WO2018181466A1 - 水溶性シート状製剤のアプリケータ - Google Patents
水溶性シート状製剤のアプリケータ Download PDFInfo
- Publication number
- WO2018181466A1 WO2018181466A1 PCT/JP2018/012726 JP2018012726W WO2018181466A1 WO 2018181466 A1 WO2018181466 A1 WO 2018181466A1 JP 2018012726 W JP2018012726 W JP 2018012726W WO 2018181466 A1 WO2018181466 A1 WO 2018181466A1
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- WIPO (PCT)
- Prior art keywords
- nozzle
- water
- tip
- applicator
- skin
- Prior art date
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Classifications
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- A—HUMAN NECESSITIES
- A45—HAND OR TRAVELLING ARTICLES
- A45D—HAIRDRESSING OR SHAVING EQUIPMENT; EQUIPMENT FOR COSMETICS OR COSMETIC TREATMENTS, e.g. FOR MANICURING OR PEDICURING
- A45D34/00—Containers or accessories specially adapted for handling liquid toiletry or cosmetic substances, e.g. perfumes
-
- A—HUMAN NECESSITIES
- A45—HAND OR TRAVELLING ARTICLES
- A45D—HAIRDRESSING OR SHAVING EQUIPMENT; EQUIPMENT FOR COSMETICS OR COSMETIC TREATMENTS, e.g. FOR MANICURING OR PEDICURING
- A45D34/00—Containers or accessories specially adapted for handling liquid toiletry or cosmetic substances, e.g. perfumes
- A45D34/04—Appliances specially adapted for applying liquid, e.g. using roller or ball
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M11/00—Sprayers or atomisers specially adapted for therapeutic purposes
- A61M11/006—Sprayers or atomisers specially adapted for therapeutic purposes operated by applying mechanical pressure to the liquid to be sprayed or atomised
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M35/00—Devices for applying media, e.g. remedies, on the human body
- A61M35/003—Portable hand-held applicators having means for dispensing or spreading integral media
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
- A61M37/0069—Devices for implanting pellets, e.g. markers or solid medicaments
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B05—SPRAYING OR ATOMISING IN GENERAL; APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
- B05B—SPRAYING APPARATUS; ATOMISING APPARATUS; NOZZLES
- B05B11/00—Single-unit hand-held apparatus in which flow of contents is produced by the muscular force of the operator at the moment of use
- B05B11/01—Single-unit hand-held apparatus in which flow of contents is produced by the muscular force of the operator at the moment of use characterised by the means producing the flow
- B05B11/10—Pump arrangements for transferring the contents from the container to a pump chamber by a sucking effect and forcing the contents out through the dispensing nozzle
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B05—SPRAYING OR ATOMISING IN GENERAL; APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
- B05B—SPRAYING APPARATUS; ATOMISING APPARATUS; NOZZLES
- B05B11/00—Single-unit hand-held apparatus in which flow of contents is produced by the muscular force of the operator at the moment of use
- B05B11/01—Single-unit hand-held apparatus in which flow of contents is produced by the muscular force of the operator at the moment of use characterised by the means producing the flow
- B05B11/10—Pump arrangements for transferring the contents from the container to a pump chamber by a sucking effect and forcing the contents out through the dispensing nozzle
- B05B11/1001—Piston pumps
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B05—SPRAYING OR ATOMISING IN GENERAL; APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
- B05B—SPRAYING APPARATUS; ATOMISING APPARATUS; NOZZLES
- B05B7/00—Spraying apparatus for discharge of liquids or other fluent materials from two or more sources, e.g. of liquid and air, of powder and gas
-
- A—HUMAN NECESSITIES
- A45—HAND OR TRAVELLING ARTICLES
- A45D—HAIRDRESSING OR SHAVING EQUIPMENT; EQUIPMENT FOR COSMETICS OR COSMETIC TREATMENTS, e.g. FOR MANICURING OR PEDICURING
- A45D2200/00—Details not otherwise provided for in A45D
- A45D2200/05—Details of containers
- A45D2200/054—Means for supplying liquid to the outlet of the container
- A45D2200/056—Reciprocating pumps, i.e. with variable volume chamber wherein pressure and vacuum are alternately generated
-
- A—HUMAN NECESSITIES
- A45—HAND OR TRAVELLING ARTICLES
- A45D—HAIRDRESSING OR SHAVING EQUIPMENT; EQUIPMENT FOR COSMETICS OR COSMETIC TREATMENTS, e.g. FOR MANICURING OR PEDICURING
