FR2663035A1 - Process for incorporating an active principle into a membrane and products thus obtained - Google Patents

Abstract

Process for the manufacture of an elastomer-based membrane incorporating an active principle, consisting in depositing on a solid support a layer of coagulant in solution, a layer of elastomer in solution and optionally an additional layer. The process according to the invention is characterised in that the active principle is incorporated essentially into the solution of coagulant and/or into the solution forming the additional layer. Application to gloves and condoms.

Description

Process for incorporating an active principle into a membrane and products thus obtained.

The present invention relates to a method of manufacturing an elastomer-based membrane in which an active principle is incorporated. The invention also relates, by way of new industrial products, to the articles obtained by implementing the method such as gloves, condoms, masks or other hygiene and / or protective products.

There are many products such as protective gloves, condoms, masks or others, for which it is necessary to combine, during their use, an active anti-viral and / or anti-mycotic and / or bactericidal and / or bacteriostatic, so as to reduce the risk of contamination by contact and to protect the skin surfaces or mucous membranes. To address this problem, compositions have been developed which are coated on the surface of the product coming into contact with the skin surface or the mucous membrane to be protected. However, coating has well-known drawbacks such as its lack of reliability and efficiency and its unsuitability for certain applications.

There are also devices for the release of active principle, in particular of medicinal active principles, which comprise a reservoir or an internal support integrating the active principle and a semi-permeable membrane or capsule which allows the active principle to diffuse at constant speed or not. These devices, an example of which is provided by patent FR-A-2,113,778 most of the time require implantation of the device in the body and have a large size.

Other devices consist of a mixture of an excipient and an active principle, the excipient gradually disintegrating over time, thus causing a release of the active principle.

Also known according to patent FR-A-87.0 # 615 is a device in which an active principle is incorporated into the solid membrane.

All of these systems have substantially the same disadvantages.

Most of them reduce the contact sensitivity which is necessary, especially when working on very thin membranes. They do not allow to favor a direction of diffusion.

The present invention therefore aims to overcome these drawbacks by proposing a method for manufacturing an elastomer-based membrane incorporating an active product in which the direction of diffusion of the active principle is predetermined at the time of manufacture.

Another object of the present invention is to develop a method which allows the diffusion of an active principle from a single membrane without the latter disintegrating over time.

Another object of the present invention is to provide a method for incorporating an active principle into a membrane intended to constitute a glove or a preservative without modifying the pre-existing production lines.

The present invention relates for this purpose to a method of manufacturing an elastomer-based membrane incorporating an active principle, consisting in depositing on a solid support a layer of coagulant in solution, a layer of Erastomer in solution, and optionally a additional layer, characterized in that the active principle is integrated essentially in the coagulant solution and / or in the solution constituting the additional layer.

This superposition of layers which are dried once they have been deposited makes it possible to direct the diffusion of the active principle in a predetermined direction. Indeed, if the layer placed first on the support is a layer incorporating the active principle and if the support corresponds to the surface to be protected, the active principle will diffuse very quickly towards the surface to be protected once the support has been removed when the membrane is in contact with a wet environment because the layers placed on top of this layer will delay or even prevent diffusion in another direction if the combination of layers has been chosen adequately. Conversely, if migration is desired preferably orienting from the surface opposite the surface in contact with the support towards the outside, the layer containing the active principle will be the last to be applied. Starting from this principle, it is also possible to have a diffusion of the active principle on the two surfaces of the membrane, this diffusion being in variable concentration according to the concentration of the solutions applied in layer. Thus, thanks to this process, membranes are obtained in which the incorporated active principle diffuses in a direction and in quantities determined at the time of manufacture.

The arrangement of the check marks being a function of the parameters stipulated above, it is easily understood that a large number of combinations is possible. However, the coagulant-based layer will generally be applied before the elastomer-based layer.

The deposition of the layers on the support can be carried out by any means. However, this deposition will preferably be carried out by spraying or centrifuging the solutions constituting the layers or by soaking the support in baths containing the solutions constituting the layers.

The invention also relates, by way of new industrial products, to the articles obtained by implementing the above manufacturing process.

