Childproof, highly inert individual packaging

Abstract

A method for producing childproof, highly inert individual dose packagings for transdermal therapeutic systems or film-like forms of administration in the form of a sealing edge bag that can be peeled back with a complete surrounding and continuous sealing surface, comprising two packaging elements, that are arranged on top of each other and form the upper side and the bottom side of a bag containing the product, wherein at least one layer of the packaging material elements is a metal layer and at least one packaging material element a film laminate with at least three-layer design; and the outer layer of the at least three-layer film laminate comprises at least one line-shaped weakening that is not touching the edge of the packaging on the upper and bottom side and the line-shaped weakening has a reduced resistance to tear for opening the packaging.

Claims

1. A method for producing successive packaging units where each packaging unit includes a single-dose packaging for transdermal therapeutic systems or forms of administration in foil form, in the form of a tear-open sealed-edge pouch including a product receiving region enclosing a packaged product, the tear-open sealed edge pouch also including a non-peelable completely surrounding and continuous sealing area or sealing seam, the tear-open sealed-edge pouch also comprising first and second packaging material elements, which are arranged with the first packaging material element lying on top of the second packaging material element and respectively forming the upper side and underside of the tear-open sealed-edge pouch which contains the product, at least one layer of the packaging material elements including a metal layer and at least one of the first and second packaging material elements being a foil laminate having an at least three-layered structure including an outer layer, a middle layer and an inner layer, and the outer layer of the at least three-layered foil laminate having a minimum resistance to tearing of 30 Newtons, the outer layer having at least one line of weakness, not touching the peripheral edge of the packaging, congruently on the upper side and underside of this outer layer and the at least one line of weakness having a reduced resistance to tearing for the opening of the packaging, the at least one line of weakness colinear with a bending line, the product receiving region has a protuberance reaching into the sealing area, the at least one line of weakness runs both through the sealing area and through the product receiving region in the protuberance, the protuberance not running the entire length of one side of the product receiving region, comprising the steps of: providing the first packaging material element or sheet having an at least three-layered foil laminate structure with the outer, tear-resistant layer of the multi-layered foil laminate structure; providing the second packaging material element or sheet; positioning the packaged product on one of the two packaging material sheets; laying the two packaging material sheets one on top of the other and joining them in such a way as to form for any packaged product the tear-open sealed-edge pouch for receiving the packaged product that is enclosed on all sides and at the peripheral edge or edges of which the two packaging material elements are unreleasably joined to one another; providing the at least one line of weakness by removing either uniformly or intermittently the outer, tear-resistant layer of the multi-layered foil laminate, the at least one line of weakness running both through the sealing area and through the product receiving region in the protuberance, the protuberance not running the entire length of one side of the product receiving region; individually separating successive packaging units by a cut or a perforation along a line which runs transversely in relation to the sheet direction of the packaging material sheets in the region of the sealing area.

2. The method as claimed in claim 1, characterized by in the step of providing at least one line of weakness, the at least one line of weakness is produced by laser ablation or laser scoring.

3. The method as claimed in 1, characterized by in the steps of providing the first and second packaging material elements or sheets they are structured in at least three layers and in the step for providing the at least one line of weakness in the first and second packaging material elements or sheets they are provided directly opposite one another.

4. The method as claimed in 1, characterized by in the step of joining the two packaging material sheets they are joined to one another by means of sealing seams of the sealing areas, using a sealing wax.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) The single-dose packaging according to the invention is further explained below with reference to the figures. The figures serve here merely to illustrate the invention, without however the invention being restricted to what is shown.

(2) FIG. 1 shows a preferred embodiment of the single-dose packaging according to the invention in plan view with protuberances of the product receiving region and position restrictors over two sides of the packaging and two orthogonally running lines of weakness, which run over the region of the protuberances.

(3) FIG. 2 shows a single-dose packaging as in FIG. 1, but only with one line of weakness along one side of the packaging.

(4) FIG. 3 shows the sequence of the bending and tearing operations for opening the single-dose packaging from FIG. 1.

DETAILED DESCRIPTION OF THE PARTICULAR EMBODIMENTS

(5) The packaging (1) according to the invention is a sealed-edge pouch comprising two packaging material elements arranged one lying on top of the other, 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 form of administration in film or foil form, is arranged. The two packaging material elements are in this case sealed to one another in such way that the product (5) is enclosed by a surrounding, continuous peripheral sealing edge (3), which is not peelable. This produces a product receiving region (4) which is closed on all sides and in which the product (5) is contained.

