Method and apparatus for impregnating a film, and method for manufacturing a transdermal treatment system.

Abstract

The method for impregnating a film 12 includes the steps of providing a film 12 to be impregnated, immersing the film 12 in an impregnating agent 14, and partially separating the impregnating agent 14 from the film 12 to provide a predetermined loading of the impregnating agent 14 in the film 12. Additionally, the apparatus 10 for impregnating a film 12 includes an immersion container 16 filled with the impregnating agent 14, a film guide, and a separating device 18 for removing the impregnating agent 14 from the film 12 to provide a predetermined loading of the impregnating agent 14 in the film 12. Additionally, a method for manufacturing a transdermal therapeutic system is provided.

Description

Technical Field

[0001] The present invention relates to a method for impregnating a film, an apparatus for impregnating a film, and a method for manufacturing a transdermal therapeutic system.

Background Art

[0002] Impregnated films, particularly membranes, are used as layers in, for example, transdermal therapeutic systems.

Summary of the Invention

Problems to be Solved by the Invention

[0003] For example, U.S. Patent No. 4,436,741 describes a transdermal therapeutic system for delivering scopolamine that includes an oil-impregnated membrane.

[0004] In a general method for impregnating a film such as a membrane, coating is performed with a coating machine using reverse roll coating with an engraving wave.

[0005] When using an engraving roller, the impregnation amount is determined by the engraving of the roller, for example, the engraving gap. It is necessary to change the roller, for example, the engraving depth, according to the change in the impregnation amount.

[0006] A disadvantage of existing methods is that the filling of the impregnating agent into the film is particularly inaccurate.

[0007] Furthermore, previous methods are time-consuming, complex in terms of manufacturing, and / or require additional working steps and / or apparatuses.

[0008] An object of the present invention is to provide a method for impregnating a film that optimizes impregnation, an apparatus for impregnating a film, and a method for manufacturing a transdermal therapeutic system.

Means for Solving the Problems

[0009] According to the present invention, the object of the present invention is achieved by a method for impregnating a film according to claim 1, an apparatus for impregnating a film according to claim 2, and a method for manufacturing a transdermal treatment system according to claim 15.

[0010] The method for impregnating a film according to the present invention is particularly preferably a method for impregnating a film for use in a transdermal treatment system. In the first step of the method, a film to be impregnated is supplied. It is preferable that the film be supplied by a roll process so that the film is unwound from the supply roller. The supplied film is immersed in an impregnating agent. In particular, the film is completely immersed in the impregnating agent. It is preferable that the impregnating agent is contained in an immersion container, also known as an impregnation bath. In a preferred embodiment, the film is guided at least partially substantially horizontally through the impregnating agent. After the film has passed through the impregnating agent, it is preferable that the film is completely filled with the impregnating agent. The impregnating agent is then partially separated from the film. This separation is carried out particularly to result in a predetermined filling of the film with the impregnating agent. In particular, the separation results in the film being filled with 5 g / m 2 ~20g / m 2 Preferably 7 g / m 2 ~13g / m 2 Particularly preferably about 10 g / m 2 The oil is then filled in. When separating, it is preferable to remove the impregnating agent from the film.

[0011] The apparatus for impregnating a film according to the present invention is particularly preferably an apparatus for impregnating a film for use in a transdermal treatment system. The apparatus comprises an immersion container filled with an impregnating agent, also known as an impregnation bath. The immersion container is configured and / or arranged to immerse a film particularly continuously in the impregnating agent. The apparatus comprises a film guide. The film guide is configured in particular to supply the film, pass the film through, immerse the film in the immersion container, and / or feed out the film. Supplying the film means in particular to guide the film into the apparatus, passing the film means in particular to guide the film into the apparatus, immersing the film means in particular to guide the film through the immersion container, and feeding out the film means in particular to guide the film out of the apparatus. Preferably, at least one guide roller, particularly a rotatable guide roller, is at least partially located in the immersion container to guide the film. It is particularly preferable that at least two guide rollers, particularly just two, are located in the immersion container so that the film can be guided substantially horizontally through at least a portion of the immersion container. Furthermore, the film guide section preferably has at least one, in particular a rotatable roller, such as a guide roller. Preferably, at least one roller is configured to be circular. Preferably, at least one roller is driven. The film guide section preferably has a supply roller for unwinding the film and / or a delivery roller for winding the film. In particular, at least one of the supply roller and the delivery roller is configured to be driven. Preferably, at least one roller, in particular the supply roller and / or the delivery roller, can be located outside the device, inside the device, or partially outside and inside the device. Furthermore, the device includes a separation device for separating the impregnating agent from the film, particularly partially. The separation device is preferably configured to separate the impregnating agent to result in a predetermined filling of the film with the impregnating agent.

