METHOD FOR MANUFACTURING A TRANSDERMAL DEVICE

Abstract

The invention relates to a method for manufacturing a transdermal patch from a drug-containing web that minimizes waste. The web is a layered composite that includes at least a backing layer and a drug-in-adhesive layer and a first strippable release liner. The web is kiss-cut along intersecting cut lines at least down to the depth of the liner, generally defining the extent of individual transdermal patches. The intersections of the cut lines define small zones that are punched out of the web in a generally star shape. The portions of the web above the liner are peeled away from the liner and transferred to a faster moving second liner so that the patches are now further spaced apart from one another. This second liner is then cut to provide transdermal patches that are mounted to release liners that are substantially broader in extent than the patches themselves.

Claims

1. A method for manufacturing a transdermal device comprising the steps of: providing a first web of material, the first web of material including a film layer, at least one drug-in-adhesive layer and a first release liner; cutting a plurality of vertical lines and horizontal lines in the first web of material to delimit a plurality of segments of the first web of material; peeling away portions of the first release liner from the plurality of segments of the first web material; and transferring the plurality of segments of the first web material beneath the peeled away portions of the first release liner to a second web of a release liner, wherein the transferred plurality of segments each comprise the transdermal device.

2. The method of claim 1 wherein the transdermal device is a transdermal patch.

3. The method of claim 1 wherein the horizontal lines are through-cut providing separable strips of the first web of material.

4. The method of claim 1 wherein the vertical lines are kiss-cut through the film layer and the at least one drug-in-adhesive layer down to a depth of the first release liner.

5. The method of claim 1 further comprising the step of: cutting out areas of the first web of material where the horizontal and vertical line intersect to provide rounded corners for the plurality of segments of the first web material.

6. The method of claim 5 wherein the step of cutting out areas of the first web is performed by stamping.

7. The method of claim 5 wherein the step of cutting out areas of the first web is performed as a kiss-cut.

8. The method of claim 1 wherein the first web of material is moved along at a first average velocity (V1) to a transfer station where the first web of material faces the second web of the release liner material and the second web of the release liner material moves at a second average velocity (V2), the second average velocity (V2) is greater than first average velocity (V1) to provide a predetermined spacing of the transferred plurality of segments on the second web of the release layer.

9. The method of claim 8 further comprising the step of cutting the transferred plurality of segments apart.

10. The method of claim 1 wherein a front rim of the first web of material contacts the second web of the release liner and the front rim then adheres to the second web of the release liner resulting in transfer of the segment of the first web material beneath the peeled away portion of the first release liner to the second web of the release liner.

11. The method of claim 10 wherein the second web of the release liner is wider than the width of the transferred plurality of segments.

12. The method of claim 10 wherein the second web of the release liner has a width which is substantially the same as the width of the transferred plurality of segments.

13. The method of claim 1 wherein each of the plurality of vertical lines and the plurality of horizontal lines are a pair of lines.

14. A transdermal device produced by the method of claim 1.

15. The transdermal device of claim 14 wherein the transdermal device is a transdermal patch.

16. The transdermal device of claim 14 wherein the horizontal lines are through-cut providing separable strips of the first web of material and the vertical lines are kiss-cut through the film layer and the at least one drug-in-adhesive layer down to a depth of the first release liner.

17. The transdermal device of claim 14 wherein the method further comprises the step of: cutting out areas of the first web of material where the horizontal and vertical line intersect to provide rounded corners for the plurality of segments of the first web material.

18. The transdermal device of claim 14 wherein the first web of material is moved along at a first average velocity (V1) to a transfer station where the first web of material faces second web of the release liner material and the second web of the release liner material moves at a second average velocity (V2), the second average velocity (V2) is greater than first average velocity (V2) to provide a predetermined spacing of the transferred plurality of segments on the second web of the release layer.

19. The transdermal device of claim 14 wherein the second web of the release liner is wider than the width of the transferred plurality of segments.

20. The transdermal device of claim 14 wherein the second web of the release liner has a width which is substantially the same as the width of the transferred plurality of segments.

21. The method of claim 5, wherein the horizontal lines are through-cut providing separable strips of the first web of material, the vertical lines are kiss-cut through the film layer and the at least one drug-in-adhesive layer down to a depth of the first release liner, the first web of material is moved along at a first average velocity (V1) to a transfer station where the first web of material faces the second web of the release liner material and the second web of the release liner material moves at a second average velocity (V2), the second average velocity (V2) is greater than first average velocity (V1) and wherein the step of cutting out areas of the first web further comprises cutting a piece of the first web down to a depth of the first release liner of a previous kiss-cut and through-cut direction to provide a strip between adjacent transdermal devices and removing the strip leaving between adjacent transdermal devices a space to facilitate the removal of the transdermal device and transfer from the first web (V1) moving at first web velocity to the second web moving at the second web velocity (V2).

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0014] FIG. 1 is a cross-sectional view of a prior art web of starting material.

[0015] FIG. 2 is a cross-sectional view of a web of starting material from which the patch is formed, with a strippable release liner attached to the prior art patch.

