JP2003155227A - Release film - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a release film for transdermal absorption medicines excellent in resistance to pharmaceutical components and resistance to organic solvents. SOLUTION: This release film 1 has a release layer 2 on either one surface of an intermediate substrate 3 and has a printing layer 4 on the other surface. In the release film 1, the printing layer 4 is formed by ultraviolet curing ink.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a drug (particularly, transdermal drug) release (release) film.

[0002]

2. Description of the Related Art Conventional release films for pharmaceuticals have been printed with vinyl urethane type two-component reaction type ink, polyester type room temperature reaction type ink, polyester type thermosetting type ink, etc. There is a problem that the resistance to certain methyl salicylate, menthol, etc. is low, and a coating film of silicone resin or the like was formed in order to give the mold release property of plaster (a drug containing a medicinal component) and a release film. There was a problem that the resistance to an organic solvent such as toluene used at that time was small, and the print became thin or disappeared.

[0003]

Therefore, the object of the present invention is excellent in resistance to medicinal components such as methyl salicylate and menthol, and to resistance to organic solvents such as toluene used when forming a releasable coating film with plaster. To provide a release film.

[0004]

In order to solve the above problems, in the present invention, a release film is printed with an ultraviolet curable ink. A coating film of a silicone resin layer is formed on the release surface of the release film. Further, it is preferable to use a polyester film as an intermediate base material of the release film.

The UV curable ink contains an acrylate resin having a urethane bond in the main molecular chain as a main component, and aziridine in a solid content ratio to the acrylate resin.
It is preferable to add 0.1 to 10% by weight.

The above-mentioned release film is suitable for use in pharmaceutical products such as transdermal drug delivery.

[0007]

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT An embodiment of the present invention will be described below with reference to the accompanying drawings. As shown in FIG. 1, release film 1
Is a laminated body including a peeling layer 2, an intermediate base material 3, and a printing layer 4. As the intermediate substrate 3, at least one selected from a synthetic resin film, paper, aluminum foil, a synthetic resin film obtained by vapor-depositing a metal or an oxide, or a composite of two or more thereof can be adopted. Polyethylene film, polypropylene film, nylon film, polyester film (PET film)
Film), polyvinylidene chloride, polyvinyl alcohol, polystyrene, ethylene vinyl acetate, ethylene vinyl alcohol copolymer film are preferable, and polyester film is particularly preferable. The thickness of the synthetic resin film is preferably from 15 to 150 μm. When the thickness is less than 15 μm, wrinkles and cracks are likely to occur because the waist (rigidity) is weak, and when it exceeds 150 μm, it is not desirable in terms of cost increase and handling.
When the intermediate base material 3 is paper, the basis weight is 20 to 150 g / m.
² pure white roll paper, kraft paper, fine paper, imitation paper,
Western paper, Japanese paper, various coated papers, etc. can be used. In the case of aluminum foil, pure aluminum foil or aluminum alloy foil having a thickness of about 5 to 100 μm is preferable. 1N30, 1070, 1100, 3003, 30 in JIS notation
04, 5052, 6061, 6063, 8021, 80
A material such as 79 can be used. Although it is possible to manufacture any of soft foil, semi-hard foil, and hard foil,
It is desirable to use a soft foil in terms of adhesiveness and the like. As a synthetic resin film on which a metal or an oxide is vapor-deposited, aluminum, silicon oxide, alumina, titanium oxide or the like is used as C
A synthetic resin film deposited by the VD or PVD method can be used. The thickness of the vapor deposition layer is generally 300 to
At 1200 Å, the above-mentioned various synthetic resin films can be adopted as the synthetic resin film serving as the base.