[0012] In the method according to the present invention, it is preferable to separate the impregnating agent using a separation device. The separation device used within the scope of the method is configured in particular as the separation device of the apparatus according to the present invention.

[0013] In a preferred embodiment, the separation device has at least one wiper. The wiper is preferably silicone coated. In particular, the wiper is preferably coated, preferably laminated, with a silicone film having a thickness of 0.8 mm to 3 mm. The wiper is preferably configured and / or positioned to be in contact with the impregnating agent, preferably pressed against the impregnating agent. In particular, the wiper is pressurized. It is preferable that the separation device separates the impregnating agent on one side of the film or on both sides of the film.

[0014] In a preferred embodiment, the separation device has at least one edge and / or at least one, preferably rotatable roller. The edge preferably has a square or circular structure. The edge is preferably configured and / or positioned to contact the film moving toward or away from it. In other words, the edge is preferably at an acute, obtuse, or right angle with respect to the film in the direction in which the film moves. The separation device preferably has at least a pressure plate forming the edge. In particular, the pressure plate can be bent.

[0015] In a preferred embodiment, the wipers are positioned on both sides of the film filled with the impregnating agent.

[0016] In a preferred embodiment, the wiper contacts the film on both sides, particularly by pressing it against the film. Preferably, at least one wiper has two opposing rollers in a double-sided configuration. On the other hand, a double-sided wiper may have two opposing edges, or one edge and one opposing pressing surface, such as an anvil.

[0017] In a preferred embodiment, the separation device, particularly at least one wiper, is configured to be variably adjustable so as to result in a predetermined filling of the film with the impregnating agent by separating the impregnating agent. Therefore, it is preferable that the separation device, particularly at least one wiper, is configured to result in a desired filling, for example, a predetermined quality of oil (liters or kilograms) per square meter of film surface.

[0018] In a preferred embodiment, the separation device has at least one adjustment device for adjusting a predetermined filling. In particular, the adjustment device has or consists of one of the following: a pneumatic device, a hydraulic device, a spring device, an elastomer, a pressure screw, and a fine adjustment screw. In particular, the adjustment device is arranged and / or configured to adjust the pressure and / or distance between at least one wiper and the film. In a double-sided configuration of at least one wiper, the adjustment device is arranged and / or configured to adjust the pressure and / or distance between two opposing elements of the wiper, such as a roller, edge, or pressure surface. In particular, the spring device has a compression spring or tension spring, particularly in the form of a spiral spring. In particular, the elastomer, including rubber, is particularly a rubber band. In particular, the angle of attack of the wiper, especially in a configuration with an edge, is preferably adjustable. For example, it is preferable that the angle of the edge of the pressure plate can be changed with respect to the opposing edge or opposing pressure surface. Because the wiper is adjustable, a variety of filling conditions can be adjusted in particular. It is preferable that the opposing elements of a double-sided wiper are offset from or parallel to each other. It is preferable that the offset of the opposing elements is adjustable. It is preferable that the separation device has one or more of the above wipers, particularly in various embodiments.

