KR100212024B1 - Preparation of disc roll for transdermal patch and apparatus thereof - Google Patents

Abstract

To obtain the efficacy of a transdermal drug, it must be firmly attached while maintaining the physical properties of the product, that is, elasticity corresponding to joint movement, as well as the composition of the drug layer. It should be able to be used, the drug should be continued without external loss of medicinal ingredients, and it should be as thin and small as possible (elliptical) in order to selectively attach to each affected area. The transdermal drug delivery system capable of meeting these requirements includes, for example, a disc roll having a release film layer, a drug layer, a stretchable film layer, a release liner, and a stretchable film layer having a cross section separately prepared by another process. A pressure-sensitive adhesive tape roll made of a pressure-sensitive adhesive + release liner is formed through a process of mutual punching and bonding while removing these release liners by a series of processes. It relates to a method for producing the disc roll and a manufacturing apparatus thereof. The apparatus of the present invention comprises a release film strip unwinding roller 20 driven by a motor, a pair of drug applying rollers 10, 10 'for applying a drug on one surface by passing the release film strip; , The drug dryer 12 installed in the advancing direction of the drug-coated release film, the unwinding roller 22 of the stretchable film + release liner, the release film strip 8 and the stretchable film + release liner coated with the drug. And a pair of adhesive rollers 24 and 24 'for adhering the strips 14 to each other to form a disc strip 16, and a disc winding roller 26 for winding the disc strip 16 together.

Description

Method for manufacturing disc roll for drug transdermal administration and its manufacturing apparatus

1 (a) and (b) are respectively a plan view and a cross-sectional enlarged view taken along line a-a of a product finally manufactured by using a disc manufactured by another apparatus according to the present invention as one component.

Figure 2 (a) (b) is an enlarged cross-sectional view taken along the line b-b showing a perspective view of the original roll for drug transdermal drug administration according to the present invention and the laminated structure of the roll.

Figure 3 is a schematic view of the manufacturing process of the original roll for drug transdermal administration according to the present invention.

Figure 4 is a view showing the lamination structure of the roll in each step when manufacturing the original roll using the manufacturing apparatus of the original roll for drug transdermal administration drug according to the present invention.

5 is a plan view of an alignment roll for preventing deflection winding during winding of the roll in the apparatus for manufacturing a raw roll for drug transdermal administration according to the present invention.

6 is a perspective view showing a drug scraper in the apparatus for manufacturing a raw roll for drug transdermal administration according to the present invention.

7 is a perspective view showing a roll split cutter in the apparatus for manufacturing a raw roll for drug transdermal administration according to the present invention.

* Explanation of symbols for main parts of the drawings

1: release film layer 2: incision

3: drug layer 4: (primary) stretchable film layer

5: release liner 6: adhesive layer

7: second stretchable film layer 8: release film layer coated with drug

10, 10 ': A pair of drug application rollers

11: drug scraper 12: dryer

14: 2nd stretch film + release liner strip

16: disc strip 17: drug tray

20: release film unwinding roller 21: drug non-coated portion

22: 2nd stretchable film + release liner unwinding roller

24. 24 ': Adhesive Roller

25: alignment roller device for preventing deflection winding

26: disc unwinding roller 27: optical sensor

28, 28 ': Pneumatic cylinder 29, 29': Plunger of pneumatic cylinder

30: cutter

31: Contact roller of the alignment roller device for preventing the deflection winding

D: drug R, R1, R2: disc roll

P: Products

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a method for producing a drug transdermal agent and a device for producing the same, and more particularly, to a method and a device for manufacturing a disc roll as a first step for producing a drug transdermal agent.

The drug transdermal drug to be prepared in connection with the present invention is a series of adhesive tape rolls composed of a release roll + drug + primary stretch film + release liner and a secondary stretch film + adhesive + release liner. The process is carried out through the process of mutual processing and bonding to a predetermined shape while removing the release liner by the process, the present invention relates to a method of manufacturing the disc roll during this process and a manufacturing apparatus thereof.

Piroxicam, an analgesic and anti-inflammatory agent effective for acute pain and acute gout of rheumatoid arthritis, osteoarthritis, musculoskeletal disorder, etc., has a strong therapeutic effect upon oral administration, but gastrointestinal disorder following oral administration It is known to cause side effects such as peptic ulcer disease.

In order to solve this problem, the inventors of the Korean Patent Application No. 93-32006 dated December 31, 1993, the substrate layer consisting of an active ingredient, a sticky polymer material and an absorbent protective agent containing pyrocampum and a non-permeable affixed thereon A transdermal agent comprising a backing layer and a release paper layer detachably attached under the substrate layer has been disclosed, and the present invention mainly focuses on the composition of the drug absorption protector and the absorption accelerator in the substrate layer. .

