Liquid agent container and applicator

Abstract

To provide a liquid agent container for filling with an efinaconazole liquid agent that provides two contradictory features of maintaining light stability while allowing the contents of the liquid agent to be visible from the outside.SOLUTION: The liquid agent container capable of filling a liquid agent containing 10% efinaconazole is formed from a synthetic resin containing titanium dioxide (IV). The light transmittance at wavelengths of 200 to 360 nm is 0.20% or less. The light transmittance at a wavelength of 700 nm is 0.25% or more. The contents of the liquid agent filled in the liquid container are visible from the outside.SELECTED DRAWING: None

Description

Technical Field

[0001] The present invention relates to a liquid agent container for filling a liquid agent containing efinaconazole. The present invention also relates to an applicator having the liquid agent container.

Background Art

[0002] Efinaconazole is a triazole compound represented by the following formula (I) having antifungal activity:

Chemical formula

[0003] In a liquid agent containing efinaconazole, an increase in efinaconazole-related substances is observed in a photo-stress test. Therefore, if a container (for example, a colorless and transparent glass container) in which the remaining amount of the liquid agent can be easily visually recognized from the outside is used, the decomposition of efinaconazole is promoted. Therefore, it is extremely important to ensure the stability of the preparation against light exposure. Therefore, conventional efinaconazole preparations are filled in white opaque light-shielding containers. However, no detailed knowledge about the photo-stability of efinaconazole has been known so far.

[0004] The treatment of onychomycosis is long-term, and when using a liquid agent containing efinaconazole, the administration period extends over several months or more. It is preferable for the patient to visit the hospital before finishing using the liquid agent. Therefore, the point that the remaining amount of the liquid agent can be visually recognized from the outside is important from the viewpoint of improving the patient's adherence (in other words, medication compliance). However, since the container of the conventional efinaconazole preparation is a white opaque light-shielding container, usually, the content volume of the liquid agent cannot be visually recognized from the outside.

[0005] Efinaconazole is used as a liquid preparation for external application to nails. Therefore, an applicator in which a liquid container capable of filling the drug and a brush member for applying to the nails are integrated is suitable. As such a coated container with a brush, for example, Patent Document 1 discloses an applicator for applying a tinea unguium drug to an affected area. As an example of the liquid container (i.e., the bottle part) constituting the applicator, a liquid container formed of an organic material and capable of holding a liquid drug is disclosed. Examples of the organic material include polyolefins such as polyethylene and polypropylene, and aromatic polyesters such as polyethylene terephthalate and polybutylene terephthalate. However, there is no description of efinaconazole in this document, let alone a disclosure of a liquid container filled with efinaconazole and capable of stably holding it.

[0006] So far, various medical containers have been proposed that can visually recognize the internal volume of the liquid preparation from the outside and prevent the degradation of the active ingredient by light. Patent Document 2 shows an ultraviolet-blocking medical container made of a plastic in which titanium oxide with an average particle size of 10 to 40 mμ is added to a thermoplastic resin in an amount of 0.01 to 1.00% by weight. Patent Document 3 shows a pharmaceutical preparation in a transparent package in which a pharmaceutical preparation containing tranilast or a salt thereof is placed in a transparent package provided with a light-shielding means for blocking light rays having a wavelength of 350 to 450 nm. Patent Document 4 shows a container using a colored transparent resin containing a coloring material in which the transmittance of light having a wavelength of 200 nm to 500 nm is 10% or less and the transmittance of light having a wavelength of 540 nm to 800 nm is 80% or more.

[0007] However, the containers described in Patent Documents 2 to 4 are not applicators for applying a liquid preparation to nails. Also, even in the container described in Patent Document 2, it is considered that the contents deteriorate from the description in the same document. The containers described in Patent Documents 3 and 4 also cannot completely block light rays in the ultraviolet region.

Prior Art Documents

Patent Documents

[0008] Patent Document 1 International Publication No. 2013 / 005434 Patent Document 2 Japanese Patent Application Laid-Open No. 8-98870 Patent Document 3 Japanese Patent Application Laid-Open No. 2014-015467 Patent Document 4 Japanese Patent Application Laid-Open No. 2007-061192 Non-Patent Document

[0009] Non-Patent Document 1 Klenafine (registered trademark) Topical Solution 10% Pharmaceutical Interview Form Revised July 2022 (8th Edition) Summary of the Invention Problems to be Solved by the Invention

[0010] One of the problems to be solved by the present invention is to provide a liquid container for filling a liquid preparation of efinaconazole, which has two contradictory characteristics: maintaining light stability while allowing the internal volume of the liquid preparation to be visually recognized from the outside.

[0011] Another problem to be solved by the present invention is to provide a brush applicator container for filling and applying a liquid preparation of efinaconazole, which has two contradictory characteristics: maintaining light stability while allowing the internal volume of the liquid preparation to be visually recognized from the outside and enabling the application of an appropriate amount of the liquid preparation (in other words, an applicator). Means for Solving the Problems

[0012] In order to solve the above problems, the present inventors have conducted a detailed study on the photo-stability of efina-conazole. As a result, it has been found that efina-conazole is extremely sensitive to light in the ultraviolet region, and yellowing over time and / or an increase in related substances are observed. Also, it has become clear that even if the light transmittance of the container in the ultraviolet region is, for example, about 1%, the decomposition of efina-conazole is promoted. As described above, various containers have been proposed as containers for liquid preparations that can suppress the transmission of light in the ultraviolet region and confirm the remaining amount of the contents. However, none of them are liquid containers or applicators for applying the liquid preparation to the nails. Also, due to the fact that efina-conazole is extremely sensitive to light in the ultraviolet region, it has been impossible to use the conventionally proposed containers as containers for efina-conazole preparations.

[0013] As a result of the study by the present inventors, it has been found that it is possible to realize a container having two contradictory characteristics, namely, maintaining the photo-stability of efina-conazole while being able to visually recognize the liquid preparation from the outside, by precisely controlling the light transmittance of the container with respect to light in both the ultraviolet region and the visible region. Specifically, it has been found that the photo-stability of efina-conazole is maintained by using a container in which the light transmittance of light in the ultraviolet region is controlled in the range of 0% to 0.20%. Also, it has been found that in order to be able to visually recognize the remaining amount of the liquid preparation, the light transmittance of light of a specific wavelength included in the visible region needs to be 0.25% or more.

[0014] Based on the above findings, the present inventors have conducted a more detailed study to find a container suitable for filling a liquid preparation containing efina-conazole.

