WO2017159779A1 - マイクロニードルパッチケース - Google Patents
マイクロニードルパッチケース Download PDFInfo
- Publication number
- WO2017159779A1 WO2017159779A1 PCT/JP2017/010639 JP2017010639W WO2017159779A1 WO 2017159779 A1 WO2017159779 A1 WO 2017159779A1 JP 2017010639 W JP2017010639 W JP 2017010639W WO 2017159779 A1 WO2017159779 A1 WO 2017159779A1
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- WIPO (PCT)
- Prior art keywords
- patch
- case
- microneedle
- applicator
- fusion
- Prior art date
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Classifications
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- 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
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
-
- 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
-
- 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
-
- 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
-
- 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
- A61M2037/0061—Methods for using microneedles
-
- 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
- A61M2209/00—Ancillary equipment
- A61M2209/06—Packaging for specific medical equipment
Definitions
- the present invention relates to a patch case convenient for storage, transportation and administration of microneedle patches.
- Oral administration and transdermal administration are often used as methods for administering drugs to human body.
- Injection is a typical transdermal administration method, but it is an unwelcome technique that can be bothersome and painful, and can also be infected.
- 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 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 microneedle patch is stored safely and hygienically after use, delivered to the user, and packed so that it can be used safely and easily. For this purpose, it is convenient to store, transport and hold the product in a convenient patch case.
- the microneedle array is administered to the skin, since the skin is generally soft, it is not easy to insert the microneedle simply by pressing it with a finger, and thus an applicator is often used as an insertion aid.
- the patch case can be attached to the applicator and inserted, it is not necessary for the user to touch the microneedle array with his / her hand, which is not only hygienic but also convenient for the user.
- the patch case is a container for storing, transporting, and holding the microneedle patch, and is a container that can be attached to the applicator while holding the microneedle patch and can administer the held microneedle to the recipient.
- Patent Documents 1 and 2 Several storage containers for storing microneedle patches have already been reported (Patent Documents 1 and 2). However, there are not many reports of patch cases attached to the applicator with the microneedle patch stored.
- a cylindrical patch holder (corresponding to a patch case) that can be attached to the applicator body, the microneedle patch is attached to a mounting shoulder (step portion) in the center of the patch holder (Patent Documents 3 and 4).
- the patch holder is attached to the applicator and impacted by the applicator, the fragile attachment area of the microneedle patch is broken and separated, and the microneedle patch leaves the patch holder and is inserted into the skin surface.
- the patch holder can be disposable. Similar patch holders are also disclosed in other documents (Patent Documents 5, 6, and 7).
- microneedle array cartridge (corresponding to a patch case) provided with a material web (substrate) and a container (cover), the microneedle array is attached to the applicator together with the cartridge (Patent Document 8).
- a patch holder (corresponding to a patch case) inserted from the side surface of the applicator has a mounting shoulder, and can hold a microneedle patch on a weakly adhesive lower surface (Patent Document 9).
- the problem to be solved by the present invention is to provide a patch case that can be easily attached to a microneedle applicator, can be easily separated when necessary, and can be used in a disposable manner.
- the body of the patch case according to the present invention made to solve the above problems is made of a thermoplastic polymer, and the support film of the adhesive tape of the microneedle patch is a material that can be heat-sealed with the body, The microneedle patch can be held.
- the edge if it is attached to the upper part of the edge, it often does not peel off well when impacted by an applicator, and there are practical difficulties. If it is attached to the lower part of the edge using the heat fusion method, such difficulty does not arise.
- a special method is not required for heat-sealing the microneedle patch and the patch case, and the point of the pointed metal rod may be heated to the melting point of the thermoplastic polymer or higher and pressed to the heat-sealed portion.
- the heat fusion surface fuses the support film to the lower part of the patch case. In that case, the film and the case are heat-sealed by pressing a pointed metal rod from the surface of the film to which the adhesive is applied.
- the thickness of an adhesion layer needs to be 300 micrometers or less.
- any of thermal fusion, high-frequency thermal fusion, laser thermal fusion, or the like may be used.