However, the drug transdermal drug is primarily of the composition of the substrate layer, but the physical properties of the product as important as the composition of the substrate layer is also important to obtain the desired effect when the product is attached to the affected area.

That is, it should be firmly attached to the joints of knees and elbows while maintaining elasticity, not to fall even during bathing or showering, to prevent contamination from the outside, and to have no external loss of medicinal components. In addition, it is desirable to be thin and small in order to selectively attach to each affected part, and its shape is preferably as circular (elliptical) as possible. Conventionally, a product having a structure in which a drug is laminated on a nonwoven fabric or a fabric cannot satisfy the above requirements at all.

An example of a transdermal administration agent capable of satisfactorily satisfying the above physical requirements while considering the composition of a substrate layer containing a drug to be used is a structure as shown in FIG. 1, and FIG. Figure 1 (b) is an enlarged cross-sectional view taken along the line aa of Figure 1 (a). Here, reference numeral 1 denotes a release material made of a film or paper, which is peeled off when the product P is attached to the affected part. A release agent, for example, is a film layer coated with silicone, on which a drug layer 3, a primary stretchable film layer 4, an adhesive layer 6, and a secondary stretchable film layer 7 are in turn It is stacked. The release film layer (1) is coated with silicon on the surface in contact with the drug when the product is attached to the affected area when peeling it off without falling off the drug clean. In the present invention, the stretchable film has an elongation of 200 More than 5 thickness To 300 Phosphorus film material refers to a product made of PU (polyurethane), PET (polyethylene terephthalate), SIS (styrene iso-styene) and the like as a main material. The primary stretchable film layer 4 laminated on the drug layer is formed to have sufficient elasticity and elasticity to adapt to joint motion and prevents water from penetrating the bath or shower to prevent contamination from the outside and also the drug layer. By preventing the loss of the liquid medicinal components in (3) to the outside to maintain the effect for a long time (for example 48 hours) and uniformly, and to release the gaseous sweat to the outside.

The drug transdermal drug (P) having the structure described above has a disc roll composed of a release film layer (1) + a drug layer (3) + a primary stretchable film layer (4) + a release liner (5). And the release tapers 5 by a series of processes using an adhesive tape roll made of a second stretchable film layer 7 + an adhesive 6 + a release liner 5 'separately prepared through another process. It is made through the process of punching (상호 加工) and mutual bonding while removing 5 '), the present invention relates to a method of manufacturing the disc roll as a first step of such a process and a manufacturing apparatus thereof.

The disc roll R produced by the apparatus according to the invention is as shown in Fig. 2 (a) (b), preferably a pair of rolls R1 (R2) at the same time by one cycle of the process. ) Is manufactured (see also second (a)), and the cross-sectional structure of each roll is from the bottom of the release film layer (1) and the drug layer, as shown in the second (b) showing the cross section along the line b-b. (3), the stretchable film layer 4 and the release liner layer 5 are used. The release line 2 as shown in FIG. 1 is not yet formed on the release film layer 1 of the disc roll, and this incision is formed in a later process through a separate device.

Hereinafter, a method for manufacturing a raw roll R for preparing a transdermal drug delivery drug according to the present invention and a manufacturing apparatus thereof will be described in detail with reference to the accompanying drawings.

3 is a simplified illustration of a raw roll manufacturing process according to the present invention. As can be seen from this figure, the manufacturing process of the disc roll according to the present invention,

Continuously unwinding the release film (1) strip coated with silicon as a release agent on the surface and wound in a roll;

A thin film of drug (D) is applied to a predetermined thickness on the silicon-coated surface of the release film by passing the unwound release film strip through a pair of drug application rolls 10 and 10 'mounted with a predetermined gap. Making a step;

Drying the drug by passing the drug applied release film strip (8) through a dryer (12);

Drug which passed this unwound stretchable film (4) + release liner (5) strip through the dryer while continuously unwinding strip (14) of separate stretchable film (4) + release liner (5) wound in roll shape Forming a disc strip 16 by successive bonding with the applied release film strip 8; And,

And winding the disc strip to form a disc roll (R).

