Panthenol-containing gel composition

By adding sodium edetate and citric acid with specific surfactants, the panthenol-containing gel composition achieves enhanced stability and prevents phase separation, maintaining its efficacy during storage.

JP7754862B2Active Publication Date: 2025-10-15HISAMITSU PHARM CO INC
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Patent Information

Application Number
JP2023023299
Authority / Receiving Office
JP · JP
Patent Type
Patents
Current Assignee / Owner
Priority Date
2022-02-25
Filing Date
2023-02-17
Publication Date
2025-10-15
Estimated Expiration
2043-02-17

AI Technical Summary

Technical Problem

Panthenol-containing gel compositions experience decreased content stability during storage and are prone to phase separation, especially when sodium edetate or citric acid is used as stabilizers.

Method used

Incorporating specific stabilizers such as sodium edetate and citric acid, along with surfactants like polyethylene glycol fatty acid esters and polyoxyethylene alkyl ethers, into the gel composition to enhance panthenol stability and prevent phase separation.

Benefits of technology

The solution significantly improves panthenol content stability and prevents phase separation during storage, ensuring the gel composition maintains its effectiveness and application properties.

✦ Generated by Eureka AI based on patent content.

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Abstract

To increase content stability of panthenols during storage to a predetermined level or more and sufficiently suppress occurrence of phase separation in a gel composition comprising panthenols which comprises panthenols, water, a thickener, a stabilizer and a surfactant.SOLUTION: There is provided a gel composition comprising panthenols which comprises panthenols, water, a thickener, a stabilizer and a surfactant, wherein the gel composition comprises at least one selected from a group consisting of sodium edetate and citric acid as the stabilizer and at least one selected from a group consisting of a polyethylene glycol fatty acid esters, a polyoxyethylene alkyl ether, a polyoxyethylene hydrogenated castor oil, polyoxyethylene lanolin, polyoxyethylene lanolin alcohol, a polyoxyethylene beeswax derivative and a polyoxyalkylene sterol as the surfactant.SELECTED DRAWING: None
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Description

[Technical Field]

[0001] The present invention relates to a panthenol-containing gel composition containing panthenol, water, a thickener, a stabilizer, and a surfactant. [Background technology]

[0002] Panthenol is a water-soluble vitamin and a type of B vitamin. It is an active ingredient that activates the skin and has tissue-protecting and wound-healing effects. It is also known to have the effect of suppressing itching and improving dry skin, and many topical preparations for administering such beneficial panthenol to the skin have been investigated.

[0003] For example, Japanese Patent Application Laid-Open Publication No. 2010-184903 (Patent Document 1) discloses an external pharmaceutical composition containing panthenols and γ-oryzanol, and describes a gel formulation containing pantothenyl ethyl ether, γ-oryzanol, hydrophobized hydroxypropyl methylcellulose, citric acid, etc., and a gel formulation containing panthenol, γ-oryzanol, carboxyvinyl polymer, diisopropanolamine, etc. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] Japanese Patent Application Laid-Open No. 2010-184903 Summary of the Invention [Problem to be solved by the invention]

[0005] However, as a result of investigations by the present inventors, when a gel preparation, i.e., a panthenol-containing gel composition, is used as a form of external preparation for administering panthenols to the skin, the present inventors have found that there is a problem in that the content stability of the panthenols decreases during storage, as will be explained below. Furthermore, when the present inventors have investigated methods for improving the content stability of the panthenols, they have found that the content stability can be improved by adding sodium edetate or citric acid as a stabilizer, but they have also found that the resulting gel composition is prone to phase separation.

[0006] The present invention has been made in view of the above-mentioned problems, and aims to increase the panthenol content stability during storage to a predetermined level or more and to sufficiently suppress the occurrence of phase separation in a panthenol-containing gel composition that contains panthenols, water, a thickener, a stabilizer, and a surfactant. [Means for solving the problem]

[0007] As a result of extensive research to achieve the above-mentioned object, the present inventors have found that by adding at least one stabilizer selected from the group consisting of sodium edetate and citric acid to a panthenol-containing gel composition and by adding a specific surfactant, it is possible to sufficiently suppress the occurrence of phase separation while improving the panthenol content stability during storage to a predetermined level or higher, and have completed the present invention.

[0008] That is, the present invention provides the following aspects.