[0015] As described above, as a container suitable for a tinea unguium treatment agent, a substantially cylindrical container having an opening is provided, and at the opening, an applicator having a columnar brush member formed by bundling synthetic fibers into a column has been proposed (Patent Document 1). The brush member functions as an application member, and the user can penetrate the liquid agent into the brush member by inverting the container and apply the liquid agent to the nail. However, when the container is inverted for use, depending on the usage environment and the design of the container, the liquid agent may be discharged in an excessive amount or the discharge amount may be small. Therefore, smooth application of the liquid agent may be hindered. Therefore, in order to achieve a preferable feeling of use as a coated container with a brush for applying to nails, for example, the material, hardness and / or thickness of the container must be appropriately designed so that an appropriate amount of the liquid agent is quickly discharged from the container under the actual usage conditions. On the other hand, since the thickness of the container also affects the light transmittance, it is difficult to design a container that well balances various problems including light stability and visibility.

[0016] In view of the above, as a result of further studies, the present inventors have found that an excellent container in which various problems such as light stability, visibility, and the feeling of use as a coated container with a brush are comprehensively solved can be obtained.

[0017] As a result of the above studies, according to one embodiment of the present invention, a suitable liquid agent container can be provided as a liquid agent container of an applicator for applying a liquid agent to a nail. Further, according to one embodiment of the present invention, an applicator having a columnar brush member formed by bundling synthetic fibers into a column can be provided at the opening of the liquid agent container. The above-described applicator including the liquid agent container according to one embodiment of the present invention has an excellent feeling of use because it can quickly and appropriately discharge the liquid agent when inverted under actual usage conditions.

[0018] Further, the applicator according to one embodiment of the present invention is characterized in that when 4 mL of an ethanol solution of 10% efinaconazole is filled in the applicator and inverted in an environment of 32 ° C, the number of drops required until dropping stops within 1 minute is 7 to 10 drops.

[0019] As described above, the present inventors examined a liquid preparation container suitable for filling a liquid preparation of efinaiconazole. As a result, they found a container that ensures the photo-stability of the active ingredient of the liquid preparation, allows the remaining amount of the liquid preparation to be visually recognized, and has an extremely good usability, thereby completing the present invention.

[0020] That is, the present invention is as follows. [1] A liquid preparation container capable of being filled with a liquid preparation containing 10% of efinaiconazole, wherein the liquid preparation container is a container formed from a synthetic resin containing titanium(IV) oxide, and the light transmittance at wavelengths of 200 to 360 nm is all 0.20% or less, and the light transmittance at a wavelength of 700 nm is 0.25% or more, and the content volume of the liquid preparation filled in the liquid preparation container is visible from the outside. [2] The liquid preparation container according to [1], wherein the liquid preparation container is a substantially cylindrical polyethylene container having an opening at the upper part, and is a single-layer container in which at least titanium(IV) oxide is uniformly dispersed in polyethylene, and is a non-flexible and rigid container. [3] The liquid preparation container according to [1] or [2], wherein the internal volume of the liquid preparation container is 8 to 12 mL, and the thickness of the side wall of the liquid preparation container is 0.8 to 1.0 mm. [4] The liquid preparation container according to any one of [1] to [3], characterized in that it contains 0.09 to 0.33 parts by weight of titanium(IV) oxide with respect to 100 parts by weight of the synthetic resin. [5] The liquid preparation container according to any one of [1] to [4], characterized in that it contains 0.10 to 0.30 parts by weight of titanium(IV) oxide with respect to 100 parts by weight of the synthetic resin. [6] The liquid preparation container according to any one of [1] to [5], characterized in that it contains 0.18 to 0.22 parts by weight of titanium(IV) oxide with respect to 100 parts by weight of the synthetic resin. [7] The liquid preparation container according to any one of [1] to [6], characterized in that it does not contain any other coloring components other than titanium(IV) oxide. [8] The liquid agent container according to any one of [1] to [6], wherein the light transmittance at wavelengths of 700 to 780 nm is all 0.25% or more. [9] The liquid agent container according to any one of [1] to [8], wherein the light transmittance at wavelengths of 700 to 780 nm is all 0.40% or more.

[10] The liquid agent container according to any one of [1] to [9], wherein the light transmittance at wavelengths of 200 to 360 nm is all 0.10% or less.

[11] The liquid agent container according to any one of [1] to

[10] , which is not packaged with an ultraviolet-absorbing film.

[12] A liquid agent container according to any one of [1] to

[11] , and A columnar brush member formed by bundling synthetic fibers into a columnar shape, An applicator having a bottomed cylindrical holder having a cylindrical body and a bottom between the liquid agent container and the columnar brush member, wherein The bottomed cylindrical holder is liquid-tightly fitted into the opening of the liquid agent container, The bottom of the bottomed cylindrical holder has at least one pore, The columnar brush member is inserted into the cylindrical body of the bottomed cylindrical holder, The liquid agent can pass from the liquid agent container to the columnar brush member through the pores, so that when the liquid agent container is inverted during use, the liquid agent penetrates into the columnar brush member, enabling the liquid agent to be applied to the user's nails. An applicator.

[13] The columnar brush member is formed by bundling synthetic fibers in the range of fiber diameter of 7 to 50 μm in a density range of 0.25 to 0.50, The applicator according to

[12] , wherein the bottomed cylindrical holder has one circular pore with a diameter of 0.9 to 1.3 mm.

[14] When the applicator filled with 4 mL of the liquid agent is inverted in an environment of 32 °C, the number of drops required until dripping stops within 1 minute is 7 to 10 drops. The applicator according to

[12] or

[13] . A method for photostabilizing efinaconazole, comprising the step of filling a liquid preparation container according to any one of

[15] to

[11] or an applicator according to any one of

[12] to

[14] with a liquid preparation containing 10% efinaconazole.

Advantages of the Invention

[0021] By using the liquid preparation container according to one embodiment of the present invention, photodegradation of efinaconazole is suppressed, so that the liquid preparation of efinaconazole can be stored stably for a long time. Moreover, the user can visually recognize the remaining amount of the liquid preparation filled in the liquid preparation container from the outside. Further, an applicator can be configured by installing a columnar brush member formed by bundling synthetic fibers in a columnar shape at the opening of the liquid preparation container having the above characteristics. The applicator can quickly discharge the liquid preparation when inverted under the actual use condition, and the dropping amount is appropriate, so it has a preferable feeling in use.

