WO2011081017A1 - テープ製剤 - Google Patents
テープ製剤 Download PDFInfo
- Publication number
- WO2011081017A1 WO2011081017A1 PCT/JP2010/072451 JP2010072451W WO2011081017A1 WO 2011081017 A1 WO2011081017 A1 WO 2011081017A1 JP 2010072451 W JP2010072451 W JP 2010072451W WO 2011081017 A1 WO2011081017 A1 WO 2011081017A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- drug
- layer
- adhesive layer
- tape preparation
- cover film
- Prior art date
Links
- 238000002360 preparation method Methods 0.000 title claims abstract description 68
- 239000002390 adhesive tape Substances 0.000 title abstract 4
- 239000010410 layer Substances 0.000 claims abstract description 106
- 239000003814 drug Substances 0.000 claims abstract description 79
- 239000012790 adhesive layer Substances 0.000 claims abstract description 66
- 239000013039 cover film Substances 0.000 claims abstract description 60
- 239000010408 film Substances 0.000 claims abstract description 53
- 239000000853 adhesive Substances 0.000 claims abstract description 16
- 230000001070 adhesive effect Effects 0.000 claims abstract description 16
- 238000010030 laminating Methods 0.000 claims abstract description 4
- 229940079593 drug Drugs 0.000 claims description 75
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- 238000000034 method Methods 0.000 claims description 24
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- 238000009472 formulation Methods 0.000 claims description 17
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- CGIGDMFJXJATDK-UHFFFAOYSA-N indomethacin Chemical compound CC1=C(CC(O)=O)C2=CC(OC)=CC=C2N1C(=O)C1=CC=C(Cl)C=C1 CGIGDMFJXJATDK-UHFFFAOYSA-N 0.000 description 4
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- KVYGGMBOZFWZBQ-UHFFFAOYSA-N benzyl nicotinate Chemical compound C=1C=CN=CC=1C(=O)OCC1=CC=CC=C1 KVYGGMBOZFWZBQ-UHFFFAOYSA-N 0.000 description 2
- YKPUWZUDDOIDPM-SOFGYWHQSA-N capsaicin Chemical compound COC1=CC(CNC(=O)CCCC\C=C\C(C)C)=CC=C1O YKPUWZUDDOIDPM-SOFGYWHQSA-N 0.000 description 2
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Images
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
- A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
- A61K9/703—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches
- A61K9/7084—Transdermal patches having a drug layer or reservoir, and one or more separate drug-free skin-adhesive layers, e.g. between drug reservoir and skin, or surrounding the drug reservoir; Liquid-filled reservoir patches
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F13/00—Bandages or dressings; Absorbent pads
- A61F13/00051—Accessories for dressings
- A61F13/00059—Accessories for dressings provided with visual effects, e.g. printed or colored
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F13/00—Bandages or dressings; Absorbent pads
- A61F13/00051—Accessories for dressings
- A61F13/00063—Accessories for dressings comprising medicaments or additives, e.g. odor control, PH control, debriding, antimicrobic
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
- A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
- A61K9/703—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches
- A61K9/7038—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F13/00—Bandages or dressings; Absorbent pads
- A61F13/02—Adhesive bandages or dressings
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F13/00—Bandages or dressings; Absorbent pads
- A61F13/02—Adhesive bandages or dressings
- A61F13/0246—Adhesive bandages or dressings characterised by the skin-adhering layer
- A61F13/0256—Adhesive bandages or dressings characterised by the skin-adhering layer characterized by the parametric properties of the adhesive
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- A—HUMAN NECESSITIES
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- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F13/00—Bandages or dressings; Absorbent pads
- A61F13/02—Adhesive bandages or dressings
- A61F13/0259—Adhesive bandages or dressings characterised by the release liner covering the skin adhering layer
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F13/00—Bandages or dressings; Absorbent pads
- A61F2013/00361—Plasters
- A61F2013/00655—Plasters adhesive
- A61F2013/0071—Plasters adhesive containing active agent
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- A—HUMAN NECESSITIES
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- A61F13/00—Bandages or dressings; Absorbent pads
- A61F2013/00361—Plasters
- A61F2013/00846—Plasters with transparent or translucent part
- A61F2013/00851—Plasters with transparent or translucent part with grid or reference marks
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- 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
Definitions
- the present invention relates to a tape preparation, and in particular, a tape preparation that has a followability to movement when attached to a joint part that is a refractive part of a human body or an uneven part, and is not easily peeled off even by perspiration. About.
