Child-resistant unit dose package for transdermal therapeutic systems or film- and sheet-type dosage forms

Abstract

Unit dose packages for transdermal therapeutic systems or film- or sheet-type dosage forms in the form of a peel-open side-sealed bag. The side-sealed bags comprise two packaging material elements arranged one upon the other. At least one consists of a tear-resistant packaging material having a low tear propagation resistance. The two packaging material elements, which are joined together by a continuous sealed seam extending around the packaged good have a tab at one end of said side-sealed bag which projects beyond the sealed margin. The tabs are half as wide as the side-sealed bag and, at the end thereof which faces away from the sealed margin, have a sealed region in which they are joined to each other. At least one of the packaging material elements has a structure for partial tearing of the packaging material in the region of the tab in which the tabs are not sealed to each other. The structure for partial tearing of the packaging material is without contact to the edge of the package.

1 . A unit dose package, for a packaged good or article that is surrounded by a sealed margin, for transdermal therapeutic systems or for film- or sheet-type dosage forms, in the form of a peel-open side-sealed bag comprising two packaging material elements which are arranged one upon the other and wherein at least one of said two packaging material elements comprises a tear-resistant packaging material having a low tear propagation resistance, wherein a continuous sealed seam extends around the packaged good for joining the two packaging material elements to each other for forming a side-sealed bag, said two packaging material elements each having a tab at one end of said side-sealed bag, and wherein each of said tabs projects beyond the sealed margin, wherein said respective tabs are half as wide as the side-sealed bag and, at the end of the side-sealed bags facing away from the sealed margin, said respective tabs have a sealed region in which the tabs are joined to each other, and wherein at least one of the packaging material elements has a structure for partial tearing of the packaging material in the region of the respective tabs in which said respective tabs are not sealed to each other, said structure for partial tearing of the packaging material not being in contact with the edge of the package. 
     
     
         2 . The unit dose package according to  claim 1 , wherein the tabs of two congruent side-sealed bags are complemented and arranged alongside each other in a surface-complementary manner to form a quadrangular surface region. 
     
     
         3 . The unit dose package according to  claim 1  wherein the tab is arranged asymmetrically and eccentrically on the side-sealed bag. 
     
     
         4 . The unit dose package according to  claim 1 , wherein the tear resistance of the tear-resistant packaging material is between 20 N and 2000 N, measured at the two interconnected packaging material elements which form the unit dose package. 
     
     
         5 . The unit dose package according to  claim 1 , wherein the tear propagation resistance is less than 10 N measured at the two interconnected packaging material elements which form the unit dose package. 
     
     
         6 . The unit dose package according to  claim 1 , wherein the ratio of tear resistance to tear propagation resistance lies in the range of from 2:1 to 200:1 relating to the tear resistance and tear propagation resistance of two interconnected packaging material elements forming the unit dose package. 
     
     
         7 . The unit dose package according to  claim 1 , wherein the tear-open force for peeling the two interconnected packaging elements open lies in the range from 1-50 N/15 mm of the width of the sealed seam. 
     
     
         8 . The unit dose package according to  claim 1 , wherein the structure for partial tearing of the packaging material is selected from the group of structures consisting of straight cuts, jagged cuts, undulating cuts, perforations, material recesses, punchings, and predetermined breaking points. 
     
     
         9 . The unit dose package according to  claim 1 , wherein at least one of the packaging material elements is formed from a monolayer or a multilayer film or sheet. 
     
     
         10 . The unit dose package according to  claim 1 , wherein the packaged good is not accessible to children without the use of tools, and, is child-resistant according to at least one standard selected from the group consisting of DIN EN 14375 and to ASTM D3475-03a. 
     