Brief Description of the Drawings

[0022]

Figure 1

Figure 2

Figure 2A

Figure 2B

Figure 2C

Figure 3

Figure 4

Figure 5

Figure 6

Figure 7

Figure 8

Figure 9

Figure 10

Figure 11

Figure 12

Figure 13

Figure 14

Mode for Carrying Out the Invention

[0023] Hereinafter, each term in this specification will be described. In this specification, when indicating a numerical range using "~", it shall include the numerical values at both ends.

[0024] In this specification, the "ultraviolet region" refers to light with wavelengths from 200 nm to 360 nm, and the "visible region" refers to light with wavelengths from 400 nm to 780 nm.

[0025] <1> Container In this specification, a liquid container may simply be referred to as a "container". Also, a liquid container with a columnar brush member attached may be referred to as a "coated brush container" or an "applicator" as a whole. One embodiment of the present invention is shown in FIGS. 1 and 2. FIG. 1 is a schematic front view showing an example of an applicator provided with a liquid agent container according to one embodiment of the present invention, and FIG. 2 is a schematic cross-sectional view of the applicator shown in FIG. 1 provided with a cap covering a columnar brush member. As shown in FIG. 1, the applicator 100 according to one embodiment of the present invention may be an applicator including a substantially cylindrical liquid agent container 1 capable of being filled with a liquid agent therein, a bottomed cylindrical holder 2, and a columnar brush member 3. Further, as shown in FIG. 2, the applicator 100 may be provided with a detachable cap 4 that covers the brush member 3. FIG. 2A is a schematic cross-sectional view showing the liquid agent container 1 alone. The liquid agent container 1 includes a liquid agent container main body 11 and a liquid agent container neck portion 12. In the illustrated example, the liquid agent container main body 11 has a substantially cylindrical shape, and the upper portion is continuously formed with the liquid agent container neck portion 12 by a curved surface. The liquid agent container neck portion 12 has an opening 14 through which the columnar brush member 3 is installed via the bottomed cylindrical holder 2 (see FIG. 2). A screw thread 15 that can be screwed with the cap 4 is provided on the outer surface of the liquid agent container neck portion 12. The liquid agent container main body 11 includes a side wall 11a extending in the circumferential direction of the substantially cylindrical liquid agent container main body 11 and a bottom wall 11b. The side wall 11a and the bottom wall 11b define a filling space S capable of being filled with a liquid agent. The applicator is placed in a state where the outer surface of the bottom wall 11b is in contact with a flat surface such as a desk while not in use or being stored. The side wall 11a is gripped by a user when the applicator 100 is used. Figure 2B is a schematic perspective view for explaining the columnar brush member 3. The columnar brush member 3 is a member formed by bundling synthetic fibers into a columnar shape. The columnar brush member 3 includes a columnar brush member main body 31, a columnar brush member head portion 32, and a columnar brush member tip portion 33. The outer surfaces of the columnar brush member main body 31 and the columnar brush member head portion 32 are solidified by an adhesive, and synthetic fibers made of fine polyester contained inside the columnar brush member 3 are integrated. The columnar brush member tip portion 33 is formed in a brush shape by loosening a synthetic fiber bundle fixed with an adhesive at the tip end portion of the columnar brush member head portion 32. Since there are voids for passing a liquid agent between the synthetic fibers inside the columnar brush member main body 31 and the columnar brush member head portion 32, when the end face of the columnar brush member main body 31 is immersed in the liquid agent, the liquid agent oozes out from the other end of the synthetic fiber due to capillary action. Figure 2C is a schematic cross-sectional view for explaining the bottomed cylindrical holder 2. The bottomed cylindrical holder 2 includes a bottomed cylindrical holder main body 21 and an annular flange portion 22. The bottomed cylindrical holder main body 21 has a cylindrical shape. The cylindrical shape can be appropriately changed according to the outer peripheral shape of the columnar brush member 3 so that the columnar brush member 3 can be inserted. As shown in Figure 2C, the bottomed cylindrical holder 2 has a bottom portion 23, and the bottom portion 23 and the cylindrical bottomed cylindrical holder main body 21 are joined together without a gap. A pore 24 is provided at the center of the bottom portion 23. Through this pore 24, the liquid agent placed inside the liquid agent container 1 can move into the bottomed cylindrical holder 2. In Figure 2C, reference numeral 35 denotes a support member formed on the inner surface of the bottomed cylindrical holder main body 21 for supporting the columnar brush member 3. However, the specific shapes of the respective components of the applicator 100 according to an embodiment of the present invention are not limited to those shown in the drawings.

[0026] The applicator according to an embodiment of the present invention is inverted during use. At this time, the brush member receives the supply of the liquid agent from the liquid agent container at one end, and the liquid agent penetrates inside the brush member due to capillary action. The other end of the brush member functions as an application member for applying the liquid agent to the nail. In this way, the liquid agent is supplied to the nail through the brush member installed at the opening of the liquid agent container. By inverting the applicator (and thus the liquid agent container) according to an embodiment of the present invention, the liquid agent can quickly penetrate from the opening of the liquid agent container into the brush member, and an appropriate amount of the liquid agent can be smoothly applied to the nails. Therefore, the applicator and the liquid agent container according to an embodiment of the present invention have a preferable feeling of use.

[0027] In one embodiment of the present invention, the liquid agent container may be in any form as long as it is a container that can be filled internally without leaking the liquid agent. For example, as shown in FIG. 2A, a substantially cylindrical container having an opening at the upper part is preferable.

[0028] The main material of the liquid agent container according to an embodiment of the present invention is not particularly limited as long as it is a synthetic resin suitable for filling the medicine internally. However, as the base resin, polyethylene terephthalate, polybutylene terephthalate, polyethylene, polystyrene, polypropylene, or vinyl chloride is preferable, and polyethylene is particularly preferable. In one embodiment of the present invention, the liquid agent container is elastically non-deformable under normal use conditions, that is, it is a hard synthetic resin container that is non-elastic or non-flexible. The hard synthetic resin container does not require adjusting the discharge amount of the liquid agent by the gripping force of the user. The liquid agent diffuses passively through the brush member by capillary action. Therefore, the discharge amount is less likely to vary among users, and it is a preferable container from that viewpoint.

[0029] In one embodiment of the present invention, the internal volume of the liquid agent container is not particularly limited, but is preferably 8 to 12 mL. In one embodiment of the present invention, the thickness of the side wall of the liquid agent container is not particularly limited, but in order to comprehensively solve the problems of the present invention, it is preferably 0.8 mm to 1.0 mm.

