The present invention relates to a press through package for enclosing, e.g., pharmaceutical products such as capsules or tablets, and more particularly to a press through package having both a press through function and an easy peel function, and its production method.
Conventionally, a press through package (which may be abbreviated as “PTP” hereinafter) is formed with a lid member, made up of an aluminum foil and a thermal adhesive layer, and a container having a large number of pockets. When finger pressure is applied to a pill such as a capsule or a tablet encased in the pocket from the back of the protrusion, the aluminum foil of the lid member is ruptured so that the pill is taken out for consumption. In this case, the aluminum foil may break into fragments, and accidental ingestions of broken pieces of aluminum foil with pills have been reported. Further, there have been complaints that it is difficult for the weak, such as the elderly or the child, to press the pills out of the PTP due to their insufficient muscle strength. Moreover, in a hospital where some tens or hundreds of pharmaceutical products are handled every day, there is a demand to readily take out a large number of pills at one time.
In order to solve the above-described problems, there has been proposed a technique of forming a lid member with a stack of a plurality of layers including aluminum foil and others, and providing a partial cut or notch on a surface layer by laser beam (Patent Documents 1 and 2). With this technique, a pill can be taken out of the PTP easily with a small force.
[Patent Document 1] Japanese Patent Application Laid-Open No. 2003-063558
[Patent Document 2] Japanese Utility Model Application Laid-Open No. 1-161469
The technique disclosed in the above Patent Documents, however, is inadequate for the following reasons. Providing a partial cut on a surface layer in a stack by means of laser beam requires an advanced skill. Even a slight misalignment of the cut may adversely affect unsealing of the package. That is, formation of the cuts requires a high-precision work, which may deteriorate the yields. Moreover, the positions for providing the cuts cannot be specified until the positions of the pockets are determined. This means that an expensive laser rifle should be used in a post-processing step.
The present invention has been accomplished to solve the above-described problems of the conventional art, and an object of the present invention is to provide an easy-to-produce PTP which exhibits good hermetic sealing performance and which can be readily and reliably opened (without variation) even if the working accuracy is reduced, and its production method.
A PTP according to the present invention includes a lid member having a resin film, an aluminum foil, and a thermal adhesive layer, and a container having a flange portion and a large number of pocket portions. The PTP is characterized in that the resin film is provided with a plurality of cut pattern units constituting weakening point-cuts arranged in a string, and a pitch of the weakening point-cuts along the string is smaller than a pitch of the pocket portions so that at least one of the weakening point-cuts or at least a part of the weakening point-cut falls within a position corresponding to each of the pocket portions.
According to the above configuration, it is possible to provide a PTP that can readily be opened (pressed through) even in the case where the positions of the weakening point-cuts are out of alignment to some extent. The weakening point-cuts are provided only in the resin film. The sufficient strength is guaranteed by the aluminum foil and the remaining part of the resin film where the weakening point-cuts are not provided. Particularly, the aluminum foil provides perfect covering, ensuring good hermetic sealing performance. The weakening point-cut provides an origin of breakage when pressed, whereby a PTP that can be easily pressed through is obtained. In the case where the weakening point-cuts are arranged as described above, formation of the weakening point-cuts and stacking of the layers do not require high-precision processing, so that the PTP can readily be produced. Moreover, variation in press through performance between the lots, between the PTPs within a lot, and between the pocket portions within a PTP can be eliminated. It is thus possible to improve the product quality while simplifying the production. Here, generally (for industrial production), the weakening string extends in the longitudinal direction of the raw sheet of the resin film. The pitch of the weakening point-cuts along the string refers to the pitch of the centers of the weakening point-cuts (equivalent to the distance from one end of a weakening point-cut to one end in the same direction of the next weakening point-cut), and a sufficiently averaged value is taken for a plurality of PTPs. The same applies to the pitch of the pocket portions and others as well.
Preferably, the pitch of the weakening point-cuts is not greater than a half of a size of the pocket portion. This can further relax the tolerance on variation in placement accuracy of the weakening point-cuts. With rare exceptions, two or more weakening point-cuts can be arranged at each pocket portion, which further facilitates pushing out the pill. In the case where the pocket portion is in a circular shape in two dimensions, the size of the pocket portion refers to the diameter of the circular rim (inside measurement) of the flange portion surrounding the pocket portion. In the case where the pocket portion is in an oval or oblong shape rather than the circular shape, the size of the pocket portion refers to a maximum diameter of the rim (inside measurement) (equivalent to a line connecting two farthest points on the rim) of the flange portion surrounding the pocket portion.
The weakening point-cuts may be arranged in the flange portion as well. This can relax the tolerance on variation in placement accuracy of the weakening point-cuts.