- the material of the support film is desirably a thermoplastic polymer film or a nonwoven fabric.
- the support film is a laminate of a plurality of films (laminate film), as long as the back side is a thermoplastic polymer film, the front side may be any film as long as it can be used as an adhesive sheet by applying an adhesive. .
- the surface is defined as the surface of the support film, and the opposite surface is defined as the back surface.
- the peripheral portion of the back surface of the support is heat-sealed to the patch case.
- the patch case body is not particularly limited as long as it is a thermoplastic resin that is solid at room temperature.
- Polyolefin resin, polyvinyl chloride, polycarbonate, nylon resin, polyethylene terephthalate (PET), etc. can be used, but the thermoforming temperature is low. Is easy to mold, so polyolefin resin is desirable.
- polyethylene, polypropylene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, and the like are preferable.
- the support film is preferably a thermoplastic resin or non-woven fabric.
- the support film material and the patch case material be the same.
- the support film may be a polyolefin resin, polyvinyl chloride, polycarbonate, nylon resin, polyethylene terephthalate (PET), or the like.
- the microneedle patch which is heat-sealed and integrated with the patch case is set in the applicator together with the case.
- a high-speed impact is applied using a piston, the thermal fusion is peeled off, and the microneedle patch is administered to the skin together with the support film.
- a spring having a spring constant of 0.258 N and a length of 70 mm was used. It is important to fuse the support film having the microneedle array on the patch case and the surface adhesive layer with necessary and sufficient strength.
- the patch case with the thermal support film attached to the applicator is attached to the applicator, and when the support film with microneedles is peeled off from the patch case due to the high-speed impact of the piston, there is a tendency that a part that does not peel off occurs. .
- a phenomenon occurs in which the microneedles are not simultaneously administered in parallel to the skin but a part is administered to the skin and the remaining part is subsequently administered. Such a phenomenon is confirmed by collecting the microneedle array after dermal administration and microscopically observing that the needle is partially bent in one direction. The administration state of the needle is more accurately examined by observing the skin of the administration part.
- the adhesive surface tends to adhere to the metal rod during the thermal fusion operation.
- the support film may be peeled off from the case during storage, movement, attachment to an applicator, and the like, which is unsuitable.
- the inventors of the present invention have made various studies on the thermal fusion between the support film and the patch case.
- the arrangement of the patch case, support film, and microneedle array is shown in FIG.
- a support film with a microneedle array is applied to the skin (lower surface) by the impact of the piston from the top of the figure.
- Point fusion, broken line fusion, or continuous line fusion may be used. In the case of point fusion, two-point fusion tends to be unstable, and therefore, multiple fusion of three or more points (three to twelve point fusion or three to six point fusion) is desirable.
- Various fusion patterns are possible, examples of which are shown in FIG.
- the strength of heat fusion was quantified by compressing the fused surface from above the patch case with the support film having the structure shown in FIG.
- the strength at which a 1 cm diameter cylindrical rod is pressed from the upper surface of the support film at room temperature and the heat fusion breaks is defined as “breaking strength” in the present invention.
- the breaking strength is obtained from the value of the yield point stress of the stress-strain curve in compression of the welded support film. An example is shown in FIG. The horizontal axis is strain (mm), the vertical axis is stress (N), the yield point is observed at 1.4 mm strain, and the value is 2.9.
- Various samples with different heat fusion conditions and different fusion patterns were prepared.
- the breaking strength is preferably 0.01N to 20N, more preferably 0.05N to 10N.
- the patch case is in principle disposable. However, once used, it can be reused by cleaning (disinfecting) it.
- the patch case When attaching the patch case to the applicator, it may be inserted from the side as in Patent Document 9, but it can also be attached to the front surface of the applicator.
- the patch case When the patch case is attached to the forefront of the applicator, the applicator does not contact the recipient's skin during administration of the microneedle patch.
- the applicator When the applicator is not in contact with the skin, there is no risk of skin infection if the patch case is replaced even when continuously administered to a large number of people.