[0030] In this specification, "blocking light rays" means using a substance that scatters light or a substance that absorbs light to prevent light from passing through. In the present invention, specific means for blocking light in the ultraviolet region are not particularly limited. However, for example, the following means can be adopted by using a substance capable of blocking ultraviolet rays in a predetermined wavelength range described later. a) A method of incorporating a substance that blocks light in the ultraviolet region into the synthetic resin used for the container (for example, a method of adding a substance that blocks ultraviolet rays, such as titanium oxide, to the base resin and molding it into the shape of the container). b) A method of separately attaching a member (for example, a film, etc.) containing a substance that blocks ultraviolet rays to the surface of the container (for example, a method of attaching a shrink film containing an ultraviolet scattering agent to the container). c) A method of applying a substance that blocks ultraviolet rays to the surface of the container.

[0031] Among the above means, b) and c) are not economical because the manufacturing process and the number of members increase. On the other hand, a) is preferable because the manufacturing process is simple, but it is not easy to block only ultraviolet rays and ensure visibility. Also, if an appropriate container material is not selected, there is a possibility that the components of the container material will elute into the content liquid.

[0032] In one embodiment of the present invention, a preferred liquid container is formed to block ultraviolet rays by a method of incorporating a substance that blocks ultraviolet rays into the synthetic resin used for the container. Therefore, a preferred liquid container in one embodiment of the present invention is a container composed of a single layer in which a substance that blocks ultraviolet rays is homogeneously dispersed in the main component of the container material. Here, the "substance that blocks ultraviolet rays" is a substance that shields ultraviolet rays, and preferably refers to titanium(IV) oxide. That is, the "container composed of a single layer in which a substance that blocks ultraviolet rays is homogeneously dispersed in the main component of the container material" refers to a container molded in a state where a coloring component such as titanium(IV) oxide is homogeneously dispersed in the base resin. In one preferred embodiment of the present invention, the liquid agent container is composed of a single thermoplastic synthetic resin layer and is not composed of multiple layers. Further, the container does not have a portion on a part of the container side surface where there is no ultraviolet shielding substance (or a portion where the concentration of the ultraviolet shielding substance is lower than that of other portions). Such a portion can function as a window portion or a gauge portion for visually recognizing the internal volume, but the preferred container in one embodiment of the present invention does not include such a window portion or a gauge portion. In one embodiment of the present invention, a preferred liquid agent container can be molded by a single molding process because the material components used for the liquid agent container are uniformly dispersed in each other. Therefore, the liquid agent container according to one embodiment of the present invention can be manufactured by a simple and low-cost manufacturing method.

[0033] In one embodiment of the present invention, a preferred liquid agent container is a synthetic resin container not packaged with an ultraviolet-absorbing film. Examples of the ultraviolet absorber used for the film include salicylic acids, benzophenones, triazines, benzotriazoles, cyanoacrylates, and the like. The ultraviolet-absorbing film can contain, for example, a shrinkable PET resin as a base material. By shrinking such an ultraviolet-absorbing film so as to cover the surface of the liquid agent container, it is possible to obtain the same effect as that of a synthetic resin container containing an ultraviolet-blocking substance. However, when using an ultraviolet-absorbing film, there is a possibility that part or all of the ultraviolet-absorbing film may be damaged due to a user's mistake or intention, inadvertently affecting the photo-stability of the contents. In addition, the manufacturing cost may increase by using an ultraviolet-absorbing film. Therefore, particularly in the case of a pharmaceutical container, it is preferable to form a single layer in which an ultraviolet-blocking substance is homogeneously dispersed in the container material by containing the ultraviolet-blocking substance in the container material without using an ultraviolet-absorbing film.

[0034] The liquid agent container of the present invention is a white (including cases where it is semi-transparent) synthetic resin container characterized by containing titanium(IV) oxide as a coloring component. Titanium(IV) oxide functions as an ultraviolet shielding substance. In one embodiment of the present invention, a preferred liquid agent container is a white synthetic resin container characterized by containing titanium(IV) oxide and not containing coloring components other than titanium(IV) oxide. Such a liquid agent container according to one embodiment of the present invention is preferable because the components in the container material do not elute into the content liquid.

[0035] When manufacturing the liquid agent container of the present invention, the method of adding titanium(IV) oxide is not particularly limited. For example, a predetermined amount of titanium(IV) oxide may be directly blended into the base resin and molded. Also, the masterbatch method is preferable. In the case of the masterbatch method, for example, a masterbatch (MB) containing titanium(IV) oxide at a high concentration is prepared by melting and / or kneading titanium(IV) oxide in a small amount of resin in advance. By mixing this masterbatch into the base resin, titanium(IV) oxide can be diluted to a predetermined concentration. In this case, the available masterbatch is not particularly limited, and examples include Polycool Master: EPH-W3380 (manufactured by Polycool Co., Ltd.).

[0036] From the viewpoint of suppressing the decomposition of efinaconazole, the light transmittance of the liquid agent container of the present invention in the ultraviolet region at wavelengths of 200 nm to 360 nm is preferably 0.20% or less, more preferably 0.10% or less.

[0037] In order to achieve the high light blocking effect in the ultraviolet region as described above, a lower limit amount of titanium(IV) oxide contained in the container of the present invention can be set. In one embodiment of the present invention, the lower limit of the content of titanium(IV) oxide contained in a liquid agent container made of polyethylene having a thickness of 0.8 mm to 1.0 mm is preferably 0.09 parts by weight, more preferably 0.10 parts by weight, still more preferably 0.11 parts by weight, and even more preferably 0.18 parts by weight with respect to 100 parts by weight of the synthetic resin. In this specification, 100 parts by weight of the synthetic resin represents the total weight of the base resin and the materials forming the container of the present invention, such as titanium(IV) oxide or masterbatch.

[0038] On the other hand, from the viewpoint of the visibility of the remaining amount of the liquid agent inside the container, the light transmittance in the visible region of the liquid agent container according to one embodiment of the present invention preferably has a light transmittance at a wavelength of 700 nm of 0.25% or more, more preferably 0.40% or more. In another embodiment of the present invention, for the light transmittance in the visible region of the liquid agent container, the light transmittance at any wavelength in the range of 700 nm to 780 nm is preferably 0.25% or more, more preferably 0.40% or more.

