Easily breakable herbal capsules

Abstract

The present invention belongs to the general field of cosmetics, and in particular to a breakable capsule (1) for both cosmetic and pharmaceutical applications, having a membrane (2) and a core (3) suitable for releasing an active ingredient contained in the membrane (2), and a process for preparing the same. The capsules (1) have excellent chemical and mechanical stability and, once applied to the skin, do not shrink or produce residue, while any residual traces caused by the membrane (2) can be absorbed or absorbed by the skin. In addition, they have excellent stability against light and destruction.

Description

[Technical Field]

[0001] The present invention relates to the general field of cosmetics, and more particularly to easily breakable capsules (1) having a membrane (2) and a core (3), suitable for releasing an active ingredient contained in the membrane (2), for cosmetic and pharmaceutical applications, and to a process for preparing the same. [Background technology]

[0002] Capsules formed by a membrane (2) and a core (3) are well known to the public. Depending on their size and contents, they are known to be useful for a variety of applications.

[0003] In the field of cosmetics, the use of various types of capsules containing products for skin application has become widespread. A problem that has been pointed out in the commercial use of these capsules is that they have an insoluble membrane (2) that leaves an unpleasant residue on the skin.

[0004] In addition to capsules having a membrane (2) and a core (3), there are other types of cosmetics that contain gelled substances and are in the form of solid capsules, but these solid capsules can break apart when applied to the skin by the consumer, sometimes leaving unabsorbed residue and causing unpleasant effects for the consumer. These hard capsules are known as microcapsules, and they tend to have stability issues, as well as limited size issues, which should be addressed by using very carefully selected excipients and / or additives to ensure temporal stability.

[0005] Therefore, there is a need to provide capsules that are larger in size (7-30 mm) and have excellent chemical and mechanical stability, which, once applied to the skin, do not shrink or leave any residue, and at the same time, any residual traces provided by the membrane (2) are absorbed or can be absorbed by the skin. In addition, they have excellent stability against light and destruction. [Overview of the project]

[0006] A first aspect of the present invention provides a spherical or essentially spherical capsule having a size of 7 to 30 mm, which solves the technical problems described at the level of the art, and whose membrane (2) allows for the encapsulation of an appropriate amount of active ingredient and at the same time prevents any visible residual trace from being left on the skin after use.

[0007] The capsule (1) of the first embodiment comprises a membrane (2) and a core (3). Optionally, an active ingredient may be placed inside the core (3), so that the capsule can contain an active ingredient in the membrane (2) and another active ingredient in the core (3), thereby accommodating two active ingredients that are incompatible or unstable in the presence of certain excipients within the same capsule.

[0008] Throughout the scope of this invention, the active ingredient refers to a pharmaceutically or cosmetically acceptable active ingredient.

[0009] The capsule of the first embodiment, as well as the membrane (2) and core (3), may be adapted as a single-dose capsule. Once applied to the skin, the single-dose capsule will not leave any visible residue.

[0010] The capsule of the first embodiment may be used by a consumer who applies it to the skin, applies appropriate pressure, and rubs it in. This mixes the components of the membrane (2) and the inner core (3) to form a homogeneous phase that is absorbed without leaving any visible trace, or which can be absorbed by the skin within seconds. The capsule of the first embodiment has sufficient flexibility, as well as sufficient mechanical and chemical stability over time, to allow its contents to be released in a controlled manner without requiring the application of significant force. The capsule of the first embodiment is stable for at least up to 30 months under storage conditions at room temperature between 15 and 25°C.

[0011] In addition, capsule (1) exhibits excellent stability for up to 30 months under storage conditions at room temperature between 15 and 25°C.

[0012] In a preferred embodiment of the first aspect of the present invention, the easily breakable capsule (1) is The capsule diameter is at least 7 mm, preferably 7 to 30 mm; The flexibility of the capsule is up to 20% of the capsule diameter, preferably up to 60%; The burst strength of the capsule is 12-40 gf / cm². 2 The bursting strength is between 20 and 30 gf / cm², preferably between 20 and 30 gf / cm². 2 It is between 25 gf / cm³ and, more preferably, at least 25 gf / cm³. 2 It is thought that; The aforementioned capsule includes a core (3) and an outer membrane (2) surrounding the inner core (3). The membrane (2) is: Water comprising at least 20% by weight relative to the total weight of the membrane (2); preferably, the water content by weight in the membrane (2) is between 40% and 99.5% of the total weight of the membrane (2), more preferably between 60% and 99.5%; Both are measured relative to the total weight of the film (2), with at least 0.2% gelling agent and at least 0.1% cosmetically acceptable excipients; With calcium, magnesium, or salts thereof; Optionally, an active ingredient present at a concentration of at least 0.01% to 10% relative to the total weight of the membrane (2); It is characterized by optionally containing a preservative in a solution at a concentration of 0.01 to 5%, Here, the thickness of the film (2) is at least 150 μm, preferably at least 300 μm.