- A45D2200/00—Details not otherwise provided for in A45D
- A45D2200/10—Details of applicators
- A45D2200/1009—Applicators comprising a pad, tissue, sponge, or the like
- A45D2200/1027—Tissues, i.e. thin applicator sheets
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
- A61M2037/0007—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin having means for enhancing the permeation of substances through the epidermis, e.g. using suction or depression, electric or magnetic fields, sound waves or chemical agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
- A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
- A61M2037/0023—Drug applicators using microneedles
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B05—SPRAYING OR ATOMISING IN GENERAL; APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
- B05B—SPRAYING APPARATUS; ATOMISING APPARATUS; NOZZLES
- B05B11/00—Single-unit hand-held apparatus in which flow of contents is produced by the muscular force of the operator at the moment of use
- B05B11/01—Single-unit hand-held apparatus in which flow of contents is produced by the muscular force of the operator at the moment of use characterised by the means producing the flow
- B05B11/10—Pump arrangements for transferring the contents from the container to a pump chamber by a sucking effect and forcing the contents out through the dispensing nozzle
- B05B11/1001—Piston pumps
- B05B11/1009—Piston pumps actuated by a lever
- B05B11/1011—Piston pumps actuated by a lever without substantial movement of the nozzle in the direction of the pressure stroke
Definitions
- the present invention relates to an applicator nozzle for applying a water-soluble sheet-form preparation to the skin and an applicator equipped with the nozzle.
- Oral administration and transdermal administration are often used as methods for administering drugs to human body.
- Injection is a typical transdermal method of administration, but is cumbersome and painful.
- the skin stratum corneum during transdermal administration serves as a barrier for drug permeation, and simply applying the drug to the skin surface does not necessarily provide sufficient permeability.
- a microneedle by perforating the stratum corneum using a fine needle, that is, a microneedle, the drug permeation efficiency can be remarkably improved as compared with the coating method.
- a microneedle array is a large number of microneedles integrated on a substrate.
- the product is easy to use with an adhesive sheet for attaching the microneedle array to the skin and a protective release sheet for protecting the adhesive sheet and supporting the microneedle array on the skin. This is called a microneedle patch.
- the skin When administering the microneedle array to the skin, it is not easy to insert the microneedle into the skin simply by pressing the microneedle array with a finger. This is because the skin is generally a soft and elastic tissue, so even if the sharp tip of the microneedle is pressed against the skin, the skin absorbs the impact and deforms to prevent the microneedle from entering the skin. It is.
- microneedle administration device (microneedle applicator) using a spring (patent documents 1-6, 8), air pressure (patent document 5), magnetic force (patent document 7), etc.
- a spring (patent documents 1-6, 8), air pressure (patent document 5), magnetic force (patent document 7), etc.
- the use of air pressure and magnetic force is not always simple.
- the conventional microneedle array administration device still has a practical problem, and a user has sought a device that can be more easily and reliably inserted.
- Microneedles made of water-soluble materials dissolve with moisture in the skin after insertion, but this takes a considerable amount of time, especially for cosmetic purposes. Conspicuously detracts from the convenience.
- a microneedle array is made of a water-soluble material, and moisture is supplied from the back side after insertion into the skin, the microneedle dissolves quickly (Patent Document 9).
- the present inventors have developed a hyaluronic acid gel sheet for cosmetics using hyaluronic acid, which is a water-soluble polymer, as a raw material, and after application to the skin, massage with a small amount of water added. It has been reported to promote skin penetration (Patent Document 10).