- the side close to the skin of the applicator in use is defined as the front of the applicator.
- Threading, fitting, adhesion, etc. can be considered as a method for attaching the patch case to the front surface of the applicator.
- the patch case needs to be easily attached to the applicator and easily removable.
- ⁇ Acrylic or rubber adhesive is used as the adhesive in the adhesive tape of the microneedle patch.
- the thickness of the adhesive is 20 to 200 ⁇ m.
- the heat fusion method can more easily bond and peel off the film than the pressure-sensitive adhesive method. Better than.
- the attachment to the lower part of the edge of the patch case can be removed more easily than the attachment to the upper part, so that the insertion is smoother and better.
- the applicator When the patch case is attached to the front surface of the applicator, the applicator does not contact the recipient's skin, and hygiene can be maintained even in continuous use.
- the patch case of the present invention not only can store, transport and hold the microneedle patch safely and hygienically, but also can be used without any complicated installation because it is immediately attached to the applicator when used. It is convenient for the person.
- FIG. 1 is a perspective view of one aspect of the patch case of Example 1.
- FIG. 2 is a plan view and a cross-sectional view of another aspect of the patch case of Example 1.
- FIG. 3 is an explanatory diagram of attachment of the microneedle patch to the patch case by heat fusion.
- FIG. 4 is a perspective view of the patch case of the second embodiment.
- FIG. 5 is a photograph of the patch case of Example 2 attached to the applicator.
- FIG. 6 is an example of an apparatus for heat-sealing a patch case and a support film at three points.
- FIG. 7 shows various heat fusion patterns of the patch case and the support film.
- FIG. 8 is a stress-strain curve of the welded support film.
- Example 1 the patch case of the present invention was used together with the applicator of Patent Document 9.
- the shape and dimensions need to be modified. Such modifications can be made within the scope of the present invention.
- a patch case equipped with a microneedle patch is inserted from the side of the applicator.
- the patch case of the present embodiment was manufactured by injection molding using polypropylene (Novatech MA3H, Nippon Polypro Industry Co., Ltd.) as a material in two forms.
- a perspective view of one of them is shown in FIG. 1, and a plan view and a sectional view of the center of the other are shown in FIG.
- Both have almost the same size, both have a circular hole of the same size in the center (its inner diameter is shown as A in FIG. 1), and an edge with a slightly smaller inner diameter at the bottom of the hole. (Shown as B in FIG. 1).
- One difference between the two is that the edges in FIG. 1 are all connected, but the edges in FIG. 2 are discrete.
- the diameter (A) of the central hole was 29 mm for both, and the edge width (B) was 3 mm for both.
- the microneedle patch is heat-sealed under the edge, but in the patch case of FIG. 2, the microneedle patch is used on the edge with the adhesive attached to the adhesive tape of the microneedle patch. And bonded. That is, both prototype patch cases differ in the attachment method and the adhesion method, and the effect of this difference was compared in this example. Reflecting this difference, in FIG. 1, the support film is bonded to the patch case and the microneedle array is bonded to the adhesive film, and the microneedle array is bonded and held on the adhesive surface. Were bonded to the upper surface of the patch case. In FIG. 2, the microneedle array was adhered to the support film and then adhered to the patch case. In addition, it is also possible to attach from below by the fusion method using the thing of FIG.
- the material of the microneedle array used is hyaluronic acid, and about 260 needles having a height of 0.8 mm stand on a circular substrate having a diameter of 10 mm.
- the support film is circular with a diameter of 28 mm, and the material is a polypropylene / PET laminate film (Panac Co., Ltd.).
- An acrylic adhesive (HiPAS, Cosmedy Pharma) Co., Ltd.) was applied to a thickness of 50 ⁇ m.
- FIG. 6 Executed with an apparatus as shown in FIG. 6 for heat-sealing the patch case and the support film.
- the upper metal part is heated and the pointed three points are pressed against the adhesive surface of the support film to fuse the support film and the patch case.
- FIG. 3 shows a cross-sectional view of the main body 2 of the patch case and its edge 5 and the support films 3 and 4 of the microneedle array 1 attached to the edge.