[0013] The term "gf" refers to grams of weight.

[0014] The capsule contains at least 15 gf / cm³ 2 When applied to the skin by continuous pressure and subsequently rubbed in, the outer membrane (2) and inner core (3) mix and are absorbed, or / or absorbed by the skin in seconds, resulting in a uniform mixture that softens the skin but is not sticky and leaves no visible residue.

[0015] In a preferred embodiment, the easily breakable capsule (1) of the first embodiment has a membrane (2) at a weight concentration between 5 and 30%, more preferably between 10 and 25%, of the total weight of the capsule (1), and a core at a weight concentration between 90 and 80%, more preferably between 70 and 95%, of the total weight of the capsule (1). In another preferred embodiment of the first embodiment, the capsule (1) includes a membrane (2) at a weight ratio of 1:4 to 1:8, preferably between 1:4.5 and 1:6, of the weight of the core (3).

[0016] In this invention, a readily breakable capsule refers to a capsule adapted to contain a cosmetic and / or pharmaceutically acceptable active ingredient, and for use and application to the skin of a target.

[0017] In this invention, the term "visible" residue refers to the ability of the capsule (1) membrane (2) to disintegrate and be absorbed, or to be absorbed 85% to 100%, preferably 100%, by the skin. Therefore, once applied to the skin, no perceptible residue will be observed.

[0018] In this invention, the term "flexibility" refers to the ability of a membrane (2) to return to its original shape without breaking and to fully maintain its properties when a capsule (1) is pressed or crushed by the fingers of an object.

[0019] In this invention, “cosmetic composition” refers to a mixture of at least one active ingredient and / or at least a cosmetically acceptable excipient. The term “cosmetically acceptable excipient” also includes pharmaceutically acceptable excipients.

[0020] In a preferred embodiment of the first aspect of the present invention, the calcium salt of the easily breakable capsule (1) is calcium ascorbate, calcium aspartate, calcium carbonate, calcium benzoate, calcium chloride, calcium citrate, calcium gluconate, calcium glycerophosphate, calcium glycinate, calcium ketoglutarate, calcium lactate, calcium phosphate, calcium sulfate, calcium tartrate, calcium pantothenate, Akomarine (登録商標) The magnesium salt of the easily breakable capsule (1) is selected from the group consisting of PCA Complex, calcium polyglutamate crosspolymer, and mixtures thereof.

[0021] The calcium and / or magnesium of the first aspect may be present in the form of a salt, either because it is incorporated in the form of a salt or because it is generated in situ. The presence of calcium, magnesium, and / or their salts facilitates the formation and hardening of the membrane (2) and the thickening of their diameters. At the same time, it provides the appropriate flexibility for accurately applying the capsule to the skin. Preferably, in order to assist in improving the control in obtaining the required membrane thickness, the calcium salt is selected from the group consisting of calcium ketoglutarate, calcium lactate, calcium phosphate, calcium carbonate, calcium sulfate, calcium glycinate, calcium glycerophosphate, and mixtures thereof.

[0022] In a preferred embodiment of the first aspect of the present invention, the capsule contains a calcium and / or magnesium salt, where the calcium and / or magnesium is present at a concentration of at least 0.01% to 3% based on the total weight of the membrane (2). Preferably, the calcium is present at a concentration of at least 0.02% to 1% based on the total weight of the membrane (2).

[0023] In a preferred embodiment of the first aspect of the present invention, the gelling agent in the membrane is in the range of 0.2% to 5% with respect to the total weight of the membrane (2). In a specific embodiment, the gelling agent may also be in the core. Preferably, the gelling agent of the present invention is sodium alginate, arginine, carrageenan, gellan gum, acacia gum, guar gum, Ceratonia Siliquagum, cellulose gum, cellulose and derivatives, Lessonia Nigrescens powder, agar, Chondrus Crispus, Colophonium, dextran, dextrin, gelatin, gatti gum, Himanthalia elongata powder, baker's dextrin, mannitol, mer powder, sclerotium gum, hydrolysed Caesalpinia Spinosagum, xanthan gum (Xanthangum), pullulan, polyvinylpyrrolidone (PVP), trehalose and monosaccharides in general, disaccharides and polysaccharides, carbomers and acrylates, pectin, gelatin, Astragalusgummifergum, cassia gum, rice, tapioca, wheat, corn starch, resin, Sterculian Urens gum, silica, Kelco-Care dutangum, dihydroxy xanthan gum, biosaccharide gum, Boswellia Serratagum, Ulva Lactuca powder, and mixtures thereof. Preferably, the gelling agent of the membrane (2) is selected from the group consisting of arginine, sodium alginate, carrageenan, xanthan gum, baker's dextrin, and gellan gum.

