oral ointment
The oral ointment formulation with polyethylene glycol, surfactant, and unsaturated fatty acid stabilizes gelled hydrocarbons, addressing syneresis issues and enhancing dispersibility and appearance.
Patent Information
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- SUNSTAR INC
- Filing Date
- 2021-12-24
- Publication Date
- 2026-04-14
AI Technical Summary
Gelled hydrocarbons in oral ointments can cause syneresis, leading to poor appearance and usability due to liquid separation.
Incorporating polyethylene glycol, a surfactant, and an unsaturated fatty acid, such as oleic acid, into the oral ointment formulation to stabilize the gelled hydrocarbons.
Suppresses syneresis, improves dispersibility of active ingredients, and maintains the ointment's appearance and usability.
Smart Images

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Abstract
Description
Technical Field
[0001] The present invention relates to an oral ointment.
Background Art
[0002] Conventionally, oral ointments for the prevention and treatment of periodontitis, stomatitis, toothache, etc. have been known. Patent Document 1 discloses an oral semi-solid preparation containing a gelled hydrocarbon, hydroxypropyl methylcellulose, and sodium polyacrylate.
[0003] Patent Document 2 discloses a mucosal application ointment containing a gelled hydrocarbon, a mucoadhesive polymer, and a sugar alcohol.
Prior Art Documents
Patent Documents
[0004]
Patent Document 1
Patent Document 2
Summary of the Invention
Problems to be Solved by the Invention
[0005] By the way, the gelled hydrocarbon contained in the above oral ointment is formed by gelling a liquid hydrocarbon such as liquid paraffin with a polymer such as a polyethylene resin. The gelled hydrocarbon may cause syneresis, which is a phenomenon in which the liquid hydrocarbon separates from the polymer. When syneresis occurs, the liquid floats in the oral ointment, resulting in poor appearance and usability, or causing localization of the formulation components.
Means for Solving the Problems
[0006] The oral ointment for solving the above problems contains a gelling hydrocarbon, polyethylene glycol, a surfactant, and an unsaturated fatty acid. In the oral ointment described above, it is preferable that the content of the unsaturated fatty acid is 0.1% by mass or more and 10% by mass or less.
[0007] In the above oral ointment, it is preferable that the average molecular weight of polyethylene glycol is 1500 or less. In the oral ointment described above, it is preferable that the surfactant is a nonionic surfactant.
[0008] In the oral ointment described above, it is preferable that the unsaturated fatty acid is oleic acid. [Effects of the Invention]
[0009] According to the present invention, it is possible to suppress the syneresis of liquid hydrocarbons in gelled hydrocarbons in oral ointments. [Brief explanation of the drawing]
[0010] [Figure 1] This is a perspective view of a container filled with oral ointment for evaluation of its synergistic properties. [Figure 2] This is a cross-sectional view of a container filled with oral ointment for evaluation of its synergistic properties. [Figure 3] This graph shows the weight of the excipient hydrocarbons. [Modes for carrying out the invention]
[0011] Embodiments of the oral ointment according to the present invention will be described. The oral ointment of this embodiment contains a gelling hydrocarbon, polyethylene glycol, a surfactant, and an unsaturated fatty acid.
[0012] By containing the above-mentioned components, the oral ointment can suppress the syneresis of liquid hydrocarbons in gelled hydrocarbons. The following describes the individual components that make up the oral ointment.
[0013] <Gelled hydrocarbons> Gelated hydrocarbons are hydrocarbons that have been gelled and are used as oil-based substrates. Specific examples of hydrocarbons include liquid paraffin, paraffin, isoparaffin, squalane, squalene, and polybutene. Gelated hydrocarbons are obtained by gelling the above hydrocarbons with polyethylene resin or the like to make them semi-solid. In this invention, commercially available gelated hydrocarbons, such as Hycol Gel (trade name) manufactured by Kaneda Corporation and Plastibase (registered trademark) manufactured by Contract Pharmaceutical Limited Canada, can be used.