For the thermal adhesive layer, an easy peel type thermal adhesive layer may be used to enhance the easy peel function. This facilitates peeling of the lid member from the container, when handling a large number of pills in a hospital or the like, so that the pills can readily be taken out in large quantities at one time.
A separating perforation may be provided to penetrate through a portion where the lid member is adhered to the flange portion of the container. This facilitates dividing the pills into a required dosage of medication.
A gripping portion in which the lid member and the container are not adhered to each other may be provided on at least one side of a periphery of the press through package. This facilitates peeling of the lid member from the container, whereby a large number of pills can readily be taken out.
The pocket portions may encase pharmaceutical products therein. This can provide the pharmaceutical products in the form where they can be stored in a hermetically sealed state, they can be easily pushed out, and they can be taken out easily in large quantities. Besides the pharmaceutical products, confectionery, health food, and others may be encased therein.
A method for producing a PTP according to the present invention is for producing a PTP that includes a lid member having a resin film, an aluminum foil, and a thermal adhesive layer, and a container having a flange portion and a large number of pocket portions. The method includes the steps of: forming in the resin film a string of weakening point-cuts with cut pattern units, such that the weakening point-cuts have a pitch smaller than a pitch of the pocket portions; stacking the resin film, the aluminum foil, and the thermal adhesive layer on one another to produce the lid member; preparing the container having the flange portion and the large number of pocket portions; and joining the lid member and the container by thermal adhesion in the state where the lid member is laid over the container such that at least one of the weakening point-cuts or at least a part of the weakening point-cut falls within a position corresponding to each of the pocket portions.
According to the above method, the weakening point-cuts are formed only in the resin film prior to stacking of the layers of the lid member. Therefore, as compared with the case where the weakening point-cuts are formed aiming at the pockets after stacking of the layers, variation in press through performance between the lots, between the PTPs within a lot, and between the pocket portions within a PTP can be reduced even in the case where the PTP is produced with a reduced accuracy. Accordingly, it is possible to improve the product quality while simplifying the production.
In the step of forming the weakening point-cuts in the resin film, the string of weakening point-cuts may be formed by using a roll having cutting protrusions corresponding to the cut pattern units arranged on a roll surface, i.e., by punching. In this manner, the arrangement of the weakening point-cuts may readily be obtained with an economically superior way.
According to the present invention, it is possible to provide an easy-to-produce PTP which exhibits good hermetic sealing performance and which can be readily and reliably opened (without variation) even in the case where the working accuracy is reduced.
3: lid member; 3a: resin film; 3b: aluminum foil; 3c: thermal adhesive layer; 3h: weakening point-cut; 3j: weakening point-cuts in string; 3t: non-adhered portion (flat portion of aluminum foil); 5: container; 5a: pocket portion; 5b: flange portion; 10: PTP; 21: tablet; 31: roll; D: diameter of non-adhered portion; G: gripping portion; M: perforation; P1: pitch of weakening point-cuts; and S1: spacing between strings of weakening point-cuts.
In the case shown in
In the present invention, it is prerequisite that the pitch P1 of the weakening point-cuts 3h provided in the resin film 3a is smaller than the pitch P0 of the positions corresponding to the pocket portions, or of the non-adhered portions 3t. In the arrangement pattern of the weakening point-cuts 3h shown in
The resin film 3a for use in the lid member of the PTP 10 according to the present invention preferably has a thickness of 6 to 50 μm. More preferably, the resin film 3a having a thickness of 6 to 25 μm is used. If the thickness is less than 6 μm, the strength is insufficient, in which case the film may break while the lid member is being peeled off. If the thickness exceeds 50 μm, the strength is unnecessary high, which may deteriorate the press through function. The resin film 3a having a thickness within the range of 6 to 50 μm suitably has both the press through function and the easy peel function. The resin film 3a is not restricted to a particular type; any of a variety of types of resin films including the following may be used: polyethylene film, polypropylene film, polyester film, polyamide (nylon) film, (meth)acrylic resin, polyvinyl chloride resin, polystyrene resin, polyvinylidene chloride resin, saponified ethylene-vinyl acetate copolymer, polyvinyl alcohol, polycarbonate resin, polyvinyl acetate resin, and acetal resin. The resin film may be monoaxially or biaxially oriented, or non-oriented. Particularly, from the standpoint of the press through function, the resin film preferably has an edge-tear resistance of not greater than 70 N, and more preferably from 20 to 60 N. An example of such a resin film is “TEARFINE (registered trademark) TF 110″ polyester film available from Toyobo Co., Ltd. (with edge-tear resistance of 45 N (longitudinal) and 45 N (transverse)). By using the resin film having the edge-tear resistance of not greater than 70 N (or more preferably from 20 to 60 N), it is possible to improve the press through function, while not impairing the easy peel function, whereby the individual contents can be taken out more smoothly. The edge-tear resistance may be measured in accordance with JIS C 2318 (with the specimen width of 20 mm).