[0024] In another specific embodiment of the first aspect, the active ingredient is in the membrane (2) at a concentration of 0.01% to 10% with respect to the total weight of the membrane (2).

[0025] In another preferred embodiment of the first aspect, the core (3) comprises water and a cosmetic composition which may include an active ingredient and / or excipients. Preferably, the concentration of the active ingredient, if present, is in the range of 0.01% to 100%, preferably 1% to 98%, of the total weight of the core (3).

[0026] In another specific embodiment of the first aspect, the active ingredient is located in the core (3) and in the membrane (2). Thus, the easily breakable capsule of the first aspect may contain and release incompatible active ingredients or excipients.

[0027] In another specific embodiment of the first aspect, the active ingredient may be a cosmetic active ingredient and / or a pharmaceutical active ingredient. In preferred embodiments, the active ingredient is selected from the group consisting of hyaluronic acid and its salts; vitamins, minerals, collagen, retinol, mucopolysaccharides; Aloe vera, Aloe Barbadensis leaf juice powder, aloe plant juice; aqueous plant extracts such as Morinda citrifolia leaves; oily plant extracts such as rosemary, calendula, arnica, chamomile, carrot, saturated or unsaturated fatty acids; oils, amino acids, peptides, and proteins, and mixtures thereof.

[0028] In a particular embodiment of the first aspect of the present invention, the type of cosmetic or pharmaceutical formulation contained in the core (3) is selected from the group consisting of powders, aqueous and oily gels, creams, ointments, serums, oils, aqueous and oily emulsions, aqueous solutions, aqueous alcohol solutions, and oily solutions.

[0029] In the present invention, the term “excipient” refers to carriers and additives. The term “carrier” refers to specific components necessary for the formation of both the film (2) and the core (3) of a cosmetic or pharmaceutical composition. The term “carrier” refers to a substance that prevents cosmetics from degrading or improves their appearance and helps to realize a stable and attractive product. Preferably, the additives of the present invention are selected from a list consisting of plasticizers, thickeners, emollients, foaming agents, dyes, pigments, fragrances, pH controllers, preservatives, antioxidants, humectants, anti-shine agents, and natural and synthetic sunscreens.

[0030] In a more preferred embodiment, the excipient is a cosmetically and / or pharmaceutically acceptable carrier and / or additive. In another preferred embodiment, the cosmetically acceptable excipient is in the range of 0.2% to 10% of the total weight of the film.

[0031] In the context of the present invention, cosmetic and / or pharmaceutically acceptable excipients are cosmetic and / or pharmaceutically acceptable carriers suitable for dissolving or mixing active ingredients, for example, physiological saline, aqueous solutions, alcoholic solutions, and oily solutions; emulsions of oily outer phases, aqueous outer phases, and silicone outer phases; aqueous and oily gels; and powders. Preferably, cosmetic and / or pharmaceutically acceptable carriers are selected from the group consisting of water, thickeners, waxes, surfactants, co-emulsifiers, silicones, organic oils, mineral oils, absorbents, organic powders, inorganic powders, stabilizers, exfoliating particles, liposomes, acid and alkali buffers and salts, and chelating agents.

[0032] In another specific embodiment of the first aspect of the present invention, the excipient is at least one plasticizer selected from the group consisting of propanediol, glycerol, propylene glycol with a molecular weight (Mn) between 400 and 2000, polyethylene glycol with a molecular weight (Mn) between 400 and 4000, pentylene glycol, and triacetin.

[0033] In another specific embodiment of the first aspect of the present invention, the core (3) of the easily breakable capsule (1) comprises a cosmetic composition comprising a cosmetically acceptable oil selected from the group consisting of Prunus Amygdalus Dulcis, Argania Spinosa, Simmondsia Chinensis seed oil, Camellia Oleifera seed oil, Citrus Nobilis peel oil, aloe oil, or mixtures thereof, and the film (2) comprises an excipient selected from the group consisting of preservatives, plasticizers, thickeners, silicones, stabilizers, antioxidants, humectants, and surfactants, wherein the concentration of the cosmetic composition in the core can be in the range of 5 to 100%. More preferably, the excipient is at least one plasticizer selected from the group consisting of propanediol, glycerol, propylene glycol with a molecular weight (Mn) between 400 and 2000, polyethylene glycol with a molecular weight (Mn) between 400 and 4000, pentylene glycol, and triacetin. Preferably, this particular embodiment is prepared by the process of the third aspect of the present invention.

[0034] In a particular embodiment of the first aspect of the present invention, the materials used to prepare the film (2) may be all natural, without incorporating any synthetic components.

[0035] In another specific embodiment of the first aspect of the present invention, the excipient is at least one preservative selected from the group consisting of benzyl alcohol, dehydroacetic acid, tocopherol, glycol, pentylene glycol, hexylene glycol, benzoic acid and phosphate, ethylhexylglycerin, phenoxyethanol, and the like.