[0019] In a preferred embodiment, the separation device is at least partially configured and / or positioned so that the separated impregnating agent is returned to the immersion container. Preferably, the separation device is at least partially configured and / or positioned so that the separated impregnating agent falls into the immersion container by gravity. Here, it is preferable that the separation device is at least partially positioned above the immersion container. In particular, the method according to the present invention includes a step of returning at least a portion of the separated impregnating agent, preferably by gravity, in addition to or instead of this configuration of the separation device. After leaving the immersion container, the film is preferably guided substantially vertically, for example, by a film guide.

[0020] In a preferred embodiment, the apparatus includes a recovery tray for recovering the separated impregnating agent, preferably connected to an immersion container. The recovery tray is preferably connected to guide the fluid into the immersion container. On the other hand, it is preferable that the recovery tray is configured separately from the immersion container. The recovery tray is preferably larger than the immersion container, particularly in terms of surface area. It is preferable that the immersion container and the recovery tray completely cover the lower area of ​​the separation apparatus, for example, that the dripping impregnating agent to be separated is recovered.

[0021] In a preferred embodiment, the impregnating agent is an oil, particularly a mineral oil. The impregnating agent is especially gentle on the skin.

[0022] In a preferred embodiment, the film contains, and more particularly, is composed of, polypropylene. The film is configured to be particularly porous, preferably microporous. In particular, the film is Cellgard® 2400 from Cellgard.

[0023] In a preferred embodiment, the method according to the invention has a further step of testing the film filled with the impregnating agent, in particular for process control. This step is carried out particularly after separating the impregnating agent for the desired filling. In particular, the current filling amount is determined during the test. This current filling amount particularly corresponds to the actual filling amount. Furthermore, it is preferable to compare the actual filling amount with the target filling amount. It is particularly preferable to further carry out the step of adjusting the separating device in order to adjust the actual filling amount to the target filling amount. The test is carried out particularly optically and / or to record the weight. For the test, it is preferable to remove a part of the film, for example cut it off, and then test that part. The test can preferably be carried out using the following test device.

[0024] In a preferred embodiment, the device comprises a test device for testing the film filled with the impregnating agent. The test device is particularly arranged behind the separating device in the direction in which the film is guided. The test device preferably has a scale for weighing the film. In addition or alternatively, the test device particularly has at least one optical control device such as a camera. The test device can be further configured magnetically or electrically so that, for example, the conductivity of the film can be measured.

[0025] In a particularly final step of the method for impregnating the film, it is preferable to feed out the impregnated film. The feeding out is particularly carried out in a roll process such that the impregnated film or the film composite having the impregnated film is wound around the delivery roller. The supply roller and / or the delivery roller can preferably be driven.

[0026] In particular, the features described within the scope of the method for impregnating the film are further applicable to the device, and vice versa. The method for impregnating the film is preferably carried out using the above device.

[0027] A method for manufacturing a transdermal therapeutic system according to the present invention is, in particular, a method for manufacturing a transdermal patch or a semi-finished product of a transdermal patch. The method for manufacturing a transdermal therapeutic system has the above-described steps of the method for impregnating a film. When performing the method for impregnating a film, it is preferable to use the above-described apparatus. The method for manufacturing a transdermal therapeutic system further has a step for adding an active ingredient into and / or onto the impregnated film. Here, the film can be coated, in particular, with a liquid active ingredient. On the other hand or in addition, it is further possible to combine the impregnated film with one or more films containing an active ingredient to form a film composite. In particular, the active ingredient contains scopolamine.

[0028] The method for impregnating a film or the method for manufacturing a transdermal therapeutic system is, in particular, a continuous method.

[0029] Within the scope of the present application, impregnation particularly means filling a film, particularly a porous film, with an impregnating agent such as oil. <>

[0030] The present invention further relates preferably to an apparatus system for manufacturing a transdermal therapeutic system. The apparatus system includes an apparatus for impregnating a film according to the present invention and an active ingredient supply apparatus. In particular, the active ingredient supply apparatus is arranged and / or configured to add an active ingredient into and / or onto the impregnated film. Here, the film can be coated, in particular, with a liquid active ingredient. On the other hand or in addition, it is further possible to combine the impregnated film with one or more films containing an active ingredient to form a film composite. In particular, the active ingredient contains scopolamine.

