Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Cosmetic – antiperspirant – dentifrice
Reexamination Certificate
2001-06-19
2004-05-25
Page, Thurman K. (Department: 1615)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Cosmetic, antiperspirant, dentifrice
C424S061000
Reexamination Certificate
active
06740326
ABSTRACT:
FIELD OF THE INVENTION
The present invention is in the field of topically applied nail care compositions, the process of manufacturing such compositions and the methods of using such compositions.
BACKGROUND OF THE INVENTION
The direct topical treatment of nail diseases and the nail care proceed practically free of side-effects, are very simple to carry out and cause only minimal costs. However, the essential problem of the direct topical use of nail compositions consists in carrying the active substances including nutrient and anabolic substances in sufficient amounts through the nail into the deeper situated tissue layers and into the nail root, completely destroying the pathogens present and providing the nail with nutrient and anabolic substances. With conventional products it is possible to ease the symptoms by direct topical treatment; however, in the regular case they reappear after termination of the treatment.
It has already been proposed to improve the results of the treatment with the direct topical use of active substances in that the active substances were used together with a so-called carrier, i.e. a substance which in addition to a good solubility for the active substance also possesses a good penetrability through the nail substance and the ability to transport the active substance through the nail tissue. As an example, EP-A-0 503 988 describes medicaments for the treatment of onychomycoses, which in addition to an antimycotically active substance and an aqueous medium, in which the antimycotic is at least partly soluble, contains at least one hydrophilic substance promoting the penetration of the antimycotic through the nail. In addition to a large number of compounds also lactic acid ethyl ester is mentioned as penetration promoting substance. The formulation principle described in EP-A-0 503 988 is in view of the partial water-solubility postulated for the active substance only useful for a limited number of active substances. In addition, and in view of the water content of the formulation when using hydrolyzable compounds as penetration promoting substances, such as lactic acid ethyl ester, no stable formulations can be prepared according to this principle, since such compounds decompose by hydrolysis during storage.
Up to the present no satisfactory product for topical treatment of nail diseases and for topical nail care exists, which contains a carrier guaranteeing the transport of the amount of active substance through the nail into the deeper situated nail bed and to the nail root (matrix) required for a long-term treatment result.
It is therefore the task of the present invention to solve the problems connected with the topical treatment of nail diseases and the topical nail care and to provide pharmaceutical and cosmetic products which enable a long-term treatment result.
SUMMARY OF THE INVENTION
According to the present invention water-free topical application products for the treatment of nail diseases and nail care are proposed, which have the following composition:
a) one or more active substances
b) one or more C
1
-C
4
-alkyl esters of lactic acid, malic acid, tartaric acid or citric acid as carrier and
c) optionally physiologically compatible adjuvants.
In an embodiment, the topical application product is characterized in that it contains an ethyl ester of lactic acid, malic acid, tartaric acid or citric acid as carrier.
In another embodiment, the topical application product is characterized in that it contains an isopropyl ester of lactic acid, malic acid, tartaric acid or citric acid as carrier.
In an embodiment, the topical application product is characterized in that it contains lactic acid ethyl ester as carrier.
In another embodiment, the topical application product is characterized in that it contains malic acid diisopropylester as carrier.
In one embodiment, the topical application product is characterized by a content of one or more active substances selected from the group consisting of antimycotics of synthetic or natural origin, antibiotics, antiseptics, corticosteroids and nutrient and anabolic substances.
