Process and a device for producing a transdermal therapeutic sys

Adhesive bonding and miscellaneous chemical manufacture – Methods – Surface bonding and/or assembly therefor

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Details

156220, 156251, 156292, 156582, 424448, A61M37/00

Patent

active

059024330

DESCRIPTION:

BRIEF SUMMARY
The present invention relates to a process and a device for the manufacture of a transdermal therapeutic system for the administration of active substances to the skin in the form of a sheet-like multichamber or multichamber-channel system.


BACKGROUND OF THE INVENTION

Transdermal therapeutic systems having chambers filled with active substances have been known for some time. In particular the transdermal systems initially placed on the market comprise chambers all filled with active substances. However, production of these systems is very expensive. In particular, the "membrane bags" which are filled with active substance must be produced individually in complicated process steps, and then be applied on suitable supporting sheets as a whole.
DE-OS 37 22 775 discloses a transdermal therapeutic system for the administration of active substances to the skin. It comprises a backing layer averted from the skin, an active substance depot, a control unit controlling the release of active substance by the system, and a pressure-sensitive adhesive device fixing the therapeutic system on the skin, the active substance depot being a multichamber system wherein discrete chambers comprise one or several active substances.
Special shaping of these systems, as is described in the above document, has not been possible as yet in an economically efficient manner. Another disadvantage lies in the fact that insufficiently subdivided chamber systems, when applied to vertical surfaces, tend to have an active substance mass accumulated at the lower edge resulting in a particularly intense supply into the skin at this point, whereas delivery in the upper part takes place to a considerably lesser extent. This can only be avoided--although imperfectly--by extremely thickening the active substance mass; however, this involves difficulties in the production of transdermal systems and limits the possibilities of design.


DESCRIPTION OF THE INVENTION

It is the object of the present invention to provide a very simple and thus cost-saving process by means of which the aforementioned transdermal therapeutic systems are manufactured in a simple manner and, as a result, at a comparatively high production rate. The universal possibilities of shaping the active substance-containing chambers or channels are intended to achieve the highest possible degree of freedom with respect to developing and forming new systems. Moreover, the process is intended to be particularly suitable for the use of liquid or semisolid active substance preparations, wherein it is in particular possible to dispense with mixing or thickening the active substance with adhesive masses; it is neither necessary to have the active substance absorbed by special materials which subsequently release the active substance again, for example, sometimes used in known nitroglycerin or nicotine patches. It is a further object of the present invention to provide a simple device particularly suitable for carrying out a continuous production process.
To achieve this object the present invention proposes to provide a suitable top layer and a bottom layer, to introduce an active substance-containing layer between these layers, and then to squeeze top and bottom layer at individual and/or coherent sites under displacement of the intermediary sites of the active substance-containing layer and formation of active substance-containing chambers or channels, and--at the same time or after that--to bond top layer and bottom layer permanently at the squeezed places.
Most advantageously the proposed process is simple and cost-saving, and it is suitable for universal possibilities of shaping the active substance islands embedded in chambers or channels as well as for the use of liquid active substances without having to provide them in a thickened form or together with absorbent materials.
According to an embodiment of the process the permanent bond of top and bottom layer is effected under the action of pressure, heat and/or ultrasonics.
According to another embodiment the permanent bonds are

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