[0009] [1] A gel composition containing panthenols, water, a thickener, a stabilizer, and a surfactant, The content of the panthenols is 0.01 to 5% by mass based on the total amount of the gel composition, The gel composition contains, as the thickener, 0.5 to 1% by mass of hydrophobized hydroxypropyl methylcellulose based on the total amount of the gel composition and 0.1 to 0.5% by mass of a carboxyvinyl polymer based on the total amount of the gel composition; The stabilizer contains 0.01 to 0.5% by mass of sodium edetate based on the total amount of the gel composition and 0.01 to 0.5% by mass of citric acid based on the total amount of the gel composition, and The surfactant may be Polyethylene glycol monostearate, polyoxyethylene cetyl ether, polyoxyethylene hydrogenated castor oil, polyoxyethylene lanolin alcohol and polyoxyethylene phytosterol The gel composition contains 0.2 to 5 mass% of a first surfactant having an HLB value of 16 to 20, which is at least one selected from the group consisting of: A panthenol-containing gel composition.

[0013] [ 2 ] The second one has an HLB value of 14-16. Polyoxyethylene sorbitan fatty acid ester is used as a surfactant. 0.2 to 5% by mass based on the total amount of the gel composition Further containing There are , [1 ] The panthenol-containing gel composition described above.

[0014] [ 3 ] The gel composition further contains at least one selected from the group consisting of 0.05 to 3% by mass of a heparinoid, 0.2 to 0.9% by mass of diphenhydramine, 2 to 10% by mass of crotamiton, and 0.3 to 7% by mass of tocopherol acetate, based on the total mass of the gel composition. [1] or [2] The panthenol-containing gel composition according to claim 1.

[0015] [ 4 ], [1] to [ 3 ] The panthenol-containing gel composition according to any one of the above items. [Effects of the Invention]

[0016] According to the present invention, in a panthenol-containing gel composition containing panthenols, water, a thickener, a stabilizer, and a surfactant, it is possible to increase the panthenol content stability during storage to a predetermined level or higher and sufficiently suppress the occurrence of phase separation. DETAILED DESCRIPTION OF THE INVENTION

[0017] The present invention will be described in detail below based on preferred embodiments thereof.

[0018] The panthenol-containing gel composition of the present invention is a gel composition containing panthenol, water, a thickener, a stabilizer, and a surfactant, and is characterized in that the stabilizer contains at least one selected from the group consisting of sodium edetate and citric acid, and the surfactant contains at least one selected from the group consisting of polyethylene glycol fatty acid esters, polyoxyethylene alkyl ethers, polyoxyethylene hydrogenated castor oil, polyoxyethylene lanolin, polyoxyethylene lanolin alcohols, polyoxyethylene beeswax derivatives, and polyoxyalkylene sterols.

[0019] The panthenols used in the present invention are active ingredients that activate the skin and have tissue protecting and wound healing effects, and include panthenol and panthenol-related substances. Specific examples include panthenol, pantothenic acid or its salts (such as alkali metal salts such as sodium salts, and alkaline earth metal salts such as calcium salts), pantothenyl alkyl ethers (such as pantothenyl ethyl ether), and acetylpantothenyl alkyl ethers (such as acetylpantothenyl ethyl ether). These may be used alone or in combination of two or more. Among these, panthenol is particularly preferred.

[0020] The content of panthenols in the gel composition of the present invention is preferably 0.01 to 5% by mass, and more preferably 0.1 to 3% by mass, based on the total amount of the gel composition. If the content of panthenols is less than the lower limit, it becomes difficult to obtain the above-mentioned effects, while if the content of panthenols is more than the upper limit, the gel composition tends to become sticky after application.

[0021] The gel composition of the present invention must contain at least one stabilizer selected from the group consisting of sodium edetate and citric acid, and it is particularly preferable to use a combination of sodium edetate and citric acid.

[0022] Sodium edetate is a compound also known as disodium ethylenediaminetetraacetate (EDTA). When sodium edetate is contained as a stabilizer in the gel composition of the present invention, the content thereof is preferably 0.01 to 0.5% by mass, more preferably 0.03 to 0.3% by mass, based on the total amount of the gel composition. If the content of sodium edetate is less than the lower limit, the effect of improving the stability of the panthenol content is difficult to obtain. On the other hand, if the content exceeds the upper limit, the viscosity of the resulting gel composition tends to decrease, and the stability of the panthenol content tends to decrease.

[0023] Citric acid may be citric acid anhydride, citric acid hydrate, or a citrate salt (e.g., sodium citrate, potassium citrate, magnesium citrate, calcium citrate). When citric acid is contained as a stabilizer in the gel composition of the present invention, the content is preferably 0.01 to 0.5% by mass, more preferably 0.01 to 0.1% by mass, based on the total amount of the gel composition. If the content of citric acid is less than the lower limit, it becomes difficult to sufficiently improve the stability of the panthenol content. On the other hand, if the content exceeds the upper limit, the viscosity of the resulting gel composition tends to decrease, and the stability of the panthenol content tends to decrease.

