Tightly sealing single dose packaging

Abstract

A single-dose package for transdermal therapeutic systems or film-shaped administration forms, in the form of a tear-open sealed-edge pouch with a completely surrounding and continuous non-peelable sealing surface. The single-dose packages are provided with two packaging material elements, which are arranged one lying on top of the other and form the upper side and underside of a pouch that contains the product. At least one packaging material element is a tear-resistant film laminate with an at least three-layer structure, wherein at least one layer of the packaging material elements is a metal layer. The single-dose package also has a linear weakening, which lies in the sealing area, does not touch the edge of the package and extends in the direction of the weaker tear resistance of the upper side and underside and the linear form of the anisotropically tear-resistant plastic.

Claims

1. A childproof single-dose package configured to contain transdermal therapeutic systems or film-shaped administration forms, comprising: a tear-open sealed-edge pouch with a completely surrounding and continuous non-peelable sealing surface forming a surrounding, continuous, non-releasable sealing edge, the tear-open sealed-edged pouch comprising two packaging material elements, which are arranged one lying on top of the other and form an upper side and an underside of the tear-open sealed-edge pouch including a product-receiving area that contains a packaged product and the surrounding, continuous, non-releasable sealing edge surrounding the product-receiving area, at least one of the packaging material elements including a tear-resistant film laminate with an at least three-layer structure, and at least one layer of the packaging material elements is a metal layer, the tear-resistant film laminate having a tear-resistant layer having a controlled tear profile, the tear-resistant layer is an outer layer with respect to the metal layer and is comprised of a plastic with anisotropic tear resistance which is oriented monoaxially, of which a minimum tear resistance in a weaker direction is at least 50 N, measured with respect to the tear-resistant layer, the single-dose package has a line of weakness comprising a perforation or reduction located only in the tear-resistant layer, the line of weakness lies in the surrounding, continuous, non-releasable sealing edge, does not touch a periphery of the package, the line of weakness is oriented such that it extends in the weaker direction of the monoaxially oriented anisotropic tear-resistant layer, the monoaxially oriented anisotropic tear-resistant layer configured to permit a tear propagation originating from the oriented line of weakness without such perforation or reduction of the line of weakness in the product receiving area, the permitted tear propagation extending in the monoaxially oriented anisotropic tear-resistant layer in the weaker direction of tear resistance of the monoaxially oriented anisotropic tear-resistant layer and the permitted tear propagation having a predetermined maximum lateral deviation of a tear profile relative to the orientation of the line of weakness and the permitted tear propagation extending from the line of weakness in the surrounding, continuous, non-releasable sealing edge in the weaker direction of the minimum tear resistance of the anisotropic tear-resistant layer into the product-receiving area and to the surrounding, continuous, non-releasable sealing edge, the permitted tear propagation within the product-receiving area extending in a predetermined maximum distance in parallel profile from the completely surrounding and continuous non-peelable sealing surface, and, position restrictors adjacent the product-receiving area and adjacent the completely surrounding and continuous non-releasable sealing edge and arranged such that the permitted tear propagation transverses each of the position restrictors and each of the position restrictors configured to prevent the product from shifting into the area of the permitted tear propagation prior to opening the package.

2. The single-dose package according to claim 1, wherein the plastic of the tear-resistant layer is chosen from the group consisting of polypropylene and polyethylene terephthalate.

3. The single-dose package according to claim 1, wherein the plastic for the completely surrounding and continuous non-peelable sealing surface of the tear-open sealed-edge pouch is chosen from the group consisting of highly gas-impermeable plastics that are inert with respect to an active substance, in particular polyvinyl chloride (PVC), polyvinylidene chloride (PVDC), copolymers of acrylonitrile and butadiene, polychloro-fluoroethylene (PCTFE) and cyclo-olefin copolymer films, wherein a layer thickness of the completely surrounding and continuous non-peelable sealing surface is 10-100 μm.

4. The single-dose package of claim 3, wherein a layer of the sealing surface is 10-50 μm.

5. The single-dose package according to claim 1, wherein the line of weakness is formed by laser ablation of the tear-resistant layer of the at least three-layer film laminate of the packaging material elements, or is a cut or a perforation.

