules:

 a) a non-polymeric envelope obtained from 0.0 to 10% of lipid compound selected from amphiphilic lipids;

 b) an oily heart composed of 0. 1 to 50%> of liquid or semi-liquid fatty substance at room temperature;

 c) 0.001 and 10%) of at least one lipophilic active agent.

 The composition according to the invention thus preferably comprises, in a pharmaceutically or cosmetically acceptable vehicle, by weight relative to the total weight of the composition, microcapsules composed of:

 a) 0. 1 to 5%> of lipid compound selected from amphiphilic lipids, preferably hydrogenated lecithin;

 b) 1 to 30% o of liquid or semi-liquid fatty substance at room temperature, preferably fatty acid esters or polyethylene glycol ethers;

 c) between 0.005 and 5% of at least one lipophilic active principle. In a preferred embodiment according to the invention, the composition comprises, in a pharmaceutically acceptable vehicle, by weight relative to the total weight of the composition:

 a) 0. 1 to 5% o hydrogenated lecithin with a content of hydrogenated phosphatidylcho line greater than 85%;

 b) 1 to 30% o fatty acid esters or ethers of polyethylene glyco l;

 c) 0.001 to 5% o of at least one lipophilic active principle.

 Preferably, the vehicle is pharmaceutically acceptable.

The pharmaceutical composition that can be used according to the invention is intended for the treatment of the skin and can be administered topically, parenterally or orally. Orally, the pharmaceutical composition may be in liquid or pasty form, and more particularly in the form of capsules, dragees, or syrups.

 Parenterally, the composition may be in the form of suspensions for infusion or for injection.

 Preferably, the composition is in a form suitable for topical administration. Topically, we mean an application on the skin, the mucous membranes, the hair or the scalp.

 Topically, the composition may be in liquid or pasty form, and more particularly in the form of creams, milks, ointments, soaked swabs, syndets, wipes, gels, sprays, foams, lotions, sticks, shampoos, or washing bases.

 The subject of the invention is also a process for the preparation of the compositions according to the invention. In a preferred manner, the object of the invention is the process for the preparation of compositions comprising at least one lipophilic active agent.

 The process according to the invention does not involve phase inversion phenomena characterized by a Phase Inversion Temperature (TIP) (used in particular in Patents FR 2 805 761 and FR 2 840 53 1), and therefore does not require a cycle (s) of rise and fall in temperature.

 The process according to the invention does not use a high pressure homogenizer (HHP) and therefore does not require a prehomogenization step.

 The process according to the invention therefore has the advantage of not having successive heating and cooling cycles, of not using organic solvents, polymer, of not requiring a gelling step. of the emulsion and no prehomogenization step.

The process as presented according to the invention and proposed for the production of lipid microcapsules of micrometric size uses equipment allowing emulsification at high shear rate.

 Different devices can be used such as high-shear rotor / stator type mixers such as Polytron (Kinematica) or Magic Lab (Ika). Alternatively to the rotor / stator, sonication can be used with eg a Branson type probe. Whatever the type of equipment used, the process consists of producing a primary emulsifier, which is then diluted in a pharmaceutically acceptable vehicle.

This primary emulsion makes it possible to vary the amount of introduction of the lipid compound, preferably hydrogenated lecithin, which can be introduced completely into the oily phase (100% oily phase) or into the aqueous phase (100%). % aqueous phase) or introduced in different ratios such as a 50/50 ratio in the oily phase and in the aqueous phase.

1 - Preparation of the primary emulsion: The production of the primary emulsion comprises 3 steps:

• Preparation of the aqueous phase

 • Preparation of the oily phase

 • Mixing of aqueous and oily phases

The preparation of the aqueous phase and the oily phase are dependent on the choice of the dispersion mode of the lipid compound, preferably hydrogenated lecithin:

• 100% in aqueous phase or

 • 100% oily phase or

 • 50/50% aqueous phase / oily phase. a) Preparation of the primary emulsion with 100% dispersion of the lipid compound, preferably hydrogenated lecithin in the aqueous phase:

Preparation of the aqueous phase

 In a container adapted to contain all of the primary emulsion, the hydrogenated lecithin used is dispersed throughout the heated aqueous phase at about 75 ° C., using a rotor / stator type mixer. high shear such as Ultra Turrax (Ika), Polytron (Kinematica) or Magic Lab (Ika), with stirring between 5,000 to 10,000 rpm, for a defined time that will not exceed 30 minutes. A preservative and an antioxidant can be added at this stage.

Preparation of the oily phase

In a suitable container and using a magnetic bar, the active ingredient, if present, is solubilized in the internal oily phase heated to about 75.degree. C., comprising, inter alia, soiling oil. active ingredient. A preservative and an antioxidant can be added to this phase after solubilization of the active ingredient. b) Preparation of the primary emulsion with 100% dispersion of the lipid compound, preferably hydrogenated lecithin in the oily phase:

Preparation of the aqueous phase

 In a container adapted to contain all of the primary emulsion, all of the aqueous phase is heated to 75 ° C. A preservative and an antioxidant can be added at this stage.

Preparation of the oily phase

 In a suitable container and using a magnetic bar, the active ingredient, if present, is solubilized in the internal oily phase heated to about 75 ° C., comprising, inter alia, the oil which solubilizes the active ingredient. A preservative and an antioxidant may be added at this stage after lubilization of the active ingredient. The lipid compound, preferably the hydrogenated lecithin used is dispersed in this oily phase still at about 75 ° C, using a high shear rotor / stator type mixer such as an Ultra Turrax (Ika) , or a Polytron (Kinematica) with stirring between 5,000 to 10,000 rpm, for a defined time that will not exceed 30 minutes. c) Preparation of the primary emulsion with dispersion of 50% hydrogenated lecithin in the aqueous phase and 50% in the oily phase: Preparation of the aqueous phase

In a container adapted to contain all of the primary emulsion, all of the aqueous phase is heated to 75 ° C. About half of the lipid compound, preferably hydrogenated lecithin, is dispersed in this aqueous phase. always heated to about 75 ° C, using a high shear rotor / stator mixer such as Ultra Turrax (Ika), Polytron (Kinematica), or the Magic Lab (Ika) with stirring included between 5,000 and 10,000 rpm, for a defined time that will not exceed 30 minutes. A preservative and an antioxidant can be added at this stage.