[0039] In order to ensure the light transmittance in the visible region as described above, the upper limit amount of titanium(IV) oxide contained in the container of the present invention can be set. In one embodiment of the present invention, the upper limit of the content of titanium(IV) oxide in a liquid agent container made of polyethylene having a thickness of 0.8 mm to 1.0 mm is preferably 0.33 parts by weight, more preferably 0.30 parts by weight, still more preferably 0.27 parts by weight, and even more preferably 0.22 parts by weight with respect to 100 parts by weight of the synthetic resin.

[0040] Therefore, one of the preferred embodiments of the liquid agent container of the present invention is a container made of synthetic resin in which the light transmittance at any wavelength in the range of 200 to 360 nm is 0.20% or less and the light transmittance at a wavelength of 700 nm is 0.25% or more. Another preferred embodiment of the liquid agent container of the present invention is a container made of synthetic resin in which the light transmittance at any wavelength in the range of 200 to 360 nm is 0.20% or less and the light transmittance at any wavelength in the range of 700 to 780 nm is 0.25% or more. One of the preferred alternative embodiments of the liquid agent container of the present invention is a synthetic resin container in which the light transmittance at wavelengths of 200 to 360 nm is all 0.10% or less, and the light transmittance at a wavelength of 700 nm is 0.25% or more. One of the preferred alternative embodiments of the liquid agent container of the present invention is a synthetic resin container in which the light transmittance at wavelengths of 200 to 360 nm is all 0.10% or less, and the light transmittance at wavelengths of 700 to 780 nm is all 0.25% or more. One of the preferred alternative embodiments of the liquid agent container of the present invention is a synthetic resin container in which the light transmittance at wavelengths of 200 to 360 nm is all 0.20% or less, and the light transmittance at a wavelength of 700 nm is 0.40% or more. One of the preferred alternative embodiments of the liquid agent container of the present invention is a synthetic resin container in which the light transmittance at wavelengths of 200 to 360 nm is all 0.20% or less, and the light transmittance at wavelengths of 700 to 780 nm is all 0.40% or more. One of the preferred alternative embodiments of the liquid agent container of the present invention is a synthetic resin container in which the light transmittance at wavelengths of 200 to 360 nm is all 0.10% or less, and the light transmittance at a wavelength of 700 nm is 0.40% or more. One of the preferred alternative embodiments of the liquid agent container of the present invention is a synthetic resin container in which the light transmittance at wavelengths of 200 to 360 nm is all 0.10% or less, and the light transmittance at wavelengths of 700 to 780 nm is all 0.40% or more.

[0041] One of the preferred embodiments of the liquid agent container of the present invention is a synthetic resin container containing 0.09 to 0.33 parts by weight of titanium(IV) oxide with respect to 100 parts by weight of the synthetic resin. One of the preferred embodiments of the liquid agent container of the present invention is a synthetic resin container containing 0.10 to 0.30 parts by weight of titanium(IV) oxide with respect to 100 parts by weight of the synthetic resin. One of the preferred embodiments of the liquid agent container of the present invention is a synthetic resin container containing 0.11 to 0.27 parts by weight of titanium(IV) oxide with respect to 100 parts by weight of the synthetic resin. One of the preferred embodiments of the liquid agent container of the present invention is a synthetic resin container containing 0.18 to 0.22 parts by weight of titanium(IV) oxide with respect to 100 parts by weight of the synthetic resin.

[0042] The liquid agent container according to an embodiment of the present invention as described above is a container that solves two conflicting problems. That is, according to an embodiment of the present invention, by precisely controlling the light transmittance for both ultraviolet light and visible light, it is possible to suppress the decomposition of efinaiconazole by ultraviolet light while providing a liquid agent container in which the remaining amount of the content can be easily visually recognized.

[0043] In this specification, the "light transmittance of light with a wavelength of X to Y nm" means the light transmittance at any one wavelength selected from the entire range of wavelengths of X to Y nm. Further, the light transmittance can be measured, for example, using a commercially available spectrophotometer (U-3310: manufactured by Hitachi, Ltd.). The "transmission spectrum" is a representation of the light transmittance at wavelengths in an arbitrarily measured range as a continuous spectrum.

[0044] The configuration of the brush member provided in the applicator of the present invention is not particularly limited as long as the effects of the present invention can be obtained, but a brush member having the configuration described with reference to FIG. 2B is preferable.

[0045] Specifically, in one embodiment of the present invention, a preferable brush member is a columnar brush member formed by bundling a plurality of synthetic fibers made of polyester. In another embodiment of the present invention, a preferable brush member is a columnar brush member formed by bundling a plurality of synthetic fibers made of polyethylene or nylon. The synthetic fibers used in the present invention are preferably in the range of 7 to 50 μm in fiber diameter, and more preferably in the range of 10 to 30 μm.

[0046] Further, the synthetic fibers used in the present invention may be adhered by an adhesive. The density of the adhesive for adhering the synthetic fibers is preferably in the range of 0.15 to 0.65 (porosity 85% to 35%), and more preferably in the range of 0.25 to 0.50 (porosity 75% to 50%). In this specification, the density refers to the ratio of the synthetic fiber and the adhesive that bonds it per unit cross-sectional area, based on a cross-section cut perpendicular to the fiber direction of the bristle member. When the density of the synthetic fiber is less than 0.15, since there are many flow paths (voids) for the chemical agent, when the container is inverted and the liquid is discharged, an excessive amount will be discharged. Also, since there are few structural parts, it becomes difficult to maintain the strength of the columnar bristle member body, and it becomes easily breakable. On the other hand, when the density of the synthetic fiber is greater than 0.65, the flow paths (voids) for the chemical agent decrease, making it difficult for the chemical agent to penetrate, which hinders smooth application of the chemical agent.

[0047] The preferable volume of the bristle member depends on the volume of the liquid agent that penetrates by capillary action and is retained in the columnar bristle member, the viscosity of the liquid agent, etc. If the viscosity of the liquid agent used in the present invention is low, it is preferable to increase the volume of the columnar bristle member. In one embodiment of the present invention, the preferable volume of the bristle member is in the range of 400 to 600 mm 3 .

[0048] The bristle member described in the examples of the present invention to be described later is made of polyethylene fibers with a fiber diameter of 18 μm and a fineness of 3.3 dtex, and is obtained by molding into a columnar shape with a density of 0.42 (porosity 58%). The volume of the columnar bristle member used in this example is 490 mm 3 .