- the conventional tape preparation includes a support 11 on which a drug-containing adhesive layer (plaster layer) 12 is laminated and a release film 13 that covers the drug-containing adhesive layer (plaster layer) 12.
- Formulation 10 In actual sticking, the release film 13 is peeled off and the plaster layer is pasted together with the support. However, in order to improve the followability at the pasting site, the support layer on which the plaster layer is laminated is stretched. Polyvinyl chloride and polyester films, knits, woven fabrics, nonwoven fabrics, etc. are used.
- the thickness of the support in this tape preparation is thin in order to ensure followability, and is about 100 to 200 ⁇ m for a film and about 700 to 1200 ⁇ m for a nonwoven fabric or knit.
- the support used is very flexible, and therefore it is difficult to handle at the stage where the release sheet is peeled off and applied, and the application often fails. ing.
- Patent Documents 1 to 4 are mainly studies on drug-containing adhesive layers.
- the formulation design with strong adhesive force avoids this problem, but it does not lead to a solution.
- the keratin was damaged or internal bleeding occurred.
- the conventional tape preparation has the following problems. (1) When affixed to a joint site or the like, peeling tends to occur from the end. (2) Peeling easily occurs due to sweating or the like. (3) A flexible support having high stretchability is difficult to handle and is often damaged. (4) The followability to the affected area is poor, and rashes and sticking marks are left. (5) Although the affected part is required to follow, the support is expensive.
- the present invention solves the above-mentioned conventional problems, and can follow the skin without using a support such as a polyvinyl chloride or polyester film, knit, woven fabric or nonwoven fabric which has been used so far. Therefore, it is an object of the present invention to provide a tape preparation that can be easily used regardless of age and sex even when applied, and that can be manufactured without changing any of the conventional production lines.
- the printing ink layer of the cover film subjected to the printing is obtained by laminating a drug-containing adhesive layer on the printed cover film instead of the conventional support.
- the present invention is characterized in that a printing ink layer is used in place of a conventional support layer in a tape preparation, and the drug layer is covered with the printing ink layer.
- the basic aspect of the present invention for solving such problems is that a drug-containing adhesive layer is laminated on the printed ink layer side of the printed cover film, and the drug-containing adhesive layer is covered with a release film. It is a tape formulation characterized by this.
- the present invention relates to the above tape preparation, wherein the adhesive strength between the cover film and the printing ink layer exceeds the adhesive strength between the drug-containing adhesive layer and the release film, and the printing ink layer and the drug-containing adhesive layer
- the tape preparation is characterized in that its adhesive strength exceeds the adhesive strength between the cover film and the printing ink layer.
- the present invention provides the above-mentioned tape, wherein the release film is peeled off and applied, and then the print cover film is peeled off so that the drug-containing adhesive layer is attached to the application site in a state where the printing ink layer is laminated. It is a formulation.
- the tape preparation is characterized in that a slit is provided in the cover film and / or the release film in order to facilitate release from the printing ink layer of the cover film or release from the drug-containing adhesive layer of the release film.
- the present invention specifically relates to a tape preparation in which a drug-containing adhesive layer is laminated on the printed ink layer side of a printed cover film, and the drug-containing adhesive layer is coated with a release film,
- the tape preparation is characterized in that after peeling off, the drug-containing adhesive layer is stuck on the application surface, and then the cover film is peeled off to complete the sticking.
- the present invention also provides a method for using the tape preparation described above, wherein the release film is peeled off and the drug-containing adhesive layer is attached to the application surface, and then the cover film is further peeled off to complete the attachment. .
- the printing ink layer is thinner than the current support, it does not hinder the original elasticity and stretchability possessed by the drug-containing adhesive layer (plaster layer). Therefore, the followability at the application site is extremely good.
- the printing ink layer also follows the stretchability of the drug-containing adhesive layer (plaster layer), peeling from the site where the tape preparation is applied due to the conventional support will not occur.
- the printing ink layer has moisture permeability, so there is no sweating action at the application site, and even if it is applied during sweating in summer, it peels off. It is difficult.
- the basic aspect of the present invention is that a drug-containing adhesive layer is laminated on the printed ink layer side of a printed cover film, and the drug-containing adhesive layer is covered with a release film.
- a tape preparation That is, the tape preparation of the present invention is characterized in that a printing ink layer is used in place of the conventional support layer.
- the schematic sectional side view was shown in FIG. That is, the tape preparation 1 of the present invention is characterized in that a drug-containing adhesive layer 4 is laminated on the printed ink layer 3 side of a printed cover film 2 and the drug-containing adhesive layer 4 is covered with a release film 5.