Preparation of the oily phase

 In a suitable container and using a magnetic bar, the active ingredient, if present, is solubilized in the internal oily phase heated to about 75 ° C., comprising, inter alia, the oil which solubilizes the active ingredient. The other part of the lipid compound, preferably hydrogenated lecithin, is dispersed in this oily phase still heated to about 75 ° C., using a high shear rotor / stator mixer such as an Ultra Turrax (Ika) or a Polytron (Kinematica), with stirring between 5,000 to 10,000 rpm, for a defined time that will not exceed 30 minutes. A preservative and an antioxidant may be added at this stage after lubilization of the active ingredient.

Once the aqueous and oily phases have been prepared, they are mixed by incorporation of the oily phase into the aqueous phase. The operating mode is dependent on the type of device used. Three types of apparatus are preferentially used to effect the mixing of the two phases resulting in the primary emulsion according to the invention: the method with Polytron, the method with Magic Lab, the method with sonication probe. According to the different types of agitators, the emulsion is produced as described: · Process with Polytron under temperature regulation at

75 ° C:

Incorporation of the oily phase on the aqueous phase gently, with stirring of between 5000 and 10,000 rpm - Once the incorporation is successful, stir at a higher speed for a minimum of 30 minutes.

• Process with Magic Lab under temperature regulation at 75 ° C:

 Simultaneous incorporation of the aqueous phase and the oily phase in the apparatus with stirring at a speed of less than 16000 rpm if the lipid compound, preferably hydrogenated lecithin, has been dispersed at 100% in the fatty phase.

 - Incorporation of the oily phase on the aqueous phase already present in the apparatus with stirring at a speed below 16000 rpm if the lipid compound, preferably hydrogenated lecithin was dispersed in 100% in the aqueous phase.

 - Once the incorporation is successful, allow the mixture to circulate until it returns to room temperature.

• Process with sonication probe with set temperature control lower than 50 ° C:

 Incorporation of the oily phase on the aqueous phase rapidly, at an ultrasound amplitude of 80 microns,

 - Leave the mixture for several tens of seconds under these conditions.

2 - Realization of the final composition according to the invention

The primary emulsion obtained above is then introduced into a pharmaceutically acceptable vehicle previously made, solution, cream, lotion and gel. In the case of a gel mainly containing only water and a gelling agent, the gelling step is carried out instantaneously at the end of the production of the primary emulsion:

- Take a specific quantity of primary emulsion and - Incorporate it gently into a previously made gel with gentle agitation. Stirring can be generated by using a light deflocculator attached to an IKA or Rayneri type stirring motor. A gentle stirring corresponds to a speed which makes it possible to obtain a homogeneous gel after 20 min without generating excessive aeration of the formulation, for example at a speed around 200 rpm.

 Alternatively, to produce a gel composition according to the invention, a quantity of primary emulsion can be removed and then diluted in one part of water. This mixture is then thickened by the addition of a gelling agent.

The process for preparing the compositions according to the invention comprises the following steps:

 (i) Preparation of the primary emulsion by:

 (a) Solubilization of the active ingredient if present in a liquid or semi-liquid fatty substance at ambient temperature, in order to obtain the oily phase;

 (b) Preparation of the aqueous phase;

 (c) Dispersion of the lipid compound in the oily phase obtained in (a) or in the aqueous phase obtained in (b) or partially in each of the oily and aqueous phases,

 (d) Heating the two oily and aqueous phases separately at about 75 ° C,

 (e) stirring mixture of the oily and aqueous phases obtained at the end of step (d);

(ii) Incorporation of the composition obtained in the previous step into a pharmaceutically acceptable carrier. The Applicant has surprisingly discovered that the mode of introduction of the lipid compound, and more particularly of hydrogenated lecithin, was likely to have an influence on the stability over time of the microcapsules dispersed within the pharmaceutically acceptable vehicle. According to the present invention, the microcapsules and processes making it possible to obtain them as described above, have the advantage over the prior art of using processes that are alternative to processes using rise and fall cycles. in temperature, or high pressure homogenizers.

 Preferably, the lipid compound is introduced either 100% into the oily phase or 100% into the aqueous phase depending on the nature of the oily core chosen to solubilize the lipophilic active ingredient in the microcapsule.

 More preferably, the hydrogenated lecithin is introduced either at 100%) in the oily phase, or at 100% in the aqueous phase depending on the nature of the oily core chosen to solubilize the lipophilic active ingredient in the microcapsule.

 In a preferred embodiment according to the invention, the preferred apparatus is the Magic Lab.

In a preferred embodiment according to the invention, the preferred mode of dispersion of the lipid compound, and more preferably hydrogenated lecithin is 100% in the fatty phase, in the case of using oily solvents of the triglyceride and ester type. acids such as diisopropyl adipate,

 In another preferred embodiment according to the invention, the preferred mode of dispersion of the lipid compound, and more preferably of hydrogenated lecithin, is 100% in the aqueous phase, particularly in the case of the use of oily solvents of the polyethylene ether type. glycols such as, for example, PPG-15-stearyl ether.

In particular, those skilled in the art will choose the oily solvent or solvents adapted according to the lipophilic active principle to be solubilized when the latter is present and thus the mode of dispersion of the lipid compound, and more preferably of hydrogenated lecithin. In one of the preferred modes, the process for preparing a composition according to the invention comprises the following steps:

 (i) Preparation of the primary emulsion by:

 a) Solubilization of the active principle if present in the internal oily phase or oily core and dispersion of the lipid compound, and more preferably of hydrogenated lecithin, in this same oily phase heated to 75 ° C.

 b) Preparation of the aqueous phase, heated to 75 ° C.

 c) Simultaneous incorporation of the aqueous phase and the oily phase into the stirred apparatus at a speed below

16,000 rpm

 d) Once the incorporation is successful, allow the mixture to circulate until it returns to room temperature. (ii) Incorporation of the primary emulsion into the pharmaceutically acceptable carrier

In one of the preferred modes, the process for preparing a composition according to the invention comprises the following steps:

 (i) Preparation of the primary emulsion by:

 a) Solubilization of the active ingredient if present in the internal oily phase or oily heart heated to 75 ° C.

 b) dispersing the lipid compound, and more preferably hydrogenated lecithin, in the aqueous phase, heated to 75 ° C.

 c) Incorporation of the oily phase on the aqueous phase already present in the apparatus with stirring at a speed below 16 000 rpm.

 d) Once the incorporation is successful, allow the mixture to circulate until it returns to room temperature.

