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Details for Patent: 5,405,486

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Details for Patent: 5,405,486

Title: Apparatus for forming a transdermal drug device
Abstract:Disclosed is a method and apparatus for forming a transdermal drug delivery device from a multilayer web comprised of a backing layer, a drug-containing pressure sensitive adhesive layer, and a release layer or liner in which cutting is progressively achieved along a line coplanar with the axes of a cutting roller and anvil roller counter-rotating in proximity to each other. In one embodiment, cutting is achieved completely through the web about the periphery of the transdermal drug delivery device, while simultaneously achieving a scoring only of the release liner without penetration of the pressure sensitive adhesive layer or backing layer. In an alternate embodiment there are two arrangements of rollers. A first arrangement has a cutting edge for scoring the web. After scoring, the web is passed to a second arrangement for cutting through the web to result in the transdermal drug delivery device.
Inventor(s): Sablotsky; Steven (Miami, FL), LaPrade; Ronald E. (Miami, FL)
Assignee: Noven Pharmaceuticals, Inc. (Miami, FL)
Filing Date:Jun 21, 1993
Application Number:08/080,223
Claims:1. An apparatus for forming a transdermal drug delivery device from a multilayer web having layer of a backing material, a drug-containing pressure sensitive adhesive, and a release liner comprising at least one combination of:

an anvil roller supported in a manner for rotating about its axis;

a cutting roller having a cylindrical surface and supported for rotating about its axis, which axis is coplanar with the axis of the anvil roller, and said cutting roller being positionable in proximity to said anvil roller;

at least one cutting section fixedly mounted on and projecting above said surface, and having at least one cutting edge extending outwardly a predetermined distance from said surface and configured as a predetermined shape for defining a region on said surface for conducting at least one of scoring or cutting only said release liner and of cutting completely through said multilayer web as it is passed between said anvil roller and said cutting roller;

a nip roller rotatably mounted in proximity to the anvil roller, for, in cooperation with said anvil roller, urging said multilayer web along the surface of said anvil roller toward the cutting roller at a substantially same linear speed as a surface speed of said anvil roller and cutting roller; and

drive means for counter-rotating the anvil roller and cutting roller at a substantially same surface speed for urging the multilayer web between the anvil roller and cutting roller such that, progressively along a line coplanar with the axes of the anvil roller and cutting roller, the cutting edge communicates with and at least one of scores or cuts only the releasable liner and of cuts completely through said multilayer web.

2. The apparatus of claim 1 in combination with an additional apparatus including an anvil roller; a cutting roller; a nip roller; drive means; and an additional cutting section configured for cutting completely through said multilayer web arranged on said cutting roller of said additional apparatus, said at least one cutting section comprising a first cutting section configured for scoring or cutting said release liner arranged on said cutting roller of said apparatus; and said apparatus and additional apparatus arranged with respect to said web to pass said web first through said apparatus for scoring or cutting and then through said additional apparatus for cutting completely through the web.

3. The apparatus of claim 1 which further comprise bearing means to support a shaft concentric with the axis of the anvil roller.

4. The apparatus of claim 1 which further comprises bearing means to support a shaft concentric with the axis of the cutting roller.

5. The apparatus of claim 4 further comprising:

a frame in which said cutting roller, anvil roller and nip roller are mounted;

pressure applying means comprising a pressure roller rotatably mounted in the frame and having pressure journals at either end, and means for exerting force against the pressure roller to be indirectly exerted on the cutting roller; and

complimentary pressure journals on the cutting roller to rotationally communicate with the pressure roller journals.

6. The apparatus of claim 5 in which the bearing means is slidable with respect to the frame.

7. The apparatus of claim 5 which further comprises bearing means to support a shaft concentric with the pressure roller journals.

8. The apparatus of claim 5 in which the means to exert force on the pressure roller is a threaded pressure applicator, which threaded pressure applicator cooperates with a threaded hole in the frame.

9. The apparatus of claim 8 in which the threaded pressure applicator causes movement of the pressure roller by sliding its bearings with respect to the frame, thereby applying pressure through the pressure roller journals and complementary pressure journals to the cutting roller.

10. The apparatus of claim 9 which further comprises pressure measuring devices attached to the frame to permit reproducibility of the positioning and pressure of the cutting roller is proximity to the anvil roller.

