Active ingredient patch for low-melting and/or volatile active i

Details Active ingredient patch for low-melting and/or volatile active i Active ingredient patch for low-melting and/or volatile active i

1995-02-27

1996-06-18

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

055275362

DESCRIPTION:

BRIEF SUMMARY
This application is a 371 of PCT/DE93/00638, filed Jul. 17, 1993.


DESCRIPTION

The present invention is concerned with an active ingredient patch for controlled topical or transdermal release of volatile active ingredients, consisting of a backing layer or carrier layer and a reservoir layer bonded to it, which consists of an SEBS three-block copolymer which serves at the same time as adhesive layer and control layer for the release of the active ingredient, and method for the production of this active ingredient patch from the melt. The skin patch is covered with a protective film, which is removed by peeling it off from the reservoir layer before the use of the patch, that is, before application of the patch on the skin.
Active ingredient patches, which permit controlled release of the active ingredient(s) into the skin are already known from the literature. Embodiments of such patches, in which the active ingredient is dissolved or dispersed homogeneously in a thin contact (pressure-sensitive) adhesive layer and is liberated from it in a diffusion-controlled manner, are transdermal or topical systems of simple design, suitable in principle for mass production.
However, in practice, the development and/or production of such active ingredient patch always has disadvantages, of which are described below, and as a result, it is correspondingly expensive:
The adhesive properties of the reservoir layer cannot be adjusted optimally at high active ingredient contents, so that the patch must have an additional adhesive layer in order to achieve good adhesion on the skin surface during use and to permit complete painless removal of the patch from the skin after use.
The reservoir must have a multilayer structure in order to be able to incorporate sufficient amounts of active ingredient into the patch and/or additional depots are to be provided which are separated spatially and functionally from the adhesive layer.
An additional control layer is necessary in order to ensure controlled, continuous liberation of the active ingredient over long application time periods and/or at least to limit skin irritation and/or systemic side effects at a given active ingredient release rate per unit time.
The contact adhesive reservoir layer is prepared from solution, so that there is the problem of elimination of solvent residues and the related evaporation of volatile active ingredients. The use of solvents in the production of active-ingredient-containing contact adhesive layers is disadvantageous for several reasons. The preparation of the solution requires at least one technologically expensive process step. For medical purposes, highly pure and thus expensive solvents must be used for the dissolution of the adhesive or of its starting materials, in order to ensure the corresponding absence of residues in the adhesive reservoir. Another problem is to achieve absence of solvent in the patch itself. Therefore, technically expensive drying sections and aspiration installations are necessary. In addition, recovery and separation of the solvent must be ensured technologically in order to avoid environmental pollution; moreover, the combustibility of solvents represents an additional risk. Furthermore, most organic solvents are damaging to the human organism, so that expensive protective measures must be provided for the personnel involved in manufacture.
Skin patches, among others, for transdermal application of bupranolol, are known from EP 0144486; here, the active ingredient is contained in a reservoir with multistep structure, whereby a multistep active ingredient concentration gradient from the outer reservoir layer that faces the carrier film to the skin is provided as control element for the release of the active ingredient.
U.S. Pat. No. 4,668,232 also describes, among others, an active ingredient patch with .beta.-blockers in which an adhesive reservoir containing bupranolol or propranolol is built up in two partial steps; in this case, water-swellable polymers are added to the reservoir to improve and control its act

REFERENCES:
patent: 4485077 (1984-11-01), Martinez
patent: 4668232 (1987-05-01), Cordes
patent: 4668332 (1987-05-01), Ohnuki et al.
patent: 5032403 (1991-07-01), Sinnreich
patent: 5126144 (1992-06-01), Jaeger
patent: 5354597 (1994-10-01), Capik

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