6. The single-dose package according to claim 1, wherein the line of weakness has a length of 2-10 mm.

7. The single-dose package according to claim 1, wherein the tear propagation extends in parallel profile at the maximum predetermined distance of less than 1 mm from the completely surrounding and continuous non-peelable sealing surface.

8. The single-dose package according to claim 1, wherein the two packaging material elements have the same structure having lines of weakness lying on top of one another.

9. The single-dose package according to claim 1, wherein a tear propagation resistance of the packaging material elements is less than 10 N, and a ratio of tear resistance to tear propagation resistance lies in the range of 20:1 to 200:1 of the two interconnected packaging material elements.

10. The single-dose package of claim 9, wherein the ratio of tear resistance to tear propagation lies in the range of 50:1 to 150:1.

11. The single-dose package of claim 1, wherein one of the two packaging material elements includes a film laminate with a lower tear resistance than a second of the packaging material elements.

12. The single-dose package of claim 1, wherein the package further includes a bending line for permitting access to the line of weakness.

13. The single-dose package of claim 12, wherein the bending line is positioned transverse to the line of weakness.

14. The single-dose package of claim 1, wherein the predetermined maximum lateral deviation of the tear profile relative to the orientation of the line of weakness is from plus 2 millimeters to minus 2 millimeters.

15. The single-dose package of claim 1, where the predetermined maximum lateral deviation of the tear profile relative to the orientation of the line of weakness is between plus or minus 2 millimeters.

16. A method for producing a single-dose package including a packaged product, said single-dose package for transdermal therapeutic systems or film-shaped administration forms, comprising: a tear-open sealed-edge pouch with a completely surrounding and continuous non-peelable sealing surface forming a surrounding, continuous, non-releasable sealing edge, the tear-open sealed-edged pouch comprising two packaging material elements, which are arranged one lying on top of the other and form an upper side and an underside of the tear-open sealed-edge pouch including a product-receiving area that contains the packaged product and the sealing edge surrounding the product-receiving area, at least one of the packaging material elements including a tear-resistant film laminate with an at least three-layer structure, and at least one layer of the packaging material elements is a metal layer, the tear-resistant film laminate having a tear-resistant layer having a controlled tear profile, the tear-resistant layer with respect to the metal layer and is comprised of a plastic with anisotropic tear resistance which is oriented monoaxially, of which a minimum tear resistance in a weaker direction is at least 50 N, measured with respect to the tear-resistant layer, the single-dose package has a line of weakness comprising a perforation or reduction located only in the monoaxially oriented tear-resistant layer, which lies in the surrounding, continuous, non-releasable sealing edge, does not touch a periphery of the package, the line of weakness is oriented such that it extends in the weaker direction of the monoaxially oriented anisotropic tear-resistant layer, the monoaxially oriented tear-resistant layer configured to permit a tear propagation originating from the oriented line of weakness without such perforation or reduction of the line of weakness extending in the product receiving area, the permitted tear propagation extending in the weaker direction of tear resistance of the monoaxially oriented tear-resistant layer and the permitted tear propagation having a predetermined maximum lateral deviation of a tear profile relative to the orientation of the line of weakness and the permitted tear propagation extending from the line of weakness in the surrounding, continuous, non-releasable sealing edge in the weaker direction of the minimum tear resistance of the tear-resistant layer into the product-receiving area and to the surrounding, continuous, non-releasable sealing edge, the permitted tear propagation extending in the product-receiving area a predetermined maximum distance in parallel profile from the completely surrounding and continuous non-peelable sealing surface, position restrictors adjacent the product-receiving area and adjacent the completely surrounding, continuous, non-releasable sealing edge and the position restrictors arranged such that the permitted tear propagation transverses each of the position restrictors and the position restrictors proximate the permitted tear propagation configured to prevent the product from shifting into the area of the permitted tear propagation prior to opening the package, said method comprising the following steps: providing the two packaging material elements including a first packaging material element having the at least three-layer film laminate with at least one layer of the packaging material elements is a metal layer, providing the tear-resistant layer having a controlled tear profile made of the plastic with the anisotropic tear resistance and is monoaxially oriented, positioning the tear-resistant layer as an outer layer with respect to the metal layer; positioning the packaged product on one of the two packaging material elements; superposing and connecting the two packaging material elements to form the product-receiving area for the packaged product, the product-receiving area is closed on all sides and receives the packaged product, the two packaging material elements are connected to each other unreleasably to form a non-peelable sealing surface forming the surrounding, continuous, non-releasable sealing edge surrounding the product-receiving area; providing the line of weakness in the surrounding, continuous, non-releasable sealing edge in the weaker direction of the predetermined minimum tear resistance of the monoaxially oriented anisotropically tear-resistant layer, permitting the tear propagation in the monoaxially oriented anisotropically tear-resistant layer having the predetermined maximum lateral deviation of the tear profile relative to the orientation of the line of weakness and the permitted tear propagation extending in the weaker direction of the predetermined minimum tear resistance from the surrounding, continuous, non-releasable sealing edge into the product-receiving area and extending in the product-receiving area the predetermined maximum distance in parallel profile from the completely surrounding and continuous non-peelable sealing surface, and, providing the position restrictors adjacent the product-receiving area and adjacent the surrounding, continuous, non-releasable sealing edge and arranged such that the permitted tear propagation transverses each of the position restrictors and each of the position restrictors configured to prevent the product from shifting into the area of the permitted tear propagation prior to opening of the package.