11. The apparatus of claim 9 in which the bearing means of the cutting roller is slidable with respect to the frame and pressure applied to the cutting roller from its pressure journals in part positions of the cutting roller in proximity to the anvil roller.

12. The apparatus of claim 1 which further comprises:

pressure applying means for selectively exerting force against the cutting roller.

13. The apparatus of claim 1 which further comprises a positive drive connection between the cutting roller and the anvil roller to achieve said substantially same surface speed.

14. The apparatus of claim 13 in which the positive drive connection is meshing spur gears on the anvil roller and cutting roller.

15. The apparatus of claim 1 which further comprises a transfer plate disposed in close proximity to the anvil roller and cutting roller to receive the transdermal drug delivery devices and scrap remains of the web from which the said devices were cut and scored.

16. The apparatus of claim 15 in which cutting sections are positioned on the cutting roller in a close packed pattern to minimize scrap losses from the web.

17. The apparatus of claim 1 in which the cutting roller is sized with a diameter to achieve a repeat length when rotating that minimizes scrap losses from the web.

18. The apparatus of claim 1 which further comprises a field of resilient material attached to the cutting roller in proximity to but not touching the at least one cutting edge.

19. The apparatus of claim 1, wherein said at least one cutting section has a first cutting edge extending outwardly a first predetermined distance from the surface for cutting completely through the multilayer web and configured as a closed loop for defining a region on said surface, and a second cutting edge extending outwardly from said surface a second predetermined distance, said second predetermined distance being less than said first predetermined distance for scoring or cutting only the release liner, and said second cutting edge dividing said region to form two sub-regions thereof.

20. The apparatus of claim 19, wherein the two subregions are symmetrical.

21. An apparatus for forming a transdermal drug delivery device from a multilayer web having layers of a backing material, a drug-containing pressure sensitive adhesive, and a release liner comprising at least one combination of:

a frame;

an anvil roller mounted in the frame to rotate about its axis;

a cutting roller having a cylindrical surface mounted in the frame to rotate about its axis, which axis is coplanar with the axis of the anvil roller;

at least one cutting section fixedly mounted on and projecting about said surface having at least one cutting edge extending outwardly a first predetermined distance from the surface and configured as a predetermined shape for defining a region on said surface for conducting at least one of scoring or cutting only said release liner and of cutting completely through said multilayer web as it is passed between said anvil roller and said cutting roller;

means to position the cutting roller in proximity to the anvil roller;

a pressure applying means for selectively exerting force against the cutting roller to achieve said at least one of scoring and of cutting;

a resiliently covered nip roller rotatably mounted in the frame in proximity to the anvil roller which nip roller rotation is caused by at least one of contact with the multilayer web and pressure communicated from the anvil roller, which nip roller in cooperation with the anvil roller urges the multilayer web toward the cutting roller at substantially a same linear speed as a surface speed of the cutting roller and anvil roller; and

a drive means to counter-rotate the anvil roller and the cutting roller to urge the multilayer web between these rollers such that, progressively along a line coplanar with the axes of these rollers.

22. The apparatus of claim 21 in combination with an additional apparatus including an anvil roller; a cutting roller; means to position the cutting roller; pressure applying means; resiliently covered nip rollers and drive means; and an additional cutting section configured for cutting completely through said multilayer web arranged on said cutting roller of said additional apparatus, said at least one cutting section comprising a first cutting section configured for scoring or cutting said release liner arranged on said cutting roller of said apparatus; and said apparatus and additional apparatus arranged with respect to said web to pass said web first through said apparatus for scoring or cutting and then through said second apparatus for cutting completely through the web.

23. The apparatus of claim 22 which further comprises bearing means to support a respective shaft concentric with the axis of each of the cutting roller.

24. The apparatus of claim 21 wherein said pressure applying means comprises a pressure roller rotatably mounted in the frame and having pressure journals at either end, and means for exerting force against the pressure roller to be indirectly exerted on the cutting roller, and complimentary pressure journals on the cutting roller to rotationally communicate with the pressure roller journals.

25. The apparatus of claim 24 in which the means to exert force on the pressure roller is a threaded pressure applicator, which threaded pressure applicator cooperates with a threaded hole in the frame.

26. The apparatus of claim 25 in which the threaded pressure applicator causes movement of the pressure roller by sliding its bearings with respect to the frame, thereby applying pressure through the pressure roller journals and complimentary pressure journals to the cutting roller.

