MXPA97001821A - Bubbles packing with non-proof desicante - Google Patents

Bubbles packing with non-proof desicante

Info

Publication number
MXPA97001821A
MXPA97001821A MXPA/A/1997/001821A MX9701821A MXPA97001821A MX PA97001821 A MXPA97001821 A MX PA97001821A MX 9701821 A MX9701821 A MX 9701821A MX PA97001821 A MXPA97001821 A MX PA97001821A
Authority
MX
Mexico
Prior art keywords
sheet
drying agent
cavities
bubble
preparation
Prior art date
Application number
MXPA/A/1997/001821A
Other languages
Spanish (es)
Other versions
MX9701821A (en
Inventor
Ulrich Flother Frank
Guntert Hanspeter
Lorca Pedro
Merkle Stefan
Original Assignee
The Rw Johnson Pharmaceutical Research Institute
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from CH02741/94A external-priority patent/CH687615A5/en
Application filed by The Rw Johnson Pharmaceutical Research Institute filed Critical The Rw Johnson Pharmaceutical Research Institute
Publication of MXPA97001821A publication Critical patent/MXPA97001821A/en
Publication of MX9701821A publication Critical patent/MX9701821A/en

Links

Abstract

The present invention relates to a bubble pack with a sheet of receptacles with cavities for preparation and cavities for drying agent, as well as a cover sheet sealed to said sheet of receptacles, characterized in that at least one cover sheet of the bubble pack it is reinforced in the region of the drying agent cavities so as to avoid the extraction of a drying agent carried by said cavity for drying agent, with the usual pressure of the finger, and so that the reinforcement on the cavities for the agent of drying can not be removed by applying usual means