[0016] FIG. 3 is a top plan view of the prior art web of starting material with rectangular sections defined by kiss-cuts shown in dashed lines.

[0017] FIG. 4 is a perspective view of the prior art web of FIG. 3, after removal of the waste material between the rectangular sections.

[0018] FIG. 5 is a top plan view of the prior art waste, with continuous lines showing where the rectangular sections have been removed;

[0019] FIG. 6 is a perspective view of a prior art transdermal patch.

[0020] FIG. 7 is a top plan view of a layered web as is utilized by the method of the present invention.

[0021] FIG. 8 depicts the web of FIG. 7, after it has been cross-cut and star-shaped sections removed at the corners. The dashed-line cross-cuts represent kiss-cuts and the continuous vertical lines represent through-cuts.

[0022] FIG. 9A is a top plan view of one strip of the layered web after it has been removed from the continuous web.

[0023] FIG. 9B is a cross-section of the strip of layered web shown in FIG. 9A.

[0024] FIG. 10 is a schematic illustration of the process of removing sections of the web from a first strippable release liner and transferring the sections to a second liner on a second line. The speed of the second web (V2) is greater than the speed of the first web (V1).

[0025] FIG. 11 is a top plan view of a finished transdermal patch produced by the method of the present invention.

[0026] FIG. 12 is a top plan view of a finished transdermal patch produced by the method of the present invention.

[0027] FIG. 13 depicts the web of FIG. 8, in which horizontal lines and vertical lines include a pair of horizontal lines and vertical lines leaving a thin strip of waste material between the patches.

DETAILED DESCRIPTION OF THE INVENTION

[0028] Reference will now be made in greater detail to a preferred embodiment of the invention, an example of which is illustrated in the accompanying drawings. Wherever possible, the same reference numerals will be used throughout the drawings and the description to refer to the same or like parts.

[0029] The method for producing transdermal devices of the present invention includes providing layered web material 170 as shown in FIG. 7. Starting web 200 of layered web material 170 is transported to cutting station 205 where it is through-cut along horizontal lines 220 into separable strips 226, and kiss-cut along vertical lines 210 down to the depth of the release liner as shown in FIG. 8. Portions 230 where horizontal lines 220 and vertical lines 210 intersect can be cut out to provide rounded corners for zones 250 of layered web material 170. For example, dies can be used to kiss-cut or punch out portions 230. Portions 230 can have a star or diamond-shaped so as to provide rounded corners 251 for zones 250. Rounded corners 251 can be cut before or after horizontal lines 220 are made for horizontal through-cuts down the length of the web that form the separable strips.

[0030] Starting web 200 can be cut into one or more separate webs 300, each made up of a series of adjoining segments 302 that are delimited by vertical lines 210 which can be kiss-cut as shown in FIG. 9A. Each of segments 302 will each include backing film layer 310, at least one drug-in-adhesive layer 320, and strippable release layer 350 as shown in FIG. 9B.

[0031] As shown in FIG. 10, web 300 is moved along at a first average velocity (V1) in the direction of arrow A1 to transfer station 390 where web 300 faces web of release liner material 400. Web of release liner material 400 moves at a second average velocity (V2). Second average velocity (V2) is greater than first average velocity (V1). Transfer machinery 500 detaches segments 302 from release layer 350 and affixes the detached segments 302 to release liner material 400 which is faster moving. Transfer machinery 500 can accomplish the transfer using a sharp edge on the machinery that raises the front rim 351 of the forward moving segment 302. Front rim 351 then contacts web of release liner 400 that moves faster than web 300. Front rim 351 then adheres to web of release liner 400 resulting in transfer of segment 302 to web of release liner 400. Web of release liner 400 is sufficiently wider to provide a broader base in the direction orthogonal to its direction of transfer, and its faster movement with respect to web 300 results in a desired level of lateral spacing, so that web of release liner 400 can then be cut to form patch 600 as shown in FIG. 11. Patch 600 can be a transdermal patch including film layer 310, at least one drug-in-adhesive layer 320 and release liner 400. Alternatively, web of release liner 400 can be the same width as patch 600, yielding a finished product with no extension of release liner 400 at the sides of patch 600 as shown in FIG. 12.

[0032] In some cases, the vertical kiss-cut 210 does not result in a clean separation of the contiguous patches, because the adjacent adhesive surfaces along the kiss-cut re-adhere after the kiss-cut. FIG. 13 illustrates an embodiment in which horizontal lines 220 and vertical lines 210 include a pair of horizontal lines 720 and vertical lines 210 leaving a thin strip of waste material 725 between the patches. Thin strip 725 is removed with the rounded corners leaving a narrow space between contiguous patches 700, preventing re-adherence between the contiguous patches 700.

[0033] It is to be understood that the above-described embodiments are illustrative of only a few of the many possible specific embodiments, which can represent applications of the principles of the invention. Numerous and varied other arrangements can be readily devised in accordance with these principles by those skilled in the art without departing from the spirit and scope of the invention.