- Japanese Translation of PCT International Publication No. 2004-510530 Japanese Translation of PCT publication No. 2004-510534
- Japanese translation of PCT publication No. 2004-510535 Japanese translation of PCT publication No. 2004-510535
- Patent No. 4659332 Japanese translation of PCT publication No. 2004-510535
- Patent No. 4682144 Japanese translation of PCT publication No. 2007-509706
- JP 2011-078711 A JP 2014-42788 A JP 2011-194189 A Patent No. 5408592
- Japanese Patent Laid-Open No. 2014-024828 Japanese Patent Laid-Open No. 2014-024828
- a microneedle array or a cosmetic gel sheet made of a water-soluble polymer as a raw material is a flexible sheet-like preparation having a thickness of about several hundred ⁇ m in order to improve the adhesion to the skin.
- a water-soluble sheet-form preparation absorbs moisture from the fingertip and adheres to the finger rather than the target skin, or when applied to the scalp, adhesion is hindered by the hair and absorbed from the scalp. Sometimes it fell off before it was done.
- the problem to be solved by the present invention is to provide means capable of reliably administering a water-soluble sheet-form preparation to the skin at various sites and supplying water from the back surface of the water-soluble sheet-form preparation.
- the water-soluble sheet-form preparation in the present invention includes a sheet-form preparation intended to be dissolved and absorbed by water immediately after application to the skin, such as a cosmetic water-soluble gel sheet as well as a microneedle array. It is a waste.
- the water-soluble sheet-form preparation is prepared using a water-soluble polymer as a base and has a thickness of about 1 mm or less.
- the water-soluble polymer include hyaluronic acid (or a sodium salt thereof) and derivatives thereof, collagen, hydroxypropyl cellulose, chondroitin sulfate, dextran, proteoglycan, and a mixture thereof.
- the back surface of the water-soluble sheet-form preparation is the surface opposite to the surface to be brought into close contact with the skin.
- the present inventors have intensively studied, and as a result, succeeded in developing a nozzle that can easily attach and detach the water-soluble sheet-form preparation. Furthermore, the present inventors have completed an apparatus capable of instantaneously applying the water-soluble sheet-form preparation to the skin and performing the dissolving operation by attaching such a nozzle to various liquid containers.
- the present invention is as follows. [1] A nozzle having at least one hole in a tip portion having a flat surface capable of holding a water-soluble sheet-form preparation, and having an uneven portion on the flat surface excluding the hole. [2] The nozzle according to [1], wherein the uneven portion has a depth of 0.1 to 3.0 mm. [3] The nozzle according to [1] or [2], wherein the uneven portion forms a groove extending from the hole toward the periphery of the tip portion. [4] The nozzle according to any one of [1] to [3], wherein a peripheral edge of the tip portion is surrounded by a convex portion that is higher than the concavo-convex portion.
- [5] The nozzle according to any one of [1] to [4], which is made of a synthetic resin selected from the group consisting of polyethylene resin, polypropylene resin, polyurethane resin, polyvinyl chloride, and silicone resin.
- An applicator for a water-soluble sheet-form preparation comprising a liquid container and the nozzle according to any one of [1] to [5].
- [7] The applicator according to [6], wherein the nozzle is attached to an opening of the liquid container.
- [8] The applicator according to [6] or [7], wherein the water-soluble sheet-form preparation is held on the tip of the nozzle and applied to the skin, and the liquid is supplied to the back surface of the preparation by pressing the liquid container. .
- the nozzle of the present invention can quickly dissolve the preparation by pressing the tip of the nozzle against the water-soluble sheet-form preparation affixed to the skin and supplying water from the nozzle hole. Since the tip portion of the nozzle of the present invention has an uneven portion, the dissolved preparation surely stays on the skin side without adhering to the tip portion of the nozzle. Since the tip portion of the nozzle of the present invention is a flat surface having a concavo-convex portion, in the case of a relatively small water-soluble sheet-form preparation, it can be applied to the skin while being held on the flat surface of the tip portion. In this case, the preparation is hygienic without being directly handled by hand.