Description

PACKING BUBBLES WITH DESICT FL CHILD TESTING TECHNICAL FIELD The present invention relates to a bubble pack, particularly a bubble pack that provides cavities for pharmaceutical preparation and cavities for the delivery agent, to pack solid pharmaceutical preparations or moisture-sensitive ernol-solids. The expression "bubble pack" is used herein in its usual meaning, that is, for any type of sheet packaging, preferably made of plastic and aluminum, having cavities for the reception of the solids to be packed in the container. sheet of receptacles (usually in the plastic sheet) and which is sealed by sealing with a second sheet, called cover sheet + a, preferably a thin sheet of coated aluminum, whereby the product in its row can pushing through the cover sheet by pressing on the sheet of receptacles. Q BACKGROUND OF THE INVENTION Presently, bubble packings are a preferred packaging form for solid or semi-solid pharmaceutical preparations S, respectively. They have the advantage that the preparations remain neatly packaged until <; They use, and in addition - due to the usual labeling on the back and / or the top side - the risk of contusion is greatly reduced. Additional advantages of bubble packaging are reduced abrasion of the product, the possibility of obtaining simple units under primary packing retention, resistance to water vapor, etc. The bubble packings used today have a certain permeability to water vapor due to the plastic sheet, which makes them unsuitable for the packaging of moisture sensitive products. The minimization of water vapor permeability by thickening the thin sheet is possible only limited, due to technical practicability and handling (oppression operation). Therefore, the moisture permeability with the generally usual packages can now be improved only by the selection of the material, ie sheets on laminar units as impervious to moisture as possible. In this regard, multi-layer sheets have proved to be suitable. These known packings, however, are not suitable for preparations that are very sensitive to humidity or moderately sensitive to humidity preparations intended for countries with a hot-humid climate. Several attempts have already been made to provide packaging for the storage of dry pharmaceutical preparations. A known process exclusively uses aluminum mix-t films such as receptacle foil and cover foil. An additional drying effect can be achieved by providing two interconnected cavities for air exchange, one of which comprises a drying agent and the other a pharmaceutical preparation. Such packaging has the disadvantage that it is relatively expensive and that, particularly due to the lack of transparency, there is a risk of mistakenly taking the drying agent instead of the effective substance comprising the preparation. Besides the If it is possible for side effects caused by some drying agents to occur, not consuming the effective substance comprising the preparation (pharmaceutical preparation) can have a very deleterious effect on the patient's state of health. Attempts have also been made to reduce moisture uptake of the bubble packings without sacrificing the transparency of the thin sheet of at least one side of the package. EP-A-0 466 068 describes a bubble pack 0 in which each cavity for a pharmaceutical preparation is connected to a cavity for a drying agent. In addition, a perforation allowing the separation of each combination of a pharmaceutical preparation and a drying agent can be provided. '5 The disadvantage of this bubble pack is that the drying agent can easily be consumed by accident, particularly with a separate unit. In FR-FI-2 593 152 a bubble pack with drying agent is also described wherein several cavities for a pharmaceutical preparation are connected to a cavity for drying agents. Although for this packaging the risk of accidentally turning the drying agent due to its exposed location and / or its amplitude is reduced, this packaging has the disadvantage that the drying effect is nociously influenced if the pharmaceutical preparations are consumed in the sequence wrong FR-ñ-2 660 634 discloses a package comprising a drying agent, in which a membrane is located between the drying agent and the cover sheet to keep the drying agent in the desired location. The loading is not made by pushing the load through the cover sheet but peeling off the cover sheet. A detachment of the cover sheet from the drying agent is made more difficult by additional seals. Child resistant packaging is also known. In DE-O? -24 04 232 a child-resistant package is disclosed, however without any means to keep the pharmaceutical preparation dry. In addition to a tear-resistant rernovible sheet on the cover sheet which prevents pushing of the load through the cover sheet, the cavities are formed so that a child can not open them by biting the bubble. U-5 172 812 discloses a child-resistant package with a breakable cover sheet and a laminated paperboard material detachable from the sheet of frangible material. In addition, a "misaligned" die cut is provided with the opening, so that only a part of the cardboard material peels away from the opening, so that the tablet can only be removed if pressure is applied in a specific manner. . This document does not disclose a package comprising drying agent. In US-3 780 856 and US 3 835 995, bubble packages are described with a cover sheet peeled off. In both packages a tear-off strip is provided in which the cover sheet is not sealed with the carrier layer.
BRIEF DESCRIPTION OF THE INVENTION The problem of the present invention is thus to provide a bubble pack for the dry storage of pharmaceutical preparations, whereby the accidental turning of the drying agent is avoided. This problem is solved by a bubble pack with a sheet of receptacles, with cavities for the pharmaceutical preparation and cavities for drying agent as well as a cover sheet, characterized in that the packaging of bubbles in the region of the cavities for drying agent it is reinforced so that the removal of the load with the usual pressure of the fingers is avoided, and the reinforcement on the 5 cavities of the drying agent can not be removed by applying the usual means. In the bubble pack of the invention, each cavity comprising a pharmaceutical preparation is connected to at least one cavity comprising a drying agent, and at least one sheet, particularly the sheet of JLO covered, is reinforced in the region of the drying agent so that the reinforcement on the cavities of drying agent can not be removed by usual application of usual means, for example pressure, push or detachment by peeling with fingers or finger nails. Through this By packing it is possible to ensure sufficiently dry storage of the tablets during the entire period of desired consumption of the pharmaceutical preparation under consideration of the climatic situation, and simultaneously to prevent the accidental use of the drying agent which can often become dangerous. . By not consuming the essential effective agent, as well as by the side effects of the drying agent, the possibly weakened organism of a patient may be further weakened. Examples of a bubble pack of the invention are shown in Figures 1 to 6.
