CA2025033C - One-step method for forming a pressure-sensitive adhesive transdermal drug device and apparatus therefor - Google Patents
One-step method for forming a pressure-sensitive adhesive transdermal drug device and apparatus thereforInfo
- Publication number
- CA2025033C CA2025033C CA002025033A CA2025033A CA2025033C CA 2025033 C CA2025033 C CA 2025033C CA 002025033 A CA002025033 A CA 002025033A CA 2025033 A CA2025033 A CA 2025033A CA 2025033 C CA2025033 C CA 2025033C
- Authority
- CA
- Canada
- Prior art keywords
- cutting
- release liner
- web
- cutting element
- cut
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired - Fee Related
Links
Abstract
A one step method and apparatus for forming a pressure sensitive adhesive transdermal drug device having a scored release liner which comprises positioning a web containing the release liner using a cutting die having a first cutting element designed to completely cut through the web to form the device and a second cutting element designed to cut only the release liner.
Description
~d ~? ~d c~ '",Fj c ) ONE-STEP METHOD FOR FORMING A PRESSURE-SENSITIVE
ADHESIVE TRANSDERMAL DRUG DEVICE AND APPARATUS THEREFOR
BACKGROUND OF THE INVENTION
The present invention relates to drug-containing pressure sensitive adhesive containing on one side, a backing) and on the other side. a release liner, (sometimes called a transdermal drug delivery device) and morn particularly, to a method and apparatus for forming a transdermal drug device and scoring its liner to permit the liner to be easily removed from the adhesive carrying drug in one step.
Many apparatus and methods hava been devised for continuously or intermittently scoring a release Liner for use with transdermal drug-containing adhesive in order to permit the liner to be, easily removed from the device immediately prior to its being used. One such method is to completely cut through the release liner. However, t!~e typical procedure for the preparation of a transdermal drug delivery device is as follows: First, a dilution or suspension of the adhesive a C'.. ~ "' '7 if ii ~~ ~> ~J ' ~..7 containing the drug is poured onto a Flexible plastic intended to function as a disposable release liner. Next, a non-releasable backing material is applied over the adhesive.
The result is a web containing an adhesive with a backing on one side and a disposable release liner on the other. A shaped device is then formed by a peripheral cutting through a11 layers oP the resulting .reb. The disposable release liner is then removed and a second, scored release liner is attached to the transdermal adhesive.
Alternatively, the liner can be first scored and assembled with the adhesive and the backing and then the assembly cut to the desired dimensions.
The purpose of the multi-step prJcedure for applying the backing and the release liner to the adhesive containing the drug is to avoid the problems encountered when a scored release liner is used in processing. IF such a completely cut release liner is used prior to coating) tha adhesive can pass through the release liner at the score causing equipment problems, cracking, separation and heat damage.
These prior art methods suffer ~r..~m the disadvantage that the procedure for applying the release liner requires many steps. It thus has a tendency to be more expensive~in large scale manufacturing than a procedure ~~rhich ~rould involve newer steps.
ADHESIVE TRANSDERMAL DRUG DEVICE AND APPARATUS THEREFOR
BACKGROUND OF THE INVENTION
The present invention relates to drug-containing pressure sensitive adhesive containing on one side, a backing) and on the other side. a release liner, (sometimes called a transdermal drug delivery device) and morn particularly, to a method and apparatus for forming a transdermal drug device and scoring its liner to permit the liner to be easily removed from the adhesive carrying drug in one step.
Many apparatus and methods hava been devised for continuously or intermittently scoring a release Liner for use with transdermal drug-containing adhesive in order to permit the liner to be, easily removed from the device immediately prior to its being used. One such method is to completely cut through the release liner. However, t!~e typical procedure for the preparation of a transdermal drug delivery device is as follows: First, a dilution or suspension of the adhesive a C'.. ~ "' '7 if ii ~~ ~> ~J ' ~..7 containing the drug is poured onto a Flexible plastic intended to function as a disposable release liner. Next, a non-releasable backing material is applied over the adhesive.
The result is a web containing an adhesive with a backing on one side and a disposable release liner on the other. A shaped device is then formed by a peripheral cutting through a11 layers oP the resulting .reb. The disposable release liner is then removed and a second, scored release liner is attached to the transdermal adhesive.
Alternatively, the liner can be first scored and assembled with the adhesive and the backing and then the assembly cut to the desired dimensions.