- Tape formulation below, it explains by explaining each component about the tape formulation which this invention provides.
- the tape preparation 1 of the present invention is characterized in that the printing ink layer 3 is used in place of the conventional support layer.
- the printing ink layer 3 is provided by printing the printing ink layer 3 on the cover film 2 using the printing ink.
- the printing ink layer 3 provided on the cover film 2 is separated from the cover film 2.
- FIG. 1 shows the structure used as the independent printing ink layer 3.
- the material of the cover film 2 is not particularly limited, and plastic films such as polypropylene (PP), polyethylene terephthalate (PET), polyethylene (PE), and polystyrene (PS), paper, and synthetic paper , Synthetic resin alone or laminated and composite, aluminum foil, laminated film and laminated material and the above materials, further corona treatment or silicon processing or fluorine processing on the single material or composite material, What gave embossing and mat processing can be used.
- plastic films such as polypropylene (PP), polyethylene terephthalate (PET), polyethylene (PE), and polystyrene (PS), paper, and synthetic paper , Synthetic resin alone or laminated and composite, aluminum foil, laminated film and laminated material and the above materials, further corona treatment or silicon processing or fluorine processing on the single material or composite material, What gave embossing and mat processing can be used.
- the method for forming the material of the cover film 2 may be any method, and specifically includes an inflation method, a T-die method, a calendar method, a casting method, and the like, and is not particularly limited.
- the shape of the cover film 2 in the tape preparation of the present invention is not particularly limited, but it is the same size as the drug-containing adhesive layer (plaster layer) 4 or the drug in consideration of productivity and handling at the time of application. It is preferably designed to be slightly larger than the contained pressure-sensitive adhesive layer (plaster layer) 4 and preferably smaller than the release film 5.
- the cover film 2 is preferably provided with a notch (slit) in order to facilitate peeling from the printing ink layer 3 after the tape preparation 1 is applied.
- the cover film 2 has a thickness of about 12 ⁇ m to 200 ⁇ m, preferably 12 ⁇ m to 100 ⁇ m. As the thickness of the cover film becomes smaller than 12 ⁇ m, it is not preferable because it is easy to cut at the time of manufacture due to its thinness, and furthermore, handling becomes difficult when peeling from the printing ink layer 3 after application. Further, as the cover film becomes thicker than 200 ⁇ m, the handling becomes easier, but it is not preferable because it increases the cost.
- a printing ink layer 3 is provided in a laminated state instead of the conventional support layer for the drug-containing adhesive layer (plaster layer) 4.
- the printing ink layer 3 is laminated by printing on the cover film 2.
- the printing method is not particularly limited, but gravure printing, offset printing, flexographic printing, silk screen printing, and the like are preferable.
- the type of ink used for printing it is preferable to use ink suitable for various printing methods.
- the printing ink layer 3 is exposed as a surface portion after being applied, It is necessary to consider oil resistance, alkali resistance, friction resistance, peelability, flexibility, etc. Furthermore, since it is in direct contact with the drug-containing adhesive layer (plaster layer) 4, consideration must be given to chemical resistance. is there.
- the first printing on the cover film 2 it is preferable to coat and protect the colored ink layer 3 by printing the above-described transparent ink or varnish having each resistance. Further, by coating the printing ink layer 3 in the same manner at the end of printing, it is possible to ensure the resistance to the drug-containing adhesive layer (plaster layer) 4 and to wind up the printed cover film 2. This has the advantage that the blocking phenomenon that occurs at the time can be suppressed.
- the thickness of the printing ink layer 3 is not particularly limited, but is preferably about 1 to 100 ⁇ m, and particularly preferably about 2 to 10 ⁇ m.
- the drug-containing adhesive layer (plaster layer) 4 is laminated on the printed ink layer 3 side of the cover film 2 subjected to the above printing.
- the adhesive layer base component constituting the drug-containing adhesive layer (plaster layer) 4 is not particularly limited as long as it becomes a base of the adhesive layer that is a paste composition, and in a conventional tape formulation Everything used is adaptable. Specifically, hydrophobic polymers such as rubber polymers, acrylic polymers, and silicon polymers are preferably used.
- the drug-containing adhesive layer 4 is laminated on the printed ink layer 3 side of the printed cover film 2, and the laminated drug-containing adhesive layer 4 is covered with the release film 5. It is comprised by.