[0031] Another advantage of the present invention is that when the film is used in a transdermal therapeutic system, in particular, the impregnation working step can be performed within an assembly system or during assembly instead of performing it as an additional coating step or within a coating system as in the case of the prior art.

[0032] The present invention will be described in more detail below with reference to the attached drawings, based on preferred embodiments. [Brief explanation of the drawing]

[0033] [Figure 1] This is a schematic side view showing an embodiment of the apparatus according to the present invention. [Figure 2a] This is a schematic diagram showing an alternative wiper based on the detailed part II of Figure 1. [Figure 2b] This is a schematic diagram showing an alternative wiper based on the detailed part II of Figure 1. [Figure 2c] This is a schematic diagram showing an alternative wiper based on the detailed part II of Figure 1. [Figure 3] This is a perspective side view showing another embodiment of the apparatus according to the present invention. [Modes for carrying out the invention]

[0034] In the drawings, similar or identical parts or elements are identified by the same reference number or a variation thereof (e.g., 12 and 12', 12'' or 14 and 14', 14'').

[0035] Figure 1 shows an embodiment of the apparatus 10 for impregnating the film 12 according to the present invention.

[0036] Preferably, a porous film 12 is unwound from a feed roller 36 that rotates counterclockwise as indicated by arrow 58. Thus, the film 12 is guided in the direction of arrow 40.

[0037] Film 12 that has not yet been filled with the impregnation agent 14 is identified by reference number 12', while film 12 that has been filled is identified by reference number 12''.

[0038] The film 12' is first guided into an immersion container 16 filled with an impregnating agent 14, where it is preferably completely filled with the impregnating agent 14. Two guide rollers 34 are positioned inside the immersion container 16 so that the film 12 moves substantially horizontally through the impregnating agent 14 within the container 16. The filled film 12'' then exits the immersion container 16.

[0039] Subsequently, the film 12'' is guided to the first wiper 20b of the separation device 18. Here, the film 12'' is pressed against a pressure surface 28 by a pressure plate 26 having an edge 27 (as indicated by arrow 29). As a result, some of the impregnating agent 14 separates from the film 12''. Such separation is illustrated by drops 14' of the removed impregnating agent 14. The placement of the first wiper 20b relative to the immersion container 16 allows the removed impregnating agent 14 to fall into the immersion container 16 and be reused. The film 12'' is further guided to another wiper 20a of the separation device 18 via guide rollers 34. The wiper 20a has two opposing rollers 22. It is preferable to pressurize at least one of the rollers 22, and especially two rollers 22 (as indicated by arrow 24), so that pressure is applied to the film 12''. The wiper 20a further removes the impregnating agent 14 from the film 12'', as illustrated by the droplet 14''. The separated impregnating agent 14'' falls into a collection tray 32 for collecting the impregnating agent 14''.

[0040] In particular, the separation device 18 carries out the predetermined filling of the film 12 with the impregnating agent 14. Here, the illustrated configuration of the separation device 18 having wipers 20a, 20b is merely one preferred possibility. Configurations of the separation device 18 having one or more wipers, various wiper configurations (see, for example, Figures 2a-2c), various wiper arrangements, and / or various adjustment devices for the wipers are possible. The adjustment devices for wipers 20a, 20b are schematically indicated in Figure 1 only by arrow 24 with respect to wiper 20a and by arrow 29 with respect to wiper 20b. It is preferable that the adjustment devices are configured to be adjustable. The adjustment devices can be, for example, pneumatic devices, hydraulic devices, spring devices, elastomers, pressure screws, and / or fine adjustment screws. It is preferable that the adjustment devices can be used to change the distance and / or angle and / or pressure between wiper elements, such as between rollers 22 or between pressure plates 26 and pressure surfaces 28.

