KR20130128596A - Release liner for percutaneous absorption materials and manufacturing method thereof - Google Patents

Abstract

The present invention relates to a release liner which is suitable for a transdermal preparation and a method for manufacturing the same. The release liner which is suitable for a transdermal preparation of the present invention is attached to the adhesive-coating side of a medical patch for transdermal or mucosal absorption and expresses release performance. The release liner comprises: a polyethylene terephthalate film; and a silicone release coating layer on one side of the polyethylene terephthalate film, containing epoxy compounds and silane compounds. The film is characterized by satisfying formulas 1-3 (formula 1: 10 ≤ RF ≤ 50, formula 2: 100 ≤ CA ≤ 115, formula 3: TSi ≤ 8.0). The release liner has superior release ability and shows print pitch stability because silicone residues are transferred on the back side of the release liner at a remarkably low transfer rate. Therefore, the release liner functions in a medical patch, especially a transdermal patch. A large amount of the release liners with uniform physical properties is provided by an in-line coating method and a simultaneous biaxially stretching method.

Description

Release liner for percutaneous absorption materials and manufacturing method etc.

The present invention relates to a release liner that can be suitably used in a transdermal absorbent and a method for manufacturing the same. More particularly, the present invention relates to a sheet-type sheet used in the treatment of various diseases on one surface of a sheet-like support made of a material such as polyethylene terephthalate. In medical transdermal absorbents, which are laminated to the adhesive surface containing the drug of the transdermal absorbents, to protect the transdermal absorbents from external contamination and are easily separated from the patch applied with the transdermal absorbents when the transdermal absorbents are used. A release liner that can be suitably used and a method of manufacturing the same.

Medical transdermal absorbents are formulated in the form of sheets, and on one side, the drug is absorbable to the human body, depending on the purpose of treatment, various preparations, such as general anesthetics, vitamins, antipyretics, anti-inflammatory analgesics, steroid hormones, Drug preparations such as local anesthetics, antibacterial agents, bactericides, antihistamines, blood pressure lowering agents, diuretics, hormone secretagogues, etc. are included in the pressure sensitive adhesive layer to form a transdermal absorbent adhesive layer having a thickness of 10 to 300 µm. The percutaneous absorbent pressure-sensitive adhesive layer is a polyurethane-based adhesive such as natural rubber, polyisobutylene, polyvinyl ether, polyisoprene, polybutadiene, styrene-isoprene copolymer, rubber-based adhesive, aliphatic polyurethane, aromatic polyurethane adhesive, etc. A hydrogel containing a pressure-sensitive adhesive, gelatin, hydroxyethyl cellulose and the like as a main component is used, and in addition to a drug preparation capable of transdermal absorption, a tackifying resin, a plasticizer, a transdermal absorption accelerator, a stabilizer, a thickener, and the like can be added in combination.

In addition, with the recent rapid transition to an aging society and an increase in life expectancy, the amount of use of such medical transdermal absorbents is increasing, and as one side contains a transdermal absorbent drug formulation in the form of a pressure-sensitive adhesive, There is also a growing demand for release liners of suitable materials that protect the face and that can be peeled off uniformly and easily in use.

The percutaneous absorption sheet is a therapeutic drug preparation for transdermal absorption on one surface of a sheet-like support made of polyethylene terephthalate, polyethylene, polyvinylidene chloride, polyvinyl acetate, polyester, polyurethane, or the like. Direct coating of the rubber, polyurethane, silicone, hydrogel and polymethacrylic acid ester pressure sensitive adhesives is carried out by gravure coating, offset coating or slot die coating, and then passed through a dryer, 10 to 300. After forming the pressure-sensitive adhesive layer of the percutaneous absorbent of μm, it is laminated with a release liner having a release peeling performance and processed in the form of a roll, and die-cutting is performed in the form of a sheet according to a specified dimension.