In addition, the manufacturing process of the original roll according to the present invention is preferably, as can be seen in Figures 6 and 7, a pair in which the release film strip 1 is mounted in a predetermined gap in the process. When a drug (D) is applied to the silicon coated surface yarn of the release film thinly by passing through the drug application rolls 10 and 10 ', a predetermined portion of the release film, such as a central portion, A drug scraping process is carried out together to form a site 21 where no drug is applied in the longitudinal direction, and in this case, the drug non-coated site 21 before winding the disc strip 16. A step of continuously cutting the central portion of the sheet in the longitudinal direction is further added, whereby two or more disc rolls R1 and R2 can be produced simultaneously in one manufacturing process cycle. If you want to make two or more disc rolls without performing this additional process, perform the normal process of making one disc roll per cycle more than two times, or first form a wide disc roll and then loosen it again later. It is necessary to make two or more rolls by cutting in a certain width while cutting out. In the former case, the productivity is less than 1/2, and in the latter case, each roll wound in the reverse direction must be rewound in the reverse direction. Therefore, not only the productivity is lowered, but also such a change in winding direction adversely affects the tensile strength of the original roll strip, the adhesive state of the drug, etc., which ultimately increases the defective rate of the product. In view of this, the method according to the present invention for producing two or more disc rolls simultaneously by the manufacturing process of one cycle greatly contributes to reducing the inventory of productivity and the defective rate of the product.

The manufacturing apparatus of the original roll for drug transdermal drug preparation according to the present invention is a device that performs a predetermined processing process (drug application, drying, bonding, incision, etc.) during the continuous unwinding and winding of strips wound onto a roll. It is a roller device. This roller apparatus for use in the manufacturing apparatus according to the present invention has at least one moving member driven by several rollers, for example, a motor, which both shafts are rotatably fixed on a frame (not shown) of a predetermined counter structure. Of rollers, tension adjusting rollers, turning rollers, compression rollers, etc., and the tension of the strips detected by the specific installation structure mounted on the frame and the load cells installed on the tension adjusting rollers. A predetermined tension controller system using a powder clutch or the like that automatically operates in response to the size does not differ from the known ones, and thus the detailed illustration and description thereof will be omitted.

Figure 4 is a view showing the lamination structure of the roll in each step when manufacturing the original roll (R) using the apparatus for producing a drug roll for drug transdermal administration according to the present invention. Referring to this drawing, the configuration of the apparatus for manufacturing a raw material roll for drug transdermal administration according to the present invention and the lamination structure of strips for each step will be described in detail.

The apparatus for manufacturing a raw material roll for drug transdermal drug administration according to the present invention is formed by passing a release film strip unwinding roller 20 driven by a main motor (not shown) and a release film strip 1 on one surface thereof. Hansa drug application rollers 10 and 10 'installed at predetermined intervals to apply the drug (D) to the dryer 12, which is installed in the advancing direction of the release film to which the drug is applied, to dry the drug, Unwinding roller 22 for releasing strip 14 of stretchable film 4 + release liner 5, release film strip 8 coated with the drug and strip 14 of stretchable film + release liner A pair of adhesive rollers 24 and 24 'for adhering the adhesive films to each other, a release film strip 8 coated with the drug, and a primary stretchable film + release liner strip 14 bonded to each other. ) Is provided with a disc winding roller 26 for winding By-step lamination structure are the same as in the fourth-degree cross-sectional enlargement (A) ~ (E).

Meanwhile, in the manufacturing apparatus as described above, a predetermined portion of the disc strip 16 made of the release film layer 1, the chemical layer 3, the stretchable film layer 4, and the release liner 5 is formed as described above. In order to manufacture two or more disc rolls simultaneously by the manufacturing process of one cycle by making a continuous cut along the longitudinal direction, the drug (D) is applied to a release film strip at a predetermined portion (ie, a cut in a later step). For this purpose, as shown in FIG. 6, a drug scraper having a predetermined width in contact with a release film at a predetermined portion of the drug applying rolls 10 and 10 ′ may be formed. 11 is attached, and as shown in FIG. 7, a cutter 30 for longitudinally cutting the center of the drug non-coated portion 21 in front of the disc roll R is added. Is installed as

Referring to the process of making a disc roll using the apparatus according to the present invention described above in detail, first, the release film strip 1 released from the release film unwinding roller 20 has a predetermined interval (gap of the chemical coating thickness) to each other. The drug D in the drug receiving tray 17 disposed between the drug applying rollers 10 and 10 'by passing between a pair of drug applying rollers 10 and 10' installed on one surface thereof. It is applied evenly to the phase, preferably drug is not applied to a predetermined portion, such as a central portion of the release film strip by the above-described drug scraper (11). The release film strip optical sensor 27 dried by the dryer 12 and a pair of pneumatic cylinders 28 and 28 'operated by receiving the signal from the optical sensor and each plunger of the pneumatic cylinder ( 29) by vibrating alignment roller device 25 (see FIG. 5) for preventing the deflection winding, which is fixed at both ends and the main body 31 is configured to contact the back surface of the release film 8 to which the drug is applied. The deflection winding is automatically prevented and bonded with the strip 14 made of the stretchable film 4 + release liner 5 unwound from the separate roller 22. The bonding is performed by the action of a pair of adhesive rollers 24 and 24 ', one of which is made of elastic rubber or silicone and the other is made of smooth metal. It is preferable that it is a roller. The stretchable film 4 is made of PU, PET, SIS, etc. as the main material as stated, and when the stretchable film is adhered to the release film strip to which the drug is applied, the release liner The reason why 5) is bonded in the sandwiched state is that the stretchable film is prevented from being stretched due to the tension generated during the winding and the winding after the bonding.