[0014] By using an oil-based ointment with gelling hydrocarbons as the main ingredient in the oral ointment, the formulation itself can be prevented from dissolving in saliva, allowing it to remain on the affected area for a longer period of time. The content of gelling hydrocarbons in oral ointment is not particularly limited, but is preferably about 30 to 90% by mass. The upper or lower limits of this range may be, for example, 32, 34, 36, 38, 40, 42, 44, 46, 48, 50, 52, 54, 56, 58, 60, 62, 64, 66, 68, 70, 72, 74, 76, 78, 80, 82, 84, 86, or 88% by mass. For example, the range may be 40 to 60% by mass.
[0015] <Polyethylene glycol> The polyethylene glycol is not particularly limited, and any known polyethylene glycol can be used. Preferably, the polyethylene glycol is liquid at 40°C, and has an average molecular weight of approximately 200 to 1500. The upper or lower limits of this range may be, for example, 300, 400, 500, 600, 700, 800, 900, 1000, 1100, 1200, 1300, or 1400. For example, the range may be 300 to 600.
[0016] By containing polyethylene glycol and the surfactant described below, the dispersibility of compounding components such as active ingredients in the gelling hydrocarbon, which is the main ingredient of the oral ointment, can be improved. Further, when the average molecular weight of polyethylene glycol is 1500 or less, it becomes easier to improve the dispersibility of compounding components such as active ingredients in the gelling hydrocarbon in the oral ointment.
[0017] The content of polyethylene glycol in the oral ointment is not particularly limited, but it is preferably contained in an amount of about 1 to 20% by mass. The upper or lower limit of this range may be, for example, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, or 19% by mass. For example, this range may be 2 to 8% by mass. <0000Specific examples of nonionic surfactants include, for example, sugar fatty acid esters such as sucrose fatty acid ester and maltose fatty acid ester, sugar alcohol fatty acid esters such as maltitol fatty acid ester, sorbitan fatty acid esters such as sorbitan monolaurate and sorbitan sesquioleate, polyoxyethylene sorbitan fatty acid esters such as polyoxyethylene sorbitan monolaurate and polyoxyethylene sorbitan monostearate, fatty acid alkanolamides such as lauric acid diethanolamide, polyoxyethylene alkyl ethers such as polyoxyethylene stearyl ether and polyoxyethylene oleyl ether, polyethylene glycol fatty acid esters such as polyethylene glycol monooleate and polyethylene glycol monolaurate, alkyl glycosides such as lauryl glycoside and decyl glycoside, polyglycerol fatty acid esters, polyoxyethylene glycerol fatty acid esters, polyoxyethylene fatty acid esters, alkyl glucosides, polyoxyethylene hydrogenated castor oil (preferably those having an average addition mole number of ethylene oxide of 10, 20, 40, 60), glycerin fatty acid esters, polyoxyethylene propylene block copolymers and the like.
[0020] (Anionic surfactant) Specific examples of anionic surfactants include, for example, sulfate esters such as sodium lauryl sulfate and sodium polyoxyethylene lauryl ether sulfate, polyoxyethylene alkyl ether phosphates·phosphates, sodium polyoxyethylene cetyl ether phosphate, sulfosuccinates such as sodium lauryl sulfosuccinate and sodium polyoxyethylene lauryl ether sulfosuccinate, acyl amino acid salts such as sodium cocoyl sarcosinate and sodium lauroyl methyl alanine, sodium cocoyl methyl taurine and the like.
[0021] (Cationic surfactant) Specific examples of cationic surfactants include quaternary alkylammonium salts such as cetyltrimethylammonium chloride, cetylpyridinium chloride, distearyldimethylammonium chloride, stearyldimethylbenzylammonium chloride, and stearyltrimethylammonium chloride, as well as chlorhexidine gluconate.