[0041] The film is guided using the guide roller 34, the supply roller 36, and the delivery roller 38. Here, various modifications are possible. The supply roller 36 and / or the delivery roller 38 can be driven.

[0042] After the film passes through the illustrated wiper 20a, the film 12''' is in the desired filled state.

[0043] Subsequently, the film 12''' is tested using the test apparatus 46. In particular, the filling state of the film 12''' is tested, preferably measured. The test apparatus 46 is illustrated to have a scale 44 for weighing the film 12'''. In particular, the weight of the surface portion of the film 12''' is weighed. Furthermore, the illustrated test apparatus 46 has an optical test device 42, such as a camera. When the film 12''' is filled, the appearance of the film 12''' generally changes. For example, the film 12''' becomes transparent as the amount of impregnating agent filled increases. This state can be detected by the optical test device 42. In addition to the illustrated test apparatus 46, other configurations are further possible, for example, a test apparatus 46 having only one scale 44 or a test apparatus 46 having only one optical test device 42. Further, an apparatus 10 with the same configuration in other respects but without the test device 46 is also possible.

[0044] The film 12''' is then wound onto the feed roller 38. The feed roller 38 is illustrated to rotate counterclockwise (as indicated by arrow 60).

[0045] It is possible to bind an active ingredient, such as scopolamine, to film 12''' before it is wound and / or after it is wound. Alternatively, it is possible to bind a further film layer containing the active ingredient to film 12''', and / or to directly bind the active ingredient to film 12''', for example, as a coating. In this way, it is possible to manufacture a transdermal treatment system.

[0046] Figures 2a-2c illustrate alternative configurations for wipers 20c, 20d, and 20e. These wipers 20c, 20d, and 20e can be used, for example, in place of wiper 20b at position II in Figure 1.

[0047] Figure 2a shows a wiper 20c in which a pressure surface 28 and a pressure plate 26 are positioned opposite each other. Here, the pressure plate 26 is configured to be adjustable in particular with respect to the pressure surface 28. For example, it is shown that the angle of the pressure plate 26 (arrow 30a) can be changed. For example, an angle of +90° to -90° from auxiliary line 31 is possible. Preferably, the angle can be adjusted between +45° and -45°. On the other hand, it is shown that the distance between the pressure plate 26 and the pressure surface 28 (arrow 30b) is further adjustable. This makes it possible to change the pressure, for example. The pressure can be changed, for example, using a spring device and / or an adjustment screw. Furthermore, it is shown that the misalignment between the pressure plate 26 and the pressure surface 28 (arrow 30c) is adjustable. In alternative preferred configurations, only one or more adjustability is available. It is preferably even more possible that other wiper configurations are adjustable.

[0048] Figure 2b shows a one-sided wiper 20d having a pressure plate 26 that removes the impregnating agent by contacting the film 12''.

[0049] Figure 2c shows another embodiment of the wiper 20e, in which two pressure plates 26 are positioned diagonally opposite each other and in contact with the film 12'' and / or impregnating agent on both sides to remove the impregnating agent.

[0050] Figure 3 shows another embodiment of the apparatus 10 for impregnating the film 12 according to the present invention. The apparatus of Figure 3 is at least partially configured similarly to the apparatus 10 of Figure 1 (see above).

[0051] The device 10 includes a mounting plate 52 positioned via a stand device 54 having two legs 56, and at least some of the components of the device 10 are attached to the mounting plate.

[0052] In Figure 3, film 12' is supplied from the right side, and film 12''' is fed out to the left side.

[0053] The apparatus 10 is equipped with multiple wipers 20e to 20h of a separation device for removing the impregnating agent from the film 12'.

[0054] Wipers 20e and 20h are configured as roller pairs, and it is preferable that the pressure can be adjusted by adjustment devices 50e and 50h.

[0055] The wiper 20f has a pressure plate 26 and a pressure surface 28, and in particular the angle of the pressure plate 26 is variable.

