AU643536B2

AU643536B2 - Package

Info

Publication number: AU643536B2
Application number: AU80311/91A
Authority: AU
Inventors: Kenji Abiko; Yumiko Awano; Mitsutaka Ebihara; Kayoko Koseki; Atsushi Kuribayashi; Shikoh Minagawa; Hiroshi Shinohara
Original assignee: KANTO ISHI PHARMA CO Ltd; Mect Corp
Current assignee: Mect Corp
Priority date: 1990-07-10
Filing date: 1991-07-10
Publication date: 1993-11-18
Anticipated expiration: 2011-07-10
Also published as: EP0466068A3; CN1057998A; BR9102914A; HU912321D0; JPH0581266B2; KR920002443A; JPH0471560A; IL98722A0; NO912688D0; CA2046375A1; RO108641B1; EP0466068A2; NZ238829A; AU8031191A; HUT62839A; HU210152B; NO912688L; RU2018470C1

Description

1'-OL 64 556

AUSTRALIA

PATENTS ACT 1990 COMPLETE SPECIFICATION NAME OF APPLICANT(S): MECT Corporation ADDRESS FOR SERVICE: DAVIES COLLISON Patent Attorneys 1 Little Collins Street, Melbourne, 3000.

INVENTION TITLE: Package The following statement is a full description of this invention, including the best method of performing it known to me/us:- 0

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la- BACKGROUND OF THE INVENTION 1. Field of the Invention This invention relates to a packaging technology, particularly, to one for keeping pharmaceuticals and foods under desired condition of water balance.

2. Related Art Statement In general, a package shown in Fig. 6 is used for packaging pharmaceuticals of capsule or pill form. Namely, as shown in Fig. 6, a plurality of capsules 100 as articles to be supplied, are packed in a so called PTP (Press Through Pack) package 101 which comprises a moisture-permeable package film having concave portions for receiving capsules and a moisture-impermeable sheet onto which the package film is sealed by heat. The package 101 is contained in a sachet 102 made of aluminum etc., together with drying agent 103.

However, there are some problems with this package, namely: 1) Because of moisture permeability of the package film, once the sachet 102 is broken, moisture intrudes through the package film, so that the water balance of the capsule 100 deviates from a desired value.

2) As a result of particularly where the pharmaceutical is, for example, a powdery inhalant drug having 25 hygroscopic properties, the distribution ratio of the drug decreases rapidly by moisture absorption just after opening of the sachet 102 and quickly becomes lower than the standard value. Therefore the preservation period of the pharmaceutical in the capsule 100 is very short.

Similarly, performance of the package cannot be maintained for other hygroscopic products to be supplied.

S.. 3) As the results of 1) and with respect to pharmaceuticals and foods susceptible to moisture, there is a possibility of unfavourable consequences such as N- I v deterioration.

930907,p:\operbj4,80311rs.spe,1 -2- SUMMARY OF THE INVENTION The present invention seeks to ameliorate the above problems by providing a package in which desired water balance or dryness can be maintained and dryness of the packed products can be reliably maintained, even if the seal of an outside sachet, if provided, is broken.

In one broad aspect of the invention there is provided: a package comprising a moisture-impermeable sheet material and a moisture-impermeable package film sealedly bonded onto the sheet material, with first spaces between the sheet material and the film containing articles to be supplied and second spaces between the sheet material and the film containing drying agents for the articles, each second space being associated with a respective one of the first spaces and communicating therewith via a respective communicating space between the sheet material and film, and wherein the communicating spaces are adapted to maintain a separation between the articles in the first spaces and the drying agents

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in the second spaces.

The above-described package according to the present invention reliably maintains the water balance and the dryness of the packaged articles by selecting kind, largeness and shape of a drying agent so as to adjust its drying capability.

Both the sheet material and package film comprising the packaging are impermeable, so that moisture does not intrude into the interior of the package, and the deterioration of the packaged articles by moisture absorption is alleviated.

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lc 7C1 930910,p\operhjBO3ll1ts.sPce 2 -3- Moreover, it is possible to alleviate the erroneous eating of drying agent, because the articles and drying agents are packed in separate spaces from each other.