In the sheet-like processing, the pressure-sensitive adhesive layer containing the drug agent should be protected from external contamination, and for ease of use, a printing layer should be formed on one side of the release liner, and attached to the affected part of the human body. In order to be exfoliated uniformly and stably with the transdermal absorbent sheet, the release liner substrate is affected by properties such as uniform release force of the release liner substrate, surface energy and release agent to the back, that is, the transfer rate of the silicone component.

Conventional in-line release film or off-line release film causes an in-process defect in a subsequent process due to variation in release peeling force, or an orange peel phenomenon in a liquid transparent adhesive coating process due to lack or excessive surface energy. Due to the wrinkles in the longitudinal direction of the existing off-line release film generated in the high temperature drying process, coating defects of the optically transparent adhesive were caused, and coating defects or non-uniformity of the pressure-sensitive adhesive containing such transdermal absorbents were The bubble-like defect is caused, and after lamination with the sheet-like transdermal absorbent, the non-uniform lamination is caused, resulting in a defect.

In addition, when the silicon component is transferred to the back of the release liner to form a print layer on the back of the release liner, it causes a poor coating of the print layer, a poor print pitch, and the like. By forming a film, a phenomenon in which the pressure-sensitive adhesive layer containing the transdermal absorbent agent is easily peeled off or not peeled off smoothly occurs, causing problems in use.

In order to solve this fatal problem, there is an urgent need to develop a release liner substrate that protects the pressure-sensitive adhesive layer containing a medical transdermal absorbent suitable for surface properties and print layer formation from external contamination and enables uniform and stable peeling. It was a situation.

Accordingly, the present invention has been made in view of the above technical problems in the prior art, and an object of the present invention is to solve the above problems in the prior art to form a stable release coating layer, while having a low silicon transfer rate to the rear surface. It is to provide a release liner substrate that can be suitably used as a medical transdermal absorbent that can be easily separated in use.

Another object of the present invention is to provide a manufacturing method that can more easily produce a release liner having the above excellent characteristics.

The present invention may also be directed to accomplish these and other objects, which can be easily derived by those skilled in the art from the overall description of the present specification, in addition to the above-mentioned and obvious objects.

Release liner that can be suitably used in the transdermal absorbent of the present invention for achieving the above object;

A release liner attached to an adhesive coated surface of a medical adhesive member for transdermal or mucosal absorption, and exhibiting release peeling performance, wherein the release liner includes a polyethylene terephthalate film and an epoxy compound and a silane compound on one surface of the polyethylene terephthalate film. Containing a silicone release coating layer comprising a, characterized in that the film satisfies the following formula 1 to 3 at the same time:

10 ≤ RF ≤ 50 --- Equation 1

100 ≤ CA ≤ 115 --- Equation 2

TSi ≤ 8.0 --- Equation 3

In the above formula, "RF" is a release peel force of the release liner for a transparent adhesive tape carrier measured using a 1-inch TESA7475 tape whose unit is 'g / inch',

"CA" is the surface contact angle measured by applying 1.8μl Pure Water droplets to the release peeling coating surface of the substrate, and the unit is °.

"TSi" is the silicon back transfer of the non-coated surface of the film as measured by XPS (X-ray Photoelectron Spectroscopy) analysis in%.

According to another configuration of the present invention, the release coating layer is characterized in that the coating composition is coated by the in-line coating method using a composition consisting of hexenyl polysiloxane or vinyl polysiloxane, hydrogen polysiloxane, epoxy compound, silane compound, chelate platinum catalyst. .

According to another configuration of the present invention, the polyethylene terephthalate film is characterized in that the silicon transfer rate to the back is controlled to 8% or less by maintaining the back side of the film substrate in an untreated state.

According to another configuration of the present invention, the silicone release coating layer maintains a thickness of 1.5㎛ or less, characterized in that the residual adhesion (Subsequent Adhesion) of the coating layer is 80% or more.

The release liner that can be suitably used in the transdermal absorbent of the present invention configured as described above has an excellent release peeling force by forming a silicone release coating layer having suitable thickness and mechanical properties through an inline coating process on a polyethylene terephthalate film having a specific configuration. Since the transfer ratio of the silicone residue on the back is significantly low to show print pitch stability, it provides a sufficient function as a release liner of a medical adhesive member, in particular, a transdermal absorption adhesive member, and also provides an inline coating method and simultaneous biaxially. Due to the stretching manufacturing method, it is possible to provide a large amount of products with uniform physical properties.