- the support film is a laminate of the adhesive tape 4 and the thermoplastic film 3.
- the microneedle patch is placed on the edge 5 of the patch case made of thermoplastic resin.
- the six pointed metal fusing heads 6 are heated to the melting point of the thermoplastic resin or higher and pressed from above the adhesive tape 4 to fuse the support film and the patch case.
- the tip of a 6 mm iron round bar was sharpened to a tip angle of about 15 degrees, and the tip was processed into a spherical surface having a radius of about 0.5 mm.
- Each fusing head is heated evenly. Light fusion is desirable as long as the support film does not leave the case during storage.
- the microneedle array is adhered to the support film before fusion. However, after the support film and the patch case are thermally fused, the microneedle array is adhered and held in the center of the support film. Also good.
- the temperature at the tip of the fusion head was about 190 ° C.
- a stopper was provided so that the heated fusion head tip would stop when it was pushed about 0.5 mm from the surface of the support film, and it was set so as not to push further.
- the fusing head was brought into contact and held for about 0.5 seconds after hitting the stopper, and the fusing head was released immediately.
- the support film was fused first, after the fusion operation, the microneedle array was adhered and held at the center of the support film. In addition, the whole was wrapped in an aluminum bag to ensure safety during storage and transportation.
- the fusion between the support film and the patch case is peeled off by impact from the back side of the microneedle patch (the impact direction is indicated by an arrow 7 in FIGS. 2 and 3), and the microneedle patch is applied to the skin of the recipient.
- Administered The prepared patch case / microneedle patch was attached to the applicator of Patent Document 9 and administered to the skin.
- One hour after administration the microneedle patch was collected and observed under a microscope, and it was examined whether all the microneedles were inserted vertically into the skin and dissolved evenly.
- Example 2 When the patch case / microneedle patch is attached to the forefront of the applicator, there is an advantage that the applicator does not contact the skin during administration.
- a patch case 10 as shown in FIG. 4 was prototyped.
- the patch case 10 includes two clasps 11 for mounting on an applicator.
- FIG. 5 shows a case in which a microneedle patch is attached to the patch case 10 by heat fusion, and the applicator 12 is fitted with a clasp.
- This patch case can be disposable, and the microneedle patch can be shipped in a state in which the patch case is previously attached.
- this patch case is attached to the front surface of the applicator, when the microneedle patch is administered to the recipient, the patch case contacts the recipient's skin, but the applicator contacts the recipient's skin. do not do.
- Example 3-6 Patch cases with support films having different breaking strengths were produced by changing the heat-sealing conditions.
- As the support film a polyethylene (thickness 50 ⁇ m) / PET (thickness 20 ⁇ m) laminate film (Panac Corporation) was used.
- An acrylic pressure-sensitive adhesive (HiPAS, manufactured by Kosmedy Pharmaceutical Co., Ltd.) was applied to a thickness of 50 ⁇ m on PET, which is a circle having a diameter of 28 mm and a front surface (lower side when viewed from the patch case).
- the patch case had an injection-molded shape as shown in FIG. 4, and the material was high-density polyethylene (Novatech HD, Nippon Polyethylene Co., Ltd.).
- the edge of the patch case (5 in FIG. 3) had an area where the support film could be sufficiently heat-sealed, and the inner diameter of the patch case was 2.3 cm.
- the support film and the patch case were fused in the same manner as in Example 1.
- the temperature at the tip of the fusion head was about 190 ° C.
- the tip of the heated fusing head was fused by being pushed about 0.2 mm to 0.5 mm from the surface of the support film.
- the fusing head was brought into contact and held for 0.3 to 1 second, and the fusing head was immediately released.
- the degree of fusion was changed in various ways by changing the indentation depth and contact time.
- the fracture strength of 5 samples of the fusion-bonded material produced under the same conditions was measured, and the maximum value and the minimum value were defined as “the present condition fracture strength”.
- the breaking strength of heat fusion was quantified by compressing the fused surface from above the patch case with the support film having the structure shown in FIG. The test was performed at room temperature and a relative humidity of 40-60%.