BRIEF DESCRIPTION OF THE DRAWINGS Preferred embodiments of the invention will now be described by way of example only with reference to the accompanying drawings, in which: Fig. 1 is an enlarged cross-sectional view of an embodiment of one unit of the package according to the present invention; Fig. 2 is a plan view of the embodiment of Fig. 1; Fig. 3 is a graphical representation showing the preservation effect of the package of Fig. 1 in comparison with the prior art; Fig. 4 is an enlarged cross-sectional view of another embodiment of a package according to the invention; Fig. 5 is an enlarged cross-sectional view of a further embodiment of the package according to the invention; and Fig. 6 is a plan view of the package of the prior art.

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a DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Embodiment 1 In this embodiment, a package 1 comprises a moistureimpermeable sheet material 2 laminated by, for example, aluminum foll or a plastic film, and a moisture-impermeable package film 3 sealedly bonded onto the sheet material 2, for

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93o9O9,p:\oper\hjc,80311re&pe,3 -4example by heat sealing.

The package film 3 is made, for example, of moistureimpermeable plastic film, being preferably transparent or translucent. For example, the package ;ilm 3 may be made of transparent resin such as polyvinylchloride film having moisture-impermeability.

As shown in Figs. 1 and 2, the package film 3 in this embodiment is provided with spaces 5 (the first spaces) to contain capsules 4 as articles to be supplied, spaces 7 (the second spaces) to contain drying agents 6, and communicating spaces 8 to communicate the spaces 5 and the spaces 7 with each other, in concave shapes, while the package film 3 is sealedly bonded to the sheet material 2 at all portions except for these spaces 5, 7 and 8.

The sheet material 2 can be broken, for example, by a fingernail to take out the capsule 4.

The communicating space 8, as shown in Figs. 1 and 2, is lower in height and narrower in width than the spaces 5 and 7, defining a constricted part, and the cross-sectional area of the communicating space 8 is smaller than the outside dimensions of the capsule 4 or the drying agent 6. Therefore, the capsule 4 or the drying agent 6 packed respectively in the spaces 5 or 7 does not move from its space 5 or 7 via the communicated space 8 to spaces 7 or 5 respectively as both capsule 4 and drying agent 6 are contained independently in spaces 5 or 7 without contacting one another.

In addition the package 1, in this embodiment, has separation lines 9 as intermittently cut lines, or continuous

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9309G7,p:\oper\hjc,8031res.spe,4 groove lines, to define each unit la so that it is possible to easily separate a combination of one capsule 4 and drying agent 6 as one unit la from another unit la. In this embodiment, for example, package 1 contains ten units la.

However, a package can contain less than ten units la or more than ten units la. For convenience of carrying, one or more units la can be easily separated from the package 1.

The whole package 1 is contained in a sachet 10 which comprises a moisture-impermeable material such as aluminum foil etc.

The method of production and the operation of this embodiment are now explained.

At first, in producing the package 1 of the embodiment, the spaces 5 to contain capsules, the spaces 7 to contain drying agents, and the communicating spaces 8 are formed in concave shapes in the moisture-impermeable package film 3 of a plastic film.

Next, the capsules 4 and the drying agents 6 of i. predetermined size are packed in the spaces 5 and the spaces 20 7 respectively. Then, all portions of the package film 3 except for the spaces 5, 7 and 8 are sealed with the moistureimpermeable sheet material 2 by using a method such as the.

heat sealing method. Next, the separation lines 9 e.g. as an intermittently cut line or continuous groove line are provided 25 for the package 1 to make each combination of a capsule 4 and o9 s contained in a sachet 10, having moisture-impermeability, 93098,p:\operbhjc,8311res.spe,5 -6and having for example ten units la.

The production process described above may be carried out in an automatic manufacturing line, not shown.