The release layer 2 laminated on one surface of the intermediate base material 3 may be made of a fluorine resin, a silicon resin, or the like, and the fluorine resin may be polytrifluoroethylene,
Examples thereof include polyvinylidene fluoride, polyvinyl fluoride, polytetrafluoroethylene, and the like, and the silicone resin is preferably a silicone resin. The thickness of the peeling layer 2 is preferably about 0.01 to 15 μm, and if it is less than 0.01 μm, it may be impossible to peel smoothly from the plaster, while 15 μm.
It is not desirable to exceed the value because the cost will increase. In order to form the release layer 2, the fluorine resin or silicon resin is appropriately diluted with a solvent such as toluene, MEK or ethyl acetate, and a roll coater, a bar coater or a doctor blade is provided on one surface of the intermediate base material 3. It may be applied by spraying, extrusion, or the like. The coating amount is 0.01 to 1 by weight after drying.
About 5 g / m ² is desirable.

As the ultraviolet curable ink used for the printing layer 4 of the release film 1, a known ultraviolet curable ink can be adopted. For example, the ultraviolet rays disclosed in Japanese Patent Laid-Open No. 2000-192260 and Japanese Patent No. 2712254. Cured inks and commercially available UV curable inks can be used. Specifically, (A) a compound having an average molecular weight of 800 or more and containing at least one epoxy group in the molecule, and (B) an acryloyl group, a methacryloyl group or other photosensitive group and a carboxyl group in the molecule. UV curing ink containing a reaction product with a compound containing and a photopolymerization initiator, aziridine in a solid content ratio based on an acrylate resin having a urethane bond in the main molecular chain as a main component,
It is possible to use an ultraviolet curable ink added with 0.1 to 10% by weight and other known ultraviolet curable ink. Commercially available UV curable inks include Lumikyua DPA-600T, DPA-620, TMN manufactured by Dainippon Ink and Chemicals, Inc.
-300, PEA-300, ETA-300, DTA-
400, DCA-200, DICURE FL-01 and the like. The addition amount of the aziridine is 0.1%.
If it is less than this, a remarkable effect is not recognized, and if it exceeds 10%, it is disadvantageous in terms of cost.

A photopolymerization initiator, a pigment, an additive, a solvent and the like are added to these ultraviolet curable inks as needed. As the photopolymerization initiator, benzophenone and its derivative, benzyl, benzoin and its alkyl ether,
There are thioxanthone and its derivatives, Lucillin TPO, Irgacure manufactured by Ciba Specialty Chemicals, and Esacure manufactured by Flattery Lamberti. As the pigment, a phthalocyanine-based, azo-based, titanium white, or other coloring pigment is added so that the pattern can be easily seen, and extender pigments such as silica, talc, clay, barium sulfate, and calcium carbonate are included. In particular, silica is an ultraviolet curable ink. After curing, it has an antiblocking effect when the film is wound up. Examples of the additive include a polymerization inhibitor such as 2-tertiarybutylhydroquinone, a defoaming agent such as silicon, a fluorine compound, and an acrylic polymer, and a leveling agent, which are appropriately added as necessary. Solvents are toluene, xylene, ME
Organic solvents such as K, IPA, ethanol, methanol and butanol, and mixed solvents of two or more thereof can be used. These solvents are necessary for applying (printing) the ultraviolet curable ink, and are substantially removed by drying after printing. Then, the coating film (printing layer 4) is cured by irradiating with ultraviolet rays to improve the adhesion, solvent resistance, chemical resistance, heat resistance and the like of the coating film (printing layer 4).

Examples of the printing method of the ultraviolet curable ink include relief printing, planographic printing represented by offset printing, intaglio printing represented by gravure printing, and stencil printing such as screen printing. The thickness of the printed layer 4 is not limited, but is usually about 0.3 to 5.0 μm.

