Drug – bio-affecting and body treating compositions – Manicure or pedicure compositions
Patent
1999-01-11
2000-12-19
Dodson, Shelley A.
Drug, bio-affecting and body treating compositions
Manicure or pedicure compositions
424401, 424405, 424487, 514345, 514506, A61K 704, A61K 700, A61K 914, A01N 2500
Patent
active
061624209
DESCRIPTION:
BRIEF SUMMARY
DESCRIPTION
Fungal diseases of the nails (onychomycoses) belong to the infectious diseases which it has not been possible to treat satisfactorily to date. Although they progress largely painlessly for the patient, the permanent presence of a focus of infection renders treatment absolutely essential. In addition to circulatory disturbances and traumas, possibly predisposing factors for nail fungus infections are also immune defence deficiencies and certain metabolic disturbances (diabetes mellitus). Toenails are preferentially infected, the nails of the big and little toe chiefly being affected.
Analysis of the pathogen spectrum shows that onychomycoses are primarily caused by dermatophytes (for example Trichophyton rubrum), but also by yeasts (for example Candida albicans) or molds (for example Scopulariopsis brevicaulis). Apart from the white, superficial onychomycosis, the majority of infections take place below the body of the nail, in the nail bed or in the region of the matrix. Systemic, local or combined forms of treatment are considered, depending on the clinical appearance and the severity of the infection. Local treatment of the affected nail is the type of treatment which is gentlest for the patient and has the fewest side effects.
One known treatment form is an antimycotic preparation in the form of a nail varnish which comprises at least one antimycotic substance and at least one water-insoluble film-forming agent (EP 0 389 778). The low lateral diffusion in the nail of the antimycotic substances employed has proved to be a disadvantage of this type of formulation, so that only very incomplete effective treatment of the infected nail matrix and the areas of the nail bed lying under the nail wall is possible. Glyceryl triacetate (1,2,3-propanetriyl triacetate; C.sub.9 H.sub.14 O.sub.6) is primarily used as a plasticizer for varnish formulations and for this purpose is also contained in a formulation according to EP 0 389 778. Glyceryl triacetate furthermore has fungistatic properties and is therefore occasionally used, especially in the USA, for treatment of superficial skin fungal diseases, but not for onychomycoses (Martindale "The Extra Pharmacopoeia", 30th Edition 1993; Roche Lexikon Medizin [Roche Dictionary of Medicine] 3rd Edition, 1993)
It has now been found that glyceryl triacetate is out-standingly suitable for treatment of onychomycoses because it shows good lateral diffusion through the nail and therefore allows treatment and prophylaxis of the nail matrix infected by dermatophytes and of the areas of the nail bed lying under the nail wall.
The invention therefore relates to the use of glyceryl triacetate for the preparation of a medicament for treatment and prophylaxis of onychomycoses.
A thorough cure can be achieved with the medicament according to the invention, especially in treatments of mycoses of the nail matrix, the nail usually growing again without deformation because growth of the dermatophytes in the nail root is prevented. In view of the poor treatment results to date, this is an extremely important finding.
The medicament according to the invention is also suitable for prophylactic use against nail mycoses, a sufficiently high depot of active compound being achieve in the nail, so that no outbreak of a nail disease caused by fungi occurs in the event of fungal contamination. The content of glyceryl triacetate in the medicament according to the invention is in general 0.1 to 25% by weight (wt. %), preferably 2 to 10 wt. %. The minimum content of glyceryl triacetate in the medicament is at least 0.1 to 1 wt. %; the medicament used for prophylaxis comprises less than 2 and advantageously at least 1 wt. % of glyceryl triacetate.
The invention furthermore relates to an antimycotic nail varnish comprising glyceryl triacetate and a water-insoluble film-forming agent.
The nail varnish according to the invention, i.e. the formulation comprising solvents, in general comprises glyceryl triacetate in an amount of 1 to 25 wt. %, preferably 2 to 10 wt. %, based on the amount of vol
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Martindale The Extra Pharmacopoeia 30th Ed., London The Pharmaceutical Press 1993, pp. 332, 1609.
Montana, et al., Cutis, 53:313-316 (1994), "A Double-Blind, Vehicle-Controlled Study of the Safety and Efficacy of Fungoid Tincture.RTM. in Patients with Distal Subungual Onychmycosis of the Toes".
Bohn Manfred
Kraemer Karl Theodor
Markus Astrid
Dodson Shelley A.
Hoechst Aktiengesellschaft
Lamm Marina
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