Plaster for the treatment of nail mycoses

Details Plaster for the treatment of nail mycoses Plaster for the treatment of nail mycoses

1996-05-06

1998-05-19

Weddington, Kevin E.

Drug, bio-affecting and body treating compositions

Preparations characterized by special physical form

Web, sheet or filament bases; compositions of bandages; or...

424449, 5142238, 514397, 514481, 514599, 514652, A61K 970

Patent

active

057532567

DESCRIPTION:

BRIEF SUMMARY
The invention relates to a plaster for the treatment of nail mycoses.
Fungal diseases of the nails are a widespread phenomenon. Indications are found in the specialist medical literature that 8% of the population suffer from them. The fact that there is a relatively high risk of infection in a damp environment (for example in swimming baths or when wearing shoes or protective gloves) plays a part here. This is a disease which only clears poorly and needs treatment.
As methods of treatment, there is the possibility of detaching the affected nail after appropriate pretreatment, which, however, is refused by many affected persons because of the unpleasantness associated with it. Additionally, modern antimycotics have recently been developed which act on fungal diseases of the nail even after oral administration. However, the treatment must be carried out over a long period of a few months, side effects occurring during the oral treatment since the whole body comes into contact with the medicament. The result is that the patient terminates the therapy and thus the fungal disorder does not clear.
Solutions and even nail varnish have been developed which contain antifungal active compounds to be released only locally at the sites of the disorder, and which thus do not have the side effects of oral therapy. However, the fungal population is in the nail bed under the nail plate (cf. Charlet, Kosmetik fur Apotheker, Wissenschaftliche Verlagsgesellschaft mbH, Stuttgart 1989), which the active compound must first get through. Solutions are washed off too rapidly, for example when washing or showering, and even a nail varnish cannot absorb sufficient active compound and permeation promoters or enhancers, i.e. substances which channel the active compound through the nail to the site of the fungal disorder. In this respect, an effective local treatment has been a problem until now.
According to the invention, a plaster for the treatment of nail mycoses is now proposed which is characterized by an antimycotically active substance (active compound), clotrimazole and bifonazole being excluded.
Preferred embodiments are clear from the sub-claims.
What is concerned here is a plaster containing an antimycotic, which is stuck onto the affected nail. The antifungal active compound can be embedded for this purpose in a polymer matrix which consists, for example, of an acrylate copolymer. Substances can furthermore be embedded in the matrix which can bring the active compound out of the matrix and/or through the nail, i.e. so-called permeation promoters or enhancers which especially affect protein-rich barriers of the nails, for example the keratin.
Moreover, additives can be added, for example Aerosil or crosslinkers customary for an acrylate copolymer, which regulate the adhesive properties. The system is thus single-layered, which simplifies the production process. The matrix can be provided with a covering film in order that no adverse effects takes place when wearing it as a result of the adhesive properties of the matrix, and the matrix with the substances contained in it is not removed when washing.
A further advantage of the plaster according to the invention is to be seen in the possibility of embedding sufficiently large amounts of active compound in the matrix in order to maintain the flow of the active compound through the nail for a long time, which is a property which is important for fungal control.
A plaster according to the invention can contain 1.1 to 1.7 mg of active compound per cm.sup.2, so as a rule a dose of 3 to 6 mg is applied to the nail, depending on individual size. The plaster according to the invention can in this case be designed such that the plaster can remain on the nail for several days, which favours patient compliance and lowers the treatment costs.
In the production of a plaster according to the invention, particular attention is paid to the selection of the polymers, the permeation promoters, the adhesive properties and the covering film. The polymers should absorb an adequate amount of the

REFERENCES:
patent: 5176916 (1993-01-01), Yamanaka et al.
patent: 5264206 (1993-11-01), Bohn et al.
patent: 5415903 (1995-05-01), Hoffman et al.
patent: 5446070 (1995-08-01), Mantelle
patent: 5464610 (1995-11-01), Hayes, Jr. et al.

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