JPH1036254A - Separating film for percutaneous patch material - Google Patents

Abstract

PROBLEM TO BE SOLVED: To prepare a separating film for a percutaneous patch material excellent in separating properties, capable of suppressing the release of an ingredient having drag efficacy and facilitating the elongation of the life time of a drag efficacy by forming a specific separating layer. SOLUTION: This separating film is prepared by forming a separating layer comprising a cured silicone resin at least on one surface of a polyethylene-2,6- naphthalenedicarboxylate film. A thermo-, ultraviolet-or radioactive ray-curable type silicone resin is usually used as the curable silicone resin and the thickness of the coated layer thereof is preferably 0.05-0.5μm. A remaining adhesion ratio which represents a curing degree of the silicone separating layer is preferably >=80%. The separating film is excellent in gas barrier properties and has e.g. <=5×10<-13> cc.cm/cm<2> .sec.cmHg permeability rate of oxygen. The separating layer is formed on the surface of the film by using a conventional method such as a bar coating method, a doctor blade method or a gravure roll coating method. The separating film capable of protecting an adhesive layer and suppressing the release of an ingredient having drag efficacy is obtained.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a release film for a patch, and more particularly to a method for protecting an adhesive layer of a patch.
The present invention relates to a release film having a low transmittance (release rate) of a medicinal ingredient.

[0002]

2. Description of the Related Art Conventionally, as a patch intended to reduce skin irritation and to absorb a clinically effective amount of a drug,
For example, a patch having a knit of microporous hollow fiber as a component thereof is known (WO087 / 00046,
WO087 / 04343, WO090 / 09784
issue). Also, a patch in which these knitted materials and an ultra-thin polyester film are laminated is known (Japanese Patent Laid-Open No. 3-8 / 1990).
No. 16044).

[0003] Paper-based release papers have been widely used as a protective layer of an adhesive layer containing a medicinal component of these patches.

This release paper has a problem that the medicinal component is gradually released from the porous nature of the base paper and the expiration date of the medicinal effect is short. For this reason, the use of release films based on polyethylene terephthalate films has been studied and some of them have been put to practical use. However, it has been revealed that this release film is insufficient in performance in order to further extend the medicinal effect in recent years.

[0005]

SUMMARY OF THE INVENTION It is an object of the present invention to be able to peel off an adhesive layer containing a medicinal component with an appropriate force, suppress the release of the medicinal component, and respond to the above-mentioned demand for extending the medicinal component life. An object of the present invention is to provide a release film for a patch.

[0006]

SUMMARY OF THE INVENTION It is an object of the present invention to provide a patch for a patch, wherein a release layer made of a cured silicone resin is provided on at least one side of a polyethylene-2,6-naphthalate film. Achieved by shaped film.

The polyethylene-2,6-naphthalate used in the present invention is a homopolymer having ethylene-2,6-naphthalate as a total repeating unit, or ethylene-2,6-naphthalate in which at least 80 mol% of all the repeating units are ethylene-2,6-naphthalate. Copolymers are preferably used.

The copolymer component constituting the copolymer is mainly a compound having two ester-forming functional groups in the molecule. Specific examples thereof include oxalic acid, adipic acid, phthalic acid, isophthalic acid, terephthalic acid, 2,7
-Dicarboxylic acids such as naphthalenedicarboxylic acid, diphenyl ether dicarboxylic acid, etc .; p-oxybenzoic acid, p
Oxycarboxylic acids such as oxyethoxybenzoic acid;
Propylene glycol, trimethylene glycol, tetramethylene glycol, hexamethylene glycol, cyclohexanedimethanol, neopentyl glycol,
Examples thereof include dihydric alcohols such as diethylene glycol.

In addition, polyethylene-2,6-naphthalate may be obtained by blocking some or all of the terminal hydroxyl groups and / or carboxyl groups with a monofunctional compound such as benzoic acid or methoxypolyalkylene glycol. Alternatively, it may be modified with a very small amount of a trifunctional or higher-functional polyfunctional compound such as glycerin or pentaerythritol within a range where a substantially linear polymer can be obtained.

As the polyethylene-2,6-naphthalate, a homopolymer comprising ethylene-2,6-naphthalate as substantially all repeating units is preferred. Such polyethylene-2,6-naphthalate may contain additives such as stabilizers, ultraviolet absorbers, colorants, flame retardants and the like.

The polyethylene-2,6-naphthalate according to the present invention may contain a small proportion of inert fine particles in order to impart lubricity to the film.

Examples of such inert fine particles include inorganic particles such as silica spherical particles, calcium carbonate, alumina and zeolite, and heat-resistant organic particles such as cross-linked silicone resin particles and cross-linked polystyrene particles. The inorganic particles are preferably synthetic products as compared with natural products, and can take any crystal form.