[0036] In a particular embodiment of the first aspect, the easily breakable capsule has an outer membrane (2) and / or an inner core (3): At least one dye; and / or, At least one fragrance; and / or, At least one fragrance, And optionally, it further includes at least one flavoring.

[0037] The process of the second aspect is known as reverse spherification.

[0038] A second aspect of the present invention relates to a method for obtaining the easily breakable capsule (1) of the first aspect, the process comprising at least the following steps: a) A step of providing a mixture comprising at least one gelling agent, one excipient, and water that is acceptable as a cosmetic; b) A step of providing a second mixture comprising an aqueous phase, preferably water, and at least one calcium / magnesium salt, optionally oil, and an emulsifier; c) A step of adding the mixture obtained in step b) to the mixture obtained in step a), wherein the mixture from step b) is added to the mixture from step a) so that the mixture from step b) precipitates on top of the mixture from step a) to form solid or semi-solid spheres; d) Adding the spheres obtained in step c) to a tank containing at least water and / or oil.

[0039] In this invention, the term "cosmetic-acceptable water" includes pharmaceutically acceptable water, and also refers to distilled water, demineralized water, or pure water. Pure water is pre-filtered, demineralized, and sterilized.

[0040] The process of the third aspect is known as spheroidization by encapsulation.

[0041] A third aspect of the present invention relates to an alternative method to the method of the second aspect for obtaining the easily breakable capsule (1) of the first aspect, the process comprising at least the following steps: a) A step of providing a mixture comprising at least one gelling agent, one excipient, and water that is acceptable as a cosmetic; b) A step of providing a second mixture comprising at least one pharmaceutically and / or cosmetically acceptable excipient and / or active ingredient, wherein the active ingredient is preferably an essential oil or a fatty acid; c) A step of simultaneously mixing the mixtures from step a) and step b) using a double-walled concentric injector to provide a spherical cosmetic composition containing the components from step a) and step b). d) Adding the spherical cosmetic composition obtained in step c) to a solution containing a calcium or magnesium salt until spheres are formed. e) A step of adding the solid spheres obtained in step d) to a tank containing water and / or oil to obtain spherical, easily breakable capsules.

[0042] In a preferred embodiment of a third aspect of the present invention, a method for preparing the easily breakable capsule (1) of the first aspect includes, in step c), using a double-walled concentric injector including an input hopper to introduce the added portion of the mixture obtained in steps a) and b).

[0043] In preferred embodiments of the second and third aspects of the present invention, the calcium salt is selected from the group consisting of calcium ascorbate, calcium aspartate, calcium carbonate, calcium benzoate, calcium chloride, calcium citrate, calcium gluconate, calcium glycolate, calcium ketogluconate, calcium lactate, calcium pantothenate, calcium PCA, calcium phosphate, calcium polyglutamate crosspolymer, calcium sulfate, calcium tartrate, calcium glycerophosphate, and mixtures thereof. Preferably, the calcium salt is selected from the group consisting of calcium ketoglutarate, calcium lactate, calcium phosphate, calcium carbonate, calcium sulfate, calcium glycinate, calcium glycerophosphate, and mixtures thereof.

[0044] In a preferred embodiment of a third aspect of the present invention, a calcium and / or magnesium salt is added to an aqueous solution, where the total concentration of both the calcium and magnesium salts in the solution is 0.01% to 5% by weight. [Brief explanation of the drawing]

[0045] [Figure 1] Figure 1 shows the structure of the capsule (1) of the present invention, where the membrane (2) and the inner core (3) are visible. [Examples]

[0046] Example 1: Composition and method for preparing an easily breakable capsule (1) of the first embodiment by means of the method of the second embodiment.

[0047] Table 1 shows the components of the capsule (1) membrane (2). The inner core (3) was constructed from cosmetic bases corresponding to the compositions listed in Table 2.

[0048] [Table 1]

[0049] [Table 2]

[0050] Method for preparing an easily breakable capsule (1) according to a second embodiment The components listed in Table 1a were mixed at a temperature between 30°C and 40°C until a mixture referred to as mixture A was formed.

[0051] [Table 3]

[0052] [Table 4]

[0053] Mixture B, also known as serum, was prepared according to Table 1b. Immediately after preparing mixture B, it was added dropwise to mixture A at a temperature between 20°C and 25°C.

[0054] The mixture obtained in the previous step was allowed to rest for 15-45 seconds until capsules formed. After this time, capsules (1) were removed and added to a container of distilled water at a temperature of 20-25°C. The mixture was left to stand for 1-10 minutes until the reaction stopped, and any unwanted components were removed from capsules (1). Once capsules were obtained, they were stored in a container containing a suitable medium, and the above process was repeated until the desired number of capsules was achieved. Immediately after completing the above process, the containers were stored in a dark, cool place such as a refrigerator.

[0055] We confirmed that the capsules from Example 1 remained stable at a temperature of 40°C for at least three months.