[0022] (Amphoteric surfactant) Specific examples of amphoteric surfactants include amino acid-type amphoteric surfactants such as N-lauryldiaminoethylglycine and N-myristyldiethylglycine, and betaine-based amphoteric surfactants such as alkyldimethylaminoacetic acid betaine, N-alkyl-N'-carboxymethyl-N'-hydroxyethylethylenediamine salt, and 2-alkyl-N-carboxymethyl-N-hydroxyethylimidazolinium betaine.
[0023] The above surfactants may be used individually or in combination of two or more. Among the above surfactants, it is preferable to include a nonionic surfactant. Including a nonionic surfactant makes it easier to improve the dispersibility of polyethylene glycol in oral ointment.
[0024] Among the surfactants mentioned above, those with an HLB value of 3 to 15, which represents the degree of affinity between water and oil, are preferred, those with an HLB value of 3 to 13 are more preferred, and those with an HLB value of 4 to 11 are even more preferred.
[0025] Examples of surfactants with HLB values within the above range include sorbitan sesquioleate (HLB: 4.0), PEG-20 hydrogenated castor oil (HLB: 10.5), PEG-40 hydrogenated castor oil (HLB: 12.5), PEG-60 hydrogenated castor oil (HLB: 14.0), and sodium polyoxyethylene cetyl ether phosphate (HLB: 10.0).
[0026] The amount of surfactant in the oral ointment is not particularly limited, but is preferably about 0.1 to 10% by mass. The upper or lower limits of this range may be, for example, 0.4, 0.7, 1.0, 1.3, 1.6, 1.9, 2.2, 2.5, 2.8, 3.1, 3.4, 3.7, 4.0, 4.3, 4.6, 4.9, 5.2, 5.5, 5.8, 6.1, 6.4, 6.7, 7.0, 7.3, 7.6, 7.9, 8.2, 8.5, 8.8, 9.1, 9.4, or 9.7% by mass. For example, the range may be 0.4 to 2.5% by mass.
[0027] <Unsaturated fatty acids> The unsaturated fatty acid is not particularly limited, and any known unsaturated fatty acid can be used. By containing an unsaturated fatty acid, the oral ointment can suppress the synplasmization of liquid hydrocarbons in the gelled hydrocarbon.
[0028] Unsaturated fatty acids may be linear or branched. They may also be monounsaturated or polyunsaturated fatty acids. The unsaturated fatty acid is preferably a higher fatty acid with 12 to 18 carbon atoms, more preferably 14 to 18 carbon atoms, and even more preferably 18 carbon atoms.
[0029] Specific examples of unsaturated fatty acids include myristoleic acid, palmitoleic acid, oleic acid, vaccenic acid, eicosenoic acid, linoleic acid, alpha-linolenic acid, gamma-linolenic acid, arachidonic acid, fumaric acid, maleic acid, and aconitic acid.
[0030] The above unsaturated fatty acids may be used individually or in combination of two or more. Among these, oleic acid, which has 18 carbon atoms, is preferred. By including oleic acid, the syneresis of liquid hydrocarbons can be more effectively suppressed.
[0031] The content of unsaturated fatty acids in oral ointment is not particularly limited, but is preferably around 0.1 to 15% by mass. The upper or lower limits of this range are, for example, 0.3, 0.5, 0.7, 0.9, 1.1, 1.3, 1.5, 1.7, 1.9, 2.1, 2.3, 2.5, 2.7, 2.9, 3.1, 3.3, 3.5, 3.7, 3.9, 4.1, 4.3, 4.5, 4.7, 4.9, 5.1, 5.3, 5.5, 5.7, 5.9, 6.1, 6.3, 6.5, 6.7, 6.9, 7.1, 7.3, 7.5, 7.7, 7.9 , 8.1, 8.3, 8.5, 8.7, 8.9, 9.1, 9.3, 9.5, 9.7, 9.9, 10.1, 10.3, 10.5, 10.7, 10.9, 11.1, 11.3, 11.5, 11.7, 11.9, 12.1, 12.3, 12.5, 12.7, 12.9, 13.1, 13.3, 13.5, 13.7, 13.9, 14.1, 14.3, 14.5, or 14.7 by mass%. For example, the range may be 0.9 to 3.1 by mass%.
