Ionophoretic device for transdermal administration of medicament

Details Ionophoretic device for transdermal administration of medicament Ionophoretic device for transdermal administration of medicament

1997-05-12

1999-11-09

Stright, Ronald

Surgery

Means for introducing or removing material from body for...

Infrared, visible light, ultraviolet, x-ray or electrical...

607149, A61N 130, A61N 100

Patent

active

059831324

DESCRIPTION:

BRIEF SUMMARY
The present invention relates to an iontophoretic device for transdermal delivery of medicinal products and, more particularly, to such a device comprising a reservoir for an active principle in ionized form, having two substantially parallel faces, first and second electrodes in electrical contact with a face of the reservoir and the skin of the patient, respectively, the other face of the reservoir being intended to be applied onto a region of the skin of the patient which lies away from the region on which the second electrode bears, and means for selectively passing an electric current between these electrodes, in order to assist the passage of a flow of the active principle under the skin of the patient. The present invention also relates to a disposable assembly forming part of such a device.
FIG. 1 of the attached drawing diagrammatically represents an iontophoretic device for transdermal delivery of medicinal products comprising, in a known manner, first and second electrodes 1, 2 respectively, at least one of these electrodes (the first in the figure) being attached to a reservoir 3 for a solution containing an active principle in ionized form. By way of example, this reservoir 3 may consist of a layer of hydrogel impregnated with the solution of active principle.
The two electrodes and the reservoir may be incorporated in a disposable assembly 4 designed to be detachably combined with an electronic module 5. The device consisting of the disposable assembly and the electronic module is designed to be fixed on a limb of a patient so that the reservoir 3 is applied onto the skin 6 of this patient, like the electrode 2, on a region of the skin which is adjacent to the region which receives the reservoir. As represented, a layer 7 of a product for protecting the skin of the patient, such as an electrically conducting hydrogel, may be formed on the electrode 2 in order to be interposed between this electrode and the skin 6 of the patient.
The electronic module 5 is supplied with electrical energy by batteries 8, preferably placed inside the disposable assembly 4. These batteries thus supply a "therapeutic" current generator 9 and a microprocessor 10 programmed to control this generator.
During use of this device, the reservoir 3 of the assembly 4 is filled with the solution of active principle to be delivered, the assembly 4 is installed on the electronic module 5 and they are fixed on a limb of the patient, for example with the aid of a strap, so that the reservoir 3 and the hydrogel 7 are applied against the skin 6 of the patient. Supply of the generator 9 and of the microprocessor 10 by the batteries 8 is then activated so that this microprocessor causes an electric current to be set up between the electrodes 1, 2, under the skin of the patient, the polarity of the current being chosen so that the ions of the active principle pass under the skin of the patient, from the reservoir 3, by flowing down the electric field thus set up.
It will be understood that it is then possible to programme the microprocessor 10 so that it selectively controls the setting up of the current between the electrodes and the strength of this current. Thus, in a known manner, a current is caused, for example, to flow for one hour, then this current is cut off for the following two hours before subsequently being reapplied, etc. according to a time programme thus spreading over six hours or more. The cut-offs of the current are used, in particular, to ensure "depolarization" as well as physiological rest of the skin of the patient, so as to limit its denaturing, which denaturing causes detrimental effects to its characteristics of permeability to the active principle.
It is observed that, during the periods in which the "therapeutic" current is cut off, active principle continues to pass under the skin of the patient, without it being possible to control the "passive" flow of active principle which is then set up. This is an osmotic flow due to the concentration gradient of the active principle which is present at the interf

REFERENCES:
patent: 5006108 (1991-04-01), LaPrade
patent: 5013293 (1991-05-01), Sibalis
patent: 5246417 (1993-09-01), Haak et al.

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