[0024] In addition to the stabilizer, the panthenol-containing gel composition of the present invention must contain at least one surfactant (first surfactant) selected from the group consisting of polyethylene glycol fatty acid esters, polyoxyethylene alkyl ethers, polyoxyethylene hydrogenated castor oil, polyoxyethylene lanolin, polyoxyethylene lanolin alcohols, polyoxyethylene beeswax derivatives, and polyoxyalkylene sterols. Among these, at least one surfactant selected from the group consisting of polyethylene glycol monostearate, polyoxyethylene cetyl ether, polyoxyethylene hydrogenated castor oil, polyoxyethylene lanolin, polyoxyethylene lanolin alcohols, polyoxyethylene beeswax derivatives, and polyoxyethylene phytosterols is preferred, with at least one surfactant selected from the group consisting of polyethylene glycol monostearate, polyoxyethylene lanolin, polyoxyethylene lanolin alcohols, polyoxyethylene beeswax derivatives, and polyoxyethylene phytosterols being particularly preferred. Such a first surfactant preferably has an HLB value of 16 to 20.

[0025] The present inventors have found that by further adding the first surfactant to a panthenol-containing gel composition containing the stabilizer, it is possible to obtain a panthenol-containing gel composition that has a panthenol content stability during storage that is higher than a predetermined level while sufficiently suppressing the occurrence of phase separation.

[0026] The content of the first surfactant in the gel composition of the present invention is preferably 0.1 to 10% by mass, and more preferably 0.2 to 5% by mass, based on the total mass of the gel composition. If the content of the surfactant is less than the lower limit, it becomes difficult to sufficiently suppress phase separation, while if the content exceeds the upper limit, the viscosity of the resulting gel composition tends to be low.

[0027] The gel composition of the present invention preferably further contains a polyoxyethylene sorbitan fatty acid ester as a second surfactant in addition to the stabilizer and the first surfactant. Such a second surfactant preferably has an HLB value of 14 to 16. The inclusion of a first surfactant and a second surfactant in combination tends to more reliably suppress the occurrence of phase separation. When the first surfactant and the second surfactant are used in combination, the content of the first surfactant is preferably 0.2 to 5 mass% based on the total weight of the gel composition, and the content of the second surfactant is preferably 0.2 to 5 mass% based on the total weight of the gel composition. If the contents of the first and second surfactants are less than the lower limit, the phase separation suppression effect is not sufficiently achieved. On the other hand, if the contents exceed the upper limit, the viscosity of the resulting gel composition tends to be low.

[0028] In the panthenol-containing gel composition of the present invention, in addition to the stabilizer and the surfactant, it is preferred that the thickener be at least one selected from the group consisting of hydrophobized hydroxypropyl methylcellulose and a carboxyvinyl polymer, and it is particularly preferred to use a combination of hydrophobized hydroxypropyl methylcellulose and a carboxyvinyl polymer.

[0029] Hydrophobized hydroxypropyl methylcellulose (hydrophobized HPMC) is a compound in which a long-chain alkyl group, which is a hydrophobic group, is introduced into hydroxypropyl methylcellulose (HPMC), a cellulose ether derivative. The long-chain alkyl group introduced into HPMC is C8 to C 24 Alkyl groups are preferred, and C 10 ~C 20 Alkyl groups are more preferred, lauryl groups, myristyl groups, palmityl groups, and stearyl groups are even more preferred, and stearyl groups are particularly preferred. As the hydrophobized HPMC, one type may be used alone, or two or more types may be used in combination.

[0030] When hydrophobized HPMC is contained as a thickener in the gel composition of the present invention, the content thereof is preferably 0.1 to 5% by mass, and more preferably 0.5 to 1% by mass, based on the total amount of the gel composition. If the content of hydrophobized HPMC is less than the lower limit, the viscosity of the resulting gel composition tends to be low. On the other hand, if the content exceeds the upper limit, the viscosity becomes excessively high, making it difficult to spread during application, and the occurrence of scum-like lumps (creases) after application, which tends to deteriorate the feel in use.

[0031] Carboxyvinyl polymers are polymers having a crosslinked structure in which polyacrylic acid is partially crosslinked as the main chain. The degree of polymerization of the carboxyvinyl polymers used in the present invention is not particularly limited, and one type may be used alone, or two or more types may be used in combination. Furthermore, the viscosity of a 0.2% by mass aqueous solution of the carboxyvinyl polymer at 25°C (viscosity measured with a Brookfield viscometer) is preferably 500 to 8000 mPa·s, more preferably 1000 to 6000 mPa·s.