- the material of the release film 5 to be used is not particularly limited, and a plastic film such as polypropylene (PP), polyethylene terephthalate (PET), polyethylene (PE), polystyrene (PS), paper, synthetic paper, synthetic resin alone, or Laminated and compounded, aluminum foil, laminated film and vapor-deposited film and the above materials, and single material or composite material, corona treatment, silicon processing, fluorine processing, embossing, mat processing, printing or Colored ones are used.
- PP polypropylene
- PET polyethylene terephthalate
- PE polyethylene
- PS polystyrene
- the film forming method of the material of the release film 5 may be any method, and specifically includes an inflation method, a T-die method, a calendar method, a casting method, and the like, and is not particularly limited.
- the shape of the release film 5 in the tape preparation 1 of the present invention is not particularly limited, but it is preferably designed larger than the drug-containing adhesive layer 4 or the cover film 2 in consideration of productivity and handling at the time of application. In order to prevent finger injury, it is preferable to chamfer the corners of the release film 5. In addition, in order to clarify the sticking method of a tape formulation, a character, an arrow, a symbol, an illustration, etc. can also be displayed or colored on the peeling film 5.
- the thickness of the release film 5 in the present invention is preferably 12 ⁇ m to 200 ⁇ m, preferably 38 ⁇ m to 150 ⁇ m. As the thickness of the release film becomes thinner than 12 ⁇ m, wrinkles are likely to occur during production due to the thinness of the release film. Moreover, it becomes unpreferable since it becomes a factor of a cost increase as the thickness of a peeling film becomes thicker than 200 micrometers.
- the tape preparation 1 of the present invention having such a configuration is peeled off the release film 5 and affixed the exposed drug-containing adhesive layer 4 to the application surface, and further peeled off the cover film 2 from the tape preparation.
- the printing ink layer 3 is exposed as a surface portion instead of the conventional support layer for the drug-containing adhesive layer 4. Therefore, in order to facilitate such sticking, the adhesive strength between the cover film 2 and the printing ink layer 3 is higher than the adhesive strength between the drug-containing pressure-sensitive adhesive layer 4 and the release film 5, and the printing ink layer 3 And the adhesive strength between the drug-containing adhesive layer 4 is preferably higher than the adhesive strength between the cover film 2 and the printing ink layer 3.
- the release film 5 is preferably subjected to moderate rigidity and light release treatment in consideration of handling at the time of release.
- This peeling of the release film 5 requires that the drug-containing pressure-sensitive adhesive layer 4 to be a sticking surface first be exposed when the tape preparation 1 of the present invention is applied, and therefore, between the cover film 2 and the printing ink layer 3, and
- the drug-containing pressure-sensitive adhesive layer must be designed to be coated with an adhesive strength lower than that between the printing ink layer 3 and the agent-containing pressure-sensitive adhesive layer 4.
- Various drugs can be blended in the drug-containing adhesive layer 4 in the tape preparation 1 provided by the present invention in accordance with its use.
- indomethacin, ketoprofen, flurbiprofen, ibuprofen, ferbinac, diclofenac, glycol salicylate, methyl salicylate, glycyrrhizic acid, dipotassium glycyrrhizinate, ⁇ -glycyrrhizic acid, etc. may be blended as analgesic / anti-inflammatory ingredients. it can.
- tocopherol acetate, capsicum extract, capsaicin, nonyl acid vanillylamide, benzyl nicotinate, benzyl alcohol and the like as an antiallergic component, diphenhydramine, chlorpheniramine maleate and the like; -Menthol, camphor, mint oil, eucalyptus oil, etc .; local anesthetic ingredients such as lidocaine, benzocaine, dibucaine, tetracaine, etc .; sinking ingredients such as crotamiton, but not limited thereto.
- These drugs can be used in combination of two or more as required.
- the blending amount of the drug to be blended is appropriately selected according to the type and use of the patch such as a tape preparation so that an effective amount preset when applied to the patient can be applied to the affected area.
- the tape agent provided by the present invention is not limited to the one containing only the above-described pharmaceutical agent, and can be applied to cosmetics such as various fragrances, moisturizing ingredients, and whitening ingredients. Absent.
- FIG. 2 is a schematic sectional side view of a tape preparation 101 based on Embodiment 1, which is a basic aspect of the tape preparation of the present invention. That is, in the tape preparation 101 of the present invention, the drug-containing adhesive layer 104 is sequentially laminated on the printed ink layer 103 side of the printed cover film 102, and the drug-containing adhesive layer is covered with the silicon-coated release film 105. The configuration is adopted.