The aluminum foil 3b for use in the lid member 3 of the PTP 10 according to the present invention may be the same as the one used for a known PTP. For example, a hard material, such as (JIS) 1N30, 8021, or 8079, having a thickness of about 10 μm to about 30 μm may be used. Aluminum foils other than those defined by JIS and the like, for example an aluminum alloy foil like an Al—Mn-based alloy, may be used as well. Although the way of stacking the aluminum foil and the resin film is not particularly restricted, dry lamination using a dry laminate adhesive is employed preferably.
The thermal adhesive layer 3c for use in the lid member 3 of the PTP 10 according to the present invention is preferably an easy peel type thermal adhesive resin. For example, ethylene-vinyl acetate copolymer film (EVA), ethylene-methacrylic acid copolymer (EMAA), a blended resin of polyethylene and polybutene, a resin obtained by mixing 10 to 90 parts by weight of EMAA resin or ethylene copolymer like the EMAA resin with 90 to 10 parts by weight of PP resin, or CMPS VN-503 (trade name; available from Dupont-Mitsui Polychemicals Co., Ltd.) may be used. The easy peel type thermal adhesive resin is preferably applied to one surface of the aluminum foil facing the container, to achieve a dry weight of about 2 g/m2 to about 15 g/m2.
The lid member 3 of the PTP according to the present invention may be applied with printing or coloring, in addition to those described above. An OP (overprint) layer, a primer layer, an anchor coat layer, and the like may be stacked according to need. A surface of any layer may be coated with any of anti-fog agent, slip agent, anti-slip agent, or other coating agents. Moreover, paper, synthetic paper, and the like may be stacked as long as they do not impair the effects of the present invention. Needless to say, the way of stacking the layers is not restricted to those described above; any known method may be employed.
The container 5 for use in the PTP 10 according to the present invention is a known container having a large number of pocket portions 5a surrounded by a flange portion 5b. The container may be formed with a resin sheet of polypropylene, vinyl chloride, or the like, by plug-assist forming, vacuum or air-pressure forming, vacuum/pressure forming, hot press forming, or the like. A commercially available PTP container may be used as well. After pharmaceutical products such as tablets or capsules (contents) are encased in the container, the opening is covered with the lid member and sealed by thermal adhesion, whereby the package of the present invention can be provided. The lid member may be applied to cover the opening in such a manner that the weakening string passes over the opening. It is very easy to do so, because a plurality of weakening strings are provided continually.
The PTP 10 according to the present invention may be provided with separating perforations M, as in the case of the commercially available PTP, to penetrate through the portion where the lid member 3 and the container 5 are adhered to each other. The perforations may be used to divide the pills into a dosage of medication or to provide a required amount of pills. A gripping portion G as shown in
For formation of the container 5, a resin of a predetermined material may be processed to have pocket portions 5a and a flange portion 5b, although a commercially available container may be used, as described above. For production of the PTP 10, pharmaceutical products may be inserted into the pocket portions 5a of the container 5, and the lid member 3 may be aligned and adhered thereto. Thereafter, the stack may be punched into a size conforming to a specification, whereby the PTP 10 according to the predetermined specification is completed. While the punching is the final step in this example, in the case of batch processing for example, the punching may be performed prior to the pill insertion step or the adhesion step, as long as it does not impair the effects of the present invention.
In the method of producing the PTP shown in
(1) Firstly, weakening point-cuts 3h or weakening strings 3j are formed only in the resin film 3a.
(2) At this time, the weakening point-cuts 3h are formed in the arrangement pattern as described above in detail.
According to (1) above, the weakening point-cuts are formed before formation of the stacked body of the lid member 3. This means that when the weakening point-cuts 3h are formed, they would not penetrate through the entire thickness of the lid member 3 or damage the aluminum foil. As a result, the interior of each pocket portion is prevented from being adversely affected by moisture during storage. According to (2) above, it is unnecessary to carefully place each weakening point-cut 3h in the position corresponding to each pocket portion. This can greatly relax the tolerance on placement accuracy. Substantially a great number of weakening point-cuts can be provided not restricted to the pocket portions, as in (2) above, because the production method used completely eliminates the possibility that the weakening point-cuts penetrate through the entire thickness of the lid member 3 or damage the aluminum foil 3b, as in (1) above. No problem will arise even if substantially a great number of weakening point-cuts are provided.
The functions and effects of the present invention will now be described with reference to examples. As specimens, Inventive Examples 1 to 10 according to the present invention and Comparative Examples 1 to 4 were used. A common container was used for each specimen, with the pocket portions in the container having a pitch of 17 mm and a size of 10 mm. The specimens will now be described.