17. The method according to claim 16, further comprising producing the at least one line of weakness by laser ablation or laser scoring.

18. The method according to claim 16, further comprising forming in a first laminate in at least three layers having a first line of weakness in the monoaxially oriented tear-resistant layer in the first packaging material element and a second film laminate in at least three layers having a second line of weakness in the monoaxially oriented tear-resistant layer in the second of the two packaging material elements, and arranging the first and second lines of weakness directly opposite one another.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) The single-dose package according to the invention is explained in more detail below with reference to the figures. The figures serve only to illustrate the invention and do not limit the invention to what is shown.

(2) FIG. 1 shows a preferred embodiment of the single-dose package according to the invention in a plan view, with an area of weakness arranged in the upper edge.

(3) FIG. 2 shows a single-dose package with position restrictors.

(4) FIG. 3 shows a strip of single-dose packages connected in pairs in waste-free production.

DETAILED DESCRIPTION OF THE INVENTION

(5) The package according to the invention is a sealed-edge pouch comprising two superposed packaging material elements, of which one packaging material element forms the top layer and the other packaging material element forms the bottom layer, between which the product (5), preferably a transdermal therapeutic system or a film-shaped administration form, is arranged. The two packaging material elements are sealed onto each other in such way that the product (5) is enclosed by a surrounding, continuous sealing edge (3), which is not peelable. This results in a product-receiving area (4) which is closed on all sides and in which the product (5) is contained.

(6) The sealed-edge pouch (1) has a front border (8), a rear border (9) and two preferably parallel side borders (10, 10′).

(7) Moreover, the sealed-edge pouch has a line of weakness (20), in the direction of which the packaging material elements can be torn open.

(8) In addition, the sealed-edge pouch in FIG. 2 has position restrictors (35, 35′), which prevent shifting of the product into the tear region.

(9) The package is made childproof by virtue of the fact that the lines of weakness for tearing open the package can be exposed only by overcoming a childproof safety feature. This safety feature results from the fact that the lines of weakness do not extend as far as the edge, and the otherwise tear-resistant material of the packaging material elements can be torn open, and the product removed, only after the start of the line of weakness has been exposed by bending the package over along a bending line, which can optionally be predefined.

(10) Because of the tear resistance of the packaging material, it is impossible for the package to be torn into manually in other areas.

(11) According to the invention, the line of weakness for tearing into the packaging material should not touch the edge of the package, such that this structure exposes the start of the area of weakness for tearing-in only when the package is folded along a line running through this structure, for example along the line A-A′ (FIG. 1).