- the tensile tester used was a small tabletop tester EZ Test EZSX manufactured by Shimadzu Corporation.
- the compression speed was 10 mm / min.
- the details of the administration test were as follows. A patch case with a support film having a microneedle array bonded to the center was attached to an applicator as shown in FIG. This applicator was fired on the shaved Wistar male rat abdomen, and the microneedle array was immediately recovered. The skin at the administration site was wetted with an aqueous solution of 1% Gentian Violet B (Wako Pure Chemical Industries, Ltd.), wiped off with gauze, the skin condition was observed, and the administration result was evaluated. The material of the microneedle array used was polyglycolic acid (Kureha Co., Ltd.), and about 800 needles having a height of 0.6 mm stand on a circular substrate having a diameter of 10 mm.
Abstract
Description
アプリケータ本体に取り付け可能な円筒形のパッチ保持具(パッチケースに相当)では、マイクロニードルパッチは、パッチ保持具の中央の取付用ショルダー(段差部分)に取り付けられている(特許文献3、4)。このパッチ保持具をアプリケータに取り付け、アプリケータにより衝撃すると、マイクロニードルパッチの壊れやすい取り付け領域が破断されて分離され、マイクロニードルパッチはパッチ保持具を離れて皮膚表面に刺入される。またこのパッチ保持具は使い捨てとすることができる。同様のパッチ保持具が他の文献でも開示されている(特許文献5、6、7)。
アプリケータの側面から挿入されるパッチホルダー(パッチケースに相当)は取付用ショルダーを有し、弱粘着性の下面にマイクロニードルパッチを保持することができる(特許文献9)。
パッチケースの縁部にあらかじめ粘着剤を塗布しておくことは、工程が増えコスト高となる。ただ縁部の上部に粘着して取り付けるときは、マイクロニードルパッチの粘着剤層を利用できるので、工程増はない。ただ、縁部の上部に取り付けると、アプリケータで衝撃したときうまく剥がれないことが多く、実際上の困難がある。
熱融着法を用いて縁部の下部に取り付ければ、このような困難が生じない。マイクロニードルパッチをパッチケースとの熱融着は特別な方法が必要ではなく、尖った金属棒の先端を熱可塑性高分子の融点以上に加熱して熱融着部へ押し付ければよい。熱融着面は支持体フィルムをパッチケース下部に融着する。その際には、フィルムの粘着剤を塗布した面から尖った金属棒を押し付けてフィルムとケースとを熱融着する。融着後金属棒を取り外すためには、パッチケースと支持体フィルムの融着強度が金属棒と粘着面との粘着強度より強くする必要がある。そのためには、粘着剤の塗布厚さが厚すぎると金属棒との接着強度が強くなりすぎるので、粘着層の厚さは300μm以下である必要がある。熱可塑性高分子の融点以上への融着を実施するには、熱融着、高周波による熱融着、レーザーによる熱融着等、いずれでもよい。
支持体フィルムが複数のフィルムの重ね合わせ(ラミネートフィルム)であるとき、背面側が熱可塑性高分子フィルムであれば、表面側は粘着剤を塗布して粘着シートとして用いうる限りどのようなフィルムでもよい。
