Patent Application
20060099241
The present invention relates to an adhesive preparation superior in operability during application to the skin. More particularly, the present invention relates to an adhesive preparation that renders adhesion operation extremely easy by an improvement in the shape of a separator.
Adhesive preparations are used for the purpose of prophylaxis, treatment or testing of diseases. In most cases, the surface of an adhesive layer of an adhesive preparation is protected by a separator until immediately before application to the skin. A separator generally used for this purpose is obtained by applying a suitable release treatment to the surface of paper, a synthetic resin film, a metal foil or a laminate thereof. To facilitate adhesion of an adhesive preparation to the application site, moreover, a method for dividing the separator into two pieces or three pieces along parting line(s) having suitable shape(s) according to the shape, size and constitution of the adhesive preparation has been practiced or proposed.
For example, a preparation having a straight parting line dividing the separator almost in halves or in two parts having different area ratios (JP-A-59-141943), a preparation having a wavy parting line dividing the separator almost in halves (JP-A-10-265372), a preparation having approximately parallel straight or wavy parting lines dividing the separator in three parts (WO00/69422) and the like have been proposed. However, these preparations may cause difficulty in handling when in use, as described below.
To be specific, a preparation having a straight parting line dividing the separator in two parts, which is proposed in JP-A-59-141943 and used for adhesive preparations put to practice, is used as follows. First of all, one of the separator pieces divided along a parting line is peeled off from the medial end to expose an adhesive surface, the exposed adhesive surface is adhered to the skin surface, the other separator piece is peeled off from the medial end toward the outer extremity while gently sliding the piece and adhering the exposed adhesive surface to the skin surface. When the support of the preparation is flexible and lacks stiffness, the preparation is bent during application. As a result, adhesive surfaces may be adhered to each other, an adhesive surface may adhere to a non-peeled separator and the like, thus preventing proper adhesion.
In a preparation having a wavy parting line dividing the separator almost in halves as proposed in JP-A-10-265372, identifiability of the cut line in the separator is high, and a small bending causes protrusion of the wavy line. Therefore, it is superior to a preparation divided into halves along a straight parting line in the handling property. However, similar inconveniences as in the preparation described in JP-A-59-141943 may occur.
Furthermore, a preparation having straight or wavy parting lines dividing the separator in approximately parallel three parts as proposed in WO00/69422 is used as follows. First of all, a divided central separator piece is peeled off to expose the adhesive surface in the center, the exposed central adhesive surface is adhered to the skin surface, the separator pieces on the both sides are peeled off from the medial end toward the outer extremity by being gently slid while allowing the exposed adhesive surface to adhere to the skin surface. Therefore, the operability can be enhanced. However, when a non-peeled separator is held for application of the preparation to the skin after peeling off the central separator piece, more flexible support of the preparation allows easy bending of the preparation. As a result, adhesive surfaces may be adhered to each other or an adhesive surface may adhere to an non-peeled separator and the like, thus preventing proper adhesion. Therefore, the preparation described in WO00/69422 requires both hands for good adhesion and application to the shoulder, waist etc. with clothes on is extremely difficult.
The present invention has been made in view of such situation and the problems to be solved is provision of an adhesive preparation superior in adhesion operability.
The present inventors have conducted intensive studies in an attempt to solve the aforementioned problems. As a result, they have found that an adhesive preparation comprising a separator divided into two pieces along an approximately wavy parting line and a dashed line-like cut line between the vertices of the parting line can be held or adhered with one hand, and can be extremely easily adhered to the shoulder, waist etc., which resulted in the completion of the present invention.
Accordingly, the present invention provides the following.
The adhesive preparation of the present invention is characterized in that it has an about quadrate planar shape and comprises a substrate layer, an adhesive layer and a separator laminated in this order, wherein the separator is divided into two pieces along an approximately wavy parting line, which starts from an about quadrate corner and ends at an about quadrate corner next to said corner, and the separator comprises a dashed line-like cut line between neighboring vertices of the parting line on the center side of the separator. Consequently, the preparation can be adhered with one hand without unexpected adhesion between adhesive layers or an adhesive layer and a non-peeled separator during adhering. Moreover, the separator can be extremely smoothly detached. Therefore, according to the adhesive preparation of the present invention, an adhesive preparation superior in a series of operations for adhesion can be provided.
