JP2011173823A - Gel preparation - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a gel preparation, securing the compliance of a patient, and having a texture or physical properties so as not to cause troubles in daily life, more specifically, excellent in use feeling such as the prevention of dripping down, and easier applicability. <P>SOLUTION: This gel preparation is provided by including a water soluble polymer having >5,000 and ≤280,000 mPa s viscosity of its aqueous solution, and setting the blending amount of the water soluble polymer as 0.5 to 5.0 mass% to obtain the gel preparation excellent in the use feeling such as the prevention of dripping down, and easier applicability. <P>COPYRIGHT: (C)2011,JPO&INPIT

Description

  The present invention relates to gel formulations.

In general, as an external preparation to be applied to the skin or the like, for example, liquids, ointments, gels, creams, aerosols, sprays and the like are known.
Among these, the gel (gel preparation) is a gel-like external preparation obtained by adding a gelling agent such as a polymer, but has characteristics such as easy application to the affected area because it is applied directly. Since it inherently has, it can be said that it is excellent in handling and feeling of use compared to other dosage forms. However, when this is used as an external preparation that is forced to be used for a long time or continuously, such as an athlete's foot treatment, further physical properties and characteristics are required to ensure patient compliance and not to interfere with daily life. It is done.

  For example, Patent Document 1 discloses an antifungal composition comprising a benzylamine antibacterial agent mixed with a fatty acid ester, a powder component, an alcohol solvent and an antipruritic component for the purpose of improving the therapeutic effect and suitable usability. Examples of the dosage form include gel preparations such as liquids and aerosols, and the usability can be improved by blending a relatively large amount of powder components (blending amount: 15 to 70% by weight). Is also described. However, in the same document, in these dosage forms, particularly gel preparations, for example, search for a feeling of use and physical properties that ensure patient compliance, such as ease of spreading and prevention of dripping, and do not interfere with daily life, No investigation has been made and no such prior art exists.

JP 2005-104917 A

  Therefore, the object of the present invention is to ensure a patient's compliance and have a feeling of use and physical properties that do not interfere with daily life, more specifically, dripping is prevented and easy to spread. The object is to provide a gel preparation with excellent usability.

  In the course of diligent research to solve the above-mentioned problems, for example, when the viscosity of the gel preparation is relatively high in order to prevent dripping off, the gel preparation is now difficult to spread. Faced a problem. For this reason, it was recognized that the above problems could not be solved unless these problems were solved at the same time, and further research was carried out to explore the means for solving these problems. It has been found that this problem can be solved brilliantly by including a water-soluble polymer having a high viscosity and the blending amount of the water-soluble polymer is in a relatively small range, thereby completing the present invention. It was.

That is, the present invention contains a water-soluble polymer whose aqueous solution has a viscosity of more than 5000 mPa · s and not more than 280000 mPa · s,
The present invention relates to a gel preparation in which the amount of the water-soluble polymer is 0.5 to 5.0% by mass.
In the present invention, the water-soluble polymer is a water-soluble cellulose derivative having a viscosity at 20 ° C. of 7500 to 140000 mPa · s as a 2% by mass aqueous solution, and / or a viscosity at 20 ° C. of 5000 mPa · s as a 0.2% by mass aqueous solution. -It is related with the gel formulation which is a carboxy vinyl polymer which is larger than s and is 29000 mPa * s or less.

Furthermore, this invention relates to the gel formulation whose compounding quantity of a water-soluble cellulose derivative is 0.5-5.0 mass%.
The present invention also relates to a gel preparation containing hydroxypropylmethylcellulose as a water-soluble cellulose derivative.
Furthermore, this invention relates to the gel formulation whose substitution degree of the hydroxypropoxy group of hydroxypropyl methylcellulose is 4 to 32.0%, and substitution degree of a methoxy group is 16.5 to 30.0%.
Moreover, this invention relates to the gel formulation whose compounding quantity of a carboxy vinyl polymer is 0.65-4.8 mass%.

Furthermore, the present invention relates to a gel preparation containing talc.
Moreover, this invention relates to the gel formulation whose compounding quantity of talc is 0.5-6.0 mass%.
Furthermore, the present invention relates to a gel formulation containing a drug that is a pharmaceutically acceptable salt.
The present invention also relates to a gel preparation containing butenafine hydrochloride.
Furthermore, the present invention contains water and an aliphatic alcohol having 1 to 3 carbon atoms,
It is related with the gel formulation whose mass ratio of the compounding quantity of water and an aliphatic alcohol is the range of 4.0: 6.0-6.0: 4.0.
Moreover, this invention relates to the gel formulation whose aliphatic alcohol is ethanol.

  ADVANTAGE OF THE INVENTION According to this invention, the gel formulation excellent in the usability of being able to prevent dripping and being easy to spread can be provided. This is particularly important as an external preparation that requires a long-term or continuous use, such as an athlete's foot treatment, and requires a patient's compliance and a feeling of use and physical properties that do not interfere with daily life. is there. Furthermore, the gel preparation contains a water-soluble cellulose derivative or carboxyvinyl polymer, so that it is possible to prevent the occurrence of a feeling of tension, and the gel preparation contains a drug that is a pharmaceutically acceptable salt (particularly butenafine hydrochloride). Even in such a case, the gel state is preferably maintained. Furthermore, since the gel preparation further contains talc, a smooth feeling is imparted at the time of applying the gel preparation, and the effects of preventing the occurrence of twisting are also exhibited.

The present invention is described in detail below. The gel preparation of the present invention contains a water-soluble polymer.
Hereinafter, each material which comprises the gel formulation of this invention is demonstrated.
The water-soluble polymer functions as a gelling agent for forming a gel in the gel preparation. In the present invention, the water-soluble polymer has an aqueous solution viscosity of more than 5000 mPa · s and 280000 mPa · s or less, and a blending amount in the gel preparation of 0.5 to 5.0 mass%. Thus, by blending relatively little water-soluble polymer with high viscosity (relatively high viscosity), water-soluble polymer with low viscosity (relatively low viscosity) or other gelling agent Compared with the case where it is blended in the usual amount, the ease of spreading the gel preparation (extensibility) can be improved, and preferable properties can be given in preventing dripping of the gel preparation. . Furthermore, by blending a relatively small amount of water-soluble polymer, the solid content contained in the gel preparation is dried when the gel preparation is rubbed on the skin, preventing the phenomenon of lumps (slipping). And drying after application is accelerated.

In the present specification, the viscosity is a value measured at 20 ° C. using a Brookfield viscometer according to the regulations of the Japanese Pharmacopoeia.
Moreover, the compounding amount of the water-soluble polymer in the gel preparation is preferably 0.5 to 4.0% by mass, and more preferably 1.0 to 3.0% by mass.

The water-soluble polymer that can be used in the present invention is not particularly limited as long as it has water-solubility and functions as a gelling agent, but the water-soluble polymer is preferably a water-soluble cellulose derivative. Or a carboxyvinyl polymer or both.
Such a water-soluble polymer can suitably gel the gel preparation even when the drug containing a pharmaceutically acceptable salt (particularly, butenafine hydrochloride) is contained in the gel preparation. Moreover, it is possible to mix | blend various drugs with the gel formulation of this invention so that it may mention later. If the total amount of the drug is large, it is difficult to obtain the required gel flow characteristics (especially spreadability and prevention of dripping) when using a general water-soluble polymer, but when using a water-soluble polymer as described above, As a result of imparting suitable viscosity and thixotropy, it is relatively easy to obtain suitable gel flow properties.

  Further, the water-soluble cellulose derivative and the carboxyvinyl polymer as described above are components that can prevent the “tension” as shown below. In general, when a gel preparation containing a water-soluble polymer is dried to form a film on the skin, the film shrinks in the course of drying, thereby causing an unpleasant “tightness” to the skin. In general, when a water-soluble polymer having a large molecular weight and easily crystallized is used, the polymer constituting the formed film has a high physical strength, and thus gives a stronger “tension”. A water-soluble polymer that is easily crystallized (crystallizable) is generally a polymer that is linear, has high molecular symmetry, and has a polar functional group. On the other hand, since the water-soluble cellulose derivative and the carboxyvinyl polymer described above are polymers having relatively low crystallinity, giving a feeling of tension is suppressed.

  Examples of the water-soluble cellulose derivative include hydroxyethyl cellulose, hydroxypropyl cellulose, methyl cellulose, ethyl cellulose, carboxymethyl cellulose, hydroxypropyl methyl cellulose (hypromellose), and one or a combination of two or more of these can be used. . Among the above-mentioned, it is preferable to use either hydroxypropyl methylcellulose or hydroxypropylcellulose, and it is more preferable to use hydroxypropylmethylcellulose.

Among the above-mentioned, hydroxypropylmethylcellulose (hypromellose) is one in which a hydroxypropoxy group and a methoxy group are partially introduced into the three hydroxyl groups of the unit sugar structure (glucose) of cellulose.
These substituents are introduced irregularly at the hydroxyl group of the unit sugar structure of cellulose. Thus, by introducing two kinds of substituents irregularly / partially, hydroxypropylmethylcellulose has low molecular crystallinity and low crystallinity of the polymer. As a result of suppressing the strength, the feeling of tension when using the gel preparation is reduced.

  Hydroxypropyl methylcellulose preferably has a hydroxypropoxy group substitution degree of 4.0 to 32.0% and a methoxy group substitution degree of 16.5 to 30.0%, more preferably, The degree of substitution of the hydroxypropoxy group is 4.0 to 12.0%, and the degree of substitution of the methoxy group is 22.0 to 30.0%. In this range, suitable gel flow characteristics can be obtained, and when the gel preparation contains a drug, a suitable therapeutic effect of the drug can be obtained.

Moreover, among the above-mentioned, hydroxypropylcellulose introduces a hydroxypropoxy group partially with respect to three hydroxyl groups of a cellulose unit (glucose).
The degree of substitution of hydroxypropoxy groups in hydroxypropylcellulose is preferably 50 to 80%.
The positions where the substituents are introduced are introduced irregularly in the hydroxyl group of the unit sugar structure of cellulose. In this way, by introducing substituents partially or irregularly, the regularity of the molecular structure of hydroxypropyl cellulose is lowered, and as a result, the strength of the film generated from the gel is suppressed, resulting in a feeling of tension when using the gel preparation. Less.
The amount of the water-soluble cellulose derivative is preferably 0.5 to 5.0% by mass, more preferably 0.65 to 2.0% by mass, and still more preferably 1.0 to 1.5% by mass. It is. By having the blending amount within the above-mentioned range, the gel preparation has sufficient thickening and suitable fluidity, is difficult to sag, and the blending amount is sufficiently small to suppress the occurrence of twisting. can do.

The viscosity of a 2% by weight aqueous solution of a water-soluble cellulose derivative at 20 ° C. is preferably 7500 to 140000 mPa · s, more preferably 11250 to 140000 mPa · s, and further preferably 75000 to 140000 mPa · s. .
In the case of hydroxypropylmethylcellulose, since hydroxypropylmethylcellulose is an ether compound, the pH of the 2% by mass aqueous solution is almost neutral (pH 5-8).
In addition, in this specification, pH of a solution etc. is measured by the method as described in the 15th revision Japanese Pharmacopoeia. That is, it is measured by a pH measurement device provided with a detection unit having a glass electrode and a reference electrode.

The carboxyvinyl polymer is a polymer partially crosslinked with polyacrylic acid as the main chain.
Since the carboxyvinyl polymer is crosslinked in the gel state and has a very large molecular weight, the gel can be thickened only by adding a small amount, which is preferable in terms of spreadability, prevention of dripping and twisting. Give properties. Moreover, by having partial bridge | crosslinking, as a result of suppressing the intensity | strength of the membrane | film | coat formed, the feeling of tension at the time of gel formulation use is suppressed.
The carboxyvinyl polymer exhibits higher viscosity by neutralizing the carboxyl group. The preferred pH for the gel formulation of the carboxyvinyl polymer-containing solution is 3.0 to 8.0.

The neutralizing agent added for neutralization is not particularly limited, but aqueous ammonia, sodium hydroxide, or an organic amine such as diisopropanolamine, di (2-ethylhexyl) amine, triethanolamine or triethylamine is used. Is preferred.
The viscosity of the 0.2% by mass aqueous solution (pH 7 to 7.5) at 20 ° C. of the carboxyvinyl polymer is preferably greater than 5000 mPa · s and less than or equal to 29000 mPa · s, more preferably greater than 5000 mPa · s and 28000 mPa · s. · S or less, more preferably greater than 6000 mPa · s and 14000 mPa · s or less.

Moreover, it is preferable that the gel formulation of this invention contains a powder component. The powder component has a function of adjusting the flow characteristics of the gel preparation.
Moreover, such a powder component is a component which can give a dry feeling to the said application | coating site | part after apply | coating a gel formulation to skin etc. This is considered as follows. As described above, when a gel preparation containing a water-soluble polymer is dried to form a film on the skin, the film shrinks in the course of drying, resulting in an unpleasant “tightness” to the skin. Let However, by blending such a powder component into the gel preparation, when the gel spreads, dries, and forms a film, the powder component rubs the film, resulting in the formation of many fragile parts in the film. Therefore, it is assumed that the strength of the film is lowered and the “tension” is extremely reduced.

The powder component is not particularly limited, and examples thereof include talc, silica, titanium oxide, kaolin, hydrous silicon dioxide, soft anhydrous silicic acid, crystalline cellulose, synthetic aluminum silicate, titanium oxide, and corn starch. Among them, one kind or a combination of two or more kinds can be used.
Of the above, talc is preferably used. Talc is natural hydrous magnesium silicate obtained by pulverizing talc Mg ₃ Si ₄ O ₁₀ (OH) ₂ . Talc is classified as a layered silicate mineral, and its crystal structure is sandwiched between two sheets with a repeating unit of SiO ₄ tetrahedron and a sheet of repeating unit of Mg (OH) ₂ octahedron. This sandwich has a structure in which the sandwiches are laminated in layers. Since the mutual bond between the sandwich layers is only van der Waals force, talc has a characteristic that it is easily cleaved and easily broken. And, as shown in Table 1, the Mohs hardness of talc is the smallest among the minerals.

このようなタルクは、上述した粉末成分の中でも、最も優れたさらさら感を付与することのできる粉末である。さらに、粉末成分としてタルクを使用することによってヨレの発生を抑制しつつさらさら感を付与することができる。また、タルクは、上述した粉末成分の中でも、水溶性高分子を有するゲル製剤中に好適に分散可能な成分であり、粉末成分としてタルクを用いた場合、ゲル製剤の製造が容易となる。

Such talc is a powder capable of imparting the most excellent dry feeling among the powder components described above. Further, by using talc as a powder component, it is possible to impart a smooth feeling while suppressing the occurrence of twisting. Talc is a component that can be suitably dispersed in a gel preparation having a water-soluble polymer among the powder components described above. When talc is used as the powder component, the preparation of the gel preparation becomes easy.

The volume-based average particle diameter of talc is preferably in the range of 1 to 30 μm. The talc powder having such a particle size has a smooth feel and is easily adhered to the skin.
The amount of talc is preferably 0.5 to 6.0%, more preferably 1.0 to 3.0% by mass. When the blending amount of talc is in the above range, the blending amount is sufficient so that the influence of stickiness due to the gel preparation can be suppressed and the gel preparation can be easily spread, and the blending amount is not excessive. Therefore, when the gel preparation is applied, the spread of the gel preparation becomes good and the occurrence of roughness can be prevented.

  Moreover, the mass ratio of the blend amount of talc and the water-soluble polymer is preferably 1:10 to 12: 1, more preferably 1: 8 to 12: 1, and still more preferably 1 : 6-6: 1.

The gel preparation usually contains a drug.
The drug that can be used in the gel preparation of the present invention is not particularly limited, but antifungal agents such as butenafine hydrochloride, terbinafine hydrochloride, naphthifine, amorolfine hydrochloride, neticonazole hydrochloride, luliconazole, laniconazole, oxyconazole Nitrate, ketoconazole, miconazole nitrate, thioconazole, bifonazole, clotrimazole, econazole nitrate, itraconazole, fluconazole, etc., anti-inflammatory analgesics (anti-inflammatory drugs) such as indomethacin, ketoprofen, felbinac, flurbiprofen, diclofenac sodium, loxoprofen, Ibuprofen, ibuprofen piconol, guaiazulene, allantoin, glycyrrhizic acid, glycyrrhetinic acid, salicylic acid, methyl salicylate Antihistamines such as ethylene glycol monosalicylate, for example, mediator release inhibitors (tranilast, cromoglycate sodium), histamine H1 receptor antagonists (oxatomide, mequitazine, emedastine, ebastine, loratadine, cetirizine, desloratidine, fezophenazine, astemizole, Azelastine, chlorpheniramine, diphenhydramine, ketotifen), histamine H2 receptor antagonist (cimetidine, ranitidine, famotidine, nizatidine), histamine H3 receptor antagonist (thioperamide, impromidine, mifetidine, impentamine, clozapine), histamine H4 receptor antagonist, etc. , Essential oil ingredients such as l-menthol, camphor, borneol, eugeno , Eucalyptus oil, thin oil, clove oil, cinnamon oil, tea tree oil, etc., bactericides such as isopropylmethylphenol, chlorhexidine gluconate, acrinol, benzalkonium hydrochloride, local anesthetics such as dibucaine hydrochloride , Lidocaine hydrochloride, procaine hydrochloride, tetracaine hydrochloride, bupivacaine hydrochloride, propitocaine hydrochloride, oxybuprocaine hydrochloride, mepivacaine hydrochloride, oxesazein, etc. Blood circulation promoters such as capsicum extract components, capsaicin, nonylic acid vanillylamide, etc., steroid hormones such as dexamethasone valerate, dexamethasone valerate, dexamethasone propionate, prednisolone acetate, valerate acetate Rednisolone, prednisolone, hydrocortisone butyrate propionate, hydrocortisone acetate, hydrocortisone butyrate, cortisone acetate, clobetasone butyrate, triamcinolone acetonide, diflucortron valerate, diflupredonate, diflorazone acetate, betamethasone dipropionate, amsinonide, bucinidon These include pharmaceutically acceptable salts such as acid alclomethasone (and other salts when the drug is a salt), and the free products of these salts, of which one or more of these are combined Can be used.

Among the above, when a drug (especially butenafine hydrochloride) which is a pharmaceutically acceptable salt is contained, gelation is generally difficult at the time of preparing a gel preparation, and a relatively large amount of gelling agent is required. . However, even when such a pharmaceutically acceptable salt drug is blended, relatively little gelation occurs when the water-soluble cellulose derivative or carboxyvinyl polymer as described above is used as a gelling agent. Gelation is possible with the compounding amount of the agent, and as a result, the flow characteristics of the gel preparation are excellent, and drying after application of the gel preparation is quick.
The compounding amount of the drug in the gel preparation of the present invention can be set to an amount capable of obtaining a suitable therapeutic effect depending on the drug used. For example, when the antifungal butenafine hydrochloride is used as a drug in the gel preparation, the blending amount that provides a suitable therapeutic effect is 0.5 to 3% by mass.

In the gel preparation of the present invention, at least one of the above-mentioned drugs can be used as a main drug, the other drugs can be used as an auxiliary drug, and a plurality of the above-mentioned drugs can be combined and blended.
For example, in a gel preparation, when combining butenafine hydrochloride as the main agent, the combination of the main agent and the active agent is preferably a combination of butenafine hydrochloride, dibucaine hydrochloride, chlorpheniramine maleate, glycyrrhetinic acid, and l-menthol. is there. More specifically, in the gel preparation, butenafine hydrochloride 0.5-2% by mass, dibucaine hydrochloride 0.1-0.5% by mass, chlorpheniramine maleate 0.2-1% by mass, glycyrrhetinic acid 0.1 A favorable therapeutic effect can be expected by using a combination of ˜0.5 mass% and l-menthol of 0.5 to 3%.

The gel preparation of the present invention contains a liquid medium, and a gel is formed by the liquid medium and the water-soluble polymer described above.
The liquid medium is not particularly limited, and water and an aliphatic alcohol having 1 to 3 carbon atoms can be used in combination.
The amount of water, that is, purified water, is preferably 30 to 60% by mass. When the blending amount is small, it is difficult to spread the gel preparation, but in the above range, suitable gel flow characteristics can be obtained.

Examples of the aliphatic alcohol having 1 to 3 carbon atoms include ethanol and isopropyl alcohol, and one or more of these can be used in combination. Among the above-mentioned, it is preferable to use ethanol.
The mass ratio of the amount of water and the aliphatic alcohol having 1 to 3 carbon atoms is preferably in the range of 4.0: 6.0 to 6.0: 4.0, more preferably 4 0.0: 6.0 to 5.0: 5.0. By setting the mass ratio of the blending amounts in such a range, the gel preparation has suitable flow characteristics, little stickiness, and quick drying.
In the gel preparation of the present invention, the amount of gel applied and the number of applications can be appropriately set according to the type and amount of the compounding components. In particular, when butenafine hydrochloride is contained as a drug, the gel preparation of the present invention can be applied to the affected skin 1 to 3 times per day because the drug can be reliably applied to the skin.

The gel preparation of the present invention is produced by mixing the above materials, for example, drug, talc, water-soluble polymer, water, aliphatic alcohol and the like into a uniform gel.
The prepared gel preparation is filled and packaged in a tube, a plastic container, a glass container or the like.

  The present invention will be described more specifically with reference to the following examples. However, the present invention is not limited to these examples, and various modifications can be made without departing from the technical idea of the present invention. is there.

Example 1
Hydroxypropyl methylcellulose (METOLOSE SR, 90SH-100000SR, manufactured by Shin-Etsu Chemical Co., Ltd.): 1.31% by mass, talc (volume-based average particle size: 10 μm, manufactured by Matsumura Sangyo Co., Ltd.): 1% by mass, purified water: 43.79% by mass %, Ethanol: 50% by mass, butenafine hydrochloride as the active ingredient: 1% by mass, and dibucaine hydrochloride as the active ingredient: 0.2% by mass, chlorpheniramine maleate: 0.5% by mass, glycyrrhetinic acid: 0.2% by mass , L-menthol: 2% by mass was mixed to form a uniform gel, thereby producing a gel preparation.
The viscosity of the 2% by mass aqueous solution of hydroxypropylmethylcellulose at 20 ° C. is 100000 mPa · s, the substitution degree of methoxy group is 22.0 to 24.0%, and the substitution degree of hydroxypropoxy group is 8.0 to 8.0. It was 12.0%.

(Examples 2 to 12)
As shown in Tables 2 and 3, gel formulations were produced in the same manner as in Example 1 except that the type and composition of each material of the gel formulation were changed.
The composition of the gel formulation of each example is shown in Table 2 and Table 3. In the table, Carbopol ETD 2050 (manufactured by Lubrizol Advanced Materials) was used as the carboxyvinyl polymer. The viscosity at 20 ° C. of a 0.2% by mass aqueous solution (pH 7.2) of this carboxyvinyl polymer was 9680 mPa · s. In the table, all numerical values other than the mass ratio of purified water: ethanol indicate the blending amount (% by mass).

[Evaluation 1]
Ten panelists applied the gel formulation of each example to 100 mg skin so that the diameter was 60 mm, and performed a sensory test evaluation while relatively comparing the properties of each gel formulation. Adopted more answers about.
1. Ease of spreading ○: Easy to spread during application.
X: Difficult to spread during application.
2. Dripping ○: No dripping occurs during application.
X: Dripping occurs during application.
3. Drying speed: Dry within 3 minutes after application.
X: It does not dry within 3 minutes after application.
4). Yole ○: After application, the solid content contained in the gel preparation dries at the time of rubbing, and no solid lump is formed.
X: When applied, the solid content contained in the gel preparation dries when it is rubbed, and a platy lump is formed.
5. Smooth feeling ○: It has a suitable smooth feeling after application.
X: After application, a smooth feeling is not felt, and a rough feeling or a sticky feeling is felt.
6). White residue ○: It can be visually recognized that the coated part is white after coating and drying.
X: After application | coating and drying, it cannot visually recognize that the application part is white.
Table 4 shows the results. In the table, “−” means that the number of persons who evaluated “good” and “good” was the same.

  As shown in Table 4, the gel preparations of Examples 1 to 12 were easy to spread, the dripping was suitably prevented, and the speed of drying was excellent. Moreover, in addition to the gel preparations of Examples 1 to 7 containing talc, the twist was suppressed, the feeling of smoothness was excellent, and the white residue was prevented.

(Examples 13 to 19)
A gel preparation was produced in the same manner as in Example 1 except that the powder material shown in Table 5 was used instead of talc.

[Evaluation 2]
Using the gel preparations of Examples 1 and 13 to 19 and evaluating the dispersibility of the powder component in the gel preparations (◯: good dispersion state, x: not well dispersed, powder agglomerates) and evaluation 1 As with, smooth feeling (○: has a suitable smooth feeling, ×: feels no smooth feeling, feels rough or sticky, etc.), twist (○: no twist, x: there is a twist) Was evaluated.

  As shown in Table 5, the gel preparation of Example 1 in which talc was blended as a powder component can suppress the occurrence of twisting as compared with the gel preparations of Examples 13 to 19 in which powder components other than talc were blended. Met.

  According to the present invention, a gel preparation which is prevented from dripping and has an excellent feeling of use such as being easy to spread, and thus has a feeling of use and physical properties which guarantees patient compliance and does not interfere with daily life. It is extremely useful in industry.

Claims (12)

A water-soluble polymer having a viscosity of an aqueous solution greater than 5000 mPa · s and less than or equal to 280000 mPa · s;
Gel formulation whose compounding quantity of water-soluble polymer is 0.5-5.0 mass%.   The water-soluble polymer is a water-soluble cellulose derivative having a viscosity at 20 ° C. of 7500 to 140000 mPa · s as a 2% by mass aqueous solution and / or a viscosity at 20 ° C. of greater than 5000 mPa · s as a 0.2% by mass aqueous solution of 29000 mPa · s. The gel preparation according to claim 1, wherein the gel preparation is a carboxyvinyl polymer having s or less.   The gel formulation of Claim 2 whose compounding quantity of a water-soluble cellulose derivative is 0.5-5.0 mass%.   The gel preparation according to claim 2 or 3, wherein the water-soluble cellulose derivative contains hydroxypropylmethylcellulose.   The gel preparation according to claim 4, wherein the hydroxypropoxy group substitution degree of hydroxypropylmethylcellulose is 4 to 32.0% and the substitution degree of methoxy group is 16.5 to 30.0%.   The gel formulation in any one of Claims 2-5 whose compounding quantity of a carboxy vinyl polymer is 0.65-4.8 mass%.   The gel formulation in any one of Claims 1-6 containing a talc.   The gel formulation according to claim 7, wherein the amount of talc is 0.5 to 6.0% by mass.   The gel preparation according to any one of claims 1 to 8, further comprising a drug that is a pharmaceutically acceptable salt.   The gel formulation in any one of Claims 1-9 containing butenafine hydrochloride. Containing water and an aliphatic alcohol having 1 to 3 carbon atoms,
The gel formulation in any one of Claims 1-10 whose mass ratio of the compounding quantity of water and an aliphatic alcohol is the range of 4.0: 6.0-6.0: 4.0.   The gel preparation according to claim 11, wherein the aliphatic alcohol is ethanol.