BRIEF DESCRIPTION OF THE DRAWINGS Figure 1 is a top plan view of a bubble pack in which each cavity for pharmaceutical preparation is connected to a cavity for drying agent by a connecting passage, with an additional protective sheet placed on the cover sheet , in the drying agent region. Fig. 2 is a section along the line II-II of the bubble pack of Fig. 1. Fig. 3 shows the structure of a specific sheet of protection against extraction which simultaneously serves as resistant to children. Figure 4 is a top plan view of a bubble pack with a specific sheet of protection against extraction, in accordance with Figure 3. Figure 5 is a section along the line V-V of the packaging of bubbles of figure 4 during the peeling off of the protection sheet on the preparation side, and figure 6 shows a bubble pack in which two preparation cavities are connected with a cavity of drying agent.
DETAILED DESCRIPTION OF THE INVENTION The bubble pack of the invention has a sheet of receptacles 4 with cavities 1 for the incorporation of preparations comprising the effective substance and cavities 2 for the incorporation of drying agents, as well as a cover sheet 5 sealed to said sheet of receptacles 4, characterized in that the packaging of bubbles in the region of the cavities for drying agent 2 is reinforced in order to avoid the extraction of a drying agent carried by said cavity 2 for drying agent with usual finger pressure, and the reinforcement on the cavities 2 of the drying agent can not be removed by applying usual means. Usually, each cavity 1 is connected to at least one cavity 2 by means of connection 3, so that it is of course possible an exchange of air, but not a direct contact of the preparation comprising the effective substance with the agent of drying Preferably, said connecting means 3 is a cavity similar to a passage in the receptacle sheet 4 formed of the bubble pack, which is particularly a plastic sheet. The shelf life of the package can be controlled by the amount of drying agent used, depending on environmental conditions. The amount of drying agent is the result of its water absorption capacity, the design of the bubble, the quality of the thin film used, the stipulated storage conditions and the desired storage life of the product. For reasons of space, it may be advantageous if more than one cavity 1 is connected to a pharmaceutical preparation with a cavity 2 for a drying agent (for example as shown in FIG. 6). Since the drying agent is also advantageously applied in the form of tablets, which facilitates the dosing as well as the introduction into the cavities 2 and additionally a clogging of the passages by loose particles, respectively, is reduced or prevented for such Alternatively, larger drying agent tablets may be used. All solid, preferably pharmaceutically innocuous substances such as molecular sieves and silica gel are suitable as drying agents. It is therefore considered essential that the package comprises additional safety elements which prevent the accidental use of the drying agent instead of the preparation comprising the effective substance. Such a safety measure can be - for example, the sealing of an additional plastic sheet in the region of the drying agent, particularly on the cover sheet 5. This additional sheet prevents pushing from one side of the drying agent to the other. through the cover sheet 5. Preferably, an additional sheet simultaneously covers several cavities 2 comprising drying agent, resulting in improved adhesion thereof. This thin sheet can be clear or colored. Provisions are possible on the side of the sheet of receptacles 4, such as local coloration, local reinforcement of the cover sheet or hood, respectively, etc., but they are technically much more expensive .. Particularly, if an additional protective sheet 6 simultaneously covers several cavities 2 for drying agent, it is preferred that the cavities 2 for drying agent be located adjacently, particularly in one or several adjacent rows. The preferred bubble packages of the invention with improved security against the extraction of the drying agents provide on the side of the cover sheet, at least in the region of the cavities 2 for the drying agent, a sheet 6. The protective sheet 6 can be of any shape, provided that the extraction of the drying agent is effectively prevented. Suitable, for example, thin sheets of plastic which, due to their toughness, prevent a thrust from side to side. Due to their toughness, for example polyethylene (PE) films or mixed polyethylene films, respectively, are preferred, for example a laminar unit made of polyethylene (PE) film and polyethylene terephthalate (PET) (PET / PE film). . Also suitable are the cover sheets 5 of a multi-layer laminar unit, the protection sheet 6 being already included (see FIG. 3). For example, such sheets that are commercially available have, inside (in contact with the receptacle sheet 4) a layer of hot melt adhesive mixture, for example a thermoplastic lacquer 10. As further layers a thin aluminum foil follows. , a laminating adhesive 12, a polyester sheet 13, for example polyethylene terephthalate (PET), an adhesion necker 14, eg another solid adhesive layer, a paper layer 15 and possibly an imprint 16. For example, a sheet with, eg, 20 μ thickness of the Al layer and 12 μm thickness of the polyester sheet is available and an adhesive with restricted adhesion in the laminar unit is available, for example from Neher, Kreuzlmgen, Switzerland, under the name Peel-Push thin sheet. The adhesive can be constructed in such a way as to provide only restricted adhesion to the laminar unit so that a manual separation between the cover sheet 5 and the protective sheet 6 is possible, or in such a way that the adhesion of the laminar unit is strong enough so that the multilayer laminar unit is peeled off as such, that is, the cover sheet 5 and the protective sheet 6 together. When such a multilayer laminar unit with restricted adhesion of the laminar unit is used, the entire region of the cover sheet, which is also the pharmaceutical preparation region, is covered. Such a cover is considered as resistant to children. It is not possible to press from side to side, in the usual way, the tablet through the laminar unit. For the packaging of bubbles of the invention it must be ensured that the part of the protective sheet of the multi-layer laminar unit can only be peeled off from the preparations comprising the effective substance but not the drying agent. This is ensured for example (as shown in Figures 4 and 5) because opening aids are provided