Anti fungal treatment of nails

• US 6,042,845 A
• Filed: 09/02/1997
• Issued: 03/28/2000
• Est. Priority Date: 12/22/1994
• Status: Expired due to Fees

• Current Assignee: Johnson and Johnson Consumer Products Inc (Johnson & Johnson)
• Original Assignee: Johnson and Johnson Consumer Products Inc (Johnson & Johnson)
• Inventors: Kimbleton, Elizabeth S., Sun, Ying, Liu, Jue-Chen, Wang, Jonas C. T.
• Primary Examiner(s): BARTS, SAMUEL A
• Application Number:
  US08/922,041
• Time in Patent Office: 938 Days
• Field of Search: 514/252, 514/562, 514/588, 514/946, 514/947, 514/953, 514/399, 424/446, 424/447, 424/448
• US Class Current: 424/446
• CPC Class Codes: A61F 13/105 for the fingers; Finger-stalls; Nail-protectors devices for correcting deformities of the nails A61F5/11
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/13 Amines A61K31/04 takes precedence
• CPC Class Codes: A61K 31/135 having aromatic rings , e.g. ketamine, nortriptyline methadone A61K31/137
• CPC Class Codes: A61K 31/17 having the group >N—C(O)—N< or >N—C(S)—N<, e.g. urea, thiourea, carmustine isoureas, isothioureas A61K31/155; sulfonylureas A61K31/64
• CPC Class Codes: A61K 31/195 having an amino group
• CPC Class Codes: A61K 31/215 of carboxylic acids
• CPC Class Codes: A61K 31/41 having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
• CPC Class Codes: A61K 31/415 1,2-Diazoles
• CPC Class Codes: A61K 31/44 Non condensed pyridines; Hydrogenated derivatives thereof
• CPC Class Codes: A61K 31/495 having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazinesA61K31/48 takes precedence ; with three nitrogen atoms A61K31/53
• CPC Class Codes: A61K 47/18 Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
• CPC Class Codes: A61K 47/183 Amino acids, e.g. glycine, EDTA or aspartame
• CPC Class Codes: A61K 47/20 containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
• CPC Class Codes: A61K 8/447 containing sulfur
• CPC Class Codes: A61K 8/4946 Imidazoles or their condensed derivatives, e.g. benzimidazoles
• CPC Class Codes: A61K 9/0014 Skin, i.e. galenical aspects of topical compositions non-active ingredients are additionally classified in A61K47/00; A61K9/0009, A61K9/0021, A61K9/7015, A61K9/7023 take precedence; cosmetic preparations A61K8/00, A61Q; preparations for wound dressings or bandages A61L26/00
• CPC Class Codes: A61K 9/703 characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches
• CPC Class Codes: A61K 9/7084 Transdermal patches having a drug layer or reservoir, and one or more separate drug-free skin-adhesive layers, e.g. between drug reservoir and skin, or surrounding the drug reservoir; Liquid-filled reservoir patches
• CPC Class Codes: A61P 17/00 Drugs for dermatological disorders
• CPC Class Codes: A61Q 3/00 : Manicure or pedicure preparations

Abstract

There is disclosed a method for the treatment of fungal diseases in nails, which comprises the topical administration to the nail and, if desired, also to the surrounding skin, of (1) a sulfhydryl containing amino acid or a derivative thereof, the pharmaceutically acceptable salts or esters thereof, or stereoisomers thereof, (2) urea, (1) and (2) being administered in an amount sufficient to enhance the permeation of antifungal drugs through nail tissue, either prior to or, preferably, concurrently with the topical administration to the nail of (3) an effective amount of an antifungal drug. There is also disclosed a bandage adapted for the topical administration of medication to the nail, said bandage comprising a T-shaped adhesive backing, and a flexible pad having an impervious backing and a nail-shaped cavity backed by said impervious backing, wherein said nail-shaped cavity contains absorptive means having absorbed therein urea and a sulfhydryl containing amino acid or a derivative thereof, a pharmaceutically acceptable salt or ester thereof, or a stereoisomer thereof.

Claims

1. A method for the treatment of fungal diseases in nails, which comprises the topical administration to the affected nail, or to the affected nail and surrounding skin:

(1) a compound represented by Formula (I);

##STR10## and (2) an effective amount of an antifungal drug is selected from the group consisting of itraconazole, pharmaceutically acceptable salts thereof and stereoisomers thereof, (1) being administered in an amount sufficient to enhance the permeation of said antifungal drug through nail tissue, and (1) and (2) being administered either prior to or concurrently with the topical administration to the nail of said antifungal drug and the composition is substantially free of urea.

2. The method of claim 1 wherein the N-acetyl-1-cysteine and antifungal drug are administered to the nail under occlusive conditions.

3. A bandage adapted for the topical administration of medication to the nail, said bandage comprising a T-shaped adhesive backing, and a flexible pad having an impervious backing and a nail-shaped cavity backed by said impervious backing, wherein said nail-shaped cavity contains absorptive means having absorbed therein N-acetyl-1-cysteine and an antifungal drug selected from the group consisting of itraconazole, pharmaceutically-acceptable salts of itraconazole and stereoisomers of itraconazole.

4. A composition comprising N-acetyl-1-cysteine, an antifungal drug selected from the group consisting of itraconazole, pharmaceutically-acceptable salts of itraconazole and stereoisomers of itraconazole, said N-acetyl-1-cysteine and said antifungal drug being present in an amount sufficient to enhance the permeation of said antifungal drug through nail tissue and said composition being substantially free of urea.

5. A composition according to claim 4 wherein said composition contains propylene carbonate and propylene glycol.