(ii) Incorporation of the primary emulsion into the pharmaceutically acceptable carrier

Preferably, these preparation processes are carried out in the absence of organic solvent vo latil. As indicated above, the composition according to the invention comprises, within a pharmaceutically or cosmetically acceptable vehicle, lipid microcapsules of micrometric size dispersed in an aqueous phase, said lipid microcapsules of micrometric size containing an internal oily phase in which at least one lipophilic active ingredient is solubilized, and a non-polymeric envelope obtained from at least one lipid compound selected from amphiphilic lipids.

 The composition according to the invention is usable as a medicament.

 In particular, the subject of the invention is also the composition as defined above for its use for treating dermatological conditions, in particular human affections, as defined below:

 1) dermatological disorders related to a keratinization disorder relating to differentiation and cell proliferation, in particular to treat vulgar, comedonal, polymorphic, rosacea acne, nodulocystic acne, conglobata, senile acnes, secondary acnes such as acne soothing, medicated or professional;

 2) disorders of keratinization, including ichthyosis, ichthyosiform states, lamellar ichthyosis, Darrier's disease, palmoplantar keratoderma, leukoplakia, pityriasis rubra pilaire and leucoplasiform states, cutaneous or mucosal lichen (oral) ;

 3) dermatological conditions with an inflammatory immunoallergic component, with or without a cell proliferation disorder, and in particular all forms of psoriasis, whether cutaneous, mucous or ungual, and even psoriatic arthritis, or even dermatitis atopic and various forms of eczema;

4) Skin disorders due to exposure to UV radiation as well as to repair or fight against aging of the skin. skin, be it photoinduced or chronological or to reduce pigmentations and actinic keratoses, or any pathologies associated with chronological or actinic aging, such as xerosis, pigmentations and wrinkles;

 5) Any condition related to benign dermal or epidermal proliferations, whether or not of viral origin such as common warts, flat warts, molluscum contagio sum and epidermis of verruciform epidermis, oral or florid papillomatosis;

 6) dermatological disorders such as immune dermatoses such as lupus erythematosus, oily immune diseases and collagen diseases, such as scleroderma;

 7) the stigmata of epidermal and / or dermal atrophy induced by local or systemic corticosteroids, or any other form of cutaneous atrophy,

 8) disorders of cicatrization, or to prevent or to repair stretch marks, or to promote healing,

 9) in the treatment of any condition of fungal origin at the cutaneous level such as tinea pedis and tinea versicolor,

 10) disorders of pigmentation, such as hyperpigmentation, melasma, hypopigmentation or vitiligo;

 1 1) cancerous or precancerous, cutaneous or mucosal states such as actinic keratoses, Bowen's disease, in-situ carcinomas, keratoacanthoma and skin cancers such as basal cell carcinoma (BCC), spinal cell carcinoma (SCC) and cutaneous tek lymphoma than T-cell lymphoma.

 Preferably, the invention relates to the composition for use in the treatment of acne, ichthyos, ichthyosiform states, palmoplantar hyperkeratosis or psoriasis.

In other words, the invention relates to the composition according to the invention for its use as a medicament in the treatment of dermatological conditions, especially human, as previously defined. In particular, the invention relates to the use of the composition according to the invention for the treatment of dermatological conditions, in particular human affections, as previously defined.

 In particular, the composition is used for the treatment of acne, ichthyos, ichthyosiform states, palmoplantar hyperkeratosis or psoriasis.

 The composition according to the invention may be a cosmetic composition.

 According to one embodiment, the cosmetic composition is used for the protection and / or skin care of the skin.

 Preferably, the cosmetic composition is used for the treatment, and in particular for moisturizing the skin.

 According to another embodiment, the cosmetic composition is used to protect the skin from the effects of ultraviolet radiation.

 Preferably, the cosmetic composition is used to prevent or delay the signs of skin aging due to ultraviolet radiation.

As an illustration and without any limiting character, various formulations of compositions comprising a lipophilic acid will now be given.

Example 1 Primary Emulsions Containing Lipid Microcapsules Placebos Before Dilution in a Composition

Using the preparation methods mentioned above and according to the dispersion mode of hydrogenated lecithin as defined above in the present description, lipid microcapsules were made with an oily heart containing an oil or a mixture of oils.

 The compositions of the primary emulsions E 1 to E 5 are therefore as follows:

Composition (% m / m)

 ingredients

 El E2 E3 E4 E5

 Diisopropyl 27.89 27.89 27.89 ~ ~

 adipate

 PPG-15 stearyl ~ ~ ~ 27.89 ~

 ether

 triglycerides

 acids

 - - - - 27.89

 caprique /

 caprylic

 Lecithin 4.04 4.04 4.04 4.04 4.04

 hydrogenated

 Propyl 0.56 0.28 0.14 0.56 0.56

 paraben

 Methylparaben 1.12 0.56 0.28 1.12 1.12

 Purified water Qsp Qsp Qsp Qsp Qsp

100 100 100 100 100

EXAMPLE 2 Examples of compositions in the form of a gel according to the invention made from the placebo primary emulsions of compositions E1 to E5 of Example 1 In order to produce the compositions in the form of G1 to G16 gel according to the invention, different amounts of primary emulsions prepared according to Example 1 were removed and diluted in a gel base.

