Compositions and methods for treating diseases of the nail

• US 10,512,640 B2
• Filed: 12/20/2017
• Issued: 12/24/2019
• Est. Priority Date: 01/03/2008
• Status: Active Grant

• Current Assignee: Bausch Health Ireland Limited (Bausch Health Cos., Inc.)
• Original Assignee: