JP2005247705A - Liquid preparation for dermatophytosis treatment spraying use and dermatophytosis treatment spraying preparation comprising the same - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a dermatophytosis treatment spraying preparation enabling a dermatophytosis treating agent to be exactly sprayed on affected parts, highly effective in dermatophytosis treatment and capable of enhancing patient compliance. <P>SOLUTION: A liquid preparation for dermatophytosis treatment spraying use is provided, being characterized by yielding a 20-80 mm pattern diameter when sprayed at wide angles, and yielding a 2-10 mm pattern diameter when sprayed at narrow angles. The dermatophytosis treatment spraying preparation comprising this liquid preparation is also provided. <P>COPYRIGHT: (C)2005,JPO&NCIPI

Description

  The present invention relates to an athlete's foot treatment spray solution, particularly to an athlete's foot treatment spray solution sprayed in a spray pattern suitable for athlete's foot treatment, and an athlete's foot treatment spray containing the solution.

The athlete's foot treatment is usually used in the form of a coating agent such as a lotion, cream or spray (see Patent Document 1).
However, lotions and creams need to be picked up once and applied to the affected area of athlete's foot, which is not necessarily preferable for hygiene purposes.
On the other hand, although such inconvenience does not occur in the spray agent, there is a problem that it is difficult to obtain a preferable application state depending on the development site of athlete's foot. For example, athlete's foot is common between the fingers and the heel or the entire sole, but the shape and area of the application surface are completely different between the fingers and the entire sole, so that there is only a single spray pattern. Then, it is difficult to apply a desired amount of a therapeutic agent to a desired area. That is, when applied to a narrow area such as between fingers with a spray pattern for wide-area spraying, an excessive amount is sprayed and dripping occurs, resulting in wasteful consumption of the liquid agent. The spray pattern suitable for the treatment has problems in treatment and patient compliance such as insufficient application to a wide area such as the entire sole.

A possible solution to this problem is to use a spray container that can change the spray pattern. As such a spray container, for example, an ejector described in Patent Document 2 capable of switching the ejection flow between a continuous linear flow and a mist-like diffusion flow can be mentioned.
However, the spray pattern of athlete's foot treatment spray depends greatly on the composition and properties of the liquid agent contained in the spray agent. However, the athlete's foot treatment spray solution can achieve two or more appropriate spray patterns with a single composition. Has never been known before.
JP-A-5-132419 JP 2003-144987 A

  An object of the present invention is to provide an athlete's foot treatment spray capable of accurately spraying an athlete's foot treatment drug on an affected area, enhancing the effect of athlete's foot treatment and enhancing patient compliance.

  The present inventors are diligently studying to achieve the above-mentioned object, and the spray pattern diameter of 20 to 80 mm has a spray pattern diameter of 2 to 10 mm for spraying a drug on a wide part such as a sole or a heel. As a result of further finding out that it is suitable for spraying to a narrow part such as between fingers and that it is possible to significantly enhance patient compliance, the present invention has been completed.

That is, the present invention is an athlete's foot treatment spray solution containing an athlete's foot therapeutic agent, which provides a pattern diameter of 20 to 80 mm when sprayed at a wide angle and 2 to 10 mm when sprayed at a narrow angle. The present invention relates to a liquid preparation for athlete's foot treatment spray that can obtain a pattern diameter.
Moreover, this invention relates to the said liquid preparation for athlete's foot treatment spray which has a viscosity of 6-20 cp.
Furthermore, this invention relates to the said liquid medicine for athlete's foot treatment spray containing 10-50 mass% polyhydric alcohol.
The present invention also relates to the above-mentioned liquid preparation for athlete's foot treatment spray, further containing 10 to 80% by mass of a lower alcohol and / or 10 to 80% by mass of water.
The present invention is further an athlete's foot treatment spray containing the above-mentioned athlete's foot treatment spray solution, wherein the solution can be sprayed in at least two different spray patterns including a wide angle spray pattern and a narrow angle spray pattern. Further, the present invention relates to the athlete's foot treatment spray, wherein the wide-angle spray pattern has a pattern diameter of 20 to 80 mm and the narrow-angle spray pattern has a pattern diameter of 2 to 10 mm.

In this specification, the “spray pattern diameter” means the vertical diameter of the spray pattern on the spray surface multiplied by the diameter in the horizontal direction, and this is obtained from the spray nozzle to the spray surface (measurement site). The value divided by the distance (50 mm unless otherwise specified) is expressed by the following formula.

  The athlete's foot treatment spray of the present invention has the above-described configuration, so that it is a single preparation, but is suitable for sites with different positions and areas, such as between fingers and soles, which are common sites of athlete's foot. It is possible to efficiently apply an appropriate amount of athlete's foot remedy, and because it has a specific range of viscosity, there is no stickiness when applied, and it is difficult to spill liquid. As this increases, patient compliance can be significantly improved. Moreover, since the liquid agent contained in the spray of the present invention can maintain almost the same pattern diameter as long as it is within a predetermined viscosity range, the change in viscosity between lots during production and the liquid agent during storage Application with a stable spray pattern is possible without being affected by changes in viscosity over time or changes in viscosity due to environmental conditions (temperature, etc.) during use.

The athlete's foot therapeutic agent contained in the liquid preparation for athlete's foot treatment spray of the present invention is not particularly limited, but thioconazole, econazole, miconazole, oxyconazole, isconazole, sulconazole, croconazole, ketoconazole, neticoconol, lanconazole, fluconazole, clotrimazole, Itraconazole, Omoconazole, Fenticonazole, Turconazole, Bifonazole, Diethyldithiocarbamic acid, Tolnaphthalate, Tolcyclate, Rilanaphthalate, Terbinafine, Naftifine, Exaramide, Butenafine, Amorolfine, Haloprozine, Cyclopiroxolamine, Guanidinothiazole, T Pyrrolnitrin, undecylenic acid, thianthol, nystatin, tri Selected from one or more compounds selected from the group consisting of lomphenylcaproic acid ester, trimethylcetylammonium pentachlorophenate, sulfur, salicylic acid, gluconic acid, benzalkonium chloride, benzethonium chloride, and salts thereof The In particular, butenafine hydrochloride and terbinafine hydrochloride are preferable because of their high therapeutic effects.
Although the athlete's foot therapeutic agent is not particularly limited, it is preferably blended in a total amount of 0.1 to 5% by mass with respect to the whole solution.
Further, if desired, 1-menthol and menthol derivatives, local anesthetics such as lidocaine, antipruritic agents such as crotamiton and diphenhydramine, anti-inflammatory agents, disinfectants and the like can be further blended as desired.

The viscosity of the liquid preparation of the present invention is preferably 6 to 20 cp, more preferably 6 to 15 cp, and particularly preferably 6.6 to 12 cp. When the viscosity of the liquid agent is 6 cp or more, the spray pattern in the narrow-angle spray can be kept sufficiently narrow, and a decrease in the therapeutic effect due to the liquid agent flowing down from the affected area can be prevented. On the other hand, when the viscosity is 20 cp or less, the spray pattern can be made sufficiently wide, and there is no stickiness and it is preferable in terms of functionality. In the viscosity range of 6 to 20 cp, the change in the spray pattern diameter is small for both wide-angle spray and narrow-angle spray, and stable spray characteristics can be maintained.
Although the adjustment method of a viscosity is not specifically limited, It is preferable to obtain a desired viscosity by mix | blending a polyhydric alcohol with this liquid agent in various ratios so that it may mention later.

The liquid agent of the present invention can further contain one or more polyhydric alcohols. The polyhydric alcohol used in the present invention is not particularly limited, but is preferably selected from the group consisting of 1,3-butylene glycol, propylene glycol, dipropylene glycol and polyethylene glycol, among which polyethylene glycol is particularly preferable.
The polyhydric alcohol is preferably blended at a total concentration of 10% by mass or more, more preferably 10 to 50% by mass with respect to the total liquid. The concentration of the polyhydric alcohol is particularly preferably 10 to 40% by mass, and most preferably 20 to 30% by mass.
When the concentration of the polyhydric alcohol is 10% by mass or more, an appropriate viscosity is obtained in the liquid agent, dripping does not easily occur when applied, and the active ingredient can be retained in the affected area for an appropriate period. On the other hand, when the concentration of the polyhydric alcohol is 50% by mass or less, an appropriate spray range can be obtained. In the concentration range of 10 to 50% by mass, the change in the spray pattern diameter is small for both wide-angle spray and narrow-angle spray, and stable spray characteristics can be maintained.

The liquid preparation of the present invention may further contain one or more lower alcohols such as ethanol and isopropyl alcohol. Lower alcohols volatilize at body temperature and take away the surrounding heat, so that when applied to the skin, an appropriate refreshing feeling can be brought about. The blending ratio of the lower alcohol is not particularly limited, but is preferably 10 to 80% by mass in total with respect to the whole liquid agent.
In addition to the above, the liquid preparation of the present invention can contain components such as water, glycerin, fatty acid esters, surfactants and solubilizers. Among these, it is preferable that water is 10-80 mass% with respect to the whole liquid agent.

The athlete's foot treatment spray of the present invention comprises at least the above-mentioned athlete's foot treatment spray solution and a spray container containing it.
As the spray container, one made of a resin such as polyethylene, polypropylene, polyethylene terephthalate, polystyrene or a metal such as aluminum can be preferably used. There is no limitation.
The spray container used in the present invention has at least two types of spray patterns including a wide-angle spray pattern and a narrow-angle spray pattern. Here, the wide-angle spray means that the spray angle of the liquid agent is 30 ° or more, and the narrow-angle spray means that the spray angle of the liquid agent is 25 ° or less.

  An example of such a spray container is, for example, a spray container that injects contents to the outside by pressing an operation button, and the operation button rotates on a member provided with a plurality of spray positions that provide different spray patterns. Although it can be freely attached and a predetermined spray pattern can be obtained when the operation button is rotated to a predetermined spray position (see Patent Document 2), it is not limited to this. . The spray pattern changing method is not particularly limited. For example, a finite number of spray patterns are set in advance, and a desired spray pattern can be selected from these patterns at the time of use. It is possible to adopt a method of continuously changing to the size of. The driving force for spraying the liquid agent is not particularly limited, and it is possible to use the increase in the internal pressure of the spray container generated when the operation button is pushed with a finger or the pressure of the propellant filled in the spray container. The former is preferable in consideration of use.

Of the spray pattern diameter of the spray agent of the present invention, the wide-angle spray pattern diameter is preferably 20 to 80 mm, and more preferably 30 to 75 mm. The most preferable wide-angle pattern diameter is 50 mm. Moreover, 2-10 mm is preferable and, as for a narrow angle spray pattern diameter, 3-9 mm is more preferable. The most preferable narrow angle pattern diameter is 6 to 8 mm.
In wide-angle spraying, spraying is performed on the affected area over a large area such as the soles of the feet and heels. Therefore, if the spray pattern diameter is 20 mm or more, the liquid agent can be applied over a sufficiently wide range and is easy to use. Further, when the spray pattern diameter is 80 mm or less, the spray range is moderately restricted, and the scattering of the liquid agent to the part other than the affected part and the air is suppressed, thereby enabling efficient application. Therefore, the thing of the spray pattern diameter which can be sprayed in the circular range 30-60 mm in diameter from the distance of 5-10 cm from an affected part is especially preferable.
On the other hand, in narrow-angle spraying, the sprayed area is sprayed in a narrow area such as between fingers. Therefore, if the spray pattern diameter is set to 10 mm or less, the spraying area can be sufficiently narrowed. Further, when the spray pattern diameter is 2 mm or more, it is easy to use because it is possible to prevent linear spraying that tends to cause dripping. Therefore, the thing of the spray pattern diameter which can be sprayed in the circular range about 10 mm in diameter from the distance of 3-5 cm from an affected part is especially preferable.

  The spray amount of the spray of the present invention is preferably 30 to 90 mg, more preferably 40 to 50 mg in the case of wide angle spray. In the case of narrow-angle spraying, 5 to 25 mg is preferable, and 10 to 20 mg is more preferable. That is, in wide-angle spraying, when spraying from a distance of 5 to 10 cm from the affected area to a circular range with a diameter of 30 to 60 mm, the liquid agent can be sufficiently applied when the spraying amount is set to 30 mg or more. When the amount is 90 mg or less, dripping hardly occurs. On the other hand, in narrow-angle spraying, when spraying from a distance of 3 to 5 cm from the affected area to a circular range with a diameter of about 10 mm, the liquid can be applied sufficiently when the spray amount is 5 mg or more. When the amount is 25 mg or less, dripping hardly occurs.

[Examples 1 to 4]
Each component shown in Table 1 was mixed at a corresponding predetermined blending ratio (mass%) to obtain a liquid preparation for athlete's foot treatment spray. Next, when sprayed with a solution having a viscosity of 10 cp, the liquid preparation for athlete's foot treatment spray obtained above was injected into a spray container having a wide-angle spray pattern diameter of 60 mm and a narrow-angle spray pattern diameter of 5 to 6 mm. 1-4 sprays were obtained.

[Comparative Examples 1 and 2]
In the same manner as in Examples 1 to 4, the components shown in Table 1 were mixed at the corresponding predetermined blending ratios to obtain athlete's foot treatment spray solutions. Subsequently, each obtained liquid agent was each injected | thrown-in to the spray container which has the same characteristic as the above, and each spray agent of the comparative examples 1 and 2 was obtained.

[Experimental Example 1]
The viscosity of each spray solution used in the sprays of Examples 1 to 4 and Comparative Examples 1 and 2 was measured at 25 ° C. with a B-type viscometer (rotor No. 1, 5 rpm). Moreover, the spray agents of Examples 1 to 4 and Comparative Examples 1 and 2 were actually sprayed, and the wide-angle spray pattern diameter and the narrow-angle spray pattern diameter at a distance of 50 mm from the spray nozzle were measured. Further, 10 subjects were sprayed with each of the above sprays from a distance of 3 to 5 cm with a narrow angle spray between the fingers, and with a wide angle spray on the heel from a distance of 5 to 10 cm, respectively. The spray state of the liquid agent was observed. The results are shown in Tables 1-3.
[Experiment 2]
A spray agent was prepared in the same manner as in Example 1 except that the blending amount of polyethylene glycol was changed to 0, 10, 20, 30, 40, 50, and 60. The narrow-angle spray pattern diameter and the wide-angle spray pattern diameter were measured. The results are shown in FIGS.

As is clear from the results in Tables 1 to 3, the spray of the present invention can appropriately spray the liquid on both the fingers and the heel, which are completely different in shape and size.
On the other hand, from FIGS. 1 and 2, when the blending amount of the polyhydric alcohol is 10 to 50% by mass and the viscosity of the liquid agent is in the range of 6 to 14 cp, the narrow angle pattern diameter and the wide angle pattern diameter with respect to these two parameters are shown. It can be seen that the change is very small.

It is the graph which showed the compounding quantity of polyhydric alcohol, the viscosity, and the narrow angle pattern diameter (Experimental example 2). It is the graph which showed the compounding quantity of polyhydric alcohol, the viscosity, and the relationship of the wide angle pattern diameter (Experimental example 2).

Claims (5)

  A liquid preparation for athlete's foot treatment spray containing a therapeutic agent for athlete's foot, wherein a pattern diameter of 20 to 80 mm is obtained when sprayed at a wide angle, and a pattern diameter of 2 to 10 mm is obtained when sprayed at a narrow angle. Liquid preparation for athlete's foot treatment spray.   The liquid preparation for athlete's foot treatment spray according to claim 1, having a viscosity of 6 to 20 cp.   The liquid preparation for athlete's foot treatment spray according to claim 1, comprising 10 to 50% by mass of a polyhydric alcohol.   The liquid agent for athlete's foot treatment sprays according to any one of claims 1 to 3, further comprising 10 to 80% by mass of a lower alcohol and / or 10 to 80% by mass of water.   An athlete's foot treatment spray comprising the athlete's foot treatment spray solution according to any one of claims 1 to 4, wherein the solution is sprayed in at least two different spray patterns including a wide angle spray pattern and a narrow angle spray pattern. The above-mentioned athlete's foot treatment spray, wherein the wide-angle spray pattern has a pattern diameter of 20 to 80 mm, and the narrow-angle spray pattern has a pattern diameter of 2 to 10 mm.

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