The purpose of the multi-step prJcedure for applying the backing and the release liner to the adhesive containing the drug is to avoid the problems encountered when a scored release liner is used in processing. IF such a completely cut release liner is used prior to coating) tha adhesive can pass through the release liner at the score causing equipment problems, cracking, separation and heat damage.
These prior art methods suffer ~r..~m the disadvantage that the procedure for applying the release liner requires many steps. It thus has a tendency to be more expensive~in large scale manufacturing than a procedure ~~rhich ~rould involve newer steps.
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SUMMARY OF THE INVENTION
The present invention overcomes the difficulties arid disadvantages associated with prior art devices by providing a method and device therefor for simultaneously cutting an assembled transdermal device from a web comprising a backing, a drug-containing adhesive and a release liner.
This invention is accomplished by providing cutting devices sized to cut completely through the periphery of the assembled web to form the transdermal device, and also sized to only cut or score the release liner at a position intermediate to the periphery of the device. The intermediate cut does not extend to the adhesive or the non-releasable backing.
These advantages are accomplished by the use of a cutting device having the configuration of .he device to be cut with an exterior cutting element sized to form the transdermal device, and the interior cutting element sized to cut only through the release liner.
BRIEF DESCRIPTION OF THE DRAWINGS
Fig. 1 is a plain view of the devi;.~.
Fig. 2 is a cross section of the device along line 2-2.
Fig. 3 is a cross section of the device taken along line 3-3.
Fig. 4 is a cross-section of the drug delivery device in the web form prior to cutting.
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SUMMARY OF THE INVENTION
The present invention overcomes the difficulties arid disadvantages associated with prior art devices by providing a method and device therefor for simultaneously cutting an assembled transdermal device from a web comprising a backing, a drug-containing adhesive and a release liner.
This invention is accomplished by providing cutting devices sized to cut completely through the periphery of the assembled web to form the transdermal device, and also sized to only cut or score the release liner at a position intermediate to the periphery of the device. The intermediate cut does not extend to the adhesive or the non-releasable backing.
These advantages are accomplished by the use of a cutting device having the configuration of .he device to be cut with an exterior cutting element sized to form the transdermal device, and the interior cutting element sized to cut only through the release liner.
BRIEF DESCRIPTION OF THE DRAWINGS
Fig. 1 is a plain view of the devi;.~.
Fig. 2 is a cross section of the device along line 2-2.
Fig. 3 is a cross section of the device taken along line 3-3.
Fig. 4 is a cross-section of the drug delivery device in the web form prior to cutting.
5Fa v5 '._s :_i <.8 DETAILED DESCRIPTION OF THE PREFERRED EMHODI~'ZENT
The preferred embodiment of the cutting die is illustrated in Fig. 1 in the form a support surface 10 having a two-dimensional cutting element 12 shown as having a generally elliptical configuration ~aith a one-dimensional central cutting element 14 of generally linear shape; and a pair of recesses 16 and 18 formed by the cutting elements 12 and 14. The web of the transdermal bandage is adapted to lay across the rigid support surface shown in Fig. 2 covering the entire well area formed by the cutting element 12. The cutting element 12 is sized with respect to the web so as to completely cut through the web, while the cutting element 14 is sized so as to cut only the release liner. The web is appl'_ed with the release liner facing the support.
Referring to Fig. 2, a cross section of the device taken along lines 2-2, the sizing of the cutting elements 12 and 14 is such that the difference in height between cutting element 12 and cutting element 14 is equal ~o the height of the release liner. Thus, cutting elements 12 and 14 are sized so that cutting element 12 is substantially the height of the web, while cutting element 14 is the height of the transdermal web less the height of a11 layers other than the release liner.
Fig. 4 shows a transdermal web in lateral cross section prior to being cut. Layer 22 is the backing material, layer 24 is the adhesive containing drug and layer 26 is the n, : '1 ~ ,'? : t, !'1 ld '!'! ~d zv '~J~ :7 !~
release liner layer. For purposes of this invention, the release liner layer prior to being cut is available as a web or a continuous roll prepared by applying the fluid adhesive to either the release liner 26 or the backing material 22, then applying either the backing material 22 over release liner 26, respectively, to the or_her side of the adhesive containing the drug. The stock or web 20 is then placed on the solid support with the release liner 26 facing the cutting elements 12 and 14. The transdermal device is then punched out with a die cooperating with the solid support.
