Active substance-containing patch

Details Active substance-containing patch Active substance-containing patch

1996-08-05

1998-06-23

Phelan, D. Gabrielle

Drug, bio-affecting and body treating compositions

Preparations characterized by special physical form

Web, sheet or filament bases; compositions of bandages; or...

424449, A61F 1302

Patent

active

057702209

DESCRIPTION:

BRIEF SUMMARY
This application is a 371 of PCT/EP94/03866, filled Nov. 23, 1994.


SPECIFICATION

The present invention relates to an active substance-containing patch for the controlled release of active substances, comprising an active substance-containing reservoir mass which softens at body temperature. The present invention further relates to a process for its production.


BACKGROUND OF THE INVENTION

Active substance-containing patches of the mentioned kind have been known for some time.
DE 35 03 111 describes a patch comprising drugs in a solid reservoir mass which softens at body temperature and is formed as a disk. The active substance release starts immediately after application.
Another patch of this kind is described in DE 35 22 060, here a reservoir mass disk is fixed to an elastic plastic disk having the same diameter. The two connected parts are present in a housing that can be fixed to the skin and which is closed on the side away from the skin but open towards the skin surface. The elastic plastic disk exerts constant pressure on the reservoir layer. In this case again, the active substance release starts immediately after application.
However, it is not always desirable that the active substance release sets in immediately after application of the patch. For instance, there may be the medical demand to manufacture a patch wherein the onset of active substance release begins after a defined period from application. This ensures that only part of the wearing period of the patch is available for active substance release. If the patch is changed daily, there are phases without any active substance release alternating with those wherein active substance is delivered to the body. A patch of this kind has not yet been known in the art.


DESCRIPTION OF THE INVENTION

It is accordingly the object of the present invention to provide an active substance-containing patch with an active substance-containing reservoir mass softening at body temperature, which releases the active substance only after a predetermined period from application.
Most surprisingly, it has been found that this object is achieved by the fact that the reservoir layer, which softens at body temperature, is spaced away from a controlling membrane by means of a device made of a material which is impermeable to the active substance and which extends over the complete, mutually facing surfaces of the reservoir and the membrane and has at least one passage for the reservoir layer which softens at body temperature.
Accordingly, the active substance-containing patch for the controlled release of active substances consists of a backing layer, an adjoining reservoir layer softening at body temperature and comprising active substances, a membrane controlling the active substance release, a pressure sensitive adhesive device permitting fixation of the patch to the skin, and a removable protective layer, wherein the reservoir layer softening at body temperature is spaced away from the controlling membrane by means of a device formed according to the present invention and made of a material which is impermeable to the active substance. the active substance. It softens after application and thereby makes it possible for the active substance to pass through the device for adjusting the distance to the membrane.
The device for adjusting the distance provides a space between reservoir layer and membrane and thereby prevents their premature contact. This prevents the active substance from reaching the membrane undesirably rapidly or spontaneously, which would cause the onset of active substance release.
The membrane has the function of controlling the active substance release and of ensuring zero-order release.
The device for regulating the distance extends over the whole, mutually facing surfaces of the reservoir and the membrane. It is provided with at least one opening for the reservoir content softening at body temperature and may consist of both a coherent body or component parts not contacting one another.
In this connection, care must be taken that at

REFERENCES:
patent: 3598122 (1971-08-01), Zaffaroni
patent: 4877618 (1989-10-01), Reed, Jr.
patent: 4911707 (1990-03-01), Heiber
patent: 4983395 (1991-01-01), Chang
patent: 5008110 (1991-04-01), Benecke
patent: 5314694 (1994-05-01), Gale

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