[0049] The bristle member in another embodiment of the present invention may be a pen-shaped bristle member in which one end of a bundle of synthetic fibers is welded.

[0050] In one embodiment of the present invention, the applicator may further include a bottomed cylindrical holder. The configuration of the bottomed cylindrical holder provided in the applicator according to one embodiment of the present invention is not particularly limited as long as the effects of the present invention can be obtained, but a bottomed cylindrical holder having the configuration described with reference to FIG. 2C is preferable.

[0051] The bottomed cylindrical holder is used to hold the bristle member and securely connect it to the liquid agent container. The bottomed cylindrical holder is cylindrical, and a brush member is inserted therein. In this case, the inner surface of the bottomed cylindrical holder and the outer surface of the brush member are in close contact with each other without any gaps. Further, the outer surface of the bottomed cylindrical holder fits liquid-tightly into the opening of the liquid container without any gaps. These prevent liquid leakage from occurring.

[0052] Fine holes are provided at the bottom of the bottomed cylindrical holder, which functions as a flow path for the liquid agent from the liquid container to the brush member. In one embodiment of the present invention, when the brush member side of the applicator is held downward, the liquid agent filled inside the liquid container penetrates into the inside of the bottomed cylindrical holder through the fine holes and reaches one end face of the brush member (the side held by the bottomed cylindrical holder). The liquid agent that has reached the end face of the brush member reaches the other end face of the brush member (the side to be applied to the nail) by capillary action. Thereby, it becomes possible to apply the liquid agent to the nail.

[0053] The discharge amount of the liquid agent can also be increased or decreased depending on the shape and size of the fine holes provided at the bottom of the bottomed cylindrical holder. The position, number, shape, and size of the fine holes can be appropriately set according to the properties such as the viscosity of the liquid medicine to be used. For example, in addition to circular shapes, elliptical, polygonal, parallelogram-shaped, etc. can be selected according to the purpose and use. Further, the size of the fine holes, with respect to a plane parallel to the bottom of the bottomed cylindrical holder, the maximum diameter is preferably in the range of 0.5 to 5 mm, and more preferably in the range of 0.9 to 1.3 mm.

[0054] The applicator described in the examples of this specification to be described later includes a bottomed cylindrical holder having the above characteristics, and one fine hole is provided at the center of the bottom and is circular (diameter 1.1 mm). Note that "good usability" for the applicator of the present invention means that when the user discharges the liquid agent from the applicator, it can be smoothly applied to the entire affected nail without excess or deficiency. For example, when the amount of use per time can be appropriately applied without being affected by the use environment (for example, temperature) and / or the gripping force of the user, the usability of the applicator is good.

[0055] <2>Liquid preparation In the present invention, the "liquid preparation" refers to a preparation in which an active ingredient and additives are dissolved, emulsified or suspended in a solvent. The liquid preparation container and applicator of the present invention are applied to a liquid preparation in which the active ingredient is efinaconazole. The liquid preparation container and applicator of the present invention are used for the treatment of onychomycosis by applying the efinaconazole liquid preparation once a day to the entire affected nail. As one embodiment of the "liquid preparation containing efinaconazole", there is a liquid preparation in which efinaconazole and, if necessary, one or more pharmaceutically acceptable additives are added to and dissolved in water, an organic solvent or a mixed solvent of water and an organic solvent. In the present invention, the content of efinaconazole is 10% based on the total weight of the liquid preparation.

[0056] The liquid preparation filled in the container of the present invention may be blended with a pharmaceutically acceptable additive if necessary. As the additive, an antioxidant may be contained, and preferably butylated hydroxytoluene (BHT) and ethylenediaminetetraacetic acid (EDTA) may be contained.

[0057] As the solvent used for the liquid preparation filled in the container of the present invention, water, an organic solvent or a mixed solvent of water and an organic solvent can be used. Examples of the organic solvent that can be used include ethanol, propylene glycol, glycerin, triacetin, isopropanol, isopropyl adipate, alkyl lactate, cyclomethicone, and a mixed solvent formed by mixing two or more of these organic solvents. A preferred solvent in the present invention is ethanol. Therefore, as the liquid preparation filled in the container of the present invention, a preferred liquid preparation is a preparation of an ethanol solution in which the content of efinaconazole is 10% based on the total weight of the liquid preparation.

Example

[0058] Hereinafter, the present invention will be described more specifically with reference to examples, but the present invention is not limited to the following examples only.

[0059] <Manufacturing example> According to Table 1, each liquid agent container was manufactured. Specifically, a predetermined amount of MB (masterbatch: polycool master, EPH-W-3380) was added to the base resin (Novatec (registered trademark) HD, HB332R), and after melt-kneading, each container was manufactured by blow molding. Each liquid agent container was non-flexible and hard. Also, as the container thickness, the thickness of the side wall of the container was measured. Each container was filled with a 10% liquid agent of efinaconazole, and a bottomed cylindrical holder into which a brush member was inserted was fitted, and each applicator was manufactured by tightening a cap. As the 10% liquid agent of efinaconazole, a liquid agent composed of 0.00025% by weight of disodium EDTA, 1.00% by weight of purified water, 0.10% by weight of anhydrous citric acid, 0.10% by weight of BHT, 10.00% by weight of C12-15 alkyl lactate, 12.00% by weight of diisopropyl adipate, 13.00% by weight of cyclomethicone, 10.00% by weight of efinaconazole, and an appropriate amount of 95% ethanol (an amount that makes the total 100.00% by weight) was used.

[0060]

Table 1

[0061] <Test Example 1> <Photo-stability Test> Among the containers shown in Table 1, a photo-stability test was carried out on the containers of Comparative Examples 1 to 2 and Examples 1 to 3. These containers are containers with different variations in container thickness and titanium(IV) oxide content. Each container was filled with 4 mL of a 10% liquid agent of efinaconazole, and specimens in which a bottomed cylindrical holder into which a brush member was inserted was fitted and a cap was tightened were arranged in a lying-down state in a photo-stability test apparatus and stored under the following conditions. As the photo-stability test apparatus, a "Stability Test Apparatus for Photo-stability Test" (LTL-200A-14WCD: manufactured by Nagano Science Co., Ltd.) was used. Light source: D65 fluorescent lamp Illuminance: 2000 lux Temperature: 25°C ± 2°C Humidity: 60%RH ± 5%RH Samples were taken out and their quality was evaluated at the start of the test (before irradiation with a D65 fluorescent lamp) and at about 1.2 million lux·hr (25 days). The amount of impurities was analyzed by high performance liquid chromatography. For the chromatogram of the sample solution, the peak area of each peak was measured by the automatic integration method, and their amounts were determined by the area percentage method. For each three containers of Comparative Examples 1-2 and Examples 1-3, the largest peak among the newly generated unknown impurity peaks in the sample was identified, and the average value of its amount was calculated. In the photostability test described in this specification, when the maximum value among the newly generated unknown impurity peaks at 1.2 million lux·hr irradiation is 0.20% or less, it is determined that the photostability is ensured, and it is marked as A in the photostability column (A evaluation). On the other hand, when the above maximum value exceeds 0.20%, it is determined that the photostability is not ensured, and it is marked as B in the photostability column (B evaluation). The results are shown in Table 2.