 To obtain a 100 gram gel comprising about 5% encapsulated oil, 17.784 grams of the primary emulsion placebo are added in the formulation. In the table below, the gels G1, G6, G9 to G12 were obtained from the primary emulsion E1, the gels G4, G7, G13 to G16 were obtained from the primary emulsion E4 and the G5 and G8 gels were obtained from the primary emulsion E5.

 To obtain a 100 gram gel comprising 10% encapsulated oil, 35.855 grams of the primary emulsion E2 of Example 1 are added to the formulation (G2 gel case).

 To obtain a 100 gram gel comprising 20% encapsulated oil, 71.71 grams of the primary emulsion E3 of Example 1 are added to the formulation (G3 gel case).

Examples of compositions in gel form obtained according to the invention are therefore the following:

Formulation of gels G1 to G8

Formulation of gels G9 to G 16

Compositions (% m / m)

 Ingredients G9 G10 G11 G12 G13 G14 G15 G16

Diisopropyl adipate 4.96 4.96 4.96 4.96 - - - -

PPG-stearyl ether - - - - 4.96 4.96 4.96 4.96

Hydrogenated lecithin 0.72 0.72 0.72 0.72 0.72 0.72 0.72 0.72

Methyl paraben 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.2

Propyl paraben 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1

Sodium hydroxide Qsp Qsp Qsp Qsp Qsp Qsp Qsp Qsp

(qsp pH 4,5-5) pH pH pH pH pH pH pH pH

Carbomer 0.5 0.7 - - 0.5 0.7 - -

Cross-linked copolymer - - 0.7 1 - - 0.7 1

Acrylates / alkyl (C 10-30)

 acrylate

 Purified water Qsp Qsp Qsp Qsp Qsp Qsp Qsp Qsp

100 100 100 100 100 100 100 100

EXAMPLE 3 Examples of Cream Compositions According to the Invention Made from the Placebo Primary Emulsions of Composition E 1, E 4 and E 5 of Example 1

In order to produce compositions in the form of C 1 to C 3 cream according to the invention, a quantity of primary emulsion prepared according to Example 1 was taken and incorporated at a given moment during the process of producing a cream.

 To obtain a cream of 100 grams comprising about 5% oil within the capsules, 17.784 grams of the primary emulsion is added to the formulation.

 The primary emulsions E 1, E 4 and E 5 lead respectively to the creams C 1, C 2 and C 3 described in the table below.

 Examples of compositions in the form of cream obtained according to the invention are therefore the following:

Compositions (% m / m)

 Ingredients Cl C2 C3

 Diisopropyl adipate 4.96 - -

 PPG-stearyl ether - 4.96 -

 Triglycerides ~ ~ 4.96

 of capric / caprylic acids

 Hydrogenated lecithin 0.72 0.72 0.72

 Methyl paraben 0.2 0.2 0.2

 Propyl paraben 0.1 0.1 0.1

 Sodium

 acryloyldimethyltaurate

 copolymer / 4 4 4

 isohexadecane / polysorbate 80

 Sodium docusate 0.05 0.05 0.05

 Disodium edetate 0.1 0.1 0.1

 Glycerol 2 2 2

 Propylene glycol 3 3 3

 Poloxamer PI 24 0.1 0.1 0.1

 Allantoin 0.2 0.2 0.2

 Talc 2.0 2.0 2.0

Xanthan gum 0.5 0.5 0.5

EXAMPLE 4 Characterization of the gel compositions of Example 2 Gl, G4 and G5 according to the invention, prepared from the E1, E4 and E5 placebo primary emulsions which were obtained according to two different modes of introduction of the hydrogenated lecithin.

Each test performed is described below:

 - The macroscopic observation is performed on the formulation in its original packaging.

 - Microscopic observation is performed using the Axio.Scope Al microscope (polarized light, objective x20).

 - The pH measurement is taken in the formulation.

 The measurement of the viscosity is carried out using a Brookfield RVDVII + type apparatus. The measurements are carried out after 1 min, in the original packaging.

 In the present examples, the primary emulsions E1, E4 and

E5 of Example 1 were carried out according to two distinct modes of introduction of hydrogenated lecithin, namely 100% of the hydrogenated lecithin in the aqueous phase and 100% of the hydrogenated lecithin in the fatty phase.

 Each primary emulsion thus leads to the production of two gels, called Gel No. 1 and Gel No. 2 in the table below.

 The equipment used to produce the primary emulsions is the Magic Lab.

 It is to highlight that :

 Gels No. 1 and No. 2 obtained from the primary emulsion

E1 have the same formulation as the gel G1 described in Example 2,

the No. 1 and No. 2 Gels obtained from the primary emulsion E4 have the same formulation as the gel G4 described in Example 2, Gel Nos. 1 and 2 obtained from the primary emulsion E4 have the same formulation as the gel G4 described in Example 2.

Depending on the oil used in the formulation, the dispersion mode of the hydrogenated lecithin may generate different characteristics.

FIGS. 1 and 2 represent the images obtained under the microscope (objective 40 and x252 magnification) of the microcapsules in the No. 1 and No. 2 gels respectively, which were made from the primary emulsion E4 containing PPG-stearyl ether as an oil.

 Microscopic observation of the microcapsules reveals that the microcapsules within the No. 1 and No. 2 gels differ in polydispersity and form.

 Indeed, it is observed that the microcapsules of Figure 1 are regular in size and shape. On the other hand, those of FIG. 2 are more irregular both in size and in shape. Thus for a defined oil, the mode of dispersion of hydrogenated lecithin can impact on the physical appearance of the microcapsules.

FIGS. 3 and 4 show the microscope images (objective 40 and x252 magnification) of the microcapsules in gels No. 1 and No. 2, respectively, which were made from the primary emulsion E5 containing triglycerides of acids capric / caprylic as oil.

 Microscopic observation of the microcapsules reveals that the microcapsules within the No. 1 and No. 2 gels do not differ in terms of polydispersity and shape.

 Thus, for another defined oil, the dispersion mode of hydrogenated lecithin does not affect the physical appearance of the microcapsules.

 The observations therefore demonstrate that the conditions leading to a better microcapsule production can be dependent on the mode of dispersion of the hydrogenated lecithin according to the oil used.