According to this embodiment, the space 5 which contains capsule 4 is connected via the communicating space 8 to the space 7 which contains drying agent 6, and both the sheet material 2 and the package film 3 heat-sealed to each other have moisture-impermeability. Thus the dryness of the capsule 4 is controlled just by the drying agent 6 even after opening the outside sachet, and the capsule 4 does not absorb any moisture from the outside. The drying agent is carefully selected for its kind, amount, size and shape to obtain the best conditions for maintaining the capsule 4, and the capsule 4 and the drying agent 6 are packed in their own spaces 5 and 7 respectively. The capsule 4 is then maintained at the best level of dryness or water balance, and unfavourable phenomenon such as deterioration of the content of the capsule 4 by intrusion of moisture, or cracking of the capsule 4 by excessive drying, can be prevented.

The package 1 in this embodiment is made up of the moisture-impermeable units la. It may be convenient to separate each unit la at the separation line 9 and to carry one of these separated units.

Moreover the capsule 4 is not contaminated by the drying 25 agent 6, because the communication space 8 has a smaller cross sectional area than either the outside dimensions of the capsule 4 or the drying agent 6, and the capsule 4 and the drying agent 6 do not contact each other. Further, accidental 93M98,p: \oper~hjc,8031 lres.spe,6 -7eating of the drying agent 6 in place of the capsule 4 can be prevented, because the drying agent 6 is not taken out simultaneously with the capsule 4, when the portion of the sheet material 2 covering the containing space 5 is broken to take out the capsule 4.

The inventors compared the operational effects of the package 1 with the prior art described in Fig. 6 and obtained the results shown in Fig. 3. In this comparison, stability of a powdery inhalant agent in capsule form, the main pharmaceutical content being aceneuramic acid sodium, which is preserved at 25 0 C-83% RH, is evaluated for respective packages by the distribution ratio of the aceneuramic acid sodium onto Stage 2+3+4 of MLI (Multi-Stage Liquid Impinger) following the time elapsed from opening the outside sachets 10 and 102. The MLI is a classification device comprised of a throat, stages 1, 2, 3 and 4 and a filter, wherein the throat and the stage 1 correspond to stomatalo and epiglottis, the stages 2, 3 and 4 correspond to lower airways and the filter corresponds to an alveolus area. According to this comparison, the package 1 showed sufficient stability 6* 9 8 throughout 28 days. In the prior art however, the distribution decreased a day after opening and showed a much lower value than the standard value after 3 days, for the distribution ratio for the aceneuramic acid sodium at the 25 stages 2+3+4 using the powdery, inhalant agent in capsule form. This comparison proved the extremely favorable stability in the package according to the present invention compared with the conventional package.

93W9O7,p:\operhj,8G3h1v5.5pe,7 Embodiment 2 This embodiment shown in Fig 4, is substantially the same as Embodiment 1 except for containing pills 4a in respective pill containing spaces 5a (the first space) in place of capsules, as articles to be supplied.

The properties including size, kind and shape of the drying agent 6 can be selected depending on the desired level of dryness of the pill 4a.

The excellent effects explained in Embodiment 1 are also obtained in this Embodiment 2.

Embodiment 3 In Fig 5 the powder 4b, as an article to be supplied, is placed in a powder containing bag 4c having moisture permeability, and then packed in a powder containing space (the first space).

The same excellent effects are obtained substantially as in Embodiments 1 and 2 above.

Further, when the powder containing bag 4c is made of, for example, an edible film, the inner powder 4b can be 20 ingested by taking the powder containing bag 4c itself after removing it by breaking the sheet material 2 with for example a fingernail.

0 0 However, it should be understood that the present invention is not restricted to the above embodiments and many 0 25 variations are possible without departing from the scope of

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the invention.

0 609 For example, shapes and allocation of the spaces for L L1, articles to be supplied, of drying agents, or of communicating E 930907,p:\opcr\hjc,80311respe,8 -9spaces are not restricted by the embodiments. The constituent materials of sheet material 2 and a package film 3 can also be variably selected.

In the above detailed description the present invention is applied to the packages of pharmaceutical capsules, pills and powder, however, the invention is not restricted to those cases, and can for example, also be applied to foods, agricultural chemicals, etc. or to other product shapes than a capsule etc.

