Reservoir which can be impregnated with a solution of active pri

Details Reservoir which can be impregnated with a solution of active pri Reservoir which can be impregnated with a solution of active pri

1996-02-26

1998-02-17

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...

424448, 424489, 604 20, A61F 1300

Patent

active

057189137

DESCRIPTION:

BRIEF SUMMARY
The present invention relates to a reservoir which can be impregnated with a solution of active principle in order to be used in an iontophoretic device for transdermal delivery of medicinal products and, more particularly, to such a reservoir loaded with a divided material which can be impregnated with this solution. A further object of the present invention is to provide a method of manufacture of such a reservoir.
Transdermal delivery of medicinal products assisted by iontophoresis is a technique which is currently well known, which has formed the subject matter of numerous publications such as, for example, European Patent Application No. 409067 and International Patent Application WO 92/10235, to which reference may be made for further details concerning the essential characteristics of this medical technique.
This technique consists in applying against the skin of a patient a reservoir of an active principle in solution and in forcing passage through the skin of an ionized form of this active principle, by the action of a suitably oriented electric field. In order to do this, a plane electrode is plated onto the reservoir and an electrical potential difference is set up between this electrode and a neighbouring electrode, optionally plated directly onto the skin of the patient. The electrode plated on top of the reservoir is polarized so as to expel the ions of the active principle under the skin of the patient so they pass into the vascular system of this patient.
In the current state of the art, the reservoir commonly consists of a hydrogel which can be impregnated with the solution of active principle. It is not permanently loaded with this solution. It is actually kept in the "dry" state in order to avoid problems of stability, for example those resulting from contamination and/or incompatibility of materials, and it is impregnated with the solution immediately before use.
For convenience of this use, it is then necessary for impregnation of the hydrogel contained in the reservoir to take place rapidly, in a time period of the order of one minute, for example. Impregnation of the hydrogel should also be homogeneous and complete.
The precise object of the invention is to produce such a reservoir, exhibiting rapid, complete and homogeneous loading.
A further object of the present invention is to provide a method of manufacture of such a reservoir which can be exploited industrially, that is to say a method which can provide a large production volume at a manufacturing cost price which is limited to the greatest possible extent.
The object of the invention, as well as others which will emerge on reading the following description, are achieved with a reservoir loaded with a divided material which can be impregnated with a solution of active principle, which is noteworthy in that it comprises a) a support sheet made of a cavitied material which is permeable to the solution and capable of contributing to the mechanical strength of the reservoir, b) a layer of particles of the impregnatable material, and c) a substrative layer interposed between one face of the support sheet and the layer of particles in order to hold the latter on the support sheet, this substrative layer consisting of a substance which is miscible with the solution of active principle.
The use of such an impregnatable particulate material makes it possible to provide a large area for absorption of the solution of active principle, which accelerates impregnation of the reservoir. The thickness of the layer of particles is preferably of the order of magnitude of the mean size of these particles, which ensures rapid and homogeneous spreading of the solution in the reservoir. Miscibility of the substrative layer with the solution of active principle which is to impregnate the reservoir ensures electrical continuity between this reservoir and an electrode designed to receive it.
In order to be fixed on such an electrode belonging to an iontophoretic device for transdermal delivery of medicinal products, the reservoir may be lined with a do

REFERENCES:
patent: 4474570 (1984-10-01), Auria
patent: 4777954 (1988-10-01), Keusch
patent: 4989607 (1991-02-01), Keusch
patent: 5069908 (1991-12-01), Henley
patent: 5162043 (1992-11-01), Lew
patent: 5306504 (1994-04-01), Lorenz
patent: 5338490 (1994-08-01), Dietz

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