[0056] The capsule in Example 1 had the following characteristics: Bursting strength: 25gf / cm 2 Capsule diameter: 10mm Flexibility: The capsule diameter can be expanded up to a maximum of 0.42 cm (limited to the point of membrane (2) rupture), and therefore can be expanded by more than 400% of its diameter. Total weight: 0.47g Core (3) weight: 0.37g (79%) Weight of membrane (2): 0.10g (21%) Thickness of film (2): 550 microns Internal volume: 0.52 ml (including membrane (2)) / 0.38 ml (excluding membrane (2))

[0057] Example 2: Capsules and a method for preparing capsules (1)2 by a process according to a second embodiment of the invention. The components of the membrane (2) of capsule (1)2 are shown in Table M2. The inner core (3) was composed of the components and quantities shown in Table N1.

[0058] [Table 5]

[0059] [Table 6]

[0060] Capsule 1(2) was prepared using the same preparation method as in Example 1. To do so, the components of Mixture A were used as shown in Table 2a.

[0061] [Table 7]

[0062] The components of mixture B used are the same as those described in Table 1b (Example 1).

[0063] Capsule (1)2 had the following characteristics: Bursting strength: 35 gf / cm 2 . Diameter: 10mm Flexibility: The diameter of the capsule (1) can expand up to 0.48 cm (up to the point of membrane (2) rupture), and thus up to 480% of its diameter. Total weight: 0.49g Core (3) weight: 0.37g (77%) Weight of membrane (2): 0.12g (23%) Thickness of film (2): 600 microns Internal volume: 0.52 ml (including membrane (2)) / 0.37 ml (excluding membrane (2))

[0064] Example 3: A method for preparing capsule (1)3 according to the technique of the third aspect of the invention. This process required the use of a double-walled, concentric injector with a corresponding hopper for precise dropping.

[0065] 1-Membrane(2) The components of the membrane (2) of capsule 3 are shown in Table M3.

[0066] [Table 8]

[0067] 2-core (3) The core of Example 3 is a complex cosmetic oil. The components of the oil are listed in Table N3.

[0068] [Table 9]

[0069] A process for preparing capsule (1)3 according to a third aspect of the present invention. The compound-forming portion of membrane (2), excluding the calcium salt, as shown in Table M3, was uniformly mixed at a temperature between 30°C and 40°C. These compounds are shown in Table Mixture3a below.

[0070] [Table 10]

[0071] The components of mixture 3a were mixed at a temperature range of 20°C to 25°C until a homogeneous mixture was obtained. These mixtures were then placed in a hopper in the external chamber of the double-walled concentric injector. The mixture of components of Table N3 was then prepared at a temperature range of 20°C to 25°C until a homogeneous mixture was obtained. Once the N3 oil was obtained, it was placed in a hopper connected to the internal chamber of the double-walled concentric injector.

[0072] The components of Table Mixture 3a and Table N3 were simultaneously added to Tank A from a predetermined height between 0.1 cm and 2 cm using an injector. Tank A contains an aqueous solution of calcium salt as shown in Table 4. The components of the reagent tank (Tank A) are shown in Table 4.

[0073] [Table 11]

[0074] The contents of the previous step were left in the tank for 10-20 seconds until capsule (1) was formed. After this, capsule (1) was removed from tank A and added to a container (tank B) containing distilled water at a temperature of 20-25°C, where it was allowed to react for 1-10 minutes until capsule (1) was obtained free of other unwanted components. Once capsules were obtained, they were stored in a container containing a suitable medium, and the process was repeated until the desired number of capsules were obtained.

[0075] Once the process was terminated, appropriate controls were implemented. The capsules were stored in appropriate containers containing a suitable stabilizing medium under temperature and humidity conditions that would stabilize them until individual packaging, as described above.

[0076] Capsule 3 had the following characteristics: Bursting strength: 32gf / cm 2 Diameter: 10mm Flexibility: The capsule diameter can be expanded up to 6mm (limit before membrane (2) breakage). Up to 60% of its diameter. Total weight: 0.38g Core (3) weight: 0.29g (75%) Weight of membrane (2): 0.10g (25%) Thickness of film (2): 500 microns Internal volume: 0.52 ml (including membrane (2)) / 0.39 ml (excluding membrane (2))

[0077] Example 4: A composition of the easily breakable capsule (1) of the first embodiment, prepared by the preparation method (reverse esterification) of the second embodiment.

[0078] [Table 12]

[0079] [Table 13]

[0080] INCINatural Mint Handgel Solution* contains the following: water, propanediol, Aloe Barbadensis leaf juice powder, Leuconostoc / Radish Root Ferment Filtrate, benzyl alcohol, C13-15 alkane, decyl glucoside, succinoglycan, peppermint oil, citric acid, dehydroacetic acid, indigofera tinctoria leaf extract, mica, tin oxide, titanium oxide. Capsule weight: 0.28 g. Film weight 0.0477 g and core weight 0.233 g Burst strength: 25 gf / cm 2

[0081] The burst strength can be measured by a texture analyzer.