Some advantages of the present invention are as follows: 1) The package comprises moisture-impermeable sheet material and moisture impermeable package film which is sealedly bonded to the sheet material, and has first spaces respectively containing articles to be supplied, second spaces respectively containing drying agents, and communicating spaces respectively communicating the first spaces with the second spaces, between the sheet material and the package film, so that dryness or water balance of the articles can be maintained by the drying 20 agent even after the opening of the outside sachet and the quality of the article can be maintained until it is used.

*9 2) The deterioration of the articles by moisture or the cracking of the articles caused by excessive drying, can 25 be effectively prevented by carefully selecting in advance the drying capability of the drying agent by its size, kind, amount, and shape.

3) Any problems that would be caused by direct contact of 930908,p:\opcr\h]C,8311re3s5Pe9 the article with the drying agent are eliminated, because the cross-sectional area of the communicating space is smaller than either the outside dimensions of the article or drying agent, which are contained in the first and second spaces respectively.

4) The dryness of the article is maintained, even when carrying only one unit or several such units, because the package consists of units each having moisture impermeability.

5) It may be convenient for carrying or storing just one or several units by dividing the package, because plural combinations of the first space, the second space and the communicating space are provided in said package film, and the separating line which separates each combination into a single unit is provided in the package film and the sheet material.

6) The problem of accidentally taking the drying agent can be prevented, because the drying agent is not removed :from the package even when the sheet material covering 20 the article is broken to take out the article.

Pharmaceuticals can be easily dispensed at a dispensary etC o 8) A package can be produced simply by adding a line for supplying the drying agents to conventional package 25 manufacturing technology, and changing the mold to form spaces for articles to be supplied, spaces for the drying agents, and for communicating spaces, thus 1/ reducing manufacturing costs.

930907,p:\ oper\hl;80311resspc,

Claims

1. A package comprising a moisture-impermeable sheet material and a moisture-impermeable package film sealedly bonded onto the sheet material, with first spaces between the sheet material and the film containing articles to be supplied and second spaces between the sheet material and the film containing drying agents for the articles, each second space being associated with a respective one of the first spaces and communicating therewith via a respective communicating space between the sheet material and film, and wherein the communicating spaces are adapted to maintain a separation between the articles in the first spaces and the drying agents in the second spaces.

2. The package according to claim 1, wherein: said first spaces, said second spaces, and said communicating spaces are formed in concave shapes in said package film.

3. The package according to any one of claims 1 or 2, wherein: said communicating spaces have a cross-section area smaller than outside dimensions of said articles to be supplied or said drying agents.

4. The package accoeding to any one of claims 1 to 3 wherein: separating lines are provided to both said package film 30 and said sheet materiasl to facilitate the separation of each unit of one first space, one second space and one communicating space. 4**b* 4 9 9 9* 9 *e 9 0 994 *see 6 6 35 9 r The package according to any one of the preceding claims, wherein: said package film is made of a transparent resin. 93O97,pp:\oper\hjc,80311em&spe,11 -12-

6. The package according to any one of the preceding claims, wherein: said package film is made of polyvinylchloride film having moisture-impermeability.

7. The package according to any one of the preceding claims, wherein: said articles to be supplied comprise pharmaceuticals or foods.

8. The package according to claim 7 wherein the pharmaceutical is a powdered inhalant in a container.

9. A package substantially as hereinbefore described with reference to the drawings, excluding Fig. 6. DATED this 7th day of September, 1993. MECT CORPORATION By Its Patent Attorneys DAVIES COLLISON CAVE *oo *e eas 930907,p:\opcr\hjc8031 Iresp, 12 ABSTRACT ABSTRACT OF THE DISCLOSURE A package comprising a moisture-impermeable sheet material and a moilAure-impermeable package film sealedly bonded onto said sheet material. The package has first spaces to respectively contain articles to be -nrcso packed, second spaces to respectively contain drying S agents, and communicating spaces having a small area in its cross-section and respectively communicating the 0 first spaces and the second spaces, between the sheet r. material and the package film. The articles to be packed and the drying agents are respectively contained in the first spaces and the second spaces, being held without contacting each other interposing the respective c i s communicating spaces. I a