[0032] By keeping the content of unsaturated fatty acids in the oral ointment within the above numerical range, the syneresis of liquid hydrocarbons in gelled hydrocarbons can be effectively suppressed. <Hydroxypropyl methylcellulose> Oral ointments preferably contain hydroxypropyl methylcellulose.
[0033] Hydroxypropyl methylcellulose is a cellulose ether obtained by introducing a hydroxypropyl group into methylcellulose, and is used as a water-soluble thickener. In this invention, commercially available products, such as METOLOSE® manufactured by Shin-Etsu Chemical Co., Ltd., can be used as hydroxypropyl methylcellulose.
[0034] When an oral ointment contains hydroxypropyl methylcellulose, a water-soluble thickening agent, it can react with saliva to form a gel-like film. This gel-like film allows the oral ointment to adhere to the oral mucosa and gingival tissue.
[0035] The type of hydroxypropyl methylcellulose is not particularly limited. Preferably, the viscosity of the hydroxypropyl methylcellulose in a 2% aqueous solution at 20°C is 50 mPa·s or more and 20,000 mPa·s or less. The viscosity of the 2% aqueous solution at 20°C is not particularly limited, but is preferably around 100 to 10,000 mPa·s. The upper or lower limits of this range may be, for example, 500, 1000, 1500, 2000, 2500, 3000, 3500, 4000, 4500, 5000, 5500, 6000, 6500, 7000, 7500, 8000, 8500, 9000, or 9500 mPa·s. For example, the range may be 2000 to 6000 mPa·s. When the viscosity of the hydroxypropyl methylcellulose is within the above numerical range, a gel-like film can be selectively formed on the surface of the oral ointment.
[0036] The viscosity of a 2% aqueous solution at 20°C is measured by the following method. (i) Method 1: Applicable to hydroxypropyl methylcellulose with a stated viscosity of less than 600 mPa·s. Accurately weigh an amount corresponding to 4.0 g of dried hydroxypropyl methylcellulose into a wide-mouthed bottle, add hot water (90-99°C) to make 200.0 g, cover the container, and stir with a stirrer at 350-450 revolutions per minute for 10-20 minutes until a uniform dispersion is obtained. If necessary, scrape off any sample adhering to the container walls, add it to the dispersion, and dissolve it in a water bath below 10°C while stirring for 20-40 minutes. If necessary, add cold water to make 200.0 g, and remove any bubbles in or on the surface of the solution by centrifugation to obtain the sample solution. Measure the viscosity of the sample solution at 20 ± 0.1°C.
[0037] (ii) Method 2: Applicable to hydroxypropyl methylcellulose with a stated viscosity of 600 mPa·s or higher. Accurately weigh an amount corresponding to 10.0 g of dried hydroxypropyl methylcellulose into a wide-mouthed bottle, add hot water (90-99°C) to make 500.0 g, and then prepare the sample solution by following the same procedure as in Method 1 above. Measure the viscosity of the sample solution at 20 ± 0.1°C.
[0038] Measurement method: A Brookfield viscometer (LV model) is used. For viscosities between 600 mPa·s and 1400 mPa·s, cylinder number 3 is used, with a rotation speed of 60 revolutions / min and a conversion multiplier of 20. For viscosities between 1400 mPa·s and 3500 mPa·s, cylinder number 3 is used, with a rotation speed of 12 revolutions / min and a conversion multiplier of 100. For viscosities between 3500 mPa·s and 9500 mPa·s, cylinder number 4 is used, with a rotation speed of 60 revolutions / min and a conversion multiplier of 100. For viscosities between 9500 mPa·s and 99500 mPa·s, cylinder number 4 is used, with a rotation speed of 6 revolutions / min and a conversion multiplier of 1000. For viscosities of 99500 mPa·s or higher, cylinder number 4 is used, with a rotation speed of 3 revolutions / min and a conversion multiplier of 2000. During measurement, activate the device and let it rotate for 2 minutes, then read the viscometer reading, and let it stop for at least 2 minutes. Repeat the same procedure twice and average the three readings.
