Method for producing transdermal patches (TTS)

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

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Details

156238, 156247, 156248, 156289, 156344, 427 231, 424449, B44C 1165, B32B 400, B23B 3100, A61L 1300, A61F 1300

Patent

active

060599138

DESCRIPTION:

BRIEF SUMMARY
The present invention relates to a process for the production of transdermal therapeutic patches (TTS) according to the introductory part of claim 1.
A process for continuously producing and filling patch packages with an active substance to be administered transdermally is known from DE-PS 32 04 582. The active substance is applied on a supporting film in portions and at certain distances, covered by metallic sealing film sections, and then, using an interlayer film, covered with an elastic adhesive film which is adherent on one side that is directed towards said interlayer film; after that the active substance portions, with their surrounding film layers, are punched to the desired size. This process involves a relatively heavy technical expenditure and relatively large amounts of useless material.
A process for the continuous production of transdermal therapeutic patches is also known. First, a laminate is produced by coating an intermediate carrier film with a flowable, active substance-containing preparation, this is then cut to strips of predetermined width, and, in further process stages, these are cut into active substance-containing sections of a defined length; these are applied at given distances on a protective film which covers them on all sides; finally, they are subdivided into single patches by cutting the protective film across the strip direction between the active substance-containing sections. Although this process most advantageously achieves the object of substantially preventing or minimizing active substance losses, it is relatively complicated because of the numerous process stages.
Another process is described in DE-OS 41 10 027. It describes a process for the continuous production of transdermal therapeutic patches having a backing layer, a pressure-sensitive adhesive active substance reservoir layer, and a removable protective layer; during manufacture active substance loss is minimized. In this process, the pressure-sensitive adhesive active substance reservoir is transferred onto the protective layer, which is formed in a later stage, in the form of a laminate consisting of an active substance-containing pressure-sensitive adhesive layer and a polymer film by means of a dispenser edge. However, the disadvantage of this process is that the final product, after removal of the protective film, has two polymer films in any case, and the resulting rigidity of the whole TTS can in some cases cause an unsatisfactory wearing comfort.
It is accordingly the object of the present invention to transfer single, active substance-containing sections at a high rate, high precision, and without active substance loss from a first web at predetermined distances one after the other onto a second web, which preferably projects the sections on all sides, in a technically simple and reliable manner; in this connection, it must be avoided that the wearing comfort of the final product is impaired by a polymer film lying within the TTS.
This object is achieved according to the present invention with a process according to claim 1. In view of the fact that it has been regarded as a standing rule for technical action among experts that pressure-sensitive adhesive films can only be transferred in the form of laminates with rigid sheet materials, this solution is all the more remarkable.
DE-OS 41 10 027, DE-OS 15 11 873, DE-PS 25 55 910, DE-OS 32 33 546, DE-PS 36 18 542, and DE 42 32 279 describe transfer processes; however, the possibility of removing the process film during the transfer of the self-adhesive laminate is not mentioned therein.
When the patch according to the present invention is produced, a more or less great number of layers may be provided according to the requirements, i.e., depending on the intended use of the patch, each individual layer consisting of suitable materials, such as metal, preferably aluminum, polymers, or textile fabrics. Depending on their respective purpose the individual layers may be self-adhesive or also repellent to adhesives, permeable or also impermeable to activ

REFERENCES:
patent: 5492590 (1996-02-01), Sakai
patent: 5681413 (1997-10-01), Hille et al.

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