[0082] To perform the burst strength test, a 2 mm cylindrical probe was used to determine the burst strength and / or compression point of the film at the contact point. The capsule was placed vertically below the cylindrical probe, and the cylindrical probe penetrated and destroyed the sample at a constant speed. The texture analyzer measured the force required to break the capsule.

[0083] Stability control of Capsules 1, 2, and 3. Immediately after preparing the capsules, their stability was determined. For this purpose, different strength assays and aging tests were conducted in the laboratory.

[0084] Stability tests at various temperatures: These tests measured the stability of Capsules 1, 2, and 3 as cosmetics. The duration of the stability test was 12 - 14 weeks.

[0085] Room temperature: between +18°C and +25°C

[0086] Objective: To evaluate the stability of the capsules at room temperature

[0087] Results at room temperature: The capsules showed no changes in any case.

[0088] Objective: To ensure real-time temperature stability, the product was subjected to accelerated aging in a 40°C oven. The temperature was maintained constant at 40°C for a period of 12 or 14 weeks.

[0089] Results: The capsule showed no changes of any kind. No leakage of the color into the external liquid occurred, which means the capsule remained stable throughout the entire research process.

[0090] Objective: To test the stability of the product at low temperatures of +4°C and +8°C. Results: The capsules showed no changes of any kind.

[0091] Lightstability test: Objective: Light testing is essential for all products whose final packaging is transparent or translucent. We observed whether there were any changes in the behavior of the product in terms of stability or physical appearance under the following two types of light. a) Natural light (without direct sunlight), and b) Artificial "fluorescence," a type of light commonly found in commercial buildings.

[0092] Results: The capsule showed no change of any kind. The capsule exhibited stable behavior in response to the two types of light tested.

[0093] In conclusion, the capsules of the first embodiment of the invention, and the capsules obtained from the second and third embodiments, were stable against fracture, texture, and use tests, and in particular, remained stable after 30 weeks, preferably 14 weeks, at room temperature of 18–25°C, and / or after 12 weeks, preferably 8 weeks, at room temperature of 40°C, with no deterioration of any type observed.

[0094] Structural and mechanical stability testing of membranes If the membrane remains stable over time, even under the imposed temperature conditions, it must be possible to break it down by applying pressure with a finger and mix it with the core.

[0095] The following will also be analyzed: A - The time it takes for the membrane and core to dissolve and mix, from immediately after pressure is applied until a homogeneous mixture is obtained in which the product forms a single phase. method: 1. Place the sample in the palm of your hand. 2. Start the digital stopwatch and, with your other hand, break the capsule (1) and rub its contents until the membrane film disintegrates and forms a single-phase homogeneous mixture with the core. 3. Observe the digital stopwatch and measure the time. (Time A) Time A is between 5 and 25 seconds, preferably less than 15 seconds. B - Duration of action on the skin after application; the action may be absorption or, depending on the excipients or active ingredients of the new phase, at least 85% absorption, preferably 100% absorption. The mixture obtained at the end of Part A should be applied to the desired area of ​​skin as a normal cosmetic, and it should be waited until the skin exhibits the intended effect of the cosmetic. In most cases, there will be no trace of the product on the skin, and the product will not be sticky. Observe and measure the time using a digital stopwatch. (Time B) Time B is 20 to 120 seconds, preferably 20 to 60 seconds, more preferably 20 to 40 seconds. Summing these times together, we obtain the sum of time A, which is the time for dissolution and mixing of the membrane and core from immediately after pressure is applied until a homogeneous mixture is obtained in which the product forms a single phase, and time B, which is the time for the product to be absorbed as a sensation (sight and touch) on the skin. The total time (time A + B) is 25 to 150 seconds, preferably 25 to 85 seconds, and more preferably 25 to 45 seconds.

Claims

1. A single-dose frangible capsule (1) that is essentially spherical, the capsule having a diameter of at least 7 mm; the flexibility of the capsule is up to 60% of the diameter of the capsule; The capsule has a burst strength of 12 to 25 gf / cm ２ and The capsule comprises a core (3) and an outer membrane (2) surrounding the inner core (3), the outer membrane (2) comprising: at least 20 wt. % water based on the total weight of the membrane; at least 0.2% gelling agent and at least 0.1% cosmetically acceptable excipients based on the total weight of the film; calcium, magnesium, or salts thereof; Optionally, an active ingredient in a concentration of at least 0.01% to 10% relative to the total weight of said membrane (2); optionally a preservative at a concentration in solution of 0.01 to 5%; The easily destructible capsule (1) is characterized in that the thickness of the membrane (2) is at least 150 μm, the membrane (2) is destroyed by rubbing it into the skin, while the components of the membrane (2) are absorbed or adsorbed by the skin by at least 85%, and the destruction and absorption or adsorption processes occur within a total time period of 25 to 150 seconds.