[0039] The content of hydroxypropyl methylcellulose in the oral ointment is not particularly limited, but is preferably about 8 to 22% by mass. The upper or lower limit of this range may be, for example, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, or 21% by mass. For example, the range may be 10 to 16% by mass.
[0040] <Crystalline cellulose> Oral ointments preferably contain crystalline cellulose. Crystalline cellulose is obtained by acid hydrolysis or alkali hydrolysis of plant pulp fibers, extracting the crystalline region of cellulose, and then purifying it.
[0041] The content of crystalline cellulose in the oral ointment is not particularly limited, but is preferably about 1 to 10% by mass. The upper or lower limit of this range may be, for example, 2, 3, 4, 5, 6, 7, 8, or 9% by mass. For example, the range may be 2 to 7% by mass.
[0042] Oral ointments are preferably substantially free of sodium polyacrylate. Here, "substantially free" means that it is acceptable for the ointment to contain it at an impurity level.
[0043] Sodium polyacrylate is a superabsorbent polymer, and if included in oral ointments, it may dehydrate the mouth, potentially causing discomfort to the user. <Other ingredients> Oral ointments may contain other ingredients besides those mentioned above, such as active ingredients, fragrances, sweeteners, colorants, stabilizers, etc., depending on the intended use, form, and application. These ingredients may be those known to be used in oral ointments. Each of these ingredients may be used individually or in combination of two or more.
[0044] Specific examples of active ingredients include anti-inflammatory drugs, steroids, disinfectants, antibacterial agents, hemostatic agents, and blood circulation promoters. Specific examples of anti-inflammatory drugs include allantoin, dipotassium glycyrrhizin, glycyrrhetinic acid, sodium azulene sulfonate hydrate, and ε-aminocaproic acid.
[0045] Anti-inflammatory drugs include non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs are anti-inflammatory drugs that are not derived from glucocorticoids, and are also called NSAIDs. NSAIDs are preferably water-soluble. Water-soluble NSAIDs are also called water-soluble NSAIDs.
[0046] Specific examples of nonsteroidal anti-inflammatory drugs (NSAIDs) include Actarit, acemetacin, ampiroxicam, amfenac, ibuprofen, indomethacin, etodolac, ketoprofen, zaltoprofen, diclofenac, sulindac, celecoxib, tiaprofenic acid, tenoxicam, naproxen, piroxicam, felbinac, pranoprofen, flurbiprofen, mefenamic acid, medicoxib, meloxicam, mofezolac, refecoxib, loxoprofen, lobenzarit, lornoxicam, and their salts. NSAIDs can also be used commercially.
[0047] The content of nonsteroidal anti-inflammatory agents in oral ointments is not particularly limited, but preferably it is about 0.01 to 10% by mass. The upper or lower limits of this range may be, for example, 0.05, 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0, or 9.5% by mass. For example, the range may be 0.05 to 2.0% by mass.
[0048] A specific example of a steroid is triamcinolone acetonide. Specific examples of fungicides include cetylpyridinium chloride hydrate and hinokitiol.
[0049] Specific examples of antibacterial agents include parabens, sodium benzoate, triclosan, chlorhexidine hydrochloride, chlorhexidine gluconate, minocycline hydrochloride, isopropylmethylphenol, benzalkonium chloride, and benzethonium chloride.
[0050] Specific examples of hemostatic agents include carbazochrome and tranexamic acid. Specific examples of blood circulation promoters include vitamins. Among the active ingredients listed above, anti-inflammatory drugs such as NSAIDs and steroids are preferred because they exert their effects by penetrating the gingival tissue and oral mucosa. Furthermore, NSAIDs are even more preferred from the standpoint of potency and fewer side effects.