[0032] When a carboxyvinyl polymer is contained as a thickener in the gel composition of the present invention, the content thereof is preferably 0.1 to 5 mass %, and more preferably 0.1 to 0.5 mass %, based on the total amount of the gel composition. If the content of the carboxyvinyl polymer is less than the lower limit, the viscosity of the resulting gel composition tends to be low, whereas if the content exceeds the upper limit, the viscosity of the resulting gel composition tends to be high.

[0033] The gel composition of the present invention contains water in addition to the panthenols, thickeners, stabilizers, and surfactants described above. The amount of water in the gel composition of the present invention is not particularly limited and may be appropriately determined depending on the composition of the other components, but is preferably 50 to 90% by mass, more preferably 60 to 80% by mass, based on the total amount of the gel composition.

[0034] In order to more reliably prevent the occurrence of phase separation, it is preferable that the gel composition of the present invention does not contain lower alcohols, and it is particularly preferable that it does not contain ethanol.

[0035] In addition to the panthenols, water, thickeners, stabilizers, and surfactants described above, the gel composition of the present invention may contain active ingredients used in pharmaceuticals, quasi-drugs, cosmetics, etc., as needed, within a range that does not impair the effects of the present invention. Examples of such active ingredients include moisturizing ingredients, antihistamine ingredients, antipruritic ingredients, blood circulation promoting ingredients, anti-inflammatory ingredients, antifungal ingredients, whitening ingredients, herbal ingredients, and local anesthetic ingredients.

[0036] Examples of moisturizing ingredients include polymeric compounds such as heparinoids, sodium hyaluronate, sodium chondroitin sulfate, and collagen; polyhydric alcohols such as glycerin; amino acids such as glycine and aspartic acid; natural moisturizing factors such as sodium lactate and urea; and lipids such as ceramides, cholesterol, and phospholipids, with heparinoids being preferred. When a moisturizing ingredient (preferably a heparinoid) is incorporated into the gel composition of the present invention, its content is preferably 0.05 to 10% by mass based on the total mass of the gel composition. If the content of the moisturizing ingredient (preferably a heparinoid) is less than the lower limit, the efficacy of the moisturizing ingredient is difficult to obtain. On the other hand, if the content exceeds the upper limit, the viscosity of the resulting gel composition tends to be low and phase separation is more likely to occur.

[0037] Examples of antihistamine components include diphenhydramine, chlorpheniramine, mequitazine, azelastine, emedastine, ketotifen, or derivatives thereof, with diphenhydramine being preferred. When an antihistamine component (preferably diphenhydramine) is incorporated into the gel composition of the present invention, its content is preferably 0.2 to 0.9% by mass based on the total mass of the gel composition. If the content of the antihistamine component (preferably diphenhydramine) is less than the lower limit, the efficacy of the antihistamine component is difficult to obtain, while if the content exceeds the upper limit, the viscosity of the resulting gel composition tends to be low.

[0038] Examples of antipruritic ingredients include crotamiton and steroids, with crotamiton being particularly preferred. When an antipruritic ingredient (preferably crotamiton) is incorporated into the gel composition of the present invention, its content is preferably 2 to 10% by mass based on the total amount of the gel composition. If the content of the antipruritic ingredient (preferably crotamiton) is less than the lower limit, it becomes difficult to obtain the aforementioned efficacy. On the other hand, if the content exceeds the upper limit, the composition tends to become sticky after application and is more likely to undergo phase separation.

[0039] Examples of blood circulation-promoting ingredients include tocopherol acetate, nonylic acid vanillylamide, dl-camphor, capsaicin, and methyl salicylate, with tocopherol acetate being preferred. When a blood circulation-promoting ingredient (preferably tocopherol acetate) is incorporated into the gel composition of the present invention, its content is preferably 0.3 to 7% by mass based on the total amount of the gel composition. If the content of the blood circulation-promoting ingredient (preferably tocopherol acetate) is less than the lower limit, the efficacy of the blood circulation-promoting ingredient is difficult to obtain, while if it exceeds the upper limit, the product tends to become sticky after application.

[0040] Examples of anti-inflammatory ingredients include glycyrrhetinic acid, glycyrrhizinic acid or derivatives thereof, licorice extract, steroid compounds (hydrocortisone, prednisolone, methylprednisolone, clobetasone, betamethasone, dexamethasone, cortisone, flumethasone, beclomethasone, fluticasone or derivatives thereof), indomethacin, ibuprofen, ibuprofen piconol, bufexamac, ufenamate, piroxicam, ketoprofen, salicylic acid or derivatives thereof, dimethylisopropylazulene, Angelica acutiloba extract, Lithospermum root extract, etc. When an anti-inflammatory ingredient is incorporated into the gel composition of the present invention, the content thereof is preferably 0.01 to 1% by mass based on the total amount of the gel composition.