1 is a cross-sectional view of a release liner which is a transparent adhesive tape according to a preferred embodiment of the present invention,
2 is a cross-sectional view of an exemplary transdermal absorption patch member with a release liner in accordance with the present invention.

Hereinafter, the present invention will be described in more detail by preferred embodiments with reference to the accompanying drawings. However, the following preferred embodiments are only intended to describe the present invention in detail and are not intended to limit the scope of the present invention.

1 is a cross-sectional view of a release liner which is a transparent adhesive tape according to a preferred embodiment of the present invention, and FIG. 2 is a cross-sectional view of an exemplary transdermal absorption patch member to which a release liner according to the present invention is attached.

As described above, the release liner suitable for use as a medical transdermal absorbent according to the present invention is a polyethylene terephthalate film (4, or A), and silicone release comprising an epoxy compound and a silane compound on one side of the polyethylene terephthalate film. Biaxially stretched polyethylene terephthalate film comprising a coating layer (3, or B), the film is characterized in that to satisfy the following formula (1) at the same time.

10 ≤ RF ≤ 50 --- Equation 1

100 ≤ CA ≤ 115 --- Equation 2

TSi ≤ 8.0 --- Equation 3

In the above formula, "RF" is a release peel force of the release liner for a transparent adhesive tape carrier measured using a 1-inch TESA7475 tape whose unit is 'g / inch',

"CA" is the surface contact angle measured by applying 1.8μl Pure Water droplets to the release peeling coating surface of the substrate, and the unit is °.

"TSi" is the silicon back transfer of the non-coated surface of the film as measured by XPS (X-ray Photoelectron Spectroscopy) analysis in%.

Preferably, the polyethylene terephthalate film (A), which is a release liner substrate suitable for the medical transdermal absorbent, is manufactured by a biaxial stretching method, and a silicone release coating layer (B) including an epoxy compound and a silane compound on one surface by an inline coating method is provided. It is applied.

In addition, the polyethylene terephthalate film (A), which is preferably a release liner substrate suitable for the medical transdermal absorbent, maintains the back side of the film substrate in an untreated state, and the silicon transfer rate to the back side is controlled to 8% or less. It is possible to form the printed layer.

In addition, preferably, the silicone release coating layer (B) of the polyethylene terephthalate film (A), which is a release liner substrate suitable for the medical transdermal absorbent, maintains a thickness of 1.5 μm or less, so as to express a uniform release peeling force.

In addition, the polyethylene terephthalate film (A), which is preferably a release liner substrate suitable for the medical transdermal absorbent, preferably has a thickness of 12 to 125 μm, and the water contact angle of the release peeling coating surface is controlled in a range of 100 to 115 degrees. By controlling the residual adhesion rate to 80% or more, it is possible to minimize the transfer of the silicone component to the transdermal absorbent coating surface.

The polyethylene terephthalate film used in the present invention is not limited in kind, and known ones known in the art can be used. In the present invention, a description will be given focusing on polyethylene-based resins such as polyethylene, polyethylene terephthalate, polybutylene terephthalate and polyethylene naphthalate.

The polyethylene terephthalate film which comprises the said film points out the polyethylene obtained by polycondensing aromatic dicarboxylic acid and aliphatic glycol. Examples of the aromatic dicarboxylic acid include terephthalic acid and 2,6-naphthalenedicarboxylic acid. Examples of the aliphatic glycol include ethylene glycol, diethylene glycol, 1,4-cyclohexanedimethanol and the like.

For the silicone release coating layer of the present invention, the organopolysiloxane may be any type such as addition type, condensation type, and ultraviolet curing type, but the representative molecular structure of the present invention is represented by the following Chemical Formula 1.

[Formula 1]

Here m and n are integers greater than or equal to zero.