- a drug-containing adhesive layer (plaster layer) on a silicon surface of 75 ⁇ m thick polyethylene terephthalate (PET) to which silicon processing (silicon coating) 35 is applied [in the figure, drug As a layer], a paste composition containing crotamiton, lidocaine, diphenhydramine is applied, and further, a matte-processed expanded polypropylene (OPP) with a thickness of 40 ⁇ m is used as a cover film for gravure printing on the entire surface of the transparent ink processed surface
- OPP matte-processed expanded polypropylene
- the laminate other than the release film is punched into a circle with a diameter of 30 mm, and after the slit 30 is applied only to the cover film layer 102 at the center of the circle, the non-circular mimetic portion is removed to prevent itching. It is a patch.
- FIG. 3 shows a schematic diagram of the usage method.
- the release film 102 is first peeled to expose the drug-containing adhesive layer, and is applied to the application affected part (skin surface) 40.
- the tape preparation including the circular drug-containing adhesive layer (drug layer) on which the printed cover film is laminated is picked so as to be lightly pinched with fingers from the end, the cover film 102 is removed from the slit portion provided in the center portion.
- the printing ink layer 103 is exposed as a surface portion, and the tape preparation is finished.
- the printing ink layer 103 is thinner than the conventional support. Therefore, the followability at the application site is extremely good without inhibiting the elasticity and stretchability of the plaster layer. Further, when the printing ink layer 103 is transparent, it is not visually noticeable at all. In addition, since the printing ink layer follows the stretchability of the paste layer, it can maintain a stable application state in which peeling from the application site of the tape preparation does not occur.
- FIG. 4 shows a schematic side sectional view of a tape preparation 201 based on Embodiment 2, which is another basic aspect of the tape preparation of the present invention. That is, even in the tape preparation 201 of the present invention, the drug-containing adhesive layer 204 was sequentially laminated on the printed ink layer 203 side of the printed cover film 202, and the drug-containing adhesive layer 204 was coated with the silicon coating 35. Although the structure covered with the release film 205 is employed, in this embodiment, the slit 30 is provided in the central portion on the release film 205 side.
- a drug-containing adhesive layer (plaster layer) 204 [in the figure, a drug is applied to the silicon surface side of polyethylene terephthalate (PET) having a thickness of 38 ⁇ m subjected to silicon processing (silicon coating). Layer] was coated with a plaster composition containing indomethacin and l-menthol, and subjected to silk screen printing with flexible ink on the corona-treated surface of 75 ⁇ m-thick stretched polypropylene that had been subjected to corona treatment. The cover film 202 was used, and the original layer was formed by coating the drug layer 204 with the printing ink layer 203.
- an analgesic / anti-inflammatory tape agent obtained by performing slit 30 treatment on the central portion of the release film 205 in the next step and punching the original fabric into a 70 mm ⁇ 100 mm square.
- FIG. 5 shows a schematic diagram of the method of use.
- the release film 205 of the analgesic / anti-inflammatory tape is folded outward, and one side of the release film 205 is peeled off.
- the exposed single-sided plaster surface (drug layer) 204 is affixed to the affected part (skin surface) 40 and temporarily fixed, and the remaining release film 205 is similarly peeled to expose the plaster surface (drug layer) 204 and press-bond. Apply the entire plaster surface to the affected area.
- FIG. 6 schematically shows how to remove the subsequent cover sheet.
- the cover film 202 having high rigidity is peeled (in the figure, an arrow), when this is grasped and peeled off, the printing ink layer 203 is exposed as a surface portion, and the pasting operation is completed.
- the tape preparation of the present invention described above with reference to the above drawings and the method for applying the tape preparation are descriptions based on specific embodiments of the present invention, and the present invention can be modified in various ways. As long as it is a tape preparation characterized by laminating a drug-containing adhesive layer on the printed ink layer side of a printed cover film and covering the drug-containing adhesive layer with a release film, the technical scope of the present invention Needless to say, it is included in
- a drug-containing adhesive layer is laminated on a printed cover film, and the printed ink layer of the printed cover film is pasted.
- a coating layer for the adhesive layer By using a coating layer for the adhesive layer, a very good tape preparation with excellent followability is provided.
- the tape preparation provided by the present invention has the effects described above, and its industrial advantages are enormous.