[0041] Examples of antifungal drug components include butenafine hydrochloride, terbinafine hydrochloride, neticonazole hydrochloride, luliconazole, efinaconazole, bifonazole, ketoconazole, lanoconazole, etc. When an antifungal drug component is incorporated into the gel composition of the present invention, the content thereof is preferably 0.01 to 1% by mass based on the total amount of the gel composition.

[0042] Examples of whitening ingredients include L-cysteine, hydroquinone, glucosamine, L-ascorbic acid, glutathione, kojic acid, ellagic acid, placenta extract, ubiquinones, and derivatives thereof. When a whitening ingredient is blended into the gel composition of the present invention, the content thereof is preferably 0.01 to 1% by mass based on the total amount of the gel composition.

[0043] Examples of herbal ingredients include Bupleurum Root, Poria Cocos Root, Cinnamon Bark, Licorice Root, Scutellaria Root, Phellodendron Bark, Coptis Rhizome, Sanshichi Blossom, Rehmannia Root, Peony Root, Cnidium Rhizome, Angelica Root, Glehnia Root, Safflower Root, Platycodon Grandiflorum, Ginger Root, Poria Root, Scutellaria Baicalensis, Mokutsu Root, Burdock Fruit, Zingiber Officinale, Siberian Root, Sophora Root, Atractylodes Rhizome, and Inchinko Root, etc. When a herbal ingredient is incorporated into the gel composition of the present invention, the content thereof is preferably 0.01 to 1% by mass based on the total amount of the gel composition.

[0044] Examples of local anesthetic ingredients include lidocaine, dibucaine, procaine, tetracaine, aminobenzoic acid, or derivatives thereof. When a local anesthetic ingredient is incorporated into the gel composition of the present invention, the content thereof is preferably 0.01 to 2% by mass based on the total amount of the gel composition.

[0045] In the panthenol-containing gel composition of the present invention, in addition to the active ingredient, oils, solubilizers, pH adjusters, higher fatty acids, preservatives, cooling agents, etc. may be blended as components for constituting the gel composition.

[0046] Examples of oils include natural animal and vegetable oils, hydrocarbon oils, ester oils, silicone oils, etc., and ester oils are preferred because they make the resulting gel composition easier to spread and tend to be less sticky after application. Examples of ester oils include diisobutyl adipate, 2-hexyldecyl adipate, di-2-heptylundecyl adipate, isostearyl isostearate, trimethylolpropane triisostearate, cetyl 2-ethylhexanoate, neopentyl glycol di-2-ethylhexanoate, trimethylolpropane tri-2-ethylhexanoate, pentaerythritol tetra-2-ethylhexanoate, cetyl octanoate, oleyl oleate, octyldodecyl oleate, decyl oleate, neopentyl glycol dicaprate, 2-ethylhexyl succinate, isocetyl stearate, butyl stearate, diisopropyl sebacate, cetyl lactate, tetradecyl lactate, and isopropyl myristate. Examples of suitable oils include octyldodecyl myristate, cetyl myristate, myristyl myristate, octyl palmitate, 2-ethylhexyl palmitate, 2-hexyldecyl palmitate, 2-heptylundecyl palmitate, cholesteryl 12-hydroxystearate, phytosteryl oleate, diisostearyl malate, para-methoxycinnamate, and pentaerythritol tetrarosinate. Among these, cetyl 2-ethylhexanoate and isopropyl myristate are preferred, and a combination of cetyl 2-ethylhexanoate and isopropyl myristate is particularly preferred, as they tend to make the resulting gel composition easier to spread and less sticky after application. When an oil (preferably an ester oil) is incorporated into the gel composition of the present invention, the content thereof is preferably 1 to 30% by mass, more preferably 5 to 20% by mass, and particularly preferably 10 to 15% by mass, based on the total mass of the gel composition. If the oil (preferably ester oil) content is less than the lower limit, the moisturizing properties of the resulting gel composition tend to decrease, while if it exceeds the upper limit, the resulting gel composition tends to dry more slowly when applied.

[0047] Examples of solubilizing agents include propylene glycol, polyethylene glycol, D-mannitol, benzyl benzoate, trisaminomethane, cholesterol, triethanolamine, sodium carbonate, and sodium citrate, with propylene glycol being preferred due to its low skin irritation. When a solubilizing agent is incorporated into the gel composition of the present invention, its content is preferably 0.5 to 20% by mass, more preferably 1 to 10% by mass, and particularly preferably 3 to 7% by mass, based on the total mass of the gel composition. If the content of the solubilizing agent is less than the lower limit, a sufficient solubilizing effect tends to be insufficient. On the other hand, if the content exceeds the upper limit, the resulting gel composition tends to be sticky after application.