- the applicator of the present invention is composed of the nozzle of the present invention and a liquid container, and any liquid container may be used as long as the opening of the liquid container and the nozzle can be fitted.
- the needle of the microneedle array is surely pierced by pressing the tip of the nozzle against the microneedle array for an appropriate time. Further, the tip of the nozzle is pressed against the microneedle array, and water is uniformly supplied from the liquid container to the entire back surface of the array, so that the microneedle array is rapidly dissolved.
- FIG. 1 is an example of the shape of the tip of the nozzle.
- FIG. 2 is a cross-sectional view and a bottom view of the nozzle according to the first embodiment.
- FIG. 3 shows an applicator in which the nozzle of Example 1 is mounted on a polyethylene liquid container.
- FIG. 4 is an example of nozzles (A, B, C). The left side shows a bottom view and the right side shows a cross-sectional view.
- FIG. 5 is another example (D, E, F) of the nozzle. The left side shows a bottom view and the right side shows a cross-sectional view.
- FIG. 6 shows examples (A, B, C) of applicators in which nozzles are mounted on liquid containers having various openings.
- the nozzle of the present invention is a water supply member intended to dissolve a water-soluble sheet-form preparation.
- the tip of the nozzle has a flat surface that can hold the water-soluble sheet-form preparation.
- the nozzle of the present invention can change the shape of the flat surface of the tip according to the size of the water-soluble sheet-form preparation, and can be a variety of shapes such as a circle, an ellipse, a ball shape, a triangle, a quadrangle, a pentagon, and a hexagon. It may be square.
- the main body of the nozzle of the present invention may be a cylindrical shape, an elliptic cylinder system, or a polygonal column in accordance with the shape of the flat surface of the tip portion. A cylindrical shape is desirable in order to be able to fit into the openings of various liquid containers.
- the tip of the nozzle of the present invention has at least one hole.
- the number of the holes may be two or more for the purpose of introducing water from the liquid container to the back surface of the water-soluble sheet-form preparation, and the size of the holes is not particularly limited.
- the position of the hole may be in the center of the plane of the tip portion or in the peripheral portion.
- the arrangement and interval of the plurality of holes are not particularly limited.
- the concavo-convex part can be any shape such as spiral, dot, or radial. May be.
- the degree of unevenness is desirably such that the depth of the unevenness is 0.1 to 3.0 mm, and more preferably 0.1 to 2.0 mm. When the depth is 0.1 mm or less, the supply to the surface of the water supplied through the hole is not quick.
- the area ratio between the convex portion or the flat portion and the groove portion or the concave portion is 20: 1 or more. If the area ratio of the recesses is too small, the groove is small and it is difficult to supply the entire bottom surface of the water. On the other hand, if the area of the groove is too large, the flat surface of the nozzle flat surface portion becomes small, and even if the water-soluble sheet is pressure-bonded to the skin with the nozzle, the degree of adhesion with the flat surface portion is insufficient and there is a possibility that it will not adhere sufficiently to the nozzle. Therefore, it is desirable that the area ratio of the convex portion or the flat portion to the groove portion or the concave portion is 1:10 or less.
- peripheral edge of the tip of the nozzle of the present invention is surrounded by a convex portion higher than the concave and convex portion so that the supplied water does not overflow.
- the peripheral convex portion serves as a weir that prevents the water that has spread through the grooves formed by the concave and convex portions from escaping to the outside of the water-soluble sheet-form preparation.
- the uneven portion has a groove extending from the hole toward the periphery of the tip portion.
- the groove is a lowland formed by two adjacent convex portions and one concave portion surrounded by the two convex portions.
- the shape of the groove is not particularly limited.
- a concentric elongated groove in the concavo-convex portion 3 that extends concentrically around the hole 2 at the center, and a radial (fan-like) groove 5 directly connected to the hole 2.
- the peripheral projection 4 is also formed on the nozzle.