The organopolysiloxane contains an alkenyl group in a molecule, alkenyl group may be present in any part of the molecule, and at least two or more are preferable. The molecular structure may be linear or branched, or may be a structure in which both linear and branched molecules are present.

In addition, as a curing agent in the composition of the coating composition according to the present invention, any type such as addition type, condensation type, and ultraviolet curing type may be used, and the representative molecular structure of organo hydrogen polysiloxane, which is a representative curing agent of the present invention, may be used. It is the same as the following formula (2).

(2)

Here, p and q are integers 0 or more.

The organohydrogen polysiloxane may be linear, branched or cyclic, or a mixture thereof. In addition, the viscosity and molecular weight are not limited, but the compatibility with the organopolysiloxane should be good, and the amount of use is such that the hydrogen atom bonded to the silicon atom for one alkenyl group of the organopolysiloxane is in the range of 0.5 to 1.2. desirable. If there are less than 0.5 hydrogen atoms bonded to a silicon atom with respect to one alkenyl group of the organopolysiloxane, there may be a problem that a good hardenability may not be obtained. If the number exceeds 1.2, elasticity or physical properties after curing may be deteriorated. Can be. On the other hand, in the silicone release composition according to the present invention, when the amount of the organohydrogen polysiloxane is higher than that of the organopolysiloxane, crosslinking proceeds a lot, resulting in reduced flexibility and cracking of the film, thereby reducing smoothness.

The film of this invention uses the biaxially stretched polyethylene terephthalate film which has the outstanding release peel force and was excellent in productivity and workability.

Although the thickness of a polyethylene terephthalate film in this invention is not limited, 12-125 microns (micrometer) is preferable, Furthermore, 50-100 micron (micrometer) is the most preferable.

In the release liner of the present invention configured as described above, as shown in FIG. 2, a printing layer 5 is coated on the back surface of the silicone release coating layer 3 (B of FIG. 1) to facilitate identification of the substrate. After that, the nonwoven fabric, the woven fabric, and the knitted fabric are used as the support 1, and are laminated on a percutaneous absorbent agent coated with a transdermally absorbable drug agent 2 on one side thereof, and suitable release peeling is performed on the transdermal absorbent agent having an adhesive function. It is used as a medical release liner, providing performance and having a fine transition of the silicone component on its back to enable formation of a suitable print layer 5.

Hereinafter, the present invention will be described in more detail using Examples and Comparative Examples. However, these examples are only presented by way of example only to more specifically describe the present invention, it is obvious to those skilled in the art that the scope of the present invention is not limited by these examples. something to do.

Example 1

By mixing a particle-free polyethylene terephthalate chip and a polyethylene terephthalate chip containing silica particles (SiO), coating an aqueous silicone release coating layer on one surface by an in-line coating method, the release peeling force is 40g / in., Residual adhesion rate A release liner having 91%, a water contact angle of 108.4 ° and a backside silicon transfer rate of 5.3% was manufactured and laminated on the coating surface thereof with a 1.0 mm thick woven support having 0.9 N / 15 mm of human adhesive adhesion for 24 hours. .

Comparative Example 1

Using a particle-free polyethylene terephthalate and coating a silicone release coating layer on one surface by an offline coating method, the release peeling force is 9.0g / in., The residual adhesion rate is 78%, the water contact angle is 84.0 °, the back silicon transfer rate is A release liner of 11.4% was prepared and laminated to the coated coated surface with a 1.0 mm thick woven support having a human adhesive adhesion of 0.9 N / 15 mm for 24 hours.

Comparative Example 2

Using a particle-free polyethylene terephthalate and coating a silicone release coating layer on one surface by an offline coating method, the release peeling force is 95g / in., The residual adhesion rate is 80%, the water contact angle is 92.6 °, the back silicon transfer rate is 6.0 A release liner of% was prepared and laminated to the coated coated surface with a 1.0 mm thick woven support having a human adhesive adhesion of 0.9 N / 15 mm for 24 hours.