[0048] Examples of pH adjusters include inorganic acids (hydrochloric acid, sulfuric acid, etc.), organic acids (lactic acid, sodium lactate, succinic acid, sodium succinate, etc.), inorganic bases (potassium hydroxide, sodium hydroxide, etc.), and organic bases (diethanolamine, triethanolamine, diisopropanolamine, triisopropanolamine, etc.), of which diethanolamine is preferred because it is liquid at room temperature, does not deliquesce, and is easy to handle. When a pH adjuster is added to the gel composition of the present invention, the content thereof is preferably 0.01 to 0.5% by mass based on the total amount of the gel composition.

[0049] Examples of higher fatty acids include isostearic acid, oxystearic acid, oleic acid, stearic acid, palmitic acid, behenic acid, myristic acid, lauric acid, lanolinic acid, linoleic acid, linolenic acid, etc., of which oleic acid is preferred. When a higher fatty acid is blended into the gel composition of the present invention, the content thereof is preferably 0.1 to 5% by mass based on the total amount of the gel composition.

[0050] Examples of preservatives include benzoic acid, sodium benzoate, dehydroacetic acid, sodium dehydroacetate, isobutyl parahydroxybenzoate, isopropyl parahydroxybenzoate, butyl parahydroxybenzoate, methyl parahydroxybenzoate, ethyl parahydroxybenzoate, propyl parahydroxybenzoate, benzyl parahydroxybenzoate, methyl parahydroxybenzoate, phenoxyethanol, etc., of which methyl parahydroxybenzoate is preferred from the viewpoints of excellent solubility in water and low skin irritation. When a preservative is incorporated into the gel composition of the present invention, the content thereof is preferably 0.01 to 1% by mass based on the total amount of the gel composition.

[0051] Examples of the refreshing agent include menthol (l-menthol, dl-menthol, etc.), camphor (d-camphor, dl-camphor, etc.), terpenoids such as borneol, essential oils containing terpenoids (mentha oil), or pharmacologically acceptable salts thereof. When a refreshing agent is blended in the gel composition of the present invention, the content thereof is preferably 0.01 to 7% by mass based on the total amount of the gel composition.

[0052] The pH of the panthenol-containing gel composition of the present invention is not particularly limited as long as it is within a physiologically or pharmaceutically acceptable range. However, from the viewpoint of skin irritation, the pH is preferably 2 to 11.5, more preferably 3 to 10, and particularly preferably 5 to 8.

[0053] The panthenol-containing gel composition of the present invention is in the form of a gel, and its preparation method is not particularly limited. It can be prepared by weighing out the above-mentioned panthenols, water, thickener, stabilizer, and surfactant, and, if necessary, the above-mentioned active ingredient and ingredients for constituting the gel composition, to a desired blend ratio, mixing them by a conventional method, and emulsifying them. [Example]

[0054] The present invention will be described in more detail below based on examples and comparative examples, but the present invention is not limited to the following examples.

[0055] In the following table, the numerical values ​​for the composition of each component are the content (mass %) of each component based on the total amount of the resulting gel composition.

[0056] Further, examples of hydrophobized hydroxypropyl methylcellulose (hydrophobized HPMC) include Sangelose 90L manufactured by Daido Chemical Industry Co., Ltd., Carbopol 981 NF POLYMER manufactured by Lubrizol Corporation, edetate sodium include Crewat N manufactured by Nagase ChemteX Corporation, anhydrous citric acid include Anhydrous Citric Acid manufactured by Junsei Chemical Co., Ltd., polyoxyethylene sorbitan monostearate include TS-10MV (HLB=14.9) manufactured by Nippon Surfactant Industry Co., Ltd., polyethylene glycol monostearate include MYS-55MV (HLB=18.0) manufactured by Nippon Surfactant Industry Co., Ltd., polyoxyethylene cetyl ether include BC-40 manufactured by Nippon Surfactant Industry Co., Ltd. The polyoxyethylene hydrogenated castor oil used was manufactured by Nippon Surfactant Kogyo Co., Ltd., trade name: HCO-100, HLB=16.5; the polyoxyethylene lanolin alcohol used was manufactured by Nippon Surfactant Kogyo Co., Ltd., trade name: BWA-40, HLB=17; the polyoxyethylene phytosterol used was manufactured by Nippon Surfactant Kogyo Co., Ltd., trade name: BPS-30, HLB=18; and the polyoxyethylene lauryl ether sodium phosphate used was manufactured by Nippon Surfactant Kogyo Co., Ltd., trade name: DLP-10, HLB=17.

