Film composite for packaging transdermal patches, and package made of such a film composite

Abstract

a film composite for manufacturing a package for planar carriers of pharmaceutical active substances, for example transdermal patches, encompassing, in a direction from the outer side of the film composite toward its inner side: a metal layer; an acrylic-acid-containing joining layer; a polyethylene layer; and a COC layer made of cycloolefin copolymer, a side of the COC layer which faces away from the metal layer being an exposed surface of the film composite, wherein provision is made that the polyethylene layer encompasses metallocene polyethylene.

Claims

1. A film composite for manufacturing a package for planar carriers of pharmaceutical active substances, comprising, in a direction from the outer side of the film composite toward its inner side: (i) a metal layer; (ii) an acrylic acid-containing joining layer; (iii) a polyethylene layer; and, (iv) a COC layer made of cycloolefin copolymer, a side of the COC layer which faces away from the metal layer being an exposed surface of the film composite, wherein the polyethylene layer comprises metallocene polyethylene to tie the COC layer to the acrylic acid-containing joining layer and thereby to the metal layer to promote the delamination stability of the film composite.

2. The film composite according to claim 1, wherein the proportion of metallocene polyethylene in terms of the total polyethylene of the polyethylene layer is at least 50 wt %.

3. The film composite according to claim 1, wherein the polyethylene layer comprises a metallocene linear low density polyethylene.

4. The film composite according to claim 1, wherein the polyethylene layer comprises at least one of a C6 metallocene polyethylene and a C8 metallocene polyethylene.

5. A film composite for manufacturing a package for planar carriers of pharmaceutical active substances, comprising, in a direction from the outer side of the film composite toward its inner side: (i) a metal layer; (ii) an acrylic acid-containing joining layer; (iii) a polyethylene layer; and, (iv) a COC layer made of cycloolefin copolymer, a side of the COC layer which faces away from the metal layer being an exposed surface of the film composite, wherein the polyethylene layer comprises a C8 metallocene linear low density polyethylene and wherein the polyethylene layer connects the COC-layer to the acrylic acid-containing joining layer and thereby to the metal layer to promote the delamination stability of the film composite.

6. The film composite according to claim 5, wherein the acrylic acid-containing joining layer is an ethylene-acrylic acid (EAA) copolymer.

7. The film composite according to claim 1, wherein each of the acrylic acid-containing joining layer, the polyethylene layer, and the COC layer, has a layer thickness in the range from about 7 μm to about 15 μm.

8. The film composite according to claim 7, wherein the thickness values of said layers, referred to the thinnest of said layers, differ by no more than 15%.

9. The film composite according to claim 8, wherein the thickness values of said layers, referred to the thinnest of said layers, differ by no more than 11%.

10. The film composite according to claim 7, wherein each of the layers, from among the acrylic acid-containing joining layer, the polyethylene layer, and the COC layer, has a layer thickness in the range from approximately 9 μm to 12 μm.

11. The film composite according to claim 10, wherein the thickness values of said layers, referred to the thinnest of said layers, differ by no more than 15%.

12. The film composite according to claim 11, wherein the thickness values of said layers, referred to the thinnest of said layers, differ by no more than 11%.

13. The film composite according to claim 1, wherein the film composite comprises, on the side of the metal layer which faces away from the COC layer, at least one further layer made of at least one of a paper and a plastic.

14. The film composite according to claim 13, wherein the at least one further layer includes a paper layer and a plastic layer.

15. The film composite according to claim 14, wherein the plastic layer is located closer to the metal layer than the paper layer.

16. The film composite according to claim 13, wherein the at least one further layer includes a plastic layer that is a biaxially oriented plastic.

17. The film composite according to claim 13, wherein the at least one further layer includes a plastic layer that is at least one of a polyethylene terephthalate and a polyimide.

18. The film composite according to claim 13, wherein the at least one further layer includes at least one of (i) a paper layer having at least one of a thickness of 35 to 45 μm and a weight per unit area of 35 to 45 g/m.sup.2 and (ii) a plastic layer having at least one of a thickness of 19 to 27 μm and a weight per unit area of 28 to 36 g/m.sup.2.