Comparative Example 3

By mixing a particle-free polyethylene terephthalate chip and a polyethylene terephthalate chip containing silica particles (SiO), coating an aqueous silicone release coating layer on one surface by an in-line coating method, the release peeling force is 40g / in., Residual adhesion rate A release liner having 88%, a water contact angle of 103.2 °, and a back silicon transfer rate of 9.4% was manufactured and laminated on the coated coating surface with a 1.0 mm thick woven support having 0.9N / 15 mm of human adhesive adhesion for 24 hours. .

Evaluation of the physical properties of the film prepared in Example 1 and Comparative Examples 1 to 3 is shown in the following Table 1.

Comparative Example 1 Comparative Example 2 Comparative Example 3 Example 1 Release Material Thickness 38 μm 188 ㎛ 75 μm 75 μm Characteristics
[Release release force]
180 ° Peel @ 300㎜ / min
TESA 7475 tape
[Residual adhesion rate]
Nitto31B tape
[Back Transfer Rate]
XPS
[Water contact angle]
Droplet: 1.8 μl
9 g / in.


78%

11.4%

84.0 °
95 g / in.


80%

6.0%

92.6 °
40 g / in.


88%

9.4%

103.2 °
40 g / in.


91%

5.3%

108.4 ° Percutaneous Absorption
Human skin adhesion
(With 24 hours affix) 0.9 N / 15 mm 0.9 N / 15 mm 0.9 N / 15 mm 0.9 N / 15 mm Peeling Uniformity and Sensation Bad Bad Bad Somewhat defective With pressure-sensitive adhesive
Lamination Bad Bad Good Good Print pitch is bad Occur Not occurring About outbreak Not occurring Longitudinal heat wrinkle 5 pcs / m 1.5 pcs / m Not occurring Not occurring

As can be seen in Table 1, Example 1 using a polyethylene terephthalate film which is a release liner substrate for adhesive tape carrier according to the present invention can be seen that it possesses excellent release properties, processability and dimensional stability.

In the present specification, only a few examples of various embodiments performed by the present inventors are described, but the technical idea of the present invention is not limited thereto, but may be variously modified and modified by those skilled in the art.

1 --- support
2 --- drug formulation
3 --- release coating layer
4 --- film
5 --- printing layer

Claims (4)

A release liner attached to an adhesive coated surface of a medical adhesive member for transdermal or mucosal absorption, and exhibiting release peeling performance, wherein the release liner comprises a polyethylene terephthalate film and an epoxy compound and a silane compound on one surface of the polyethylene terephthalate film. A release liner comprising a release coating layer comprising silicon, wherein the film may be suitably used in a transdermal absorbent, wherein the film satisfies Equation 1 to 3 below:
10 ≤ RF ≤ 50 --- Equation 1
100 ≤ CA ≤ 115 --- Equation 2
TSi ≤ 8.0 --- Equation 3
In the above formula, "RF" is a release peel force of the release liner for a transparent adhesive tape carrier measured using a 1-inch TESA7475 tape whose unit is 'g / inch',
"CA" is the surface contact angle measured by applying 1.8μl Pure Water droplets to the release peeling coating surface of the substrate, and the unit is °.
"TSi" is the silicon back transfer of the non-coated surface of the film as measured by XPS (X-ray Photoelectron Spectroscopy) analysis in%.
The transdermal coating according to claim 1, wherein the silicone release coating layer is coated with an inline coating method using a hexenyl polysiloxane or vinyl polysiloxane, hydrogen polysiloxane, epoxy compound, silane compound, or chelate platinum catalyst as a coating composition. Release liner that can be used suitably for the absorbent.
The release according to claim 1, wherein the polyethylene terephthalate film maintains the back side of the film substrate in an untreated state so that the silicon transfer rate to the back side is controlled to 8% or less. Liner.
According to claim 1 or 2, wherein the silicone release coating layer maintains a thickness of less than 1.5㎛, Subsequent Adhesion of the coating layer can be used suitably for transdermal absorbents, characterized in that 80% or more. Release liner.

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