- FIGS. 4A and 4C A further embodiment of the nozzle of the present invention is shown in FIGS. 4A and 4C, a radial groove 5 and a concentric groove are formed.
- the concavo-convex portion 3 is formed of a large number of dots, and a dot-like groove 5 is formed from the hole 2 toward the periphery.
- a spiral groove 5 is formed from the hole 2 toward the periphery.
- FIG. 5E a large hole 2 is formed at the center, and a concentric groove 5 is formed around the large hole 2.
- minute uneven portions 3 are formed on the entire plane except for the holes 2, and mesh-like grooves that cannot be observed with the naked eye are formed.
- the material of the nozzle of the present invention is not particularly limited, and various materials such as metal, ceramic, and plastic can be used.
- plastic is preferable, and among them, polyolefin resin such as polyethylene resin and polypropylene resin, and synthetic resin such as polyvinyl chloride, polyurethane resin, and silicone resin are more preferable.
- a soft polymer substance is preferable.
- the Young's modulus which is a measure of the hardness of the nozzle material, is preferably 500 to 5 MPa.
- soft polyolefin resins, polyurethane resins and silicone resins are preferable, and silicone resins are even more preferable.
- the nozzle made of synthetic resin can be manufactured by a known method. For example, it can be manufactured by injecting a raw material resin into a mold and molding it.
- the applicator of the present invention includes a liquid container and the nozzle of the present invention.
- the liquid container and the nozzle may be combined separately.
- a nozzle is attached to the opening of the liquid container during use.
- the liquid container may be filled with a liquid in advance, or the liquid may be injected immediately before use.
- the liquid is typically water, but may be a mixed liquid with a solvent other than water as long as the water-soluble sheet-form preparation can be dissolved.
- the aqueous solution which contains the medicinal component and valuable component applied to skin as needed may be sufficient.
- the material of the liquid container is not particularly limited, and various materials such as metals, ceramics, and plastics can be used in consideration of the fitting property with the nozzle.
- plastic is preferable, and among them, polyolefin resin such as polyethylene resin and polypropylene resin, and synthetic resin such as polyvinyl chloride, polyurethane resin, and silicone resin are more preferable.
- the applicator of the present invention has the nozzle of the present invention.
- the applicator shown in FIG. 6C can be mentioned.
- the water-soluble sheet-form preparation can be held at the tip of the nozzle and applied to the skin, and the liquid can be supplied to the back of the preparation by pressing the liquid container.
- the amount of liquid to be supplied can be appropriately set according to the size (area, thickness) of the water-soluble sheet-form preparation.
- the amount of liquid can be adjusted by the size of the nozzle hole, the pressure applied to the liquid container, the number of times of pressing, and the like.
- the applicator of the present invention is equipped with a nozzle at the tip opening of the spraying device.
- the applicator shown in FIG. 6B can be mentioned.
- a water-soluble sheet-form preparation can be held at the tip of the nozzle and applied to the skin, and liquid can be supplied to the back of the preparation by firing of the spray device.
- the amount of liquid to be supplied can be appropriately set according to the size (area, thickness) of the water-soluble sheet-form preparation.
- the amount of liquid can be adjusted by the size of the nozzle hole, the drainage capacity of the spray device, the number of firings, and the like.
- the applicator of the present invention is equipped with a nozzle at the tip opening of the pump.
- the applicator shown to FIG. 6A is mentioned.
- the water-soluble sheet-form preparation can be held at the tip of the nozzle and applied to the skin, and the liquid can be discharged to the back of the preparation by pushing the pump.
- the amount of liquid to be discharged can be appropriately set according to the size (area, thickness) of the water-soluble sheet-form preparation.
- the amount of liquid can be adjusted by the size of the nozzle hole, the discharge capacity of the pump, the number of discharges, and the like.