 As such, a mode of dispersion of hydrogenated lecithin may be preferred for each type of oil.

In a preferred embodiment according to the invention, with the triglycerides and esters of acids such as diisopropyl adipate as oily solvent, the preferred mode of dispersion of hydrogenated lecithin is 100% in the fatty phase. In a preferred embodiment according to the invention, with the ethers of polyethylene glycols such as for example PPG-15-stearyl ether as an oily solvent, the preferred mode of dispersion of hydrogenated lecithin is 100% in the aqueous phase.

EXAMPLE 5 Study of Stability of Gels No. 1 and No. 2 of Example 4 According to the Oil Applied to Ore (From Emulsions E4 and E5 of Example 1) and According to the Mode of Introduction of Lecithin hydrogenated

The stability of Gels No. 1 and No. 2, described in Example 4 and obtained from the primary emulsion E4 of Example 1, is studied over a period of 6 months at room temperature, at 4 ° C. and at 40 ° C. Each test performed is described below:

 - The macroscopic observation is performed on the formulation in its original packaging.

 - Microscopic observation is performed using the Axio.Scope Al microscope (polarized light, objective x20).

 - The pH measurement is taken in the formulation.

The measurement of the viscosity is carried out using a Brookfield RVDVII + type apparatus. The measurements are carried out after 1 min, in the original packaging.

Gel No. 1: dispersion in aqueous phase obtained from the primary emulsion E4 of Example 1

 (oil used: PPG-stearyl ether)

Gel N ° 2: Fat phase dispersion

 obtained from the primary emulsion E4 of Example 1

 (oil used: PPG-stearyl ether)

The stability of Gels No. 1 and No. 2, described in Example 4 and obtained from the primary emulsion E5 of Example 1, is studied over a period of 6 months at room temperature, at 4 ° C. and at 40 ° C. Gel No. 1: Dispersion in aqueous phase

 obtained from the E5 emulsion of Example 1 (oil used: capric / caprylic acid triglycerides)

Gel N ° 2: Fat phase dispersion

 obtained from the composition E5 of Example 1 (oil: capric / caprylic acid triglycerides)

FIGS. 5 and 6 show the images obtained under the microscope (objective 40 and x225 magnification) of the microcapsules in No. 1 and No. 2 gels which were made from the primary emulsion E4 containing PPG-stearyl ether. as an oil after 6 months of storage at a temperature of 40 ° C.

The microscopic observation of the microcapsules in the gel No. 1 and No. 2 proved to be significant concerning the stability of the microcapsules according to the dispersion mode of the hydrogenated lecithin. With the dispersion of 100% hydrogenated lecithin in the fatty phase, the microcapsules are very irregular in size and deformed (FIG. 6).

 With the dispersion of 100% hydrogenated lecithin in the aqueous phase, the microcapsules are more regular and more uniform in size (FIG. 5).

 The observations therefore demonstrate that the conditions leading to a better stability of the capsules over time is the 100% dispersion of the hydrogenated lecithin in the aqueous phase, when PPG-15 stearyl ether is used.

 FIGS. 7 and 8 show the images obtained under the microscope of the microcapsules in No. 1 and No. 2 gels which were made from the primary emulsion E5 containing capric / caprylic acid triglycerides after 6 months of storage at a temperature of 40 ° C.

 The microcapsules are generally uniform and uniform in size, after 6 months of stability at 40 ° C. (FIGS. 7 and 8).

 The observations therefore demonstrate that the conditions leading to a stability of the microcapsules over time can take place with a 100% dispersion of hydrogenated lecithin in the aqueous phase or at 100%> in the fatty phase, in case of implementation of the Triglycerides d capric / caprylic acids.

In this respect and in view of these results, a mode of dispersion of hydrogenated lecithin may be all the more justified for each type of oil. EXAMPLE 6 Characterization of Gel Compositions According to the Invention, Made from the Placebo El Primary Emulsion of Example 1

In the examples, the equipment that was used to make the primary emulsion is the Magic Lab.

 The preferred dispersion mode for hydrogenated lecithin with diisopropyl adipate is 100% in the fat phase.

 In the table below, Gels No. 1, No. 2 and No. 3 have the same formulation as the G1, G9 and G11 gels described in Example 2.

Example 7 Study of Stability of the Gels of Example 6

Gel N ° l

 (thickening agent: sodium acryloyldimethyltaurate copolymer / isohexadecane / polysorbate 80)

 obtained from the primary emulsion El

 (oil used: diisopropyl adipate)

Gel No. 2 (thickening agent used: Carbomer) Obtained from the primary emulsion El (oil used diisopropyl adipate)

Gel N ° 3

 (thickening agent: Acrylates / C 10-30 Alkyl Acrylate Crosspoly

 obtained from the primary emulsion E l

 (used oil diisopropyl adipate)

The results show that the gels obtained are stable at one month or three months at room temperature or at a temperature of 40 ° C., whatever the nature of the thickening agent used. EXAMPLE 8 Characterization of the gel compositions of Example 2 G2 and G3 according to the invention, made from E2 and E3 placebo primary emulsions of Example 1

In the present examples, the equipment that has been used for producing the primary emulsions is the Magic Lab

 The primary emulsions E2 and E3 were made by introducing 100% of the hydrogenated lecithin into the fatty phase in order to obtain the corresponding gels.

 It should be noted that the Gels No. 1 and No. 2 correspond to the Gels G2 and G3 of Example 2.

Example 9 Study of Stability of the Gels of Example 8

The stability of the gels of Example 8, obtained from the primary emulsions E2 and E3, was studied for a period of one month.

Gel N ° l

 obtained from the primary emulsion E2 of Example 1 (oil used: 10% diisopropyl adipate)

Gel N ° 2

 obtained from the primary emulsion E3 of Example 1 (oil used: 20% diisopropyl adipate)

The results show that the gels obtained are stable for a period of one month at room temperature or a temperature of 40 ° C., whatever the diisopropyl adipate content used of the primary emulsion.