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Abstract
Description
これらのテープ製剤は、その目的に応じて貼付する部位が千差万別であり、屈曲部位である肘或いは膝の関節など、或いは顔、首、肩等の湾曲部位への貼付されることが多い。
従来のテープ製剤は、図7に示すように、薬剤含有粘着層(膏体層)12を積層する支持体11と、薬剤含有粘着層(膏体層)12を被覆する剥離フィルム13からなるテープ製剤10である。
実際の貼付に際しては、剥離フィルム13を剥がして、膏体層を支持体と共に貼付するものであるが、貼付部位での追随性を向上させるために、膏体層を積層する支持体には伸縮性のあるポリ塩化ビニルやポリエステルのフィルム、ニットや織物、不織布等が使用されている。
そのうえ、テープ製剤にあっては、使用されている支持体は極めて柔軟なものであり、したがって、剥離シートを剥がして貼付する段階で、取扱いが困難になり、貼付に失敗する場合が頻繁に起こっている。
また、テープ製剤に特有の引き攣りシワの発生がみられ、貼付したテープ製剤が端部から剥がれ易くなる問題もみられている。
さらに、支持体としてポリ塩化ビニルやポリエステルフィルム等を使用した場合には、その密封性による発汗作用でテープ製剤の剥がれが生じてしまうことがある。
これらの検討は、主として薬物含有粘着層についての検討であり、例えば、粘着力の強い製剤設計でこの問題を回避しているものの解決には至らず、逆に患部からテープ製剤を剥がす際の副作用として、角質を損壊したり内出血を起こしたりする場合がみられるものであった。
(1)関節部位等に貼付した際に、端部より剥がれが生じやすい。
(2)発汗等により、剥がれが生じやすい。
(3)伸縮性が高い柔軟な支持体は、取扱いが困難で貼り損じが多い。
(4)患部への追随性が悪く、かぶれや貼付跡が付く。
(5)患部追随性を求めるものの、支持体が高価なものとなる。
すなわち、本発明のテープ製剤にあっては、
(1)印刷インク層は、現行の支持体よりも薄いものとなることから、薬剤含有粘着層(膏体層)が所有する本来の弾性、及び伸縮性を阻害することがない。
したがって、適用部位における追随性が極めて良好なものとなる。
(2)印刷インク層は、また、薬剤含有粘着層(膏体層)の伸縮性に追随するので、従来の支持体に起因するテープ製剤の貼付部位からの剥がれが生じないこととなる。
(3)印刷インク層は、従来のフィルム状の支持体とは異なり、水分透過性を有しているため、貼付部位での発汗作用がなく、また、夏場の発汗時に貼付したとしても、剥がれにくいものである。
(4)貼付部位への追随性が良好なため、薬剤含有粘着層(膏体層)粘着性を強める必要がなく、したがって、貼付部位に対する負荷が減少し、貼付跡が残りにくいものである。
(5)適用部位への貼付に際しては、カバーフィルムの剛性により、テープ製剤自体の取扱いが容易になることから、貼り損じが少なくなる。
(6)従来の生産ラインを変更することなく加工が可能であり、また、高価な原材料、特に高価な支持体を必要としないものであり、コストダウンが図れる利点を有している。
すなわち、本発明のテープ製剤にあっては、従来の支持体層に代えて、印刷インク層を使用する点に特徴を有するものである。
すなわち本発明のテープ製剤1は、印刷を施したカバーフィルム2の印刷インク層3側に薬剤含有粘着層4を積層させ、該薬剤含有粘着層4を剥離フィルム5で被覆したことを特徴とするテープ製剤である。
以下に、本発明が提供するテープ製剤について、各構成要素を解説することにより説明していく。
なお、カバーフィルム2には、テープ製剤1の貼付後において印刷インク層3からの剥離を容易ならしめるため、切り込み(スリット)を設けることが好ましい。
カバーフィルムの厚みが12μmより小さくなるにつれ、その薄さから製造時に切断し易くなり、更に、貼付後において印刷インク層3から剥離する際の取扱いが困難になるので好ましいものではない。
また、カバーフィルムの厚みが200μmを超えて厚くなるにつれ、取扱いは容易になるものの、コストアップの要因になることから好ましいものではない。
この印刷インク層3の積層手段としては、カバーフィルム2に印刷を施すことによって行われる。かかる印刷方法は、特に限定されないが、グラビア印刷、オフセット印刷、フレキソ印刷、シルクスクリーン印刷等が好ましい。
更に、印刷の最後に、印刷インク層3を同様にコーティングすることで、薬剤含有粘着層(膏体層)4への耐性を確保することができ、そのうえ、印刷されたカバーフィルム2を巻き取る際に生じるブロッキング現象を抑制することができる利点を有している。
かかる薬剤含有粘着層(膏体層)4を構成する粘着層基剤成分としては、膏体組成物である粘着剤層の基剤となるものであれば特に限定されず、従来のテープ製剤において使用されているものが全て適応できる。具体的には、ゴム系高分子、アクリル系高分子、およびシリコン系高分子等の疎水性高分子が好ましく使用される。