- the present invention can provide applicators of various modes by using various liquid containers and mounting the nozzle of the present invention in a form that can be fitted into the opening of the liquid container. . Therefore, the nozzle and the liquid container can be freely combined according to the shape, application purpose, application frequency, application site, etc. of the water-soluble sheet-form preparation. Further, since the nozzle of the present invention can be mass-produced at a low cost, it can be used after being replaced for each subject and every application day. The used applicator can be removed from the nozzle, the opening is sealed with a lid or the like, the liquid remaining in the liquid container is refrigerated and used again within the expiration date. Furthermore, the applicator of the present invention can be used as a disposable device that can be used once by mounting a liquid container filled with a liquid amount and a nozzle.
- Example 1 A nozzle as shown in FIG. 1 was produced.
- a silicone resin one-component RTV rubber, Shin-Etsu Chemical Co., Ltd.
- the diameter of the nozzle tip 1 plane was 12 mm
- the depth of the concentric uneven portion 3 was 0.5 mm
- the interval between the uneven portions was 1 mm.
- a cross section of the entire nozzle is shown in the upper part of FIG. 2, and a bottom view of the nozzle is shown in the lower part of FIG.
- the hole 2 penetrates the center of the nozzle body 10 and is visible at the center of the tip.
- the nozzle was attached to a polyethylene container (see FIG. 3), and 0.1 g of rim veil HV (aqueous solution containing 1.2% fucoidan, Tanglewood Co., Ltd.) was dissolved in 200 g of water to fill the extract containing fucoidan to obtain an applicator.
- rim veil HV aqueous solution containing 1.2% fucoidan, Tanglewood Co., Ltd.
- the microneedle patch was manufactured as follows. Hyaluronic acid (FCH-80, culture-derived, Kikkoman Biochemifa Co., Ltd.) 5 g and Rimvale HV 5 g were added to 90 g of water to obtain a uniform solution. The aqueous solution was cast on a mold, dried at room temperature for 24 hours, and extracted from the mold to obtain a microneedle array sheet. The sheet was cut to obtain a microneedle array having a diameter of 1 cm. The fucoidan content per microneedle was 25 ⁇ g. This microneedle patch and extract are preparations intended for hair growth.
- Hyaluronic acid FCH-80, culture-derived, Kikkoman Biochemifa Co., Ltd.
- Rimvale HV 5 g were added to 90 g of water to obtain a uniform solution.
- the aqueous solution was cast on a mold, dried at room temperature for 24 hours, and extracted from the mold to obtain a microneedle array sheet. The
- the back surface of the microneedle array was pressed and held by the applicator nozzle. Fucoidan extract was supplied from the back of the microneedle array by pressing against the forehead of the volunteer and pressing the container. When the applicator was removed after 1.5 minutes, the microneedle array was dissolved on the skin. The microneedle array sheet did not remain in the nozzle part of the applicator.
- the microneedle array dissolves instantaneously (in a very short time) while the microneedle array is pressed against the skin. By pressing with an applicator for the time until dissolution, the hair-restoring agent can be reliably delivered into the skin.
- Example 1 A test similar to that in Example 1 was performed using a nozzle having a flat bottom surface with no irregularities (the outer shape is the same as that in Example 1). Fucoidan extract was supplied from the back of the microneedle array by squeezing the container. When the applicator was removed after 1.5 minutes, the microneedle array was adhered to the bottom surface of the nozzle, and since uniform wetting of the bottom surface of water was not realized, the dissolution of the microneedle array was insufficient.