2. 2. The breakable capsule (1) according to claim 1, wherein the thickness of the membrane (2) is at least 300 μm.

3. 3. The frangible capsule (1) according to claim 1 or 2, wherein the calcium salt is selected from the group consisting of calcium ascorbate, calcium aspartate, calcium carbonate, calcium benzoate, calcium chloride, calcium citrate, calcium gluconate, calcium glycerophosphate, calcium glycinate, calcium ketoglutarate, calcium lactate, calcium phosphate, calcium sulfate and calcium glycinate, calcium tartrate, calcium pantothenate, derivatives of algae-derived carrageenan, calcium polyglutamate crosspolymer, calcium glycerophosphate, and mixtures thereof; and / or the magnesium salt is selected from the group consisting of magnesium hydroxide, magnesium carbonate hydroxide, calcium magnesium silicate, dolomite, magnesium chloride, magnesium citrate, magnesium alginate, magnesium glycerophosphate, magnesium glycinate, magnesium lactate, magnesium myristate, magnesium PCA, or mixtures thereof.

4. The frangible capsule (1) according to any one of claims 1 to 3, wherein the amount of calcium and magnesium is at a concentration of at least 0.01% to 3% relative to the total weight of the membrane.

5. The breakable capsule (1) according to any one of claims 1 to 4, wherein the core (3) contains a cosmetic composition.

6. The breakable capsule (1) according to any one of claims 1 to 5, wherein the core (3) contains a cosmetic composition in a range of between 1% and 98% by weight of the total weight of the core.

7. A frangible capsule (1) according to any one of claims 1 to 6, wherein the cosmetic composition comprises an active ingredient which is a cosmetically acceptable oil selected from the group consisting of Prunus Amygdalus Dulcis, Argania Spinosa, Simmondsia Chinansis seed oil, Camellia Oleifera seed oil, aloe oil, Citrus Nobilis peel oil, and mixtures thereof.

8. 8. The frangible capsule (1) according to any one of claims 1 to 7, wherein the gelling agent is in the range of between 0.2% and 5%, and the cosmetically acceptable excipient is in the range of between 0.2% and 10%, both measured relative to the total weight of the membrane.

9. The breakable capsule (1) according to any one of claims 1 to 8, wherein the diameter of the capsule ranges between 7 mm and 30 mm.

10. The breakable capsule (1) according to any one of claims 1 to 9, wherein the water content by weight in the membrane (2) is between 40% and 99.5% with respect to the total weight of the membrane.

11. 11. The frangible capsule (1) according to any one of claims 1 to 10, wherein the weight percentage of the membrane (2) relative to the weight of the capsule (1) is between 5 and 30% and / or the weight percentage of the core (3) relative to the weight of the capsule (1) is in the range between 70 and 95%.

12. 12. The breakable capsule (1) according to any one of claims 1 to 11, wherein the active ingredient is located in the core (3).

13. 13. The breakable capsule (1) according to any one of claims 1 to 12, wherein the active ingredient is present in the core (3) at a concentration of at least 0.01% to 100% relative to the total weight of the core (3).

14. 14. The breakable capsule (1) according to any one of claims 1 to 13, wherein the active ingredient is in the core (3) and in the membrane (2).

15. The gelling agent of the membrane (2) is selected from the group consisting of sodium alginate, carrageenan, gellan gum, acacia gum, guar gum, locust bean gum, sclerotium gum, hydrolyzed caesalpinia spinosa gum, xanthan gum, cellulose gum, cellulose and cellulose derivatives, Lessonia nigrexiens powder, agar, Chondrus crispus, Kelco-Care 15. The frangible capsule (1) of any one of claims 1 to 14, wherein the frangible ingredient is selected from the group consisting of diutan gum, dihydroxyxanthan gum, biosaccharide gum, Boswellia serrata gum, colophonium, dextran, dextrin, gelatin, ghatti gum, Himantaria elongata powder, Bakgadextrin, mannitol, mel powder, xanthan gum, pullulan, trehalose, monosaccharides, disaccharides, polysaccharides, polyvinylpyrrolidone, carbomer, acrylates, pectin, gelatin, astragalus gum, cassia gum, rice, tapioca, wheat, and corn starch, rosin, Sterculian Urens gum, silica, Urubara cutuka powder, and mixtures thereof.

16. 16. The breakable capsule (1) of claim 15, wherein the gelling agent of the membrane (2) is selected from the group consisting of alginic acid, sodium alginate, carrageenan, xanthan gum, dextrin, and gellan gum.