[0051] The fragrance may be natural or synthetic. It may also be a single fragrance or a blended fragrance. Specific examples of fragrances include l-menthol, d-carvone, anethole, eugenol, methyl salicylate, limonene, ocimene, n-decyl alcohol, citronellol, α-terpineol, methyl acetate, citronellyl acetate, methyl eugenol, cineole, linalool, ethyl linalool, thymol, spearmint oil, peppermint oil, lemon oil, orange oil, sage oil, rosemary oil, perilla oil, wintergreen oil, clove oil, eucalyptus oil, pimento oil, d-camphor, d-borneol, fennel oil, cinnamon oil, cinnamaldehyde, peppermint oil, vanillin, and others.
[0052] Specific examples of sweetening components include saccharin, sodium saccharin, sucralose, stevioside, acesulfame potassium, aspartame, xylitol, maltitol, erythritol, cycloheptamylose, sorbitol (also called sorbitol solution), and palatinose (also called reduced palatinose).
[0053] Specific examples of colorants include legally approved pigments such as Green No. 1, Blue No. 1, and Yellow No. 4, as well as titanium dioxide. Specific examples of stabilizers include sodium edetate, sodium thiosulfate, sodium sulfite, calcium lactate, lanolin, triacetin, castor oil, and magnesium sulfate.
[0054] <Application forms and uses of oral ointment> The application forms of oral ointment are not particularly limited and can be used, for example, as a pharmaceutical, quasi-drug, or cosmetic. Examples of uses for oral ointment include oral application agents, gingival anti-inflammatory agents, periodontal disease treatment agents, denture fitting agents, and implant care agents.
[0055] The water content in oral ointments is preferably 3% or less, more preferably 1% or less, even more preferably 0.5% or less, and most preferably substantially water-free. <Mechanism and Effects> The action of the oral ointment of this embodiment will now be explained.
[0056] By containing polyethylene glycol and surfactants in the oral ointment, the dispersibility of the gelling hydrocarbons and active ingredients in the oral ointment can be improved. On the other hand, gelling hydrocarbons typically have a stable gel structure in which linear polymer polyethylene forms a network structure with liquid paraffin molecules in the gaps. Therefore, when liquid components such as polyethylene glycol and surfactants are added, they may displace the liquid paraffin molecules and enter the gaps. As a result, the liquid paraffin may overflow, causing synthesis. The oral ointment of the present invention contains unsaturated fatty acids, which can suppress synthesis of liquid hydrocarbons in gelling hydrocarbons.
[0057] The effects of the oral ointment of this embodiment will be described. (1) The oral ointment contains a gelling hydrocarbon, polyethylene glycol, a surfactant, and an unsaturated fatty acid.
[0058] Therefore, it is possible to improve the dispersibility of active ingredients and other components in the gelled hydrocarbon, which is the main component of oral ointment. In addition, it is possible to suppress the syneresis of liquid hydrocarbons in the gelled hydrocarbon.
[0059] (2) The content of unsaturated fatty acids is 0.1% by mass or more and 10% by mass or less. Therefore, synthesization of liquid hydrocarbons in gelled hydrocarbons can be suitably suppressed. (3) The average molecular weight of polyethylene glycol is 1500 or less. Therefore, it becomes easier to improve the dispersibility of active ingredients and other components in the gelled hydrocarbon, which is the main component of oral ointment.
[0060] (4) The oral ointment contains a nonionic surfactant. Therefore, it is easier to improve the dispersibility of the active ingredients and other components in the gelling hydrocarbon, which is the main component of the oral ointment.
[0061] (5) The unsaturated fatty acid is oleic acid. Therefore, synthesis of liquid hydrocarbons can be more effectively suppressed. [Examples]
[0062] The following are examples to illustrate the structure and effects of the present invention in more detail, but the present invention is not limited to these examples. The oral ointments of Examples 1-3 and Comparative Example 1 shown in Table 1 were prepared by mixing each component according to a conventional method. There are no particular restrictions on the mixing order of the components. In Table 1, the numbers to the right of each component represent the content (mass%) of each component, and the mixtures were formulated to total 100% by mass.