The solid support and the die are preferably made of steel or relatively incompressible rigid material. It can be machined from a solid member or cast with a generally desired configuration and then machined to the prwper dimensions. In any event, the outer cutting element 14 generally has a circumference of from 3 to 40 arm and preferably from 7.9 to 17.7 mm, depending on the surface area needed for delivery of the drug and a radius of .48 to 6.4 mm and preferably 1.3 to 2.8 mm, again depending on the appropriate radius for the drug to be delivered. as is known to those skilled in the art.
Any configuration of cutting ele:~~ents 12 and 14 is possible; however, superior results have been found where cutting element 12 has a single .slanted face directed toward the periphery of the template, and cutting element 14 has a dual slant terminating in a central apex.
-S-i :~ .~ e3 (~J a Cutting elements 12 and 14 are sized so that cutting element, in cooperation with the web, passes completely through the web, while cutting element 14 passes only through the release liner. In general, cutting element 12 is from 100 to 1500 in height, and preferably 900 to 1000, and more preferably, 930 to 950 microns, although obviously the height of the cutting element is dependent upon the height of the web.
Again, the cutting element 14 is preferably 100 to 1S00 microns and more preferably 850 to 950 microns and even more preferably 92S to 945 microns, although again the height is totally dependent on the thickness of the release liner.
For example, with a stock of 10 microns in thickness where the release liner is 4 microns in thickness, cutting element 12 would 937 in height while cutting element 14 would be 93S
microns in height.
Obviously, the cutting element 14 has to extend sufficiently into the release liner to cause a score) but not sufficiently to also cut the adhesive drug-containing layer.
Although the apparatus of this invention can be used with release liners that are as flexible, as more flexible than or equally flexible as the combination of the backing and adhesive layer, .it is desirable to use a backing having the same order of frangibility as the release liner, so that the " force needed to cut the entire device and at the same time score only the release backing could be about the same.
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The foregoing arrangement allows the outside cutting rule to cut complete through a11 layers of the transdermal device while the center cutting rule only cuts through the release liner. The device further can have the peripheral cutting device extending on one side only toward the periphery, thus permitting straight lines on the interioL surface of the cutting element. The dual edge of the intermediate cutting device avoids uncut material in the area. Other variations of the instant device mill be apparent to one skilled in the art.
-?-
The preferred embodiment of the cutting die is illustrated in Fig. 1 in the form a support surface 10 having a two-dimensional cutting element 12 shown as having a generally elliptical configuration ~aith a one-dimensional central cutting element 14 of generally linear shape; and a pair of recesses 16 and 18 formed by the cutting elements 12 and 14. The web of the transdermal bandage is adapted to lay across the rigid support surface shown in Fig. 2 covering the entire well area formed by the cutting element 12. The cutting element 12 is sized with respect to the web so as to completely cut through the web, while the cutting element 14 is sized so as to cut only the release liner. The web is appl'_ed with the release liner facing the support.
Referring to Fig. 2, a cross section of the device taken along lines 2-2, the sizing of the cutting elements 12 and 14 is such that the difference in height between cutting element 12 and cutting element 14 is equal ~o the height of the release liner. Thus, cutting elements 12 and 14 are sized so that cutting element 12 is substantially the height of the web, while cutting element 14 is the height of the transdermal web less the height of a11 layers other than the release liner.
Fig. 4 shows a transdermal web in lateral cross section prior to being cut. Layer 22 is the backing material, layer 24 is the adhesive containing drug and layer 26 is the n, : '1 ~ ,'? : t, !'1 ld '!'! ~d zv '~J~ :7 !~
release liner layer. For purposes of this invention, the release liner layer prior to being cut is available as a web or a continuous roll prepared by applying the fluid adhesive to either the release liner 26 or the backing material 22, then applying either the backing material 22 over release liner 26, respectively, to the or_her side of the adhesive containing the drug. The stock or web 20 is then placed on the solid support with the release liner 26 facing the cutting elements 12 and 14. The transdermal device is then punched out with a die cooperating with the solid support.
The solid support and the die are preferably made of steel or relatively incompressible rigid material. It can be machined from a solid member or cast with a generally desired configuration and then machined to the prwper dimensions. In any event, the outer cutting element 14 generally has a circumference of from 3 to 40 arm and preferably from 7.9 to 17.7 mm, depending on the surface area needed for delivery of the drug and a radius of .48 to 6.4 mm and preferably 1.3 to 2.8 mm, again depending on the appropriate radius for the drug to be delivered. as is known to those skilled in the art.
Any configuration of cutting ele:~~ents 12 and 14 is possible; however, superior results have been found where cutting element 12 has a single .slanted face directed toward the periphery of the template, and cutting element 14 has a dual slant terminating in a central apex.