19. The film composite according to claim 18, wherein the at least one further layer includes at least one of (i) a paper layer having at least one of a thickness of 39 to 41 μm and a weight per unit area of 39 to 41 g/m.sup.2 and (ii) a plastic layer having a thickness of 22 to 24 μm and a weight per unit area of 31 to 33 g/m.sup.2.

20. A film composite for manufacturing a package for planar carriers of pharmaceutical active substances, comprising, in a direction from the outer side of the film composite toward its inner side: (i) a metal layer; (ii) an acrylic acid-containing joining layer; (iii) a polyethylene layer; and (iv) a COC layer made of cycloolefin copolymer, wherein the polyethylene layer comprises metallocene polyethylene to tie the COC layer to the acrylic acid-containing joining layer and thereby to the metal layer to promote the delamination stability of the film composite, and wherein each of the layers, from among the acrylic acid-containing joining layer, the polyethylene layer, and the COC layer, has a layer thickness in the range from about 7 μm to about 15 μm, and wherein the thickness values of said layers, referred to the thinnest of said layers, differ by no more than 15%.

21. A film composite for manufacturing a package for planar carriers of pharmaceutical active substances, comprising, in a direction from the outer side of the film composite toward its inner side: (i) a layer made of at least one of a paper and a plastic; (ii) a metal layer; (iii) an acrylic acid-containing joining layer; (iv) a polyethylene layer; and, (v) a COC layer made of cycloolefin copolymer, a side of the COC layer which faces away from the metal layer being an exposed surface of the film composite, wherein the polyethylene layer comprises metallocene polyethylene to tie the COC layer to the acrylic acid-containing joining layer and thereby to the metal layer to promote the delamination stability of the film composite, and wherein each of the layers, from among the acrylic acid-containing joining layer, the polyethylene layer, and the COC layer, has a layer thickness in the range from about 7 μm to about 15 μm, and wherein the thickness values of said layers, referred to the thinnest of said layers, differ by no more than 15%.

22. The film composite according to claim 21, wherein the at least one further layer includes a paper layer and a plastic layer.

23. The film composite according to claim 22, wherein the plastic layer is located closer to the metal layer than the paper layer.

24. The film composite according to claim 23, wherein the at least one further layer includes a plastic layer that is a biaxially oriented plastic.

25. The film composite according to claim 24, wherein the at least one further layer includes a plastic layer that is at least one of a polyethylene terephthalate and a polyimide.

26. The film composite according to claim 21, wherein the at least one further layer includes at least one of (i) a paper layer having at least one of a. a thickness of 35 to 45 μm and b. a weight per unit area of 35 to 45 g/m.sup.2 and (ii) a plastic layer having at least one of a. a thickness of 19 to 27 μm and b. a weight per unit area of 28 to 36 g/m.sup.2.

27. A package for a planar carrier of pharmaceutical active substances, comprising two film-composite sheets of claim 1, wherein the two film-composite sheets are arranged with mutually facing COC layers to form a carrier receiving space and wherein the two film-composite sheets are joined to one another by local sealing of regions of the COC layers.

28. The package according to claim 27, wherein the package is a four-side-sealed pouch having a sealed seam surrounding the carrier receiving space.

29. The package according to claim 28, having a planar active-substance carrier, in particular a transdermal patch, contained in the carrier receiving space, the pharmaceutical active substance containing at least one of nicotine, fentanyl and lidocaine.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) The invention may take physical form in certain parts and arrangement of parts, a preferred embodiment of which will be described in detail and illustrated in the accompanying drawings which form a part hereof and wherein:

(2) FIG. 1 is a cross-sectional view through an embodiment according to the present invention of a film composite of the present Application;

(3) FIG. 2 is a plan view of a package, constituted with participation of the film composite of FIG. 1, of a transdermal patch; and

(4) FIG. 3 is a cross-sectional view of the package of FIG. 2 along section plane III-Ill of FIG. 2.