in the part of the preparation comprising the effective substance, e.g., free sealing zones 7, as well as a perforation or a tr-aneversal cut 8 in the region of the drying agent. By In the middle of the perforation or the cross section 8, respectively, it is ensured that, starting from the sealing free zone 7, the part of the protective sheet of the multilayer film unit only detaches in the region of the preparations that they comprise the effective substance. The free sealing zones 7 are preferably located directly in the perforation or the cross section 3, or at the intersection of the perforation or cross section 8 and the perforation or cross section 9, so that the direction of the detachment necessarily leads outside the drying agent. The sealing free zone 7 is for example made so that the sealing tool, for example a die, provides respective "cold" parts, and / or by means of deep stretching of the packaging form in the respective region, so that contact can not be made, and at the same time the grasping of the detached part of the sheet is facilitated, or by punching the respective area of the receptacle sheet before sealing it with the cover sheet. Advantageously, it is also provided between two cavities of pharmaceutical preparation and / or between two cavities of drying agent, a perforation or cross section 9, respectively. The perforation or the cross-section 8, respectively, as well as the perforation or cross-section 9 preferably affect at least the portion of the protective thin sheet of the multi-layered laminar unit. Particularly, a perforation 9 can be provided through the entire bubble pack so that indual units can be separated. Since the region of the drying agent, by virtue of which the thin protective sheet is secured against extraction, there is also no risk for a 1: 1 combination (a preparation comprising the effective substance per tablet of drying agent). However, it is important that the paper + PET complex be peelable only from the region of the preparation. This is achieved because the opening aids 7 are present exclusively in the field of preparation. If a sheet with an adhesive that provides strong adhesion to the strong laminar unit between the cover sheet 5 and the protective sheet 6 is used, a perforation or transverse cut 8 as well as a perforation or cross section 9 must be provided to ensure that the The multilayer laminar unit is only detached by peeling an effective substance preparation, which is then opened. C? .or an additional protection measure, particularly with. In the case of a multilayer laminar unit, the paper layer, particularly in the reaction on the drying agent, can be colored or provided with an imprint of 0 warning. A label in the region of the product is also advantageous, for example specification of the days of the week, etc. in which the respective tablet should be consumed. Said label decreases in addition to the probability that the sequence of the return -v.gr., for packages with several units L5 for which a unit comprises more than one preparation cavity 1 per cavity of drying agent 2- such that all tablets of a unit are consumed except one at the beginning of consumption, and the remaining tablet, however, is consumed as the last of all the units, so that the r > 0 drying agent - due to increased moisture access through the broken area of the cover sheet 6 over the tablet cavities 1 - is under extreme deformation. In addition, a tracking device can be provided with the package indicating the full consumption of the drying agent or the increase in humidity, respectively. In this connection, for example, silica gel with indicator, a silica gel colored with C0Cl2, is known to show the absorption of water. Due to the side effects that can occur with the ingestion of C0CI2, the silica gel with indicator should only be used in bubble packes of the invention provided with additional protection to avoid the ingestion of the drying agent. The permeability to moisture of the sheet of receptacles same-as already mentioned before-, it should be as low as possible. In addition, it must be sealable as well as also have good compatibility with the product. A film currently used for such applications is a combination sheet of PVC (polyvinyl chloride), PE (polyethylene) and PVDC (polyvinylidene chloride). Such sheet is sold for example ba or Alfo? LR, Tristar, "Aclar * names etc., and is widely used for pharmaceuticals. A usual sheet can also be used as cover sheet, particularly one comprising an aluminum layer or a thin sheet of aluminum such as a thin sheet of aluminum coated with commonly used polymer, or the multilayer laminar unit mentioned above, respectively The sheet of receptacles is formed in accordance with the bubble design by customary methods and is particularly sealed after introducing the drying agent and the product connected to the thin cover sheet in a usual manner for bubble packings.
EXAMPLE 1 Protection Against Extraction for Bubble Packages On the cover sheet, a usual aluminum foil, a PET / PE protection foil (thickness of approximately 60 μr) is sealed at approximately 120-130 ° C in the region of the part to be protected against extraction (drying agent region). Due to the toughness of the PET / PE sheet, oppression of the drying agent from side to side is not possible. Bubble packaging secured in this way can be drilled at will, preferably between each unit.
EXAMPLE 2 Protection Against Extraction, with a Laminar Unit of Multiple Layers. The filled receptacle sheet is sealed at approximately 200 ° C with a multi-layer laminar unit (Peel-Push-Folie from Neher, Kreuzlmgen, Switzerland), according to Figure 3, as a cover sheet and protective sheet instead of an aluminum foil, so that, for each unit, at least one sealing-free zone is formed in the region of the product in the perforation line for the drying agent region and in the perforation line between the units. If the sealing is done by stamping, this is achieved by means of "cold" zones in the stamping itself. A perforation is then made between the preparation cavities and the cavities of the drying agent.
The extraction of the product is done in several stages: - Optional separation of the bubble zone along the perforation lines. - Peel off of the layers l the outer cover sheet, here complex of paper + PET, in the free sealing corners. -Orpress through the product, through the thin sheet of aluminum fi a on the bottom by heat sealing. Since the sealing-free zones are located on the boundary line between the region of the drying agent and the region of the product, so that peeling away to the location away from the region of the drying agents, the part of the protective sheet of the multilayer laminar unit can be detached by peeling exclusively in the region of the product. This is not possible in the region of the bite agents since any opening aid such as a free sealing zone is absent.