EXAMPLE 10 Primary Emulsions Containing the Lipid Microcapsules Containing a Lipophilic Active Element Before Dilution in a Composition Using the methods cited above and according to the dispersion method of hydrogenated lecithin as defined above in the present description, lipid microcapsules were produced and contain in the oily heart a lipophilic active solubilized in an oil.

 The lipophilic active agents used in primary emulsions are indigo naturalis, travoprost, clobetasol propionate, hydroxyquinone and rucino l.

The compositions of the primary emulsions Ε Ί to Ε Ί 1 are therefore the following:

Composition (% m / m)

 Ingredients ΕΊ E'2 E'3 E'4 E'5 E'6

Indigo Naturalis 0.014 0.014 - - - -

Travoprost - - 0.007 - - -

Clobetasol - - - 0.140 0.093 0.07 proprionate 10

Butyl 0.139

 hydroxy

 Toluene

 Olea Europea 27.89

(olive) 15 fruit oil

 Triglycerides 27.89 Acids 27.89

 capric /

caprylic 20

PPG-stearyl - - 27.89 - 27.89 - ether

 Apricot kerneil 27.89

oil

 PEG-6 esters 25

Lecithin 4,042 4,042 4,042 4,042 4,042 4.042 hydrogenated

 Methyl paraben 0.279 0.279 0.279 0.558 0.372 0.279

Propyl paraben 0.14 0.14 0.14 0.279 0.186 0.14

Purified water Qsp Qsp Qsp Qsp Qsp Qsp

100 100 100 100 100 100

Composition (% m / m)

 Ingredients E'7 E'8 E'9 ΕΊ0 ΕΊ 1

Hydroquinone 2.789 2.789 - - -

Rucinol - - 9.297 9.297 13.945

Ascorbyl palmitate 0.028 0.028 0.037 0.037 0.056

Triglycerides 27.89

acids

capric / caprylic

 Diisopropyl adipate 27.89 - - - 27.89

PPG-stearyl - 27.89 - 27.89 - ether

 Lecithin 4.042 4.042 4.042 4.042 4.042 hydrogenated

 Methyl paraben 0.279 0.279 0.372 0.372 0.558

Propyl paraben 0.140 0.140 0.186 0.186 0.279

Purified water Qsp Qsp Qsp Qsp Qsp

100 100 100 100 100

EXAMPLE 11 Examples of compositions in the form of a gel according to the invention made from the primary emulsions E'I and E'2 containing Indigo Naturalis of Example 10

In order to produce compositions in gel form according to the invention, a quantity of primary emulsion prepared according to Example 1b was taken and added to the formulation.

 To obtain a gel of 100 grams to 0.01% in Indigo Naturalis, contained in the presence of 20% solvent oil within the microcapsules, 71.71 grams of the primary emulsion are added in the formulation.

 Preferably, 71.71 grams of the primary emulsion are added with stirring to 26.29 grams of water. This mixture is then thickened by the addition of a gelling agent at 2%, with moderate stirring.

 Stirring can be generated by the use of a deflocculator light attached to an IKA or Rayneri type stirring motor. Moderate stirring corresponds to a speed which makes it possible to obtain a homogeneous gel after 20 minutes without generating excessive aeration of the formulation, for example a speed of between 400-600 rpm.

In the table below, the G'1 and G'2 gels were respectively obtained from the primary emulsions E'I and E'2.

Composition

(% m / m)

ingredients

 G 'I G'2

Indigo Naturalis 0.01 0.01

Olea Europaea (olive) fruit oil 20 -

Triglycerides of acids - 20 capric / caprylic

 Butyl hydroxy Toluene 0.1 -

Hydrogenated lecithin 2.90 2.90

Methyl paraben 0.2 0.2

Propyl paraben 0.1 0.1

Sodium acryloyldimethyltaurate 2 2 copolymer /

isohexadecane / polysorbate 80

Purified water Qs 100 Qs 100

EXAMPLE 12 Examples of compositions in gel form according to the invention made from the primary emulsion E '3 containing the Travoprost of Example 10

In order to produce compositions in gel form according to the invention, a quantity of primary emulsion prepared according to Example 1b was taken and added to the formulation.

 To obtain a gel of 100 grams 0.005% Travoprost, contained in the presence of 20% solvent oil in the microcapsules, 71.71 grams of the primary emulsion E'3 are added in the formulation.

 Preferably, 71.71 grams of the primary emulsion E'3 are added with stirring to 26.29 grams of water. This mixture is then thickened by the addition of a gelling agent at 2%, with moderate stirring.

 Stirring can be generated by the use of a deflocculator light attached to an IKA or Rayneri type stirring motor. Moderate stirring corresponds to a speed which makes it possible to obtain a homogeneous gel after 20 min without generating excessive aeration of the formulation, for example a speed of between 400-600 rpm.

In the table below, the gel G'3 was obtained from the primary emulsion E'3.

Composition

 (% m / m)

Ingredients G'3

5

 Travoprost 0.005

PPG-stearyl ether 20

Hydrogenated lecithin 2.90

Methyl paraben 0.2

Propyl paraben 0.1

Sodium acryloyldimethyltaurate

 copolymer / 2 isohexadecane / polysorbate 80

Purified water Qs 100

EXAMPLE 13 Examples of Gel and Cream-type Compositions According to the Invention Made from the Primary Emulsions E'4 to E'6 of Example 10 Containing Clobetasol Proprionate

In order to produce gel compositions according to the invention, a quantity of primary emulsion prepared according to Example 1b was taken and added to the formulation.

 To obtain a gel of 100 grams at 0.05% clobetasol propionate, contained in the presence of 20% solvent oil within the capsules, 71.71 grams of the primary emulsion E'6 are added in the formulation.

 Preferably, 71.71 grams of the primary emulsion E'6 is added with stirring to 26.29 grams of water having a pH equal to 5. This mixture is then thickened by the addition of a gelling agent to

2%> with moderate agitation.

 Stirring can be generated by the use of a deflocculator light attached to an IKA or Rayneri type stirring motor.

A moderate stirring corresponds to a speed which makes it possible to obtain a homogeneous gel after 20 minutes without generating too much aeration of the formulation, for example a speed between

400-600 rpm.