DESCRIPTION OF PREFERRED EMBODIMENTS

(5) Referring now to the drawings wherein the showings are for the purpose of illustrating preferred and alternative embodiments of the invention only and not for the purpose of limiting the same, in FIG. 1, an embodiment according to the present invention of a film composite of the present Application is labeled in general with the number 10. The depiction in FIG. 1 is merely schematic. In particular, the thicknesses of the individual layers of film composite 10 are not illustrated accurately to scale. Film composite 10 has on its designated inner side a COC layer 12 that has a COC content of approximately 99.8 wt %. The proportion of COC in COC layer 12 is selected to be as high as possible in order to provide, with COC layer 12, an optimum barrier layer against migration and diffusion of pharmaceutical active substances such as nicotine and/or fentanyl and/or lidocaine. A surface 12a of COC layer 12 constitutes an exposed outer surface of film composite 10. COC layer 12 preferably has a thickness of 9.8 to 10.0 μm.

(6) A polyethylene layer 14 is joined to COC layer 12 by coextrusion. Polyethylene layer 14 is preferably devoid of COC, and encompasses at least 50 wt % metallocene polyethylene, preferably C8 metallocene LLDPE. In the example depicted, the proportion of C8 metallocene LLDPE in terms of the total polyethylene mass of polyethylene layer 14 is more than 95 wt %. Extremely good adhesion of COC layer 12 to polyethylene layer 14, and thus good protection from delamination, are thereby achieved. The use of C8 metallocene LLDPE, as opposed to the C4 or C6 types that are also possible, results not only in good adhesion of COC layer 12 to a polyethylene layer 14 but also in a polyethylene layer 14 having advantageous rigidity properties. The melt flow index (MFR) of polyethylene layer 14 is approximately 8 g/10 min., measured per ISO 1133 at a test temperature of 190° C. using a test weight of 2.16 kg. The density of polyethylene layer 14 is preferably 0.919 g/m.sup.2.

(7) Thanks to the value selected for the melt flow index, although polyethylene layer 14 is not an external layer of film composite 10 it can participate in a sealed join of film composite 10 on COC layer 12 side. High sealing strength values, and a very high-quality sealed seam, are thereby achieved. COC layer 12 is not only a barrier layer of film composite, but also its sealable layer.

(8) In the example depicted, the thickness of polyethylene layer 14 is between 10.8 and 11.0 μm. Polyethylene layer 14 and COC layer 12 are thus of approximately equal thickness; COC layer 12 can be slightly thinner. This balanced thickness relationship between polyethylene layer 14 and COC layer 12 also contributes to the attainment of permanently strong and diffusion-proof sealed joins.

(9) On the side facing away from COC layer 12, polyethylene layer 14 is joined to a joining layer 16 made of an ethylene-acrylic acid (EAA) copolymer, in order to join COC layer 12 and polyethylene layer 14, by means of joining layer 16, to an aluminum layer 18.

(10) Joining layer 16, which is between 10.6 and 10.8 μm thick in the example depicted, has been coextruded together with polyethylene layer 14 and COC layer 12, and applied onto aluminum layer 18 in the course of coextrusion.

(11) Aluminum layer 18, which serves as a further barrier layer, is 8 to 10 μm thick, preferably 9 μm thick, in the example depicted.

(12) A film composite made up of layers 12, 14, 16, and 18 is already a stable composite that is outstandingly suitable for manufacturing a package for products that contain pharmaceutical active substances such as nicotine, fentanyl, or lidocaine.

(13) In order to protect the aforesaid composite, made up of layers 12, 14, 16, and 18, from being undesirably opened or torn by curious children, who might thereby gain access to a packaged pharmaceutical active substance that is entirely unsuitable for children, a layer 22 made of biaxially oriented plastic, preferably of polyethylene terephthalate or polyamide, is laminated, by means of a layer 20 made of solvent-containing laminating adhesive at an application weight of 3 g/m.sup.2, onto that side of aluminum layer 18 which faces away from COC layer 12.

(14) Layer 22 can be imprinted on its side facing away from aluminum layer 18 product so that information regarding a product that is packaged using film composite 10 can be conveyed to a consumer. Layer 22 can then be an externally located layer, opposite from COC layer 12, of film composite 10.

(15) Layer 22 can also be a paper layer rather than a plastic layer 22.