[0063] [Table 1] As shown in Table 1, commercially available gelling hydrocarbons were used. Commercial polyethylene glycol with an average molecular weight of approximately 400 was used. Commercial PEG-60 hydrogenated castor oil was used as the surfactant. Commercial HPMC with a stated viscosity (viscosity of a 2% aqueous solution at 20°C) of 4000 mPa·s was used. Commercial crystalline cellulose was used. Diclofenac sodium, a water-soluble NSAID, was used as the nonsteroidal anti-inflammatory agent.
[0064] (Evaluation test) The weight of the liquid hydrocarbons released from the oral ointments of Examples 1-3 and Comparative Example 1 was evaluated. The evaluation method and results are described below.
[0065] (Method for evaluating syneresis) As shown in Figures 1 and 2, a bottomed cylindrical plastic container 10 with an inner diameter of 43 mm and a depth of 38 mm was prepared. Each container 10 was filled with the oral ointment 20 for each example. A triangular ruler (not shown) was inserted from above into the oral ointment 20 inside the container 10. Specifically, the triangular ruler was inserted so that the 90-degree angle portion was facing downwards, and the two sides on either side of the 90-degree portion were in contact with the upper end 10a of the opening of the container 10. In this state, the triangular ruler was rotated horizontally to partially scrape off the oral ointment 20.
[0066] A conical recess 20a was formed in the oral ointment 20 by partially scraping it with a triangular ruler, with the diameter decreasing towards the bottom of the container 10. The angle α at the tip of the recess 20a was 90 degrees. The container 10 with the recess 20a formed in the oral ointment 20 was left in a 45°C constant temperature chamber for one week, and the weight of the liquid component 30 accumulated at the bottom of the conical recess 20a was measured. Each example was tested three times, and the average value was calculated. The results are shown in Table 1 and Figure 3. In Figure 3, the standard deviations in weight for Examples 1-3 and Comparative Example 1 were 0.0040, 0.0083, 0.0016, and 0.0040, respectively.
[0067] (Evaluation results) Table 1 and Figure 3 show that in Comparative Example 1, the weight of the exfoliated liquid was 0.0323 g, whereas in Examples 1-3, the weight of the exfoliated liquid was 0.01 g or less, confirming that the exfoliation of liquid hydrocarbons was suppressed. In particular, in Example 3, the weight of the exfoliated liquid was 0.005 g or less, indicating that the exfoliation of hydrocarbons was suitably suppressed. Examples 1-3 suggest that suppressing the exfoliation of liquid hydrocarbons improves the appearance of the oral ointment. Furthermore, Examples 1-3 exhibited flexibility suitable for use as an ointment.
[0068] Table 2 shows examples of formulations of the present invention. In Table 2, the values listed to the right of each component represent the content (mass%), and together with the gelling hydrocarbons, they amount to 100 mass%.
[0069] [Table 2] [Explanation of symbols]
[0070] 10...container, 10a...upper end of opening, 20...oral ointment, 20a...recess, 30...liquid component, α...angle.
Claims
1. It contains gelling hydrocarbons, polyethylene glycol, surfactants, and unsaturated fatty acids. The polyethylene glycol has an average molecular weight of 400 or more and 1500 or less. The aforementioned surfactant is characterized by having an HLB value of 4 or more and 14 or less, and being at least one selected from PEG-20 hydrogenated castor oil, PEG-40 hydrogenated castor oil, PEG-60 hydrogenated castor oil, sorbitan sesquioleate, and sodium polyoxyethylene cetyl ether phosphate.
2. The oral ointment according to claim 1, wherein the content of the unsaturated fatty acid is 0.1% by mass or more and 10% by mass or less.
3. The oral ointment according to claim 1 or 2, wherein the surfactant is a nonionic surfactant.
4. The oral ointment according to any one of claims 1 to 3, wherein the unsaturated fatty acid is oleic acid.
Citation Information
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