27. The apparatus of claim 26 in which the bearing means of the cutting roller is slidable with respect to the frame and pressure applied to the cutting roller from its pressure journals in part positions the cutting roller in proximity to the anvil roller.

28. The apparatus of claim 27 which further comprises pressure measuring devices attached to the frame to permit reproducibility of the positioning and pressure of the cutting roller in proximity to the anvil roller.

29. The apparatus of claim 21 which further comprises a positive drive connection between the cutting roller and the anvil roller to achieve substantially identical surface speeds.

30. The apparatus of claim 29 in which the positive drive connection is meshing spur gears on the anvil roller and cutting roller.

31. The apparatus of claim 21 which further comprises a transfer plate disposed in close proximity to the anvil roller and cutting roller to receive the transdermal drug delivery devices and scrap remains of the web from which the said devices were cut and scored.

32. The apparatus of claim 21 in which the cutting roller is sized with a diameter to achieve a repeat length when rotating that minimizes scrap losses from the web.

33. The apparatus of claim 32 in which cutting sections are positioned on the cutting roller in a close packed pattern to minimize scrap losses from the web.

34. The apparatus of claim 21 which further comprises a field of resilient material attached to the cutting roller in proximity to but not touching said at least one cutting edge.

35. The apparatus of claim 21, wherein said at least one cutting section has a first cutting edge extending outwardly a first predetermined distance from the surface for cutting completely through the multilayer web and configured as a closed loop for defining a region on said surface, and a second cutting edge extending outwardly from said surface a second predetermined distance, said second predetermined distance being less than said first predetermined distance for scoring or cutting only the release liner, and said second cutting edge dividing said region to form two sub-regions thereof.

36. The apparatus of claim 35, wherein the two subregions are symmetrical.

37. The apparatus of claim 21 which further comprises bearing means to support a shaft concentric with the axis of the anvil roller.

38. An apparatus for forming a transdermal drug delivery device from a multilayer web having layers of a backing material, a drug-containing pressure sensitive adhesive, and a release liner, comprising:

an anvil roller supported in a manner for rotating about its axis;

a cutting roller having a cylindrical surface and supported for rotating about its axis, which axis is coplanar with the axis of the anvil roller, and said cutting roller being positionable in proximity to said anvil roller;

at least one cutting section fixedly mounted on and projecting above said surface, and having at least one cutting edge extending outwardly a predetermined distance from said surface and configured as a predetermined shape for defining a region on said surface for conducting at least one of scoring or cutting only said release liner and of cutting completely through said multilayer web as it is passed between said anvil roller and said cutting roller;

said anvil roller and cutting roller being counter rotatable in relation to each other, whereby counter rotation of said anvil roller and cutting rollers functions to urge the multilayer web between said cutting roller and anvil roller such that, progressively along a line coplanar with the axes of the rollers, such that at least one of the cutting edge communicates with and cuts through the multilayer web or the cutting edge communicates with and scores or cuts only the release liner occurs; and

pressure applying means for selectively applying pressure to said anvil roller for causing said at least one of cutting and of scoring or cutting to occur.

39. The apparatus of claim 38 in combination with an additional apparatus including an anvil roller; a cutting roller; and pressure applying means; and an additional cutting section configured for cutting completely through said multilayer web arranged on said cutting roller of said additional apparatus; said at least one cutting section comprising a first cutting section configured for scoring or cutting said release liner arranged on said cutting roller of said apparatus and additional apparatus arranged with respect to said web to pass said web first through said apparatus for scoring or cutting and then through said additional apparatus for cutting completely through the web.

40. The apparatus of claim 38 wherein said pressure applying means comprises a pressure roller rotatably mounted and having pressure journals at either end, and means for exerting force against the pressure roller to be indirectly exerted on the cutting roller, and complimentary pressure journals on the cutting roller to rotationally communicate with the pressure roller journals.

41. The apparatus of claim 38 wherein said at least one cutting section comprises a first cutting edge extending outwardly or first predetermined distance from the surface for cutting completely through the multilayer web and configured as a closed loop for defining a region on said surface, and a second cutting edge extending outwardly from said surface a second predetermined distance, said second predetermined distance being less than said first predetermined distance for scoring only the release liner, and said second cutting edge dividing said region to form two sub-regions thereof.

42. The apparatus of claim 41, wherein the two subregions are symmetrical.
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