In another embodiment, the topical application product is characterized by a content of one or more antimycotic active substances selected from the group consisting of (±)-cis-2,6-dimethyl-4-[2-methyl-3-(p-tert-pentyl phenyl)propyl]morpholine (amorolfin), amphotericin, 6-cyclohexyl-1-hydroxy-4-methyl-2(1H)pyridinone (ciclopirox), bis-phenyl-(2-chlorophenyl)-1-imidazolylmethane (clotrimazol), 1-[2-(2,4-dichlorophenyl)-2-(4-chlorobenzyloxy)ethyl-1-imidazole (econazol), 2,4-difluoro-&agr;,&agr;-bis(1H-1,2,4-triazol-1-ylmethyl)benzylalcohol (fluconazol), 5-fluorocytosine (flucytosin), 7-chloro-trimethoxy-methylspiro-[benzofuran-cyclohexenp]dione-(griseofulvin), 1-[2,4-dichloro-&bgr;-(2,6-dichlorobenzyloxy)phenethyl]-imidazole (isoconazol), (±)-1-sec-butyl-4-{4-[4-(4-{[2R*, 4S*)-2-(2,4-dichlorophenyl)-2-(1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy}phenyl)-1-piperazinyl]phenyl}-4,5-dihydro-1,2,4-triazol-5-one (itraconazol), (±)-cis-1-acetyl-4-{4-([2-(2,4-dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy)phenyl}piperazine (ketoconazol), 1-[2,4-dichloro-&bgr;-(2,4-dichlorobenzyloxyl)-phenethyl]-imidazole(miconazol), (E)-N-cinnamyl-N-methyl-1-naphthylmethylamine (naftifin), nystatin, (E)-N-(6,6-dimethyl-2-hepten-4-ynyl)-N-methyl-1-naphthylmethylamine (terbinafin), 1[2-{(2-chloro-3-thienyl)methoxy}-2(2,4dichlorophenyl)ethyl]-1H-imidazole (tioconazol), O-2-naphthyl-N-methylN(3-tolyl)-thiocarbamate (tolnaftat) and &agr;-(2,4-difluorophenyl)-5-fluoro-&bgr;-methyl-&agr;-(1H-1,2,4-triazol-1-ylmethyl)-4-pyrimidinethanol (voriconazol).
In one embodiment, the topical application product is characterized by a content of one or more antibacterially or antimycotically active substances selected from tea tree oil, lavender oil, thuja oil and leaf extract of the nim tree.
In one embodiment, the topical application product is characterized by a content of one or more antibiotic substances selected from &agr;-amino-4-hydroxybenzylpenicillin (amoxicillin), D-(−)-&agr;-aminobenzylpenicillin (ampicillin), 3,3-dimethyl-7-oxo-6-phenylacetamido-4-thia-1-azabicyclo-[3.2.0]-heptan-2-carboxylic acid (benzylpenicillin), benzylpenicillin-benzathin, 3-chloro-7-D-(2-phenylglycinamido)-cephalosporanic acid (cefaclor), 7&bgr;-[D-2-amino-(4-hydroxyphenyl)-acetylamino]-3-methyl-cephalosporanic acid (cefadroxil), amino-phenylacetamido-methyl-cephalosporanic acid (cefalexin), D(−)-threo-2-dichloroacetamido-1-(4-nitrophenyl)-1,3-propanediol (chloramphenicol), 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(piperazinyl)3-quinolinecarboxylic acid (ciprofloxacin), (Z)-(2R,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]heptan-2-carboxylic acid (clavulanic acid), 7-chloro-7-desoxy-1-lincomycin (clindamycin), 6-desoxy-5-hydroxytetracycline (doxycyclin), 1-ethyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-1,8-naphthyridin-3-carboxylic acid (enoxacin), erythromycin, 3-(2-chloro-6-fluorophenyl)5-methyl-4-isoxazolyl-penicillin (flucloxacillin), kanamycin, lincomycin, 7-dimethylamino-6-desoxy-desmethyltetracycline (minocycline), 6-(2-ethoxy-1-naphthamido)-penicillin (nafcillin), 1-ethyl-1,4-dihydro-7-methyl-4-oxo-1,8-naphthyridin-3-carboxylic acid (nalidixic acid), neomycin, 1-ethyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid (norfioxacin), (±)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de][1,4]benzoxazin-6-carboxylic acid (ofloxacin), 6-(5-methyl-3-phenyl-4-isoxazolcarboxamido)penicillanic acid (oxacillin), 6-phenoxyacetylamino-penicillanic acid (phenoxymethylpenicillin) and 4-dimethylamino-octahydro-pentahydroxy-1,11-dioxo-6-methyl-naphtacene-2-carbamide (tetracyclin).
In another embodiment, the topical application product is characterized by a content of one or more a
Meyer Hans
Wasmer Hermann
BioEqual AG
Channavajjala Lakshmi
LandOfFree
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