The above-mentioned inert fine particles have an average particle size of 0.05.
It is preferably in the range of .about.1.5 .mu.m. In particular, when the inert fine particles are inorganic particles, the average particle size is 0.1 to 0.1.
It is more preferably in the range of 8 μm,
It is particularly preferred to be in μm. When the inert fine particles are crosslinked silicone resin particles, the average particle size is 0.1 to 1.5.
It is particularly preferred to be in the range of μm. When the inert fine particles are crosslinked polystyrene particles, the average particle size is 0.1%.
More preferably, it is in the range of １1 μm.

When the average particle size of the inert fine particles is smaller than 0.05 μm, the effect of improving the film's slipperiness, abrasion resistance or winding property is small, while the average particle size is 1.5 μm.
If it is larger than μm, the film surface is too rough, which is not preferable.

The content of the inert fine particles is preferably 0.001% by weight or more, more preferably 0.005 to 20% by weight. If the content is less than 0.001% by weight, the slipperiness of the film tends to be insufficient, which is not preferable.

The timing of adding the inert fine particles is not particularly limited as long as it is a stage before the formation of polyethylene-2,6-naphthalate, and may be, for example, a polymerization stage or a stage before the film formation.

The polyethylene-2,6-naphthalate film of the present invention can be produced by a conventionally known method. For example, polyethylene-2,6
-After drying the naphthalate, it is melted by an extruder, extruded from a die (for example, T-die, I-die, etc.) onto a rotary cooling drum, quenched to make an unstretched film, and then the unstretched film is biaxially extruded. It can be manufactured by stretching in the direction and, if necessary, heat setting. The thickness of the film is not particularly limited, but may be from 1 to 100 μm,
~ 75 µm is preferred.

In the present invention, polyethylene-2,6
-A silicone release layer is provided on at least one side of the naphthalate film, and the release layer is formed from a curable silicone resin.

As the curable silicone resin, heat,
An ultraviolet or radiation curing type is generally used. Specific curing methods include: (1) Thermal condensation reaction type: an organotin-based catalyst comprising silanol-functional dimethylpolysiloxane at both ends and methylhydrogenpolysiloxane or methylmethoxysiloxane. (2) thermal addition reaction type: a methylvinylpolysiloxane having a vinyl group at both ends of the molecular chain or at both ends and in a side chain, and methylhydrogenenepolysiloxane as a platinum-based catalyst. (3) UV-curable type: radical addition type: siloxane containing alkenyl group and mercapto group added with a photopolymerizing agent, hydrosilyl type: the same platinum-based catalyst as heat addition reaction type Used, radical polymerization type: (meth) acrylic group-containing siloxane plus photopolymerizing agent,
Cationic polymerization type: a siloxane having an epoxy group and an onium salt photoinitiator added. (4) Electron beam curing type: a radical polymerizable group-containing siloxane (there is no need for a functional group, and no photoinitiator And so on). The form of the coating material can be appropriately selected from a solvent type, an emulsion type, a non-solvent type and the like.

The curable silicone resin has a degree of polymerization of about 50 to 200,000, preferably 1,000.
１００100,000 is preferred. Specific examples of these are KS-718, manufactured by Shin-Etsu Silicone Co., Ltd.
774, -775, -778, -779H, -830,
-835, -837, -838, -839, -841,
-843, -847, -847H, X-62-241
8, -2422, -2125, -2492, -249
4, -470, -2366, -630, X-92-14
0, -128, KS-723A / B, -705F, -7
08A, -883, -709, -719; TPR-6701, -6702, -670 manufactured by Toshiba Silicone Co., Ltd.
3, -3704, -6705, -6722, -672
1, -6700, XSR-7029, YSR-302
2, YR-3286, DK manufactured by Dow Corning Co., Ltd.
Q3-202, -203, -204, -210, -24
0, -3003, -205, -3057, SFXF-2
560, SD-7226,7 manufactured by Toray Silicone Co., Ltd.
320, 7229, BY24-900, 171, 31
2,374, SRX-375, SYL-OFF23, S
RX-244, SEX-290, and SILCOLASE 425 manufactured by ICI Japan Ltd. Further, silicone resins described in JP-A-47-34447 and JP-B-52-40918 can also be used.

When the cured silicone resin coating (silicone release layer) is formed on the film surface, the coating solution may be applied to the film surface by a bar coating method, a doctor blade method, a reverse roll coating method or a gravure roll coating method. A conventionally known method such as a method can be used. The application of the silicone resin coating film is performed in equipment provided with measures for preventing foreign matter from entering.