[0057] The gel compositions obtained were evaluated by the following methods.

[0058] <Phase separation (during production)> The phase separation of the gel composition immediately after production was visually evaluated according to the following criteria. A: The emulsified state was maintained and no phase separation was observed (passed). B: Phase separation was confirmed.

[0059] <Phase separation (storage at 60°C, over time)> The risk of phase separation occurring over time when the obtained gel composition was stored at 60° C. was evaluated using the following method: The produced gel composition was stored in a storage cabinet at 60° C. and at predetermined intervals until 36 days had passed since the start of storage (storage ended at that point if phase separation was observed), the gel composition was removed from the storage cabinet, allowed to stand at room temperature for approximately 8 hours, and then stirred with a spatula 20 times, after which phase separation was visually evaluated according to the following criteria. A: The emulsified state was maintained for 36 days, and no phase separation was observed (passed). B: The number of days until the occurrence of phase separation was confirmed is shown in the table ("-" indicates that phase separation occurred during production and therefore was not evaluated).

[0060] <Panthenol content stability> The panthenol content of the obtained gel compositions was measured by high performance liquid chromatography immediately after production and after storage in a storage facility at 50°C for 2 weeks (2W) or 1 month (1M). The panthenol content relative to the initial content was calculated using the following formula to evaluate the content stability ("-" indicates no evaluation). Initial content = (Panthenol content after storage at 50°C for 2W (or 50°C for 1M)) / (Panthenol content immediately after production).

[0061] (Comparative Examples 1 to 6) The components listed in Table 1 were weighed out to the desired blend ratio, mixed and emulsified by a conventional method to prepare panthenol-containing gel compositions. The amount of diethanolamine was adjusted so that the resulting gel compositions had the pH values ​​shown in the table. The evaluation results are shown in the table.

[0062] [Table 1]

[0063] From the results shown in Table 1, it was confirmed that in the absence of a stabilizer (Comparative Example 1), phase separation occurred over time, and furthermore, the panthenol content decreased. Furthermore, in the gel compositions containing only sodium edetate as a stabilizer (Comparative Examples 2 to 4), although content stability improved, phase separation occurred over time, and it was confirmed that phase separation occurred from the time of production when the sodium edetate content was 0.3% by mass or more. Furthermore, in the gel compositions containing only citric acid as a stabilizer (Comparative Examples 5 and 6), although content stability improved, phase separation occurred over time, and it was confirmed that phase separation occurred from the time of production when the citric acid content was 0.1% by mass or more.

[0064] (Examples 1 to 3, Comparative Examples 7 to 11) The components listed in Table 2 were weighed out to the desired blend ratio, mixed and emulsified by a conventional method to prepare panthenol-containing gel compositions. The amount of diethanolamine was adjusted so that the resulting gel compositions had the pH values ​​shown in the table. The evaluation results are shown in the table.

[0065] [Table 2]

[0066] From the results shown in Table 2, no phase separation inhibitory effect was observed in gel compositions (Comparative Examples 7 and 8) in which the stabilizer content was reduced compared to the gel compositions of Comparative Examples 2 to 6 shown in Table 1. Furthermore, no significant improvement in the phase separation inhibitory effect was observed in gel compositions (Comparative Examples 10 and 11) in which the polyoxyethylene sorbitan fatty acid ester content was increased compared to the gel composition of Comparative Example 9. On the other hand, the gel compositions of the present invention (Examples 1 to 3) had good content stability and no phase separation occurred even after storage at 60°C for 36 days, confirming a significant phase separation inhibitory effect.

[0067] (Examples 4 to 6, Comparative Example 12) The components listed in Table 3 were weighed out to the desired blend ratio, mixed and emulsified by a conventional method to prepare panthenol-containing gel compositions. The amount of diethanolamine was adjusted so that the resulting gel compositions had the pH values ​​shown in the table. The evaluation results are shown in the table.

[0068] [Table 3]

[0069] From the results shown in Table 3, the gel compositions of the present invention (Examples 4 to 6) had good content stability and did not undergo phase separation even after storage at 60°C for 36 days, confirming a significant phase separation suppression effect. On the other hand, in the gel composition (Comparative Example 12) using a surfactant outside the scope of the present invention, phase separation was confirmed after storage at 60°C for 11 days.

[0070] Examples 7 to 9 The components listed in Table 4 were weighed out to the desired blend ratio, mixed and emulsified by a conventional method to prepare panthenol-containing gel compositions. The amount of diethanolamine was adjusted so that the resulting gel compositions had the pH values ​​shown in the table. The evaluation results are shown in the table.