(16) In the example depicted in FIG. 1 film composite 10 comprises, in addition to plastic layer 22, an externally located paper layer 26 joined by means of a further laminating-adhesive layer 24 made of solvent-containing laminating adhesive.

(17) Paper layer 26 can be imprinted on its outward-facing exposed surface 26a. The imprint can be covered by a protective layer, for example clear lacquer.

(18) In the example depicted, plastic layer 22 has a thickness of approximately 22.7 to 23.3 μm. Paper layer 26, on the other hand, has a thickness of approximately 39.5 to 40.5 μm at a weight per unit area of approximately 40 g/m.sup.2.

(19) The total thickness of film composite 10 is thus between 108.4 μm and 110.6 μm.

(20) Film composite 10 not only has outstanding barrier properties with respect to migration and diffusion of pharmaceutical active substances or constituents thereof from outer surface 12a of COC layer 12 to outer surface 26a of paper layer 26. The rigidity of film composite 10 is furthermore very suitable for constitution of a package, and it has outstanding running properties on processing machines for processing film composite 10.

(21) FIG. 2 is a plan view of a package 30 constituted from two film-composite sheets of film composite 10 of FIG. 1, for packaging planar carriers of pharmaceutical active substances. Because of the plan view, only one film-composite sheet 32 is visible. A further film-composite sheet 33 is located behind film-composite sheet 32 depicted in FIG. 2 and is concealed by it (see FIG. 3). The viewer of FIG. 2 is looking onto outer side 26a of paper layer 26 of film-composite sheet 32. A “film-composite sheet” is understood for purposes of the present Application to mean any predetermined piece cut out of a film composite, regardless of the manner of cutting. The cut-out piece can therefore also be stamped or the like.

(22) Package 30 is configured in the form of a four-side-sealed pouch having a surrounding sealed seam 34. Located radially inside sealed seam 34 is a carrier receiving space 36 in which a planar carrier 38 of a pharmaceutical active substance (see FIG. 3) is received.

(23) Package 30 can comprise a notch 40 at at least one point, for example in an edge region, for easier opening.

(24) FIG. 3 is a longitudinal section through package 30 of FIG. 2 along section plane III-III of FIG. 2. Section plane III-Ill is oriented orthogonally to the drawing plane of FIG. 2.

(25) The distribution of layers within film-composite sheets 32 and 33 is no longer depicted separately in FIG. 3 in the longitudinal section through sheets 32 and 33. That distribution corresponds to the layer distribution of film composite 10 as depicted in FIG. 1. The two COC layers 12 of the respective film-composite sheets 32 and 33 are arranged facing toward one another and are fused to one another along sealed seam 34. A transdermal patch 39, constituting a planar carrier 38 of a pharmaceutical active substance, is received in carrier receiving space 36 that is constituted radially inside sealed seam 34. Carrier receiving space 36 is thus radially externally delimited by sealed seam 34 and orthogonally thereto by the two film-composite sheets 32 and 33.

(26) Sealed seam 34 extends, in a thickness direction of the respective film-composite sheets 32 and 33, not only through the respective COC layers 12 that also serve as sealing layers but also, beyond those COC layers 12, into polyethylene layers 14. Sealed seam 34 is thus constituted by COC layers 12 (which are in contact with one another before sealing) of the two film-composite sheets 32 and 33 and by material of polyethylene layers 14 which are located, from the viewpoint of the contact point of the two COC layers 12 before sealed seam 34 is produced, behind the respective COC layers 12. Because the material of COC layers 12, like the material of polyethylene layers 14, is an olefin, the materials of the two layers 12 and 14 are mutually compatible and can blend with one another in sealed seam 34.

(27) While considerable emphasis has been placed on the preferred embodiments of the invention illustrated and described herein, it will be appreciated that other embodiments, and equivalences thereof, can be made and that many changes can be made in the preferred embodiments without departing from the principles of the invention. Furthermore, the embodiments described above can be combined to form yet other embodiments of the invention of this application. Accordingly, it is to be distinctly understood that the foregoing descriptive matter is to be interpreted merely as illustrative of the invention and not as a limitation.