パッチケースと表面粘着層にマイクロニードルアレイを有する支持体フィルムの背面熱融着は必要十分な強度による融着が重要である。熱融着が強すぎると、支持体フィルムを熱融着したパッチケースをアプリケータに取り付けピストンの高速衝撃によってパッチケースからマイクロニードル付の支持体フィルムを剥離するに際し剥離しない部分が生じがちである。そうすると、マイクロニードルアレイが皮膚に投与されるに際し皮膚に対してマイクロニードルが平行に同時投与されず一部が皮膚に投与され残部がその後投与される現象が生じる。そのような現象は、皮膚投与後のマイクロニードルアレイを回収し顕微鏡観察すると針が部分的に一方方向に曲がっていることにより確認される。投与部分の皮膚の観察によってより正確に針の投与状態が検査される。
また、熱融着が弱すぎると熱融着作業に際し金属棒に粘着面が付着してしまいがちである。また、保管、移動、アプリケータへの取り付け、等の際に支持体フィルムがケースから剥離することがあり不適である。
パッチケース、支持体フィルム、マイクロニードルアレイの配置図を図3に示す。同図の上からピストンの衝撃により皮膚(下面)にマイクロニードルアレイ付き支持体フィルムを皮膚に投与する。熱融着のパターンは特に制限はない。点融着でも破線融着でも、連続線融着でもよい。点融着の場合は2点融着は不安定になりがちなので3点融着以上の複数融着(3~12点融着、あるいは3~6点融着)が望ましい。種々の融着パターンが可能であり、その例を図7に示す。
なお、本明細書において、使用の際アプリケータの皮膚に近い側をアプリケータの前と定義する。
本実施例では、本発明のパッチケースを特許文献9のアプリケータと共に使用した。他のアプリケータと共に使用するときは、形状や寸法に修正が必要なのは当然である。このような修正は、本発明の範囲内で行うことができる。特許文献9のアプリケータはマイクロニードルパッチを装着したパッチケースをアプリケータの側面から挿入する。
なお、この相違点を反映し、図1のものでは支持体フィルムをパッチケースに融着してからマイクロニードルアレイを接着したものとマイクロニードルアレイを粘着面に接着保持して支持体フィルム粘着面をパッチケース上面に接着したものを比較した。図2のものではマイクロニードルアレイを支持体フィルムに接着してから、パッチケースに接着した。
なお、図2のものを用いて融着法で下から取り付けることも可能である。
さらに全体をアルミ袋に包装し保管・運搬の際の安全を確保した。
製作したパッチケース/マイクロニードルパッチを特許文献9のアプリケータに取り付け皮膚に投与した。投与1時間後にマイクロニードルパッチを回収し、顕微鏡観察を行い、全てのマイクロニードルが皮膚に垂直に刺入され、均等に溶解しているかを検査した。
(1)マイクロニードルパッチとパッチケースの間の接着は、熱融着法の方が、粘着法よりスムースな取り外しができる。
(2)マイクロニードルパッチはパッチケースの縁部の上に置くより下に取り付ける方が、スムースな取り外しができる。
アプリケータの最前面にパッチケース/マイクロニードルパッチを装着すると、投与に際してアプリケータが皮膚に接触しない利点がある。
アプリケータ最前面にパッチケースを装着するため、図4のようなパッチケース10を試作した。このパッチケース10は、アプリケータに装着するための留め金11を2個備えている。このパッチケース10にマイクロニードルパッチを熱融着により取り付けた上、アプリケータ12に留め金を用いてはめ込み装着したものを図5に示す。
このパッチケースは使い捨てとすることができ、またマイクロニードルパッチはあらかじめパッチケースに装着した状態で出荷することができる。
多数の被投与者にマイクロニードルパッチを連続投与する際には、マイクロニードルパッチが取り付けられている使い捨てパッチケースを取り替えていけば、皮膚感染の恐れなしに同じアプリケータを用いて連続投与することができる。
熱融着条件を変化させて破断強度が異なる支持体フィルム付パッチケースを作製した。支持体フィルムはポリエチレン(厚さ50μm)/PET(厚さ20μm)ラミネートフィルム(パナック株式会社)を用いた。支持体フィルムは直径28mm円形であり前面(パッチケースから見て下方)であるPET上にアクリル粘着剤(HiPAS、コスメディ製薬(株)製)を厚さ50μmに塗布した。パッチケースは射出成型した図4の形状であり、材料は高密度ポリエチレン(ノバテックHD、日本ポリエチレン(株))であった。パッチケースの縁(図3の5)は支持体フィルムを十分に熱融着可能な面積を有し、パッチケースの内径は2.3cmであった。実施例1と同様にして支持体フィルムとパッチケースとを融着した。融着ヘッド先端の温度は190℃程度であった。