(12) Said line of weakness, which makes it possible for the packaging material element(s) to be torn into, can be present in one of the two packaging material elements, for example if the second packaging material element has a lower tear resistance, or in both packaging material elements, the last-mentioned embodiment being preferred. In this case, the line of weakness for tearing into the packaging material is arranged congruently in both packaging material elements. However, the line of weakness can also be a cut or a perforation.

(13) By means of the combination, according to the invention, of a packaging material with anisotropically tear-resistant and in particular monoaxially oriented polymer film, of the line of weakness, and of the design of the childproof safety feature, it is possible to design the package in such a way that it can be opened only by an ordered sequence of at least two steps: (i) folding or bending the package over along a line, by which means the weakening structure for tearing into the package becomes accessible; (ii) tearing into the package at the weakening structure then located at the edge, and further tearing along the direction of this structure.

(14) This handling involves considerable difficulties for children, particularly for infants, especially since the line of weakness is not readily discernible, and, in a preferred embodiment, there is only slight removal of material and no incision. For adults, however, it is possible without any problem and without the aid of implements. In a particularly preferred embodiment, the single-dose package is childproof in accordance with DIN EN 14375 and/or ASTM D3475-03a.

(15) The present invention also relates to a method for producing a single-dose package for transdermal therapeutic systems or film-shaped administration forms. This method is distinguished by the fact that it is particularly material-saving compared to the known methods.

(16) Since there are no peelable seals present and the package is torn directly along the line of weakness, no additional surfaces that expose gripping aids and the like, as are known from DE 10 2004 047 445 A1, are needed for a childproof package. The individual packages lie directly against one another, and additional material consumption, beyond the size of the packaged product, is occasioned only by the thickness of the sealing surfaces and, in certain embodiments, by the protuberances and position restrictors. There is likewise no scrap caused by a complex outer shape. The single-dose packages according to the invention can therefore be produced without loss of packaging material.

(17) The method for producing a single-dose package according to one of the preceding claims comprises the following steps: providing a first packaging material web having an at least three-layer structure, wherein the packaging material web comprises a tear-resistant layer made of an anisotropically tear-resistant and preferably monoaxially oriented polymer; providing a second packaging material web; positioning the packaged product on one of the two packaging material webs; superposing and connecting the two packaging material webs in such a way as to form for each packaged product a compartment that is closed on all sides and receives the packaged product, at the edge or edges of which compartment the two packaging material elements are connected to each other unreleasably; providing at least one line of weakness by incision, perforation or removal of the uppermost, tear-resistant film layer of the multi-layer film laminate, wherein the line of weakness does not however touch the edge of the package; individually separating the successive package units by a cut or a perforation along a line that runs transversely with respect to the web direction of the packaging material webs in the area of the sealing surface.

(18) The sequence of the method steps that is indicated above is not obligatory; for example, the lines of weakness for tearing into the packaging material can also be provided only in a later step.

(19) The unreleasable connection between the packaging material elements is preferably produced by heat sealing at temperatures in the range between 50° C. and 200° C., in particular 100° C. to 200° C. However, the unreleasable connection between the two packaging material webs can also be produced by other heat sealing or cold sealing methods such as ultrasonic sealing, laser sealing or the like.

(20) The package can, for example, be efficiently produced from strip stock by series production on rotary sealing machines.

(21) In a preferred embodiment, the line of weakness is obtained by laser ablation or laser scoring during production, the lines of weakness being provided congruently and directly opposite one another when tear-resistant film laminates are used for the first and second packaging material elements.

(22) In another embodiment, position restrictors are arranged in the product-receiving area, preferably by heat sealing.

(23) In a particularly preferred embodiment according to FIG. 3, the individual packages are produced as a waste-free strip (40), with pairs of packages being formed.

(24) Two single-dose packages in a pair of packages are connected with point symmetry via tabs.

(25) The present invention further relates to the use of the single-dose packages described above for the packaging of transdermal therapeutic systems or film-shaped administration forms.