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- Heart & Thoracic Surgery (AREA)
- Hematology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
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- Cosmetics (AREA)
Abstract
Description
本発明が解決しようとする課題は、水溶性シート状製剤を様々な部位の皮膚に確実に投与でき、水溶性シート状製剤の背面から水分を供給することができる手段を提供することである。
ここで、本発明における水溶性シート状製剤は、マイクロニードルアレイのみならず化粧用水溶性ゲルシートのように皮膚に適用後速やかに水分により溶解し皮膚吸収されることを目的とするシート状製剤を含むものである。水溶性シート状製剤は、水溶性高分子を基剤として調製され、厚さが約1mm以下である。水溶性高分子としては、ヒアルロン酸(又はそのナトリウム塩)及びその誘導体、コラーゲン、ヒドロキシプロピルセルロース、コンドロイチン硫酸、デキストラン、プロテオグリカンなど、並びにこれらの混合物などが挙げられる。水溶性シート状製剤の背面とは、皮膚に密着させる面とは反対側の面である。
〔1〕 水溶性シート状製剤を保持可能な大きさの平面を有する先端部に少なくとも1つの穴を有し、該穴を除く該平面上は凹凸部を有するノズル。
〔2〕 前記凹凸部の深さが0.1~3.0mmである〔1〕に記載のノズル。
〔3〕 前記凹凸部が前記穴から前記先端部の周縁に向かって延伸する溝を形成している〔1〕又は〔2〕に記載のノズル。
〔4〕 前記先端部の周縁が前記凹凸部よりも高い凸部で囲まれている〔1〕~〔3〕のいずれかに記載のノズル。
〔5〕 ポリエチレン樹脂、ポリプロピレン樹脂、ポリウレタン樹脂、ポリ塩化ビニル、及びシリコーン樹脂からなる群より選ばれる合成樹脂製である〔1〕~〔4〕のいずれか1項に記載のノズル。
〔6〕 液体容器と、〔1〕~〔5〕のいずれかに記載のノズルとから構成される水溶性シート状製剤のアプリケータ。
〔7〕 前記液体容器の開口部に前記ノズルが装着されている〔6〕に記載のアプリケータ。
〔8〕 前記ノズルの先端部に水溶性シート状製剤を保持して皮膚に適用し、前記液体容器の押圧により該製剤の背面に液体を供給する〔6〕又は〔7〕に記載のアプリケータ。
〔9〕 前記液体容器が噴霧装置を装備し、該噴霧装置の先端開口部に前記ノズルが装着されている〔6〕に記載のアプリケータ。
〔10〕 前記ノズルの先端部に水溶性シート状製剤を保持して皮膚に適用し、該噴霧装置の発射により該製剤の背面に液体を供給する〔9〕に記載のアプリケータ。
〔11〕 前記液体容器がポンプを装備し、該ポンプの先端開口部に前記ノズルが装着されている〔6〕に記載のアプリケータ。
〔12〕 前記ノズルの先端部に水溶性シート状製剤を保持して皮膚に適用し、該ポンプを押して該製剤の背面に液体を吐出する〔11〕に記載のアプリケータ。
本発明のアプリケータは、本発明のノズルと液体容器とから構成され、液体容器の開口部とノズルとが嵌合可能な限りはいずれの液体容器を用いてもよい。本発明のアプリケータを用いて水溶性マイクロニードルアレイを投与する場合、ノズルの先端をマイクロニードルアレイに押し付けて適当な時間を置くことにより、マイクロニードルの皮膚への刺しいれが確実となる。さらに、ノズルの先端をマイクロニードルアレイに押し付けて液体容器から水をアレイの背面に均一に全面に供給することにより、マイクロニードルアレイの溶解が迅速に行われる。本発明のアプリケータを用いて化粧用水溶性ゲルシートを適用する場合、ノズルの先端をゲルシートに押し付けて背面から液体容器内の水を供給することにより、ゲルシートが迅速に溶解して皮膚表面に広がり、皮膚の保湿、有価成分の吸収が促進される。
凸部もしくは平面部と溝部もしくは凹部との面積比は20:1以上であることが望ましい。凹部の面積比が小さすぎると溝部が小さく水の底面部全面供給が難しい。また溝部の面積が大きすぎるとノズル平面部の平面が小さくなり水溶性シートをノズルで皮膚に圧着しても平面部との密着度が不十分でありノズルに十分に付着しない恐れが生じる。それゆえ凸部もしくは平面部と溝部もしくは凹部との面積比は1:10以下であることが望ましい。