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

(7) Furthermore, the sealed-edge pouch has lines of weakness (20, 21) with reduced resistance to tearing, along which the packaging material elements can be torn open.

(8) In addition, the sealed-edge pouch in FIG. 1 has protuberances (31, 30) at the front edge (8) and at the side edge (10), through which the tearing line defined by the lines of weakness runs, so that the product (5) is not damaged. Displacement of the product is prevented by the position restrictors (35, 35).

(9) The packaging is made childproof by it only being possible to expose the lines of weakness for tearing open the packaging by overcoming a childproof seal. The seal consists in that the lines of weakness do not run as far as the peripheral edge and in that the otherwise tear-resistant material of the packaging material elements can only be torn open and the product removed after exposing the beginning of the line of weakness by bending the packaging over along a bending line, which may optionally be predetermined. On account of the resistance to tearing of the packaging material, it is not possible for the packaging to be torn into manually in other regions.

(10) Since, for the weakening, merely the uppermost layer of the laminates is removed or reduced in only a very small region in relation to the surface area of the packaging, the resistance and impermeability of the packaging is impaired only minimally.

(11) According to the invention, the line of weakness for tearing into the packaging material should not touch the peripheral edge of the packaging, so that this structure only exposes the beginning of the region of weakness for tearing-in by folding the packaging along a line running through the structure, for example along the line A-A (FIG. 3).

(12) Said line of weakness, which makes it possible for the packaging element/s to be torn into, may be present in one of the two packaging material elements if, for example, the second packaging material element has a lower resistance to tearing or in both, the latter embodiment being preferred. In this case, the line of weakness for tearing into the packaging material is arranged congruently in the two packaging material elements.

(13) The combination according to the invention of the packaging material and the configuration of the childproof seal makes it possible to design the packaging in such a way that opening is only possible by an ordered sequence of at least two steps:

(14) (i) folding or bending over the packaging along a line, whereby the weakening structure becomes accessible for tearing-in;

(15) (ii) tearing into the packaging at the then peripheral weakening structure and further tearing along the structure.

(16) This handling involves considerable difficulties for children, particularly small children, especially since the line of weakness is not readily evident since 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 packaging is childproof in accordance with DIN EN 14375 and/or ASTM D3475-03a.

(17) The present invention also relates to a method for producing a single-dose packaging for transdermal therapeutic systems or forms of administration in film form. This method is distinguished by the fact that it is particularly material-saving in comparison with the known methods.

(18) Since there are no peelable seals and the packaging is torn directly along the line of weakness, no additional areas that expose gripping aids and the like, as are known from DE 10 2004 047 445 A1, are required for a childproof packaging. The individual packagings lie directly against one another and additional material consumption, beyond the size of the packaged product, is dictated merely by the thickness of the sealing areas and, in certain embodiments, by the protuberances and position restrictors. There is likewise no scrap due to a complex exterior form. The production of the single-dose packagings according to the invention can consequently take place without any loss of packaging material.

(19) The method for producing a single-dose packaging according to one of the preceding embodiments comprises the steps of:

(20) providing a first packaging material sheet having an at least three-layered structure;

(21) providing a second packaging material sheet;

(22) positioning the packaged product on one of the two packaging material sheets;

(23) laying the two packaging material sheets one on top of the other and joining them in such a way as to form for any packaged product a compartment for receiving the packaged product that is enclosed on all sides and at the peripheral edge or edges of which the two packaging material elements are unreleasably joined to one another;

(24) providing at least one line of weakness by removing the uppermost, tear-resistant foil layer of the multi-layered foil laminate, the line of weakness running both through the sealing area and through the non-sealed product receiving region, but not touching the peripheral edge of the packaging;

(25) individually separating the successive packaging units by a cut or a perforation along a line which runs transversely in relation to the sheet direction of the packaging material sheets in the region of the sealing area.

(26) 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 may also be provided only in a later step.

(27) The unreleasable joining bond between the packaging material elements is preferably produced by heat sealing at temperatures in the range between 50 C. and 200 C., in particular 50 C. to 90 C. However, the unreleasable joining bond between the two packaging material sheets may also be produced by other heat sealing or cold sealing methods such as ultrasonic sealing, laser sealing or the like.

(28) The packaging may, for example, be efficiently produced from strip stock by series production on rotary sealing machines.

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

(30) Another embodiment provides that position restrictors are arranged in the product receiving region, preferably by heat sealing.