     
         11 . A method of producing a unit dose package according to  claim 1 , comprising the steps of:
 providing a first packaging material web;   providing a second packaging material web;   positioning a good or product to be packaged on one of the two packaging material webs;   placing the packaging material webs on top of each other and connecting the packaging material webs to form a compartment, the compartment having at least one margin and being closed on all sides of the compartment, for each product to be packaged, for receiving the product to be packaged, and detachably interconnecting the two packaging material webs at the margin or margins of said compartment, with two unit dose packages that succeed each other in the direction of the web being arranged in pairs at a time in such a way that the sealed margins facing each other are directly adjacent to one another, and with a surface section remaining between the two successive unit dose packages of a pair, in which surface section the two packaging material webs are not sealed to each other;   applying two structures for partial tearing of the packaging material in at least one of the two packaging material webs at the opposing longitudinal edges within the surface section in which the two packaging material webs are not sealed to each other; and   making a cut along a line that runs transversely to the web direction of the packaging material webs for separating the successive pairs of packages, and partitioning off the two unit dose packages of a pair of packages by making a cut along a line that in the one longitudinal half of the interconnected packaging material webs runs in the region of the front sealed margin of a unit dose package of a pair of packages, and in the other longitudinal half of the interconnected packaging material webs runs in the region of the front sealed margin of the other unit dose package of said pair of packages to separate the unit dose packages of a pair of packages, so that surface-complementary tabs are formed.   
     
     
         12 . The method according to  claim 11 , wherein the cut for separating the two unit dose packages forming a pair of packages extends in a configuration selected from the group consisting of the shape of an S, sigmoidally, angularly, obliquely and diagonally through the surface section in which the two packaging material webs are not sealed to each other. 
     
     
         13 . The method according to  claim 11 , wherein the packaging material webs are interconnected by sealed seams or sealed areas by using a sealing lacquer. 
     
     
         14 . The method according to  claim 11 , comprising the step of providing at least one structure for partial tearing of the packaging material with both packaging material webs, in the section where the packaging material webs are not sealed to each other, said at least one structure being configured to be alike or similar and being arranged to be congruent with each other. 
     
     
         15 . The method according to  claim 14 , wherein the at least one structure for partial tearing of the packaging material is selected from the group of structures consisting of straight cuts, jagged cuts, undulating cuts, perforations, material recesses, punchings, and predetermined breaking points. 
     
     
         16 . The method according to  claim 11 , further comprising the step of applying a fold-over line or bending line for each unit dose package that extends from the front edge of the unit dose package to the longitudinal edge of the unit dose package, at the side of which is located the structure for partial tearing of the packaging material, and that intersects said structure. 
     
     
         17 . The unit dose package according to  claim 4 , wherein the tear resistance of the tear-resistant packaging material is between 50 N and 150 N measured at the two interconnected packaging material elements which form the unit dose package. 
     
     
         18 . The unit dose package according to  claim 17 , wherein the tear resistance of the tear-resistant packaging material is between 70 N and 100 N measured at the two interconnected packaging material elements which form the unit dose package. 
     
     
         19 . The unit dose package according to  claim 5 , wherein the tear propagation resistance is less than 2 N measured at the two interconnected packaging material elements which form the unit dose package. 
     
     
         20 . The unit dose package according to  claim 19 , wherein the tear propagation resistance is less than 1.5 N, measured at the two interconnected packaging material elements which form the unit dose package. 
     
     
         21 . The unit dose package according to  claim 6 , wherein the ratio of tear resistance to tear propagation resistance lies in the range of from 50:1 to 150:1 relating to the tear resistance and tear propagation resistance of two interconnected packaging material elements forming the unit dose package. 
     
     
         22 . The unit dose package according to  claim 7 , wherein the tear-open force for peeling the two interconnected packaging elements open lies in the range from 3-20 N/15 mm of the width of the sealed seam. 
     
     
         23 . The unit dose package according to  claim 8 , wherein said perforations are selected from the group consisting of successively arranged holes and cuts, and said punchings are selected from the group consisting of arrow-like punchings, triangular-shaped punchings and diamond-shaped punchings. 
     
     
         24 . The unit dose package according to  claim 9 , wherein both of the packaging material elements are formed from a monolayer or a multilayer film or sheet. 
     
     
         25 . The method according to  claim 15 , wherein said perforations are selected from the group consisting of successively arranged holes and cuts, and said punchings are selected from the group consisting of arrow-like punchings, triangular-shaped punchings and diamond-shaped punchings.