 In the same way, to obtain a gel of 100 grams to 0.05%) of clobetasol propionate, contained in the presence of 15% solvent oil within the capsules, 53.78 grams of the primary emulsion are added in the formulation.

 Preferably, 53.78 grams of the primary emulsion E'5 are added with stirring to 44.22 grams of water having a pH equal to 5. This mixture is then thickened by the addition of a gelling agent at 2%, with stirring. moderate.

In the table below, the G'4 and G'5 gels were respectively obtained from the primary emulsion E'5 and E'6. In order to produce compositions in cream form according to the invention, a quantity of primary emulsion prepared according to the example was taken and added to the formulation.

 To obtain a cream of 100 grams to 0.05% in

Clobetasol propionate, contained in the presence of 10%> solvent oil within the capsules, 35.855 grams of the primary emulsion E'4 are added in the formulation.

 Preferably, 35.855 grams of the primary emulsion are added with stirring to 57.145 grams of water having a pH equal to 5. This mixture is then thickened by the addition of a 4% gelling agent, with moderate stirring.

 After obtaining a smooth gel, 5 grams of cyclomethicone are incorporated in said gel with moderate agitation. A cream is thus obtained.

In the table below, the cream Cl was obtained from the primary emulsion E'4.

EXAMPLE 14 Examples of compositions in gel form according to the invention made from the primary emulsions E '7 and E' 8 of Example 10 containing hydroquinone

In order to produce gel compositions according to the invention, a quantity of primary emulsion prepared according to the example was taken and added to the formulation.

 To obtain a gel of 100 grams at 2% Hydroquinone, contained in the presence of 20% solvent oil in the microcapsules, 71.71 grams of the primary emulsion are added in the formulation.

 Preferably, 71.71 grams of the primary emulsion are added with stirring to 26.29 grams of water put having a pH equal to 5. This mixture is then thickened by the addition of a gelling agent to 2%, with moderate stirring.

 Stirring can be generated by the use of a deflocculator light attached to an IKA or Rayneri type stirring motor.

 Moderate stirring corresponds to a speed which makes it possible to obtain a homogeneous gel after 20 minutes without generating excessive aeration of the formulation, for example a speed of between 400-600 rpm.

In the table below, the G'6 and G'7 gels were obtained from the primary emulsions E'7 and E'8.

Composition (% m / m)

Ingredients G'6 G'7

Hydroquinone 2 2

Ascorbyl palmitate 0.02 0.02

Diisopropyl adipate 20 -

PPG-15 stearyl ether - 20

Hydrogenated lecithin 2.90 2.90

Methyl paraben 0.2 0.2

Propyl paraben 0.1 0.1

Sodium acryloyldimethyltaurate 2 2 copolymer /

isohexadecane / polysorbate 80

 Citric acid Qsp pH 5 Qsp pH 5

Purified water Qs 100 Qs 100

EXAMPLE 15 Examples of Gel and Cream-type Compositions According to the Invention Made from the Primary Emulsions E'9 to E'11 of Example 10 Containing Rucinol

In order to produce gel compositions according to the invention, a quantity of primary emulsion prepared according to Example 11 was taken and added to the formulation.

 To obtain a gel of 100 grams at 5% Rucinol, contained in the presence of 15% solvent oil within the capsules, 53.78 grams of the primary emulsion are added in the formulation.

 Preferably, 53.78 grams of the primary emulsion are added with stirring to 44.22 grams of water having a pH equal to 5. This mixture is then thickened by the addition of a gelling agent at 2%, with moderate stirring.

 Stirring can be generated by the use of a deflocculator light attached to an IKA or Rayneri type stirring motor. Moderate stirring corresponds to a speed which makes it possible to obtain a homogeneous gel after 20 minutes without generating excessive aeration of the formulation, for example a speed of between 400-600 rpm.

 In the table below, the G'8 and G'9 gels were respectively obtained from the primary emulsion ΕΊ0 and E'9.

 In order to produce cream-type compositions according to the invention, a quantity of primary emulsion prepared according to Example 1b was taken and added to the formulation.

 To obtain a cream of 100 grams at 5% Rucinol, contained in the presence of 10%> solvent oil in the microcapsules, 35.855 grams of the primary emulsion E'11 are added in the formulation.

Preferentially, 35.855 grams of the primary emulsion E'11 are added with stirring to 57.145 grams of water having a pH equal to This mixture is then thickened by the addition of a 4% gelling agent, with moderate stirring.

 After obtaining a smooth gel, 5 grams of cyclomethicone is incorporated in said gel with moderate agitation. A cream is thus obtained.

 In the table below, C'2 cream was obtained from the primary emulsion E '11 of Example 11.