加熱された融着ヘッド尖端を、支持体フィルムの表面から0.2mm~0.5mm程度押し込んで融着させた。融着ヘッドを接触させ0.3秒~1秒保持しすぐに融着ヘッドを離した。押し込み深さと接触時間を変化させることにより融着の度合いを種々に変化させた。同一条件で作製した融着物5サンプルの破断強度を測定して、その最大値及び最小値を「本条件破断強度」とした。熱融着の破断強度に関しては、引っ張り試験機を用い直径1cmの円柱棒を図3に示す構成の支持体フィルム付パッチケースの上方から融着面を圧縮することにより定量化した。試験は室温下で相対湿度40~60%において実施した。引っ張り試験機は島津製作所製、小型卓上試験機EZ Test EZSXを用いた。圧縮速さは10mm/minであった。
投与に先立ち全サンプルは保存、輸送安定性試験を実施した。本試験は、マイクロニードルアレイ/支持体フィルム/ケースが一体化したものを高さ1mから床に自然落下させることを10回繰り返し融着部の剥離を観察した。以上の結果を表2に示す。
2 パッチケース
3 熱可塑性フィルム
4 粘着テープ
5 パッチケースの縁部
6 金属製融着ヘッド
7 アプリケータの衝撃方向
10 アプリケータ前面装着用パチッケース
11 留め金
12 アプリケータ
Claims (9)
- 熱可塑性高分子を素材とし、
該熱可塑性高分子と熱融着可能な支持体フィルムを備えるマイクロニードルパッチを保持しているパッチケース。 - 前記熱可塑性高分子と前記支持体フィルムの熱融着可能な素材とが、共にポリオレフィンであることを特徴とする請求項1に記載のマイクロニードルパッチを保持しているパッチケース。
- 前記熱可塑性高分子と前記支持体フィルムの熱融着可能な素材とが、共に同一の熱可塑性高分子であることを特徴とする請求項1又は2に記載のマイクロニードルパッチを保持しているパッチケース。
- 前記パッチケースの縁部の下側に前記マイクロニードルパッチを熱融着により取り付けていることを特徴とする請求項1~3のいずれか1項に記載のマイクロニードルパッチを保持しているパッチケース。
- 熱融着部の破断強度が0.01~20Nであることを特徴とする請求項4に記載のマイクロニードルパッチを保持しているパッチケース。
- 熱融着パターンが3点以上の複数点融着、破線融着、実線融着、または全面融着であることを特徴とする請求項4又は5に記載のマイクロニードルパッチを保持しているパッチケース。
- アプリケータの前面に取り付けるための、留め金若しくはネジを有することを特徴とする請求項1~6のいずれか1項に記載のマイクロニードルパッチを保持しているパッチケース。
- 熱可塑性高分子を素材とし、
該熱可塑性高分子と熱融着可能な支持体フィルムを備えるマイクロニードルパッチを保持できるパッチケース。 - 熱可塑性高分子を素材とし、保持されるマイクロニードルパッチの粘着テープの支持体フィルムは該熱可塑性高分子と熱融着可能な素材であり、該マイクロニードルパッチを保持しているパッチケースをアプリケータの前面に取り付けることを特徴とするマイクロニードルパッチを保持しているパッチケースの使用方法。
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AU2017232609B2 (en) | 2022-01-13 |
EP3431133A4 (en) | 2019-11-13 |
AU2017232609A1 (en) | 2018-10-04 |
JP6923183B2 (ja) | 2021-08-18 |
CN109069816A (zh) | 2018-12-21 |
CN109069816B (zh) | 2022-03-25 |
JP2017170139A (ja) | 2017-09-28 |
EP3431133A1 (en) | 2019-01-23 |
EP3431133B1 (en) | 2022-04-20 |
KR102377747B1 (ko) | 2022-03-23 |
KR20180124042A (ko) | 2018-11-20 |
US20190099590A1 (en) | 2019-04-04 |
US11484695B2 (en) | 2022-11-01 |
CA3017704C (en) | 2024-02-20 |
CA3017704A1 (en) | 2017-09-21 |
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