[0062]

Table 2

[0063] In Comparative Example 1, the maximum value among the newly generated unknown impurity peaks at 1.2 million lux·hr irradiation was 0.28%, and it was a container that did not meet the evaluation criteria for photostability in this test (B evaluation). Comparative Examples 2 and Examples 1-3 were containers that met the evaluation criteria for photostability (A evaluation). Also, in Examples 1-3, the total amount of impurities at 1.2 million lux·hr irradiation was 0.08 - 0.15%. From these results, it was shown that the containers of Examples 1-3 are containers that can stably store the efinaconazole liquid formulation.

[0064] As is clear from Table 2, as the content of titanium(IV) oxide increased, the light transmittance at wavelengths of 200 nm to 360 nm decreased. Also, as the thickness of the container increased, the light transmittance at wavelengths of 200 nm to 360 nm decreased. In Comparative Example 2, Example 1, Example 2, and Example 3, the efinaiconazole liquid formulation could be stored stably. On the other hand, it was confirmed that in Comparative Example 1, an increase in impurities derived from efinaiconazole could not be suppressed. From this, the photo-stability of the efinaiconazole liquid formulation filled in each container depends on the light transmittance at wavelengths of 200 nm to 360 nm, and it became clear that when the light transmittance at wavelengths of 200 nm to 360 nm is all 0.20% or less, the efinaiconazole liquid formulation can be stored stably.

[0065] From the above results, regarding the increase in impurities due to light exposure of the efinaiconazole liquid formulation, the light transmittance at wavelengths of 200 nm to 360 nm is important, and it was confirmed that the decomposition of efinaiconazole can be suppressed by blocking light rays in such a wavelength region. Here, Example 4 and Example 5, which are not shown in Table 2, hardly transmit ultraviolet light (Table 1), similar to Example 3. Example 4 has the same container thickness as Example 2 and Example 3 that satisfy the evaluation criteria of the photo-stability test, and the container has a higher content of titanium(IV) oxide than Example 2 and Example 3. Also, Example 5 has the same content of titanium(IV) oxide as Example 1 and Example 3 that satisfy the evaluation criteria of the photo-stability test, and the side wall is thicker than Example 1 and Example 3. Therefore, the containers of Example 4 and Example 5 are understood to be more stable containers against light and satisfy the evaluation criteria of the photo-stability test in this specification (A evaluation).

[0066] <Test Example 2> <Light Transmittance Test> The side walls of each container of Comparative Examples 1 to 4 and Examples 1 to 5 were cut into a rectangular shape of about 1 cm × 2 cm using scissors. Each cut bottle piece was placed on the light emitting part side of the cell holder of the spectrophotometer, and the transmittance spectrum at wavelengths of 200 to 800 nm was measured. Table 3 shows the measurement results and the results of evaluating whether the remaining amount of the liquid agent could be visually recognized from outside the container when the container was filled with the efina conazole liquid agent.

[0067]

Table 3

[0068] The containers used in the light transmittance test were also containers with different variations in container thickness and titanium(IV) oxide content, and 9 types of containers shown in Table 3 were used. Also, whether the light transmittance at a wavelength of 700 nm, the light transmittance at wavelengths of 700 nm to 780 nm, and the amount of the liquid agent filled inside each container could be visually recognized from outside the container were shown in Table 3. In Comparative Examples 2 to 4, it was difficult to visually recognize the internal liquid agent, while in Comparative Example 1 and Examples 1 to 5, the internal liquid agent could be visually recognized. Incidentally, in any of the containers, the transmittance spectrum at wavelengths of 700 nm to 780 nm was upward-sloping to the right, and the light transmittance at a wavelength of 700 nm showed the minimum value in this range. Also, the transmittance spectra of each container of Comparative Examples 1 to 4 and Examples 1 to 5 are shown in FIGS. 3 to 14. In FIGS. 3 to 14, the horizontal axis represents the wavelength (nm), and the vertical axis represents the light transmittance (%).

[0069] As is clear from Table 3, as the content of titanium(IV) oxide in the container increased, the light transmittance at wavelengths of 700 nm to 780 nm decreased. Also, as the thickness of the container increased, the light transmittance at wavelengths of 700 nm to 780 nm decreased. The visibility of the efina conazole liquid agent filled in each container from outside the container was related to the light transmittance at wavelengths of 700 nm to 780 nm. In Comparative Example 1 and Examples 1, 2, 3, 4, and 5 where the light transmittance at a wavelength of 700 nm was 0.25% or more, the contents could be visually recognized. On the other hand, in Comparative Examples 2, 3, and 4 where the light transmittance at a wavelength of 700 nm was less than 0.25%, the contents could not be visually recognized.

[0070] From the above results, it was confirmed that a visible container for efinaiconazole solution requires at least a light transmittance of 0.25% or more at a wavelength of 700 nm.

[0071] <Test Example 3> <Coating Test> 4 mL of a 10% solution of efinaiconazole was filled into the containers of Comparative Example 2 and Example 3 shown in Table 1, and a bottomed cylindrical holder into which a brush member was inserted was fitted, and a specimen with the cap tightened was manufactured. After measuring the bottle mass before applying the chemical solution, the chemical solution was applied to the entire surface of 5 stainless steel pieces of 4 cm 2 . The above method was repeated twice, and after applying the chemical solution equivalent to 10 stainless steel pieces, the bottle mass after applying the chemical solution was measured. Note that this operation assumed an application amount for 10 toenails. The application amount was calculated by subtracting the bottle mass after applying the chemical solution from the bottle mass before applying the chemical solution. When applying the chemical solution, hold the entire container as if gripping it, and the inclination (angle) of the container during application was set to three types: 90°, 45°, and 10 - 20° with respect to the application surface. The test was conducted 5 times for each container and application angle, and the average application amount and standard deviation were calculated. The results of this test are shown in Table 4 below.