本発明のノズルのさらなる態様を、図4及び図5に示す。図4A及び図4Cは、放射状の溝5と同心円状の溝が形成されている。図4Bは、凹凸部3が多数のドットで形成され、穴2から周縁に向かってドット状の溝5が形成されている。図5Dは、穴2から周縁に向かって螺旋状の溝5が形成されている。図5Eは、中央に大きな穴2が形成され、その周囲に同心円状の溝5が形成されている。図5Fは、穴2を除く平面全面に微小の凹凸部3が形成され、肉眼では観察できない網目状の溝が形成されている。
図1に示すようなノズルを作製した。シリコーン樹脂(1液型RTVゴム、信越化学工業(株))を用いて型注入成形により作製した。ノズル先端1平面の直径は12mm、同心円状の凹凸部3の深さは0.5mm、凹凸部の間隔は1mmであった。ノズル全体の断面を図2の上図に、ノズルの底面図を図2の下図に示す。穴2は、ノズル本体10の中央を貫通し、先端部の中心部に見える。液体は穴2から出て、溝5に広がり、さらに凹凸部3を経由して平面全体に広がる。
凹凸がない平面底面を有するノズル(外形は実施例1と同じ)を用いて、実施例1と同様な試験を実施した。容器を圧迫することによりフコイダンエキスをマイクロニードルアレイの背面から供給した。1.5分後アプリケータを外すとマイクロニードルアレイはノズル底面に付着しており、また水の底面均一全面濡れが実現できていないので、マイクロニードルアレイの溶解も不十分であった。
マイクロニードルアレイをボランティアの前額部に貼付し、その背面を医療用テープで覆い皮膚に保持した。この場合は、針部が溶解するのに3時間を要した。
2 穴
3 凹凸部
4 周縁の凸部
5 溝
10 ノズル本体
20 液体容器
21 開口部
22 ポンプ
23 噴霧装置
Claims (12)
- 水溶性シート状製剤を保持可能な大きさの平面を有する先端部に少なくとも1つの穴を有し、該穴を除く該平面上は凹凸部を有するノズル。
- 前記凹凸部の深さが0.1~3.0mmである請求項1に記載のノズル。
- 前記凹凸部が前記穴から前記先端部の周縁に向かって延伸する溝を形成している請求項1又は2に記載のノズル。
- 前記先端部の周縁が前記凹凸部よりも高い凸部で囲まれている請求項1~3のいずれか1項に記載のノズル。
- ポリエチレン樹脂、ポリプロピレン樹脂、ポリウレタン樹脂、ポリ塩化ビニル、及びシリコーン樹脂からなる群より選ばれる合成樹脂製である請求項1~4のいずれか1項に記載のノズル。
- 液体容器と、請求項1~5のいずれか1項に記載のノズルとから構成される水溶性シート状製剤のアプリケータ。
- 前記液体容器の開口部に前記ノズルが装着されている請求項6に記載のアプリケータ。
- 前記ノズルの先端部に水溶性シート状製剤を保持して皮膚に適用し、前記液体容器の押圧により該製剤の背面に液体を供給する請求項6又は7に記載のアプリケータ。
- 前記液体容器が噴霧装置を装備し、該噴霧装置の先端開口部に前記ノズルが装着されている請求項6に記載のアプリケータ。
- 前記ノズルの先端部に水溶性シート状製剤を保持して皮膚に適用し、該噴霧装置の発射により該製剤の背面に液体を供給する請求項9に記載のアプリケータ。
- 前記液体容器がポンプを装備し、該ポンプの先端開口部に前記ノズルが装着されている請求項6に記載のアプリケータ。
- 前記ノズルの先端部に水溶性シート状製剤を保持して皮膚に適用し、該ポンプを押して該製剤の背面に液体を吐出する請求項11に記載のアプリケータ。
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JP2018164688A (ja) | 2018-10-25 |
JP2021178209A (ja) | 2021-11-18 |
KR102660645B1 (ko) | 2024-04-26 |
US11452852B2 (en) | 2022-09-27 |
EP3607992B1 (en) | 2023-11-08 |
JP7253838B2 (ja) | 2023-04-07 |
AU2018243023B2 (en) | 2022-06-02 |
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JP6931217B2 (ja) | 2021-09-01 |
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