[0071] [Table 4]

[0072] From the results shown in Table 4, it was confirmed that the gel compositions of the present invention (Examples 7 to 9) had good content stability even when the content of the first surfactant varied within the range of 0.3 to 5% by mass, and no phase separation occurred even after storage at 60°C for 36 days, demonstrating a significant phase separation suppression effect.

[0073] ( Comparative Examples 13 to 16 ) The components listed in Table 5 were weighed out to the desired blend ratio, mixed and emulsified by a conventional method to prepare panthenol-containing gel compositions. The amount of diethanolamine was adjusted so that the resulting gel compositions had the pH values ​​shown in the table. The evaluation results obtained are shown in the table.

[0074] [Table 5]

[0075] From the results shown in Table 5, the gel composition of the present invention ( Comparative Examples 13 to 16 ) in 、6 No phase separation occurred even after storage at 0°C for 36 days, confirming a significant phase separation suppression effect. However, it was confirmed that content stability tends to decrease when the content of sodium edetate or citric acid increases beyond a specified amount.

[0076] (Examples 14 to 17) The components listed in Table 6 were weighed out to the desired blend ratio, mixed and emulsified by a conventional method to prepare panthenol-containing gel compositions. The amount of diethanolamine was adjusted so that the resulting gel compositions had the pH values ​​shown in the table. The evaluation results are shown in the table.

[0077] [Table 6]

[0078] From the results shown in Table 6, in the gel composition of the present invention, when the content of panthenol was 5% by mass (Example 14), when the contents of hydrophobized hydroxypropyl methylcellulose and carboxyvinyl polymer as thickeners were 1% by mass and 0.5% by mass, respectively (Example 15), when the contents of polyoxyethylene sorbitan monostearate as the second surfactant and polyethylene glycol monostearate as the first surfactant were 5% by mass and 5% by mass, respectively (Example 16), and when the contents of polyoxyethylene sorbitan monostearate as the second surfactant and polyethylene glycol monostearate as the first surfactant were 5% by mass and 0.5% by mass, respectively (Example 17), the content stability was good, and no phase separation occurred even after storage at 60°C for 36 days, confirming a significant phase separation suppression effect. [Industrial Applicability]

[0079] As described above, according to the present invention, in a panthenol-containing gel composition containing panthenols, water, a thickener, a stabilizer, and a surfactant, it is possible to increase the panthenol content stability during storage to a predetermined level or higher and sufficiently suppress the occurrence of phase separation.

[0080] Therefore, the panthenol-containing gel composition of the present invention provides a good feeling during and after application, even under various storage and use environments, and the desired efficacy of the panthenol is stably exhibited.

Claims

1. A gel composition comprising panthenols, water, a thickener, a stabilizer, and a surfactant, The content of the panthenols is 0.01 to 5% by mass based on the total amount of the gel composition, The gel composition contains, as the thickener, 0.5 to 1% by mass of hydrophobized hydroxypropyl methylcellulose based on the total amount of the gel composition and 0.1 to 0.5% by mass of a carboxyvinyl polymer based on the total amount of the gel composition; The stabilizer contains 0.01 to 0.5% by mass of sodium edetate based on the total amount of the gel composition and 0.01 to 0.5% by mass of citric acid based on the total amount of the gel composition, and the surfactant is at least one selected from the group consisting of polyethylene glycol monostearate, polyoxyethylene cetyl ether, polyoxyethylene hydrogenated castor oil, polyoxyethylene lanolin alcohol, and polyoxyethylene phytosterol, and the first surfactant has an HLB value of 16 to 20, and the first surfactant is contained in an amount of 0.2 to 5 mass% based on the total amount of the gel composition; A panthenol-containing gel composition.

2. 2. The panthenol-containing gel composition according to claim 1, further comprising a polyoxyethylene sorbitan fatty acid ester as a second surfactant having an HLB value of 14 to 16 in an amount of 0.2 to 5% by mass based on the total amount of the gel composition.

3. 3. The panthenol-containing gel composition according to claim 1, further comprising at least one selected from the group consisting of 0.05 to 3% by mass of a heparinoid based on the total amount of the gel composition, 0.2 to 0.9% by mass of diphenhydramine based on the total amount of the gel composition, 2 to 10% by mass of crotamiton based on the total amount of the gel composition, and 0.3 to 7% by mass of tocopherol acetate based on the total amount of the gel composition.

4. 3. The panthenol-containing gel composition according to claim 1, further comprising 1 to 30% by mass of an ester oil based on the total amount of the gel composition, and 0.5 to 20% by mass of a solubilizing agent based on the total amount of the gel composition.

Citation Information

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