Drying and curing (thermal curing, ultraviolet curing, etc.) of the coating film can be performed individually or simultaneously. When performing simultaneously, it is preferable to perform at 100 degreeC or more. Desirable drying and heat curing conditions are 100 ° C. or higher and about 30 seconds. If the drying temperature is 100 ° C. or less, and the curing time is 30 seconds or less, the curing of the coating film is incomplete,
Uneasiness remains in durability such as falling off of the coating film.

The thickness of the cured silicone resin coating is not particularly limited, but is preferably in the range of 0.05 to 0.5 μm. If the thickness is too small, the release performance is reduced, and satisfactory performance cannot be obtained. On the other hand, if it is too thick, it takes a long time for curing, which causes inconvenience in production.

The silicone adhesive release layer has a residual adhesion ratio, which is a measure of the degree of curing, preferably 80% or more, more preferably 85% or more, particularly preferably 90% or more. This residual adhesion rate is 80
%, The transfer of the silicone resin to the adhesive layer containing the medicinal component becomes apparent, and the yield of the product deteriorates.
Not preferred.

The release film of the present invention has, for example, an oxygen gas permeation rate of 5 × 10 ⁻¹³ cc · cm / cm ² · sec.
Since it is excellent in gas permeation barrier properties of not more than cmHg and has excellent release characteristics, it is useful as a release film for patches.

[0026]

The present invention will be described in more detail with reference to the following examples. In addition, "part" in an example is a weight part. Each characteristic value of the film was measured by the following method.

1. Peel strength (rubbing test) A polyester adhesive tape (nit-31B) is adhered to the release layer surface of the sample film, pressed with a 5 kg pressure roller, left for 20 hours, and then subjected to a tensile test for the peel force between the release layer and the adhesive tape. Measure with a machine.

2. Residual adhesion rate Polyester adhesive tape (Knit-31B)
Cold rolled stainless steel sheet (SUS3
04) was measured, and the base adhesive strength (f) was measured.
₀ ). Further, the polyester adhesive tape is pressed against a release layer coated surface of a sample release film with a 5 kg pressure roller, left for 30 seconds, and then the adhesive tape is peeled off. And stick the peeled adhesive tape on the stainless steel plate,
The peeling force of the bonded portion is measured and is defined as a residual adhesive force (f).
From the obtained basic adhesive strength (f ₀ ) and residual adhesive strength (f), the residual adhesive rate is determined using the following equation.

[0029]

## EQU1 ## Residual adhesion rate (%) = (f / f ₀ ) × 100

3. Oxygen gas permeation rate 25%
At a measurement temperature of ° C., the gas permeation amount of the mixed gas of oxygen / carbon dioxide = 80/20 into the film is measured by gas chromatography.

[Example 1] The intrinsic viscosity was 0.62 dl / g.
Polyethylene-2,6-naphthalate is melted by an extruder, and the film-like molten polymer is melted at about 40 ° C. from a die.
The film was extruded onto a rotating cooling drum maintained in this manner, and the film-shaped molten polymer was rapidly cooled while being in close contact with the cooling drum using an electrostatic adhesion method to obtain an unstretched film. Then
The unstretched film was stretched 3.7 times in the machine direction, then 3.8 times in the transverse direction, and heat-set at 240 ° C. to obtain a biaxially oriented film having a thickness of 50 μm. After performing a corona discharge treatment on the film surface thus obtained, KS839 (manufactured by Shin-Etsu Chemical Co., Ltd.) was used as a release agent on the corona discharge treatment surface, and the thickness after drying and curing was 0.1 μm.
m by an offset gravure coater and dried to obtain a release film. Table 1 shows the characteristics of the release film.

Example 2 A release film was obtained in the same manner as in Example 1, except that UV-curable release agent X-62-7052 (manufactured by Shin-Etsu Chemical Co., Ltd.) was used. This characteristic is shown in Table 1.

Comparative Example 1 A release film was obtained in the same manner as in Example 1, except that polyethylene terephthalate was used instead of polyethylene-2,6-naphthalate. This characteristic is shown in Table 1.

Comparative Example 2 A protective film was prepared in the same manner as in Example 1 except that no release layer was provided. This characteristic is shown in Table 1.

[0035]

[Table 1]

[0036]

According to the present invention, it is possible to provide a release film for a patch, which is excellent in releasability, releases less of a medicinal ingredient, and can respond to a demand for a longer life of a medicinal effect.

Claims (3)

[Claims] 1. A release film for a patch, wherein a release layer made of a cured silicone resin is provided on at least one surface of a polyethylene-2,6-naphthalate film. 2. The release film according to claim 1, wherein the residual adhesion ratio of the release layer is 80% or more. 3. The film has an oxygen gas transmission rate of 5 × 10.
^2. The release film according to claim 1, which has a pressure of ^-13 cc.cm/cm<2>.sec.cmHg or less.