The disk strip 16 having a cross section as shown in the enlarged portion D of FIG. 4, which has been completed by bonding, has a length of its non-coated portion 21 by the cutter 30 as shown in FIG. The disk roll (R) (R ') is formed by winding the disk winding roller 26 while continuously cutting in the direction.

As described in the introduction, drug transdermal drugs must be firmly attached to joints such as knees and elbows, must be firmly attached, not fall off during bathing or showering, as well as prevent contamination from the outside. There should be no external loss and should be as thin, small and as circular (elliptical) as possible in order to be selectively attached to each affected area. The disc roll for preparing the drug transdermal drug according to the present invention as detailed above A basic element of the composition to satisfy the physical requirements of the agent, and another apparatus of the present invention is a useful invention that can produce such a disc roll with high productivity and low failure rate.

Claims (6)

The unwinding roller 20 which unwinds the release film strip 1 driven by a motor, and a pair of drug application rollers installed at predetermined intervals by which the drug is applied on one surface by passing the release film strip. (10) (10 '), a dryer (12) installed in the advancing direction of the drug-applied release film (8) to dry the drug, and a strip (14) made of a stretchable film (4) + release liner (5). 1) A pair of adhesive rollers for producing the original stream 16 by bonding the unwinding roller 22 for unwinding), the release film strip 8 coated with the drug, and the strip 14 made of a stretchable film + release liner. (24) (24 ') and the disc winding roller 26 which winds the said disc strip 16, The manufacturing apparatus of the disc roll for manufacture of drug transdermal administrations characterized by the above-mentioned. The drug scraper (11) according to claim 1, wherein the pair of drug applying rollers (10) and (10 ') form one or more portions (21) on which a drug is not applied in a length direction on a predetermined portion of the release film. Is mounted, and a cutter 30 is provided at the front of the disc winding roller 26 to cut in the longitudinal direction the central portion of the drug non-coated portion of the disc strip. Apparatus for producing a disc roll for drug transdermal administration, characterized in that the two or more disc roll can be formed at the same time. The air conditioner according to claim 1, further comprising an optical sensor 27 and a pair of pneumatic cylinders 28 (28 ') automatically operated in response to a signal of the optical sensor in front of the pair of adhesive rollers (24, 24'). Both ends are fixed to each of the plungers 29 and 29 'of the pneumatic cylinder and are provided with a rubber main body roller 31 disposed to abut against the back surface of the release film 8 to which the drug is applied. An apparatus for producing a disc roll for drug transdermal administration, further comprising an alignment roller device (25). Continuously unwinding a strip of the release film 1 wound in a roll, coated with silicon as a release agent on one surface; By passing the unwound release film strip through a pair of drug application rolls 10 and 10 ′ mounted with a predetermined gap, the drug D may be formed on the silicon-coated surface of the release film film to a predetermined thickness. Applying thinly; Drying the drug by passing the drug-applied release film strip (8) through a dryer (12); The disc strip 16 is formed by continuously joining the unwound stretchable film 4 with the drug-applied release film strip 8 passing through the dryer while continuously unwinding a separate stretchable film wound in a roll shape. Steps; And winding the disc strip to form a disc roll (R). 5. The drug according to claim 4, wherein the release film strip 1 is passed through a pair of drug application rollers 10 and 10 ′ mounted with a predetermined gap so as to pass on the silicon-coated surface of the release film film. During the step of applying a thin film (D) to a predetermined thickness, at a predetermined portion of the pair of drug applying rollers 10 and 10 ', a portion 21 in which the drug is not applied in the longitudinal direction is formed at a predetermined portion of the release film. The drug scraping process is performed together, wherein the drug non-coated portion 21 of the disc strip is formed between forming the disc strip 16 and winding the disc strip to form the disc roll R. ), Further comprising the step of continuous cutting in the longitudinal direction thereof, whereby two or more disc rolls can be simultaneously produced in one manufacturing process cycle. 5. The stretchable film (4) according to claim 4, wherein the stretchable film (4) is made of PU, PET, SIS, etc. as a main material, and when the stretchable film is bonded to the release film strip coated with the drug, the release liner is formed on the back side of the stretchable film. (5) is bonded in a sandwiched state, the elastic film is prevented from being stretched by the tension generated at the time of the winding after the adhesion and adhesion, the manufacturing method of the raw material roll for drug transdermal administration.