Films based on copolymers, their applications in transdermal sys

Details Films based on copolymers, their applications in transdermal sys Films based on copolymers, their applications in transdermal sys

1994-10-27

1996-09-17

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...

424449, A61F 1300

Patent

active

055566359

DESCRIPTION:

BRIEF SUMMARY
FIELD OF THE INVENTION

The present invention relates to films based on copolymers which are capable of being used as active principle matrices in transdermal systems, to transdermal systems containing the said films and to the process for the preparation of the said films and copolymers.


DISCUSSION OF THE BACKGROUND

Transdermal administration can, in certain cases, be a favourable administration route for medicaments; in fact, such a route makes it possible to optimize the systemic effect or topical effect, to increase the therapeutic effectiveness, to reduce undesirable effects and to avoid, in the case of a systemic action, the effect of a first passage through the liver.
Transdermal systems are generally forms intended to make possible the passage of active principles, incorporated in a reservoir, through the skin, either in order to have a systemic action or in order to obtain a more local action, by fixation in the underlying tissues of the skin.
Such systems can take essentially two forms: adhesive semi-permeable membrane placed against the skin and which controls the release and the passage of the active principle towards the skin; in this case, the membrane controls the release of the active principles and therefore, in the case of a systemic action, their blood concentration. adhesive, which controls the release towards the skin of the active principle; this form contains two variants: (1) either the polymeric matrix consists of an adhesive, with responsibility for attaching the system to the skin, which acts as reservoir, (2) or the polymeric matrix and the adhesive are separate and only the polymeric matrix acts as reservoir and controls the release of the active principle, the only function of the adhesive being to hold the system onto the skin without hindering the passage of the active principle.
The rate of release is thus controlled either by the membrane placed between the reservoir and the skin or by the reservoir itself (generally then known as matrix).
Taking into account the above, many factors must be considered in developing a transdermal system.
It is, in particular, important to have available a reservoir which makes possible a steady release of the active principle, providing a constant blood concentration or a sufficient concentration in the underlying tissues, for a sufficiently long period of time (several days), so as to avoid excessively frequent applications of such systems.
Many systems have been proposed in the prior art and recommend particularly the presence of a membrane which controls the release of the active principles and thus, in particular, their blood concentration.
In the case where the skin is not sufficiently permeable to the active principle, permeability stimulators are combined with said active principles.
Application EP 399 765, on behalf of Advanced Polymer Systems Inc., describes particularly a transdermal system including an impermeable support and a matrix, made of appropriate adhesive material such as a polyisobutylene or an acrylic, and which includes a plurality of polymeric particles; these polymeric particles include at least one penetration stimulator (or permeability stimulator), whereas the active principle to be administered can be present either in the solid form or in the liquid form in the said matrix or in the said polymeric particles.
It is specified that the choice of the matrix and of the permeability stimulator are related to the active principle; in particular, when the active principle is levonorgestrel, the matrix, which must be both a reservoir for active principles and for polymeric particles, is EVA and the stimulator is an ethyl acetate/ethanol mixture and is included in the said polymeric particles, which can be prepared from unsaturated monoethylenic monomers (acrylic or methacrylic acid esters).
International Application WO 90/07940, on behalf of Noven Pharmaceuticals Inc., describes a transdermal system which comprises an adhesive layer which includes the active principle and an impermeable support.
The adhesive layer is

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