[0056] The wiper 20g has two pressure plates 26, which are shown to be slightly offset. Corresponding arrangements with no offset or greater offset are further possible. It is further possible that the angle of one or both of the pressure plates 26 is variable.

[0057] The guide roller 34 is particularly adjustable by the adjustment device 48.

[0058] It is preferable that the method for impregnating a film according to the present invention and / or the method for manufacturing a transdermal treatment system according to the present invention can be carried out using one or more features shown in Figures 1 to 3.

Claims

1. A method for manufacturing a transdermal treatment system, The process includes an impregnation step in which the film is impregnated. The aforementioned impregnation process is The process of supplying the film to be impregnated, The steps include immersing the film in an impregnating agent contained in an immersion container, and A step of partially separating the impregnating agent from the film in order to provide a predetermined filling of the impregnating agent into the film. It has, The method further comprises the step of adding an active ingredient to and / or onto the film.

2. The method according to claim 1, wherein the impregnating agent is separated by a separation device.

3. The method according to claim 2, wherein the separation device has at least one wiper.

4. The method according to claim 3, wherein the wiper has at least one edge and / or at least one roller.

5. The method according to claim 3 or 4, wherein the wipers are arranged on both sides of the film filled with the impregnating agent.

6. The method according to any one of claims 2 to 4, wherein the separation device is configured to be variably adjustable to bring about the predetermined filling by separating the impregnating agent.

7. The method according to claim 3 or 4, wherein the separation device has at least one adjustment device for adjusting the pressure and / or distance of the wiper.

8. The method according to any one of claims 2 to 4, wherein the separation device is arranged so that the separated impregnating agent returns to the immersion container.

9. The method according to any one of claims 1 to 4, wherein a recovery tray is provided for recovering the separated impregnating agent.

10. The method according to any one of claims 1 to 4, wherein the impregnating agent contains oil.

11. The method according to any one of claims 1 to 4, wherein the film is a porous film.

12. The method according to any one of claims 1 to 4, further comprising a step for testing a film filled with an impregnating agent.

13. The method according to any one of claims 1 to 4, wherein a test apparatus is provided for testing a film filled with an impregnating agent.

14. An apparatus system for manufacturing a transdermal treatment system, It is equipped with an impregnation device for impregnating the film, The impregnation device, An immersion container filled with an impregnation agent, A film guide unit for supplying a film to be impregnated, immersing the film in the immersion container, and feeding out the film, A separation device for separating the impregnating agent from the film in order to provide a predetermined filling of the impregnating agent into the film, It is equipped with, The apparatus system further comprises an active ingredient supply device for adding an active ingredient to and / or onto the impregnated film.

15. The apparatus system according to claim 14, wherein the separation device has at least one wiper.

16. The apparatus system according to claim 15, wherein the wiper has at least one edge and / or at least one roller.

17. The apparatus system according to claim 15 or 16, wherein the wipers are arranged on both sides of the film filled with the impregnating agent.

18. The apparatus system according to any one of claims 14 to 16, wherein the separation device is configured to be variably adjustable to bring about the predetermined filling by separating the impregnating agent.

19. The apparatus system according to claim 15 or 16, wherein the separation device has at least one adjustment device for adjusting the pressure and / or distance of the wiper.

20. The apparatus system according to any one of claims 14 to 16, wherein the separation device is arranged so that the separated impregnating agent returns to the immersion container.

21. The apparatus system according to any one of claims 14 to 16, further comprising a recovery tray for recovering the separated impregnating agent.

22. The apparatus system according to any one of claims 14 to 16, wherein the impregnating agent contains oil.

23. The apparatus system according to any one of claims 14 to 16, wherein the film is a porous film.

24. The apparatus system according to any one of claims 14 to 16, further comprising a test apparatus for testing a film filled with an impregnating agent.

25. The method according to any one of claims 1 to 4, wherein when the active ingredient is added, the film is coated with the active ingredient, and / or the film is bonded with one or more films containing the active ingredient to form a composite film.

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