-S-i :~ .~ e3 (~J a Cutting elements 12 and 14 are sized so that cutting element, in cooperation with the web, passes completely through the web, while cutting element 14 passes only through the release liner. In general, cutting element 12 is from 100 to 1500 in height, and preferably 900 to 1000, and more preferably, 930 to 950 microns, although obviously the height of the cutting element is dependent upon the height of the web.
Again, the cutting element 14 is preferably 100 to 1S00 microns and more preferably 850 to 950 microns and even more preferably 92S to 945 microns, although again the height is totally dependent on the thickness of the release liner.
For example, with a stock of 10 microns in thickness where the release liner is 4 microns in thickness, cutting element 12 would 937 in height while cutting element 14 would be 93S
microns in height.
Obviously, the cutting element 14 has to extend sufficiently into the release liner to cause a score) but not sufficiently to also cut the adhesive drug-containing layer.
Although the apparatus of this invention can be used with release liners that are as flexible, as more flexible than or equally flexible as the combination of the backing and adhesive layer, .it is desirable to use a backing having the same order of frangibility as the release liner, so that the " force needed to cut the entire device and at the same time score only the release backing could be about the same.
-&-Ed ~ ~ h ~:.~ ~r :.a c.~
The foregoing arrangement allows the outside cutting rule to cut complete through a11 layers of the transdermal device while the center cutting rule only cuts through the release liner. The device further can have the peripheral cutting device extending on one side only toward the periphery, thus permitting straight lines on the interioL surface of the cutting element. The dual edge of the intermediate cutting device avoids uncut material in the area. Other variations of the instant device mill be apparent to one skilled in the art.
-?-
Claims (2)
1. A method of forming a transdermal drug delivery device having a scored release liner on one side thereof and having a backing on the other side thereof, said release liner being releasably adherable to said adhesive, said method comprising the steps of:
positioning a web containing said release liner, said adhesive and said backing on a rigid support surface; and cutting said web with a cutting die, said cutting die having a first cutting element with a two-dimensional shape, to cut completely through said web to form a shaped device and having a second linear cutting element interior to the first cutting element, said second cutting element having a one-dimensional shape, and sized to cut only the release liner layer.
positioning a web containing said release liner, said adhesive and said backing on a rigid support surface; and cutting said web with a cutting die, said cutting die having a first cutting element with a two-dimensional shape, to cut completely through said web to form a shaped device and having a second linear cutting element interior to the first cutting element, said second cutting element having a one-dimensional shape, and sized to cut only the release liner layer.
2. An apparatus for forming a pressure sensitive adhesive transdermal device for use with a web carrying pressure sensitive adhesive, having a release liner on one side thereof and a backing on the other side, said liner being releasably adherable to said adhesive, said method comprising:
a means for providing a rigid support structure in contact with one side of said web; and cutting means mounted in cooperation with said rigid support and having a two-dimensional peripheral cutting blade of a length and width for cutting the entire periphery of the formed web and a second cutting layer sized so as to only cut the release liner when said web is in position to be cut using said cutting means.
a means for providing a rigid support structure in contact with one side of said web; and cutting means mounted in cooperation with said rigid support and having a two-dimensional peripheral cutting blade of a length and width for cutting the entire periphery of the formed web and a second cutting layer sized so as to only cut the release liner when said web is in position to be cut using said cutting means.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US07/407,874 US5032207A (en) | 1988-03-04 | 1989-09-15 | One-step method for forming a pressure-sensitive adhesive transdermal drug device |
| US407,874 | 1989-09-15 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CA2025033A1 CA2025033A1 (en) | 1991-03-16 |
| CA2025033C true CA2025033C (en) | 1999-08-31 |
Family
ID=23613894
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002025033A Expired - Fee Related CA2025033C (en) | 1989-09-15 | 1990-09-11 | One-step method for forming a pressure-sensitive adhesive transdermal drug device and apparatus therefor |
Country Status (1)
| Country | Link |
|---|---|
| CA (1) | CA2025033C (en) |
-
1990
- 1990-09-11 CA CA002025033A patent/CA2025033C/en not_active Expired - Fee Related
Also Published As
| Publication number | Publication date |
|---|---|
| CA2025033A1 (en) | 1991-03-16 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| EEER | Examination request | ||
| MKLA | Lapsed | ||
| MKLA | Lapsed |
Effective date: 20020911 |