17. 17. The frangible capsule (1) according to any one of claims 1 to 16, wherein the active ingredient is selected from the group consisting of hyaluronic acid and its salts, mucopolysaccharides, aloe vera, Barbados aloe leaf powder or juice, and aloe plant juice, aqueous plant extracts, oily plant extracts, amino acids, peptides, and proteins, vitamins, minerals, and mixtures thereof.

18. 18. The frangible capsule (1) according to any one of claims 1 to 17, wherein the core or the cosmetically acceptable excipient is a cosmetically acceptable carrier suitable for forming saline, aqueous, alcoholic, and oily solutions, emulsions of an oily external phase, an aqueous external phase, and a silicone external phase, aqueous and oily gels, and powders.

19. 19. The frangible capsule (1) according to any one of claims 1 to 18, wherein the excipient is selected from the group consisting of preservatives, dyes, pigments, thickeners, waxes, emulsifiers, co-emulsifiers, silicones, organic oils, mineral oils, absorbents, organic powders, inorganic powders, stabilizers, surfactants, exfoliating particles, liposomes, acids and alkalis, buffers, salts, antioxidants, sequestering agents, moisturizers, anti-shining agents, natural and synthetic sunscreens.

20. 20. The frangible capsule (1) according to any one of claims 1 to 19, wherein the excipient is selected from the group consisting of preservatives, plasticizers, thickeners, silicones, stabilizers, antioxidants, humectants, and surfactants.

21. 21. The frangible capsule (1) according to any one of claims 1 to 20, wherein the excipient is at least one plasticizer selected from the group consisting of propanediol, glycerol, propylene glycol with a molecular weight (Mn) between 400 and 2000, polyethylene glycol with a molecular weight (Mn) between 400 and 4000, pentylene glycol, and triacetin.

22. The frangible capsule (1) according to any one of claims 1 to 21, wherein the excipient is at least one preservative selected from the group consisting of benzyl alcohol, dehydroacetic acid, glycerin soybean oil, tocopherol, glycol, benzoic acid and phosphate salts, ethylhexylglycerin, and phenoxyethanol.

23. The outer membrane (2) and / or the inner core (3) may be at least one dye, and / or 23. The frangible capsule (1) according to any one of claims 1 to 22, comprising at least one fragrance.

24. 24. The frangible capsule (1) according to any one of claims 1 to 23, wherein the type of cosmetic formulation contained in the core (3) is selected from the group consisting of powders, aqueous and oily gels, creams, ointments, serums, oils, aqueous and oily emulsions, aqueous solutions, hydroalcoholic solutions, and oily solutions.

25. 25. The frangible capsule (1) according to claim 24, wherein the membrane (2) is broken by rubbing it into the skin, while the components of the membrane (2) are absorbed or adsorbed by the skin by at least 85%, and the time for the process of breaking down and the absorption or adsorption is between 25 and 120 seconds.

26. 26. The frangible capsule (1) according to any one of claims 1 to 25, which is stable at room temperature between 15 and 25°C for at least 30 weeks.

27. a) providing a mixture comprising at least one gelling agent, one excipient, and cosmetically acceptable water; b) providing a second mixture comprising an aqueous phase, at least one calcium and / or magnesium salt, and optionally an oil and an emulsifier; c) adding the mixture of step b) to the mixture of step a) such that upon addition of the mixture of step b) to the mixture of step a), the mixture of step b) precipitates on the mixture of step a) to form solid or semi-solid spheres; 27. A method for preparing a breakable capsule (1) according to any one of claims 1 to 26, comprising the step of: d) adding the spheres obtained in step c) to a water bath and / or an oil bath.

28. a) providing a mixture comprising at least one gelling agent, one excipient, and cosmetically acceptable water; b) providing a second mixture comprising at least one pharmaceutically and / or cosmetically acceptable excipient and / or active ingredient; c) simultaneously mixing the mixtures of step a) and step b) by using a double-walled concentric injector to provide a spherical cosmetic composition comprising the ingredients of step a) and step b); 27. A method for preparing the breakable capsule (1) according to any one of claims 1 to 26, comprising the steps of: d) adding the spherical cosmetic composition obtained in step c) to a solution containing a calcium salt or a magnesium salt until solid spheres are formed; and e) adding the solid spheres obtained in step d) to a bath containing water and / or oil to obtain spherical breakable capsules.

29. 29. The method for preparing a frangible capsule (1) according to claim 28, wherein the double-walled concentric injector comprises an input hopper for adding the mixture obtained in steps a) and b) in step c).

30. 30. A method for preparing a frangible capsule (1) according to any one of claims 27 to 29, wherein the calcium salt and / or the magnesium salt is selected from the group according to claim 3.

31. 31. The method for preparing a breakable capsule (1) according to any one of claims 28 to 30, wherein the calcium salt and / or magnesium salt is added to the aqueous solution of step d), wherein the concentration of the calcium salt and the magnesium salt in the aqueous solution is between 0.01% and 5% by weight.

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