The invention relates more particularly to gloves or condoms consisting of a membrane incorporating an active principle and obtained by superposition of coagulant-based layers, of elastomer and possibly of other layers, said membrane releasing the active principle on its internal surface. and / or on its external surface in contact with a wet environment.

Other characteristics of the invention will appear further on reading the examples which follow, these examples being given solely by way of indication.

Example 1
A first solution is prepared, consisting of an ethanol / methanol / calcium nitrate mixture, the percentages of each of the elements being respectively 60.30.30% by weight. To this solution is added an active principle, for example a quaternary ammonium, and preferably benzalkonium chloride. The final concentration of this benzalkonium chloride is for example equal to 30% by weight of the total solution. Due to the presence of calcium nitrate, this final solution A constitutes the solution which will coagulate the latex.

 A second solution is prepared consisting of a dispersion of latex B '(60% dry rubber, 40% serum) to which an aqueous solution is added, the concentration of benzalkonium chloride is equal to 1% by weight. The final concentration of benzalkonium chloride is preferably between 0.02 and 0.05% by weight.

A solid support, which is preferably a form, is first of all soaked in solution A for a few tens of seconds and then dried for a few minutes. The form is then soaked in solution B and then dried.

The glove-like membrane is vulcanized. The finished product is then talcée then sterilized.

In this glove, the active principle will tend to diffuse towards the inside of the glove, thus forming a protective film. The quantities broadcast may reach 72% of the total quantity broadcast during the first hour. Over 24 hours, the quantity diffused will be approximately 50% of the total quantity contained in the membrane. As the diffusion is very important during the first hour, this process turns out to be particularly suitable for the manufacture of gloves or condoms.

Example 2
Solutions A, B and B 'prepared in Example 1 are stored and an alkoclic solution C is prepared containing an ethanol / methanol / benzalkonium chloride mixture in proportions 50/30/20.

The form is soaked in solution C for a few tens of seconds, the form is dried, the form is soaked in the solution
B ', the form is dried, the form is dipped in solution A, the form is dried and finally the form is dipped in solution B.

The membrane thus obtained can diffuse its active principle at the same time on the two surfaces of the membrane
The membrane subsequently undergoes vulcanization, talcage and sterilization treatments as described in Example 1.

The invention is not limited to the examples cited above but on the contrary encompasses all possible alternative embodiments.

Claims (13)

1. Method for manufacturing an elastomer-based membrane incorporating an active principle, consisting in depositing on a solid support a layer of coagulant in solution, a layer of elastomer in solution, and optionally an additional layer, characterized in that that the active principle is integrated essentially in the coagulant solution and / or in the solution constituting the additional layer. 2. Method according to claim I, characterized in that drying is carried out after each deposition. 3. Method according to one of claims i and 2, characterized in that the deposition of the solutions on the solid support is carried out by soaking said support. 4. Method according to one of claims 1 to 3, characterized in that the solid support is a form. 5. Method according to one of claims 1 and 2, characterized in that the deposition of the solutions on the solid support is carried out by spraying the solutions on said solid support. 6. Method according to one of claims 1 and 2, characterized in that the deposition of the solutions on the solid support is carried out by centrifugation of the solutions. 7. Method according to one of claims 1 to 6, characterized in that the solution constituting the additional layer is a solvent for the active principle, for example an alcoholic solution consisting of an ethanol / me # hanol mixture or a squous solution . 8. Method according to one of claims 1 to 7, characterized in that the active principle is an anti-viral and / or anti-mycotic and / or contraceptive and / or bactericidal and / or bacteriostatic product, for example a quaternary ammonium , preferably benzalkonium chloride. 9. Method according to one of claims 1 to 7s characterized in that the coagulant is calcium nitrate, preferably in alcoholic solution.  10. Method according to one of claims i to 9, characterized in that the elastomer is a natural elastomer, for example latex. 11. Article, in particular hygiene and / or protection article, characterized in that they comprise a membrane obtained by the manufacturing process according to one of claims 1 to 10 and incorporating an active principle and obtained by superposition of coagulant, elastomer and possibly other layers, said membrane releasing the active ingredient on its internal surface and / or on its external surface in contact with a wet medium. 12. Article according to claim 11, characterized in that it is in the form of a glove. 13. Article according to claim 117 characterized in that it is in the form of a condom.