使用する剥離フィルム5の素材としては特に限定されず、ポリプロピレン(PP)、ポリエチレンテレフタレート(PET)、ポリエチレン(PE)、ポリスチレン(PS)等のプラスチックフィルムや紙、合成紙、合成樹脂を単体、またはラミネートして複合させたものや、アルミ箔、蒸着フィルムと上記素材をラミネートさせたもの、及び上記単一素材又は複合素材にコロナ処理またはシリコン加工やフッ素加工やエンボス加工、マット加工更には印刷又は着色を施したものが用いられる。
なお、テープ製剤の貼付方法を明確にするために、剥離フィルム5には文字、矢印、記号、イラスト等を表示または着色することもできる。
また、剥離フィルムの厚みが200μmより厚くなるにつれて、コストアップの要因になることから好ましくない。
したがって、かかる貼付を容易ならしめるために、カバーフィルム2と印刷インク層3間の接着強度は、薬剤含有粘着層4と剥離フィルム5間の接着強度より上回るものであり、且つ、印刷インク層3と薬剤含有粘着層間4の接着強度がカバーフィルム2と印刷インク層3間の接着強度より上回ることが好ましい。
具体的には、鎮痛・抗炎症成分として、インドメタシン、ケトプロフェン、フルルビプロフェン、イブプロフェン、フェルビナク、ジクロフェナク、サリチル酸グリコール、サリチル酸メチル、グリチルリチン酸、グリチルリチン酸ジカリウム、β-グリチルリチン酸等を配合することができる。
なお、これら薬物は必要に応じて2種類以上併用することも可能である。
図2は、本発明のテープ製剤の基本的態様である、実施の形態1に基づくテープ製剤101の概略側断面図である。
すなわち、本発明のテープ製剤101は、順次、印刷を施したカバーフィルム102の印刷インク層103側に薬剤含有粘着層104を積層させ、該薬剤含有粘着層をシリコンコートされた剥離フィルム105で被覆した構成を採用している。
図3に、その使用方法の概略図を示した。
図中に示すように、最初に剥離フィルム102を剥離して薬剤含有粘着層を露呈させ、適用患部(皮膚面)40に貼付する。次いで、印刷を施したカバーフィルムが積層された円形の薬剤含有粘着層(薬剤層)を含めたテープ製剤を端から手指で軽く挟むように摘むと、中央部に設けたスリット部分からカバーフィルム102が剥離される(図中、矢印)ので、これを掴んで各々引き剥がすと、表面部分として印刷インク層103が露出して、テープ製剤の貼付作業が終了する。
また、印刷インク層は、膏体層の伸縮性に追随するため、テープ製剤の貼付部位からの剥がれが生じない安定した貼付状態を維持し得ることとなる。
図4に、本発明のテープ製剤の別の基本的態様である、実施の形態2に基づくテープ製剤201の概略側断面図を示した。
すなわち、本発明のテープ製剤201にあっても、順次、印刷を施したカバーフィルム202の印刷インク層203側に薬剤含有粘着層204を積層させ、該薬剤含有粘着層204をシリコンコート35された剥離フィルム205で被覆した構成を採用しているが、本実施例においては、剥離フィルム205側中央部にスリット30を施しているものである。
図5に、その使用方法の概略図を示した。
図中に示すように、最初に鎮痛・消炎テープ剤の剥離フィルム205を外側に折り曲げて、剥離フィルム205の片方を剥がし取る。
次いで、露出した片面の膏体面(薬剤層)204を患部(皮膚面)40に貼付して仮止めし、残る剥離フィルム205も同様に剥がして膏体面(薬剤層)204を露出させ、圧着させ、患部に膏体面全体を貼付する。
また、印刷インク層は、膏体層の伸縮性に追随するため、テープ製剤の貼付部位からの剥がれが生じない安定した貼付状態を維持し得ることとなる。
本発明により提供されるテープ製剤は、前記した効果を有するものであり、その産業上の利点は、多大なものである。
2、102、202 カバーフィルム
3、103、203 印刷インク層
4、104、204 薬剤含有粘着層
5、105、205 剥離フィルム
30 スリット
35 シリコン層
Claims (6)
- 印刷を施したカバーフィルムの印刷インク層側に薬剤含有粘着層を積層させ、該薬剤含有粘着層を剥離フィルムで被覆したことを特徴とするテープ製剤。
- カバーフィルムと印刷インク層の接着強度が薬剤含有粘着層と剥離フィルム間の接着強度を上回り、且つ、印刷インク層と薬剤含有粘着層間の接着強度がカバーフィルムと印刷インク層の接着強度を上回ることを特徴とする請求項1に記載のテープ製剤。
- 剥離フィルムを剥がして貼付した後、印刷カバーフィルムを剥がすことにより、貼付部位に薬剤含有粘着層が印刷インク層を積層した状態で貼付されることを特徴とする請求項1又は2に記載のテープ製剤。
- カバーフィルム及び/又は剥離フィルムにスリットを設けたことを特徴とする請求項1、2又は3に記載のテープ製剤。
- 印刷を施したカバーフィルムの印刷インク層側に薬剤含有粘着層を積層させ、該薬剤含有粘着層を剥離フィルムで被覆したテープ製剤であって、剥離フィルムを剥がした後、薬剤含有粘着層を適用面に貼付後、カバーフィルムを剥がして貼付を完了させることを特徴とする請求項1ないし4のいずれかに記載のテープ製剤。
- 剥離フィルムを剥がして薬剤含有粘着層を適用面に貼付後、さらにカバーフィルムを剥がして貼付を完了させることを特徴とする請求項1ないし4のいずれかに記載のテープ製剤の使用方法。