Claims

1. Lipid microcapsule containing an oily internal phase and a non-polymeric envelope obtained from at least one lipid compound chosen from amphiphilic lipids.  2. Microcapsule according to claim 1, characterized in that it contains at least one lipophilic active ingredient solubilized in the oily internal phase.  3. Microcapsules according to claim 1 or 2, characterized in that 50% of the microcapsules have at least one average size between 1 and 80μιη, preferably between 1 and 50 μιη, and more particularly between 1 and 20 μπι.  4. Microcapsule according to claim 1 or 2, characterized in that the lipid compound is selected from phospholipids.  5. Microcapsule according to any one of claims 1 to 4, characterized in that the lipid compound is chosen from hydrogenated lecithins having an amount by weight of phosphatidylcho line greater than 85%.  Microcapsule according to one of claims 1 to 5, characterized in that the lipid compound is present in an amount of between 0.01 and 10%, preferably between 0.05 and 5% by weight, and more preferably between 0.1 and 1% by weight relative to the total weight of the microcapsule .  Microcapsule according to one of Claims 1 to 6, characterized in that the lipid compound has a transition temperature above 35 ° C, preferably a transition temperature above 45 ° C.  8. Microcapsule according to any one of claims 1 to 7, characterized in that it is free of co-surfactant.  9. Microcapsule according to any one of claims 1 to 8, characterized in that it is free of volatile organic solvent. 10. Microcapsule according to any one of claims 1 to 9, characterized in that it is free of polymer. 1 1. Microcapsule according to any one of Claims 1 to 10, characterized in that the oily internal phase comprises at least one liquid or semi-liquid fatty substance at ambient temperature.  12. Microcapsule according to claim 11, characterized in that the oily internal phase comprises at least one oily solvent of the active principle chosen from polyethoxylated fatty acids, triglycerides and oils containing them, fatty acid esters and ethers. polyethylene glycols.  13. Microcapsule according to one of claims 1 1 and 12 characterized in that the oily internal phase is a fatty acid ester or ethers of polyethylene glycol.  14. Microcapsule according to one of claims 1 1 and 12, characterized in that the oily internal phase is diisopropyl adipate or PPG-15-stearyl ether.  15. Microcapsule according to one of claims 1 to 14, characterized in that the oily internal phase is present in an amount of between 50 and 99.997% by weight relative to the total weight of the internal phase.  16. Microcapsule according to any one of claims 2 to 12 characterized in that the lipophilic active ingredient is selected from plant extracts, prostaglandin analogs, corticosteroids and phenolics derivatives.  17. Microcapsule according to claim 16, characterized in that the plant extract corresponds to indigo Naturalis.  Microcapsule according to Claim 16, characterized in that the prostaglandin analogues are chosen from travoprost, latanoprost and tafluprost, in particular travoprost.  19. Microcapsule according to claim 16, characterized in that the corticosteroids are chosen from clobetasol and its esters, betamethasone and its esters, aclomethasome and its esters. 20. Microcapsule according to claim 16, characterized in that the phenolic derivatives are chosen from hydroquinone, rucinol or lucino l, resorcinol, 4-hydroxyaniso l, hydroquinone monoethyl ether and hydroquinone monobenzyl ether.  21. Oil-in-water emulsion comprising the microcapsules according to any one of the preceding claims 1 to 20, characterized in that the microcapsules are dispersed in an aqueous phase.  22. Emulsion according to claim 21 characterized in that the ratio between the internal oily phase and the amount of hydrogenated lecithin is between 5 to 10 for one.  23. Emulsion according to claim 2 1 characterized in that the ratio between the water and the internal oily phase is between 1.5 to 5 for one.  24. Process for preparing the emulsion according to one of claims 2 1 to 23, characterized in that the lipid compound, preferably hydrogenated lecithin, is incorporated in 100% aqueous phase of the emulsion.  25. A process for the preparation of the emulsion according to any one of claims 21 to 23, characterized in that the lipid compound, preferably hydrogenated lecithin, is incorporated in 100% fat phase of the emulsion.  26. A composition characterized in that it comprises, within a pharmaceutically or cosmetically acceptable vehicle, the emulsion as defined according to one of claims 21 to 23. 27. A composition comprising at least one lipophilic active principle, characterized in that it comprises, within a pharmaceutically or cosmetically acceptable vehicle, lipid microcapsules of micrometric size dispersed in an aqueous phase, said lipid microcapsules of micrometric size containing an oily internal phase in which the lipophilic active principle is solubilized, and a non-polymeric envelope obtained from at least one lipid compound selected from amphiphilic lipids. 28. Composition according to one of claims 26 or 27, characterized in that the pharmaceutically or cosmetically acceptable vehicle is a gel.  29. Composition according to one of claims 26 or 27, characterized in that the pharmaceutically or cosmetically acceptable vehicle is a solution.  30. Composition according to one of claims 26 or 27, characterized in that the pharmaceutically or cosmetically acceptable vehicle is a cream.  31. Composition according to one of claims 26 to 30, characterized in that it comprises, in a pharmaceutically or cosmetically acceptable vehicle, by weight relative to the total weight of the composition, microcapsules composed of:  a) 0.01 to 10% of lipid compound selected from amphiphilic lipids;  b) 0.1 to 50% of liquid or semi-liquid fat at room temperature;  c) 0.001 and 10%) of at least one lipophilic active principle.  32. Composition according to claim 21, characterized in that it comprises in a pharmaceutically or cosmetically acceptable vehicle, by weight relative to the total weight of the composition:  a) 0.1 to 1% of hydrogenated lecithin;  b) 1 to 5% of fatty acid esters or polyethylene glycol ethers;  c) 0.001 to 5% of at least one lipophilic active principle. 33. Composition according to one of claims 26 to 32, characterized in that it is in a form suitable for topical administration. 34. Composition according to one of claims 27 to 33, as a medicament. 35. A composition as defined according to any one of claims 27 to 34 for its use in the treatment of dermatological conditions.  36. Composition according to claim 35, characterized in that the dermatological affections are acne, ichthyosis, ichthyosiform states, palmoplantar hyperkeratosis or psoriasis.  37. Process for the preparation of the compositions according to any one of claims 26 to 36, characterized in that it comprises the following steps:  (i) Preparation of the primary emulsion by:  a) solubilization of the active principle if present in the internal oily phase or oily core and dispersion of the hydrogenated lecithin in this same oily phase heated to 75 ° C,  b) Preparation of the aqueous phase, heated to 75 ° C.  c) Simultaneous incorporation of the aqueous phase and the oily phase in the stirred apparatus at a speed of less than 16,000 rpm  d) Once the incorporation is successful, allow the mixture to circulate until it returns to room temperature. (ii) Incorporation of the primary emulsion into the pharmaceutically acceptable carrier 38. Process for the preparation of the compositions according to any one of claims 26 to 36, characterized in that it comprises the following steps:  (i) Preparation of the primary emulsion by:  a) solubilization of the active principle if present in the internal oily phase or oily heart heated to 75 ° C,  b) Dispersion of the hydrogenated lecithin in the aqueous phase, heated to 75 ° C. c) Incorporation of the oily phase on the aqueous phase already present in the apparatus with stirring at a speed below 16 000 rpm. d) Once the incorporation is successful, allow the mixture to circulate until it returns to room temperature.  (ii) Incorporation of the primary emulsion into the pharmaceutically acceptable carrier