Claims (1)

NOVELTY OF THE INVENTION CLAIMS
1. - Bubble pack with a 5-well sheet (4) with cavities for pharmaceutical preparation (1) and cavities for drying agent (2), as well as a cover sheet (5) sealed to said sheet of receptacles (4), characterized in that the bubble packing is reinforced in the region of the cavities for drying agent (2) so 10 that the extraction of a drying agent carried by said cavity for drying agent (2) is avoided, with the usual pressure of the finger, and so that the reinforcement on the cavities for drying agent (2) can not be removed applying usual means. fifteen ? . - Bubble packaging according to claim 1, further characterized in that at least one cavity pair preparation (1) is connected with at least one cavity for drying agent (2). 3.- Bubble packing in accordance with the 0 claim 1 or 2, further characterized in that the drying agent cavities (2) are located adjacently, particularly in one or several adjacent rows. 4. Bubble package according to any of claims 1 to 3, further characterized by the fact that > At least one preparation cavity (1) is connected to at least one cavity for drying agent (2) by means of a connecting passage (3). 5. Bubble pack according to any of claims 1 to 4, further characterized in that the cover sheet (5) comprises an aluminum layer or a sheet of aluminum ada, respectively. 6. Bubble packaging according to any of claims 1 to 5, further characterized in that in the region of the cavities for drying agent (2) on the cover sheet (5) is provided at least one sheet of protection (6). 7. Bubble package according to claim 6, further characterized in that the protective sheet (6) is a plastic sheet, particularly a PET / PE sheet. 8. Bubble packaging according to claim 6, further characterized in that the cover sheet (5) and the protection sheet (6) together form a multi-layered laminar unit and the multi-layered laminar unit between the cavities for preparation (1) and the cavities for drying agent (2) is perforated or sectioned at least in the protection sheet portion (6) of the multi-layered laminar unit and the bubble packing has on the preparation side in the region of the perforation or cross section (8) at least one free sealing zone (7). 9. Bubble packaging according to claim 8, further characterized in that the multi-layered laminar unit between the cover sheet (5) and the protection sheet (6) has a layer with restricted adhesion to the laminar unit, particularly a lamination adhesive. 10. Bubble packaging according to claim 8, further characterized in that the cover sheet (5) and the protective sheet (6) are inseparably connected, so that the multi-layer sheet unit is peelable as? n everything and because the bubble packaging in addition to the perforation or cross section (8), has a perforation or cross section (9) at least between the cavities for preparation (1), preferably between the cavities for preparation and between the cavities for drying agent.
MX9701821A 1994-09-07 1995-09-05 Childproof blister package with dessicant. MX9701821A (en)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
CH02741/94A CH687615A5 (en) 1994-09-07 1994-09-07 Tropical packaging.
CH2741/94 1994-09-07
CH2741/94-0 1994-09-07
PCT/IB1995/000728 WO1996007601A1 (en) 1994-09-07 1995-09-05 Childproof blister package with dessicant

Publications (2)

Publication Number Publication Date
MXPA97001821A true MXPA97001821A (en) 1997-06-01
MX9701821A MX9701821A (en) 1997-06-28

Family

ID=4240569

Family Applications (1)

Application Number Title Priority Date Filing Date
MX9701821A MX9701821A (en) 1994-09-07 1995-09-05 Childproof blister package with dessicant.

Country Status (14)

Country Link
EP (1) EP0779872B1 (en)
JP (1) JPH10505047A (en)
AT (1) ATE173710T1 (en)
AU (1) AU700873B2 (en)
CA (1) CA2199263C (en)
CH (1) CH687615A5 (en)
DE (1) DE69506267T2 (en)
DK (1) DK0779872T3 (en)
ES (1) ES2125643T3 (en)
IL (1) IL115202A (en)
MX (1) MX9701821A (en)
TW (1) TW308577B (en)
WO (1) WO1996007601A1 (en)
ZA (1) ZA957530B (en)

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