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CA2785263A CA2785263C (en) | 2009-12-28 | 2010-12-14 | Tape preparation |
US13/519,440 US9149443B2 (en) | 2009-12-28 | 2010-12-14 | Tape preparation |
CN201080059854.7A CN102665624B (zh) | 2009-12-28 | 2010-12-14 | 胶带制剂 |
ES10840875T ES2739469T3 (es) | 2009-12-28 | 2010-12-14 | Preparación de cinta adhesiva |
AU2010337633A AU2010337633B2 (en) | 2009-12-28 | 2010-12-14 | Tape Preparation |
EP10840875.8A EP2520257B1 (en) | 2009-12-28 | 2010-12-14 | Adhesive tape preparation |
JP2011547487A JP5756029B2 (ja) | 2009-12-28 | 2010-12-14 | テープ製剤 |
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EP (1) | EP2520257B1 (ja) |
JP (1) | JP5756029B2 (ja) |
KR (1) | KR101791712B1 (ja) |
CN (1) | CN102665624B (ja) |
AU (1) | AU2010337633B2 (ja) |
CA (1) | CA2785263C (ja) |
ES (1) | ES2739469T3 (ja) |
TW (1) | TWI554254B (ja) |
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EP3305259A4 (en) * | 2015-05-29 | 2019-02-13 | Kyowa Limited | MEDICAL TAPE |
EP3167855A1 (en) * | 2015-11-13 | 2017-05-17 | Mölnlycke Health Care AB | Medical dressing |
WO2018126170A1 (en) * | 2016-12-30 | 2018-07-05 | Euromed, Inc. | Adhesive patch containing an improved release liner system |
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DE102018220589A1 (de) * | 2018-11-29 | 2020-06-04 | Lts Lohmann Therapie-Systeme Ag | Transdermales System mit Überpflaster und Ringsystem |
JP7057299B2 (ja) * | 2019-02-21 | 2022-04-19 | ニチバン株式会社 | 伸縮性パッドを用いた医療用貼付材 |
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Also Published As
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US20120316519A1 (en) | 2012-12-13 |
JP5756029B2 (ja) | 2015-07-29 |
JPWO2011081017A1 (ja) | 2013-05-09 |
KR101791712B1 (ko) | 2017-10-30 |
AU2010337633B2 (en) | 2014-01-30 |
CA2785263A1 (en) | 2011-07-07 |
EP2520257A1 (en) | 2012-11-07 |
ES2739469T3 (es) | 2020-01-31 |
EP2520257B1 (en) | 2019-06-19 |
US9149443B2 (en) | 2015-10-06 |
AU2010337633A1 (en) | 2012-07-12 |
CA2785263C (en) | 2018-04-10 |
TW201132338A (en) | 2011-10-01 |
CN102665624A (zh) | 2012-09-12 |
CN102665624B (zh) | 2017-03-08 |
KR20120099288A (ko) | 2012-09-07 |
EP2520257A4 (en) | 2013-06-05 |
TWI554254B (zh) | 2016-10-21 |
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