[0072]

Table 4

[0073] The application amount of each container was appropriate, and it functioned properly as an applicator. When comparing the application amounts of Comparative Example 2 and Example 3, it was found that Example 3 tended to have a reduced application amount. Also, regarding the application angle, a tendency was observed for the application amount to increase as the container approached vertical (90° ≥ 45° ≥ 10 - 20°).

[0074] <Test Example 4> <Discharge Test (Drop Time) and Usability Test> For each of Comparative Example 2 and Example 3, five containers were prepared. These containers were each filled with 4 mL of a 10% solution of efinaiconazole, and the test was conducted using a product in which a bottomed cylindrical holder into which a brush member was inserted was fitted. After fixing each container in an inverted state using a silicon tube connected to a constant temperature water bath, the container was heated to 32°C, and the state of the solution dripping was observed. The number of droplets was counted, and the time required for each drop was measured. In Comparative Example 2 and Example 3, the time required from the start of the test to the first drop was 22.4 seconds and 41.5 seconds, respectively. Also, the time required from the first drop to the second drop was 2.6 seconds and 6.3 seconds, respectively. The number of drops until dripping stopped within 1 minute was 13 drops and 8 drops, respectively. Thus, when comparing Comparative Example 2 (side wall thickness: 0.7 mm) with Example 3 (side wall thickness: 0.9 mm), the latter takes a longer time to drip.

[0075] Next, the usability of Comparative Example 2 and Comparative Example 4 was evaluated by 80 panelists. As a result, Comparative Example 4 was evaluated as being able to apply the solution more smoothly without excessive solution discharge. Here, since the content of titanium(IV) oxide in the container material does not affect the usability, Examples 2 to 4 having the same side wall thickness as Comparative Example 4 are considered to have a preferable usability equivalent to that of Comparative Example 4.

[0076] As described above, Examples 1 to 5 are preferable because they can stably fill a 10% solution of efinaiconazole and can visually recognize the internal volume. In particular, Examples 2 to 4 are considered to be more preferable from the viewpoint of usability.

Industrial Applicability

[0077] The container of the present invention blocks light rays having a wavelength that promotes the photodegradation of efinaiconazole while maintaining a preferable usability, and can visually recognize the remaining amount of the solution filled inside the container from the outside of the container. Therefore, it is useful as a container for filling a solution of efinaiconazole.

Description of Symbols

[0078] S Filling Space 1 Liquid Agent Container 2 Bottomed Cylindrical Holder 3 Columnar Brush Member 4 Cap 11 Liquid Agent Container Body 11a Side Wall 11b Bottom Wall 12 Liquid Agent Container Head 14 Opening 15 Screw Thread 21 Bottomed Cylindrical Holder Body 22 Annular Flange Portion 23 Bottom Portion 24 Fine Hole 31 Columnar Brush Member Body 32 Columnar Brush Member Head 33 Columnar Brush Member Tip Portion 35 Support Member 100 Applicator

Claims

1. A liquid container capable of being filled with a liquid containing 10% efinaconazole, The aforementioned liquid container is a container formed from a synthetic resin containing titanium(IV) oxide, A liquid container having a light transmittance of 0.20% or less at wavelengths of 200 to 360 nm, and a light transmittance of 0.25% or more at a wavelength of 700 nm, wherein the amount of liquid contained in the liquid container is visible from the outside.

2. The liquid container according to claim 1, characterized in that the liquid container is a substantially cylindrical polyethylene container having an opening at the top, and is a single-layer container in which at least titanium(IV) oxide is homogeneously dispersed in polyethylene, and is a non-flexible and rigid container.

3. The liquid container according to claim 1, wherein the internal volume of the liquid container is 8 to 12 mL, and the thickness of the side wall of the liquid container is 0.8 to 1.0 mm.

4. The liquid container according to claim 1, characterized in that it contains 0.09 to 0.33 parts by weight of titanium(IV) oxide per 100 parts by weight of synthetic resin.

5. The container according to claim 1, characterized in that it contains 0.10 to 0.30 parts by weight of titanium(IV) oxide per 100 parts by weight of synthetic resin.

6. The liquid container according to claim 1, characterized in that it contains 0.18 to 0.22 parts by weight of titanium(IV) oxide per 100 parts by weight of synthetic resin.

7. A liquid container according to claim 1, characterized in that it does not contain any coloring components other than titanium dioxide (IV).

8. The liquid container according to claim 1, wherein the light transmittance at wavelengths of 700 to 780 nm is 0.25% or more.

9. The liquid container according to claim 1, wherein the light transmittance at wavelengths of 700 to 780 nm is 0.40% or more.

10. The liquid container according to claim 1, wherein the light transmittance at wavelengths of 200 to 360 nm is 0.10% or less for all wavelengths.

11. A liquid container according to claim 1, which is not packaged with an ultraviolet-absorbing film.

12. A liquid container according to claim 1, A columnar brush member formed by bundling synthetic fibers into a columnar shape, An applicator comprising a bottomed cylindrical holder having a cylindrical body and a bottom, between the liquid container and the columnar brush member, The bottomed cylindrical holder is fitted liquid-tightly into the opening of the liquid container. The bottom of the bottomed cylindrical holder has at least one small hole, The columnar brush member is inserted into the cylindrical body of the bottomed cylindrical holder, The liquid agent is passable from the liquid agent container to the columnar brush member through the pores, thereby allowing the liquid agent to penetrate the columnar brush member when the container is inverted during use, enabling the liquid agent to be applied to the user's fingernails.

13. The columnar brush member is formed by bundling synthetic fibers with a fiber diameter in the range of 7 to 50 μm to a density in the range of 0.25 to 0.

50. The coating device according to claim 12, wherein the bottomed cylindrical holder has one circular pore with a diameter of 0.9 to 1.3 mm.

14. The applicator according to claim 12, characterized in that when the applicator filled with 4 mL of the liquid is inverted in an environment of 32°C, the number of drops required for it to stop dripping in 1 minute is 7 to 10 drops.

15. A method for light-stabilizing efinaconazole, comprising the step of filling a liquid container according to claim 1 with a liquid containing 10% efinaconazole.

16. A method for light-stabilizing efinaconazole, comprising the step of filling the applicator described in Claim 12 with a liquid containing 10% efinaconazole.

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