A roll provided with protrusions was used to form weakening strings in a 9 to 12 μm-thick PET film (polyethylene terephthalate film) for each of Inventive Examples 1 to 9, and in a 14 μm-thick polyester film (TEARFINE (registered trademark) described above) for Inventive Example 10. The shapes and sizes (maximum lengths per point) of the weakening point-cuts are as shown in Table 1. A 17 to 20 μm-thick aluminum foil (1N30, hard foil) was laminated by dry lamination using a polyurethane adhesive (with a dry weight of 1.5 g/m2), and then, on the aluminum foil surface, a wax-added polypropylene easy peel type thermal adhesive was applied to have a dry weight of 5 g/m2, whereby the lid member for each of Inventive Examples 1 to 10 was formed. Tablets, 8 mm in diameter, were housed in a plurality of pockets formed in a polypropylene PTP container, which was then heat-sealed by each of the above-described lid members at 100° C. to produce the PTP package. According to Table 1, as will be shown below, the pitch of the weakening point-cuts in each specimen of Inventive Examples 1 to 10 is smaller than the pitch, 17 mm, of the pocket portions of the container, thereby satisfying the requirement of the present invention.
The PTP package was produced in a similar manner as in Inventive Example 1, except that the weakening strings were not formed.
An overprint (OP) agent was applied in a thickness of about 1 μm on one surface of a 20 μm-thick aluminum foil (1N30, hard foil), and an ethylene-vinyl alcohol (EVA)-added polypropylene thermal adhesive was applied in a dry weight of 5 g/m2 on the other surface of the aluminum foil, to form the lid member of Comparative Example 2. Tablets, 8 mm in diameter, were housed in a plurality of pockets formed in a polypropylene PTP container, which was then heat-sealed by the lid member at 100° C. to produce the PTP package.
An overprint (OP) agent was applied in a thickness of about 1 μm on one surface of a 20 μm-thick aluminum foil (1N30, hard foil) and, on the other surface of the aluminum foil, a 30 μm-thick co-extrusion easy peel type thermal adhesive film, made up of polypropylene/polyethylene/polystyrene alloy graft polymer resin, was laminated by dry lamination using a polyurethane adhesive (with a dry weight of 3 g/m2), to form the lid member of Comparative Example 3. Tablets, 8 mm in diameter, were housed in a plurality of pockets formed in a polypropylene PTP container, which was then heat-sealed by the lid member at 100° C. to produce the PTP package.
An overprint (OP) agent was applied in a thickness of about 1 μm on one surface of a 20 μm-thick aluminum foil (1N30, hard foil), and a polypropylene easy peel type thermal adhesive was applied in a dry weight of 5 g/m2 on the other surface of the aluminum foil, to form the lid member of Comparative Example 4. Tablets, 8 mm in diameter, were housed in a plurality of pockets formed in a polypropylene PTP container, which was then heat-sealed by the lid member at 100° C. to produce the PTP package.
A press through test and an easy peel test were conducted for each of the above-described specimens. The tests are as follows.
Finger pressure was applied onto the bottom (the pocket portion opposite from the lid member) of the container of each package to see whether the tablet can be pushed out through the lid member. Evaluation results are shown using the following symbols:
0: The tablet can be taken out with no problem.
x: The tablet cannot be pushed out through the lid member.
An end of the lid member of each package was pinched with the fingers and pulled, to see whether the lid member can be peeled from the container. Evaluation results are shown using the following symbols:
0: The lid member is peeled off with no problem, and the tablet can be taken out.
x: The lid member is not peeled off even if force is applied, and the tablet cannot be taken out.
xx: The lid member is broken and cannot be opened.
The results of the tests described above are shown in Table 1. According to the same, Inventive Examples 1 to 10 exhibited good results in both of the press through test and the easy peel test, without exception. Particularly, even in Inventive Examples 6 to 10 where the resin film and the aluminum foil were increased in thickness, good press through performance was obtained with no problem. In contrast, it is understood that, in Comparative Examples provided with no weakening point-cuts, the press through performance is inferior for example in Comparative Example 1 where a resin film was arranged. As to the easy peel test, degradation in performance is evident in the case where no easy peel type thermal adhesive layer is provided.
It should be understood that the embodiments disclosed herein are illustrative and non-restrictive in every respect. The scope of the present invention is defined by the terms of the claims, rather than the description above, and is intended to include any modifications within the scope and meaning equivalent to the terms of the claims.
According to the PTP and its production method of the present invention, it is possible to obtain a high-quality product which can readily be opened, without variation in press through performance between the lots, between the PTPs within one lot, or between the pocket portions within one PTP, even in the case where the working accuracy is reduced, whereby their contribution to the field is expected.
Number | Date | Country | Kind |
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2007-280781 | Oct 2007 | JP | national |
Filing Document | Filing Date | Country | Kind | 371c Date |
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PCT/JP2008/069260 | 10/23/2008 | WO | 00 | 5/17/2010 |