In the Figures, the symbols show the following items: 1 substrate layer, 3 adhesive layer, 5 separator, 7 parting line, 9 cut line, 10 adhesive preparation.
A preferable embodiment of the adhesive preparation of the present invention is explained in detail in the following. In the explanation of the Figures, the same symbol is assigned to the same element and duplicate explanation is omitted. For convenience of drawing, the size ratios of the Figures are not necessarily the same as those in the explanation.
The planar shape of the adhesive preparation 10 is about quadrate. As the about quadrate, an about square, an about rectangle, a rhombus, a trapezoid and the like can be mentioned. Of these, as the planar shape of the adhesive preparation 10, an about rectangle is preferable because the effect of the present invention is particularly easily achieved. As the about rectangle, for example, a rectangle and a shape having four rounded corners can be mentioned. As used herein, the “about quadrate” is a concept encompassing a shape having four rounded corners as shown in
A shorter side S of the adhesive preparation 10 is preferably 20 mm-150 mm, more preferably 40 mm-120 mm. The longer side L of the adhesive preparation 10 is preferably 40 mm-300 mm, more preferably 80 mm-250 mm. When the shorter side S is less than 20 mm and/or the longer side L is not less than 40 mm, the adhesive preparation as a whole tends to become too small to manipulate easily with one hand and too long to handle easily. When the shorter side S exceeds 150 mm and/or the longer side L exceeds 300 mm, the preparation as a whole tends to become unnecessarily big or considerably elongated, making handling difficult.
Where necessary, the four corners of the adhesive preparation 10 may have circular arcs having a suitable curvature radius. The curvature radius is preferably 1-15 mm, more preferably 3-12 mm. When the curvature radius is less than 1 mm, the roundness causes little difference and the formation of circular arc is rather meaningless. When it exceeds 15 mm, the formation of circular arc loses significance for the preparation characteristics and tends to be economically disadvantageous because the production yield becomes low.
The separator 5 of the adhesive preparation 10 is divided into two pieces by an about wavy parting line 7. As shown in
The parting line 7 has one or more vertices (e.g., C) on the outer circumference side of a separator 5 (e.g., shorter side S side) and two or more vertices (e.g., B1, B2) on the center side of the separator 5. The parting line 7 preferably has 1-5, more preferably 1-3, vertices on the shorter side S side. On the other hand, the parting line 7 preferably has 2-6, more preferably 2-4, vertices on the center side of the separator 5. When the parting line 7 has vertices in the number exceeding 6 on the center side of the separator 5, a certain amount of area of exposed adhesive layer 3 needs to be ensured so as to obtain sufficient skin adhesion on initial adhesion. For this end, a wavy shape having an extremely large amplitude is inevitable. As a result, a suitable dashed line-like cut line 9 cannot be formed easily between vertices on the center side (e.g., between B1-B2), and the operability tends to be degraded.
The amplitude H of the parting line 7 is preferably 10-70 mm, more preferably 20-60 mm. When the amplitude H is less than 10 mm, a sufficient exposed surface of adhesive layer 3 to ensure sufficient skin adhesion upon application to the skin surface cannot be obtained easily, and peeling off of the remaining non-peeled separator tends to be difficult. On the other hand, when the amplitude H exceeds 70 mm, the remaining non-peeled separator around the longer side is not delaminated clean and fine adhesion to the skin surface tends to be difficult to achieve.
To prevent the adhesive preparation 10 from bending to allow adhesion between adhesive surfaces or an adhesive surface and a non-peeled separator during operation after peeling off one piece of separator 5 of the adhesive preparation 10, the shortest distance from the vertex C of the parting line 7 on the separator outer circumference side to the outer circumference of the separator (shorter side S) needs to be sufficiently small. From this aspect, the shortest distance D from the vertex C of the parting line 7 to the shorter side S is preferably 1-30 mm, more preferably 2-20 mm. When the shortest distance D is less than 1 mm, the object of the present invention cannot be achieved sufficiently, and the production tends to be difficult. On the other hand, when the shortest distance D exceeds 30 mm, the adhesive preparation 10 bends to allow adhesion between adhesive surfaces or an adhesive surface and a non-peeled separator during adhering operation, and the desired effect of the present invention tends not to be expressed.
For application of the adhesive preparation 10, one piece of separator 5 is peeled off, the exposed adhesive surface is adhered to the application site while holding the non-peeled separator with one hand, and then the non-peeled separator is peeled off. It is preferable to form a dashed line-like cut line 9 between vertices of the about wavy parting line 7 on the center side to facilitate peeling off of the non-peeled separator. This has an effect that the non-peeled separator is easily bent suitably and can be readily held with fingers, which in turn enables to peel off the non-peeled separator easily.
The dashed line-like cut line 9 have a cut section E and a non-cut section F. The cut line 9 is preferably formed as a straight line between plural vertices (e.g., between B1-B2) on the center side of the parting line 7. The length of the cut section E is preferably 5-30 mm, more preferably 8-25 mm. The length of the non-cut section F is preferably 0.2-2 mm, more preferably 0.5-1.5 mm. The lengths of the cut section E and non-cut section F are appropriately determined depending on the size of the adhesive preparation 10 and the shape of the wavy parting line 7. When the length of the cut section E is less than 5 mm, it is difficult to make the separator suitably bend with ease unless the length of the non-cut section F is set to be considerably small and the processing also becomes complicated. On the other hand, when the length of the cut section E exceeds 30 mm, a non-uniform force applies during peeling off of the non-peeled separator and the adhesive preparation may not be applied properly or the non-cut section F may be broken. Moreover, when the length of the non-cut section F is less than 0.2 mm, the non-cut section F may be broken during peeling off of the non-peeled separator, and the adhesive preparation may not be applied properly. In addition, the processing may become very difficult. On the other hand, when the length of the non-cut section F exceeds 2 mm, the non-peeled separator may become too stiff to the extent that suitable bending with ease is difficult to achieve.
The material of the separator 5 of the adhesive preparation 10 is not particularly limited as long as it is easily peeled off from the adhesive layer 3 during use and the operability is fine during adhering. Specifically, a film of polyester, polyvinyl chloride, polyvinylidene chloride, polyethylene terephthalate etc., which is subjected to a silicone treatment of the contact surface with an adhesive layer 3, or a laminate film of polyolefin and quality paper or glassine and the like can be mentioned. Particularly, when a polyethylene terephthalate film is used, the effect of the present invention is sufficiently exerted. The thickness of the separator 5 is generally not more than 500 μm, preferably 20-200 μm and, from the aspect of operability during adhering, more preferably 30-100 μm. When the thickness of the separator 3 is less than 20 μm, stiffness becomes weak and may give rise to a problem in the operability during adhering. When it exceeds 500 μm, the separator may become too stiff or bulky, possibly giving rise to a problem in the operability during adhering.
In view of the object of the present invention, a substrate layer 1 is expected to show a higher effect when the flexibility is higher, and the material etc. thereof is not particularly limited. As the substrate layer 1, specifically, single films of polyesters (e.g., polyethylene terephthalate etc.); polyamides (e.g., nylon etc.); polyolefin (e.g., polyethylene, polypropylene etc.); polyvinyl chloride; plasticized polyvinyl chloride; plasticized vinyl acetate-vinyl chloride copolymer; polyvinylidene chloride; ethylene-vinyl acetate copolymer; cellulose acetate; ethylcellulose; ethylene-ethyl acrylate copolymer; polytetrafluoroethylene; polyurethane; ionomer resin; metal foils (e.g., aluminum foil etc.); and the like or laminate films thereof and the like can be mentioned. The thickness of the substrate layer 1 made from such materials may be any as long as the softness of the adhesive preparation 10 can be maintained and it is generally 1-25 μm, preferably 1-15 μm.
To impart flexibility and stretchability, the substrate layer 1 may be made from a woven fabric, a nonwoven fabric or a knitted fabric using a synthetic resin. Particularly, the use of a knitted fabric having low bending resistance is expected to achieve a high effect of the present invention. The material of the synthetic resin is not particularly limited as long as the constituent component is impermeable and can be practically used. Specifically, viscose rayon, copper ammonia rayon, diacetate, triacetate, promix, nylon, vinylon, vinylidene, polyvinyl chloride, polyethylene terephthalate, acrylic resin, polyethylene, polypropylene, polyolefin, polyurethane, benzoate, polychlal and the like can be used. The thickness of the substrate layer 1 made from such materials is generally 100-2000 μm, preferably 200-1000 μm. Moreover, a film and a fabric may be laminated to give a substrate layer 1.
The material of the adhesive layer 3 is not particularly limited, and acrylic adhesive, natural rubber adhesive, synthetic rubber adhesive, silicone adhesive, vinyl ester adhesive, vinyl ether adhesive, acrylic or vinyl water-containing adhesive and the like conventionally used for medical applications are preferable. The thickness of the adhesive layer 3 is generally 5-2000 μm, preferably 10-1000 μm.
The adhesive layer 3 may contain a drug. Preferably, the aforementioned drug can be contained in a dissolution state, dispersion state or crystal precipitation state in the adhesive layer 3 and can transdermally express systemic or topical efficacy. As such drugs, corticosteroids, analgesic antiphlogistic, sedative hypnotic, ataractic, antihypertensive, hypotensive diuretic, antibiotic, systemic anesthesia, antibacterial agent, antifungal agent, vitamin agent, coronary vasodilator, antihistamine agent, antitussive agent, sex hormone, antidepressant, cerebral circulation activator, antiemetic agent, antitumor agent, biological drug, narcotic and the like can be specifically mentioned.
The adhesive preparation 10 can be produced by a conventionally known method. For example, a solution containing a polymer compound for forming an adhesive layer 3 is applied to a separator 5 and dried to give the adhesive layer 3, a film, a fabric and the like for forming a substrate layer 1 is adhered to one surface of the adhesive layer 3 and a separator 5 is laminated on the other surface of the adhesive layer 3 to give a whole sheet. Alternatively, a solution containing the above-mentioned polymer compound is directly applied to a film, a fabric and the like for forming a substrate layer 1 and dried to give an adhesive layer 3, and a separator 5 is laminated on the surface where the adhesive layer 3 is exposed to give a whole sheet wherein the substrate layer 1, the adhesive layer 3 and the separator 5 are laminated in this order. The adhesive preparation 10 can be produced by punching out the whole sheet obtained as mentioned above into a shape of an outer frame of the adhesive preparation, and making an about wavy parting line 7 and a dashed line-like cut line 9 in separator 5 alone with a metal blade etc.
The adhesive preparation 10 can be applied to the surfaces such as skin, mucous membrane and the like, and widely used as medical or sanitation materials, taping and the like.
The present invention is explained in more detail in the following by referring to Examples, which are not to be construed as limitative.
A solution of acrylic acid/octyl acrylate copolymer in ethyl acetate was applied to a 75 μm-thick polyethylene terephthalate film after a silicone release treatment, such that the thickness of the adhesive layer after drying became 80 μm, and the film was dried. Then, a polyethylene terephthalate knitted fabric (basis weight 90 g/m2) was adhered thereto to give a whole sheet. The whole sheet was punched out into a 100 mm×140 mm about rectangle having four rounded corners with a curvature radius of 9 mm. As shown in
The whole sheet obtained in Example 1 was punched out into a 100 mm×140 mm about rectangle having four rounded corners with a curvature radius of 9 mm. Then, three periods of a sine-wave parting line wherein the shortest distance from two vertices on the outer circumference side of the wavy line to the shorter side is 9 mm and the amplitude is 50 mm, with the longer-side end-point of one of the two circular arcs of the shorter side as the origin of the line, and the longer-side end-point of the other circular arc of the shorter side as the end of the line, and dashed line-like cut lines comprising 8 mm long cut sections and 0.6 mm long non-cut sections between two vertices (2 sets) on the center side of the wavy line were formed on the separator alone with a metal blade to give an adhesive preparation.
The whole sheet obtained in Example 1 was punched out into a 70 mm×100 mm about rectangle having four rounded corners with a curvature radius of 9 mm. Then, two periods of a sine-wave parting line wherein the shortest distance from the vertex on the outer circumference side of the wavy line to the shorter side is 9 mm and the amplitude is 30 mm, with the longer-side end-point of one of the two circular arcs of the shorter side as the origin of the line, and the longer-side end-point of the other circular arc of the shorter side as the end of the line, and a dashed line-like cut line comprising 8 mm long cut sections and 0.5 mm long non-cut sections between two vertices on the center side of the wavy line were formed on the separator alone with a metal blade to give an adhesive preparation.
The whole sheet obtained in Example 1 was punched out into a 70 mm×100 mm about rectangle having four rounded corners with a curvature radius of 9 mm. Then, three periods of a sine-wave parting line wherein the shortest distance from two vertices on the outer circumference side of the wavy line to the shorter side is 9 mm and the amplitude is 30 mm, with the longer-side end-point of one of the two circular arcs of the shorter side as the origin of the line, and the longer-side end-point of the other circular arc of the shorter side as the end of the line, and dashed line-like cut lines comprising 6 mm long cut sections and 0.5 mm long non-cut sections between two vertices (2 sets) on the center side of the wavy line were formed on the separator alone with a metal blade to give an adhesive preparation.
The whole sheet obtained in Example 1 was punched out into a 100 mm×140 mm about rectangle having four rounded corners with a curvature radius of 9 mm. Then, two periods of a sine-wave parting line wherein the shortest distance from the vertex on the outer circumference side to the shorter side is 35 mm and the amplitude is 50 mm, with the longer-side end-point of one of the two circular arcs of the shorter side as the origin of the line, and the longer-side end-point of the other circular arc of the shorter side as the end of the line, and a dashed line-like cut line comprising 8 mm long cut sections and 0.6 mm long non-cut sections between two vertices on the center side of the wavy line were formed on the separator alone with a metal blade to give an adhesive preparation.
The whole sheet obtained in Example 1 was punched out into a 100 mm×140 mm about rectangle having four rounded corners with a curvature radius of 9 mm. Then, three periods of a sine-wave parting line having an amplitude of 10 mm, with the center of the longer side as the origin of the line, and the center of the opposite longer side as the end of the line, was formed on the separator alone with a metal blade. In this way, an adhesive preparation having a separator divided into halves was obtained. When using this adhesive preparation, one piece of the separator was peeled off first.
The whole sheet obtained in Example 1 was punched out into a 100 mm×140 mm about rectangle having four rounded corners with a curvature radius of 9 mm. Then, two straight parting lines (20 mm intervals) were formed in the separator alone from the center of the longer side to the center of the opposite side with a metal blade. In this way, an adhesive preparation having a separator divided into three parts was obtained. When using this adhesive preparation, the central piece of the separator was first peeled off.
The adhesive preparations obtained in the above-mentioned Examples 1-5 and Comparative Examples 1, 2 were evaluated by 10 adults. Each of them horizontally adhered the preparation to the waist of one's own and evaluated in 4 levels with regard to the following evaluation items. An average of 10 individuals was determined for each item and the results are shown in Table 1.
(Operability after Peeling off First Separator)
0 point Operation is difficult.
From the above-mentioned results, the adhesive preparations of Examples 1-5 are superior in handling property during adhering. Particularly, unexpected adhesion between adhesive surfaces or an adhesive surface and a non-peeled separator does not occur during operation for adhering, and one-hand operation is possible. In addition, a separator can be peeled off extremely smoothly. Therefore, the adhesive preparation was confirmed to be a superior preparation, wherein a series of adhesion operations have been improved from conventional ones.
This application is based on patent application No. 2004-322806 filed in Japan, the contents of which are hereby incorporated by reference.
| Number | Date | Country | Kind |
|---|---|---|---|
| 322806/2004 | Nov 2004 | JP | national |