Examples of the drug to which the release film 1 can be applied include transdermal patches. This patch contains a medicinal component, an adhesive, and the like. As the pressure-sensitive adhesive, acrylic pressure-sensitive adhesive, rubber pressure-sensitive adhesive, silicone pressure-sensitive adhesive, urethane pressure-sensitive adhesive and the like can be preferably used. In addition to tackifiers such as rosin-based resins, terpene-based resins, coumarone-indene resins, petroleum-based resins, terpene-phenolic resins, liquid polybutene, mineral oil, lanolin, liquid isobutylene, liquid poly A plasticizer such as acrylate, a filler, an antiaging agent, etc. may be added. The medicinal ingredients are not particularly limited, but include anesthetics, analgesics, anxiolytics, antipyretics, steroidal anti-inflammatory agents, antiphlogistics, antihistamines, vasoconstrictors, vasodilators, antiallergic agents, ulcer treatments, and wounds. Protective agents, hemostatic agents, vitamin agents, antidotes, etc. Usually, the content of the medicinal component is preferably 0.01 to 15% by weight of the adhesive. In addition, a percutaneous absorption enhancer may be contained, for example, a monovalent or polyvalent alcohol, a monovalent or polyvalent organic acid (salt), a fatty acid ester, a surfactant and the like may be contained. Percutaneous absorption promoter is usually 0.1 to 0.1 in the adhesive.
It is preferable to contain 20% by weight. Specific examples of the transdermal patch include adhesive plasters, poultices, poultices, anti-inflammatory analgesics, and fish eye therapeutic agents.

[0013]

[Evaluation ink]

(Example) A: UV curable acrylate resin alone B: UV curable acrylate resin + aziridine 0.05
(Solid content weight ratio)% C: UV curable acrylate resin + aziridine 0.1% D: UV curable acrylate resin + aziridine 1% E: UV curable acrylate resin + aziridine 5% F: UV curable acrylate resin + aziridine 10% ( Comparative Example) X: Two-component curing type vinyl urethane type resin Y: Thermosetting type polyester type resin 5% by weight of phthalocyanine blue is used for all inks.
Was added. [Evaluation items] Ink adhesion: 1 crosswise scratches on the printing surface with a cutter knife at intervals of 1 x 1 mm (10 in total)
Book), a cellophane tape was attached on it, and the ink peeling when peeled off was evaluated. Heat resistance: 150 ° C × 1 kg / cm ² × 10 on the printed surface
The heat resistance of the ink was evaluated by pressing the hot plate under the condition of minutes. Toluene resistance: Dipped in toluene for 20 minutes, dried and then rubbed with a cotton swab to evaluate ink peeling. Chemical resistance: The printed matter was immersed in a solution prepared by diluting 3 g each of DL camphor, L-menthol, and methyl salicylate with 100 g of methanol for 24 hours, and then rubbed with a cotton swab to evaluate ink peeling.

The evaluation results are shown in FIG. In the figure, ○ indicates that there is no problem in use and the printed surface is good, Δ indicates that there is no problem in use, but the ink is slightly peeled off, and × indicates that there is a problem in use and the printed surface is defective. Indicates that.

[0015]

[Effects] According to the present invention, as described above, since the release film is printed by using the ultraviolet curing ink, it is possible to prevent deterioration of printing due to cautions in use, usage method, etc., and prevent accidents. Can be useful for

[Brief description of drawings]

FIG. 1 is a sectional view showing an example of a release film of the present invention.

FIG. 2 is a table showing evaluation results of examples and comparative examples.

[Explanation of symbols]

1 Release film 2 Release layer 3 Intermediate substrate 4 printing layers

Claims (6)

[Claims] 1. A release film printed with an ultraviolet curable ink. 2. The release film according to claim 1, wherein the release surface comprises a silicone resin layer. 3. The release film according to claim 1, which comprises a polyester film as an intermediate substrate. 4. The release film according to claim 1, wherein the main component of the ultraviolet curable ink is an acrylate resin having a urethane bond in its main molecular chain. 5. The release film according to claim 4, wherein the ultraviolet curable ink is obtained by adding 0.1 to 10% by weight of aziridine in a solid content ratio to the acrylate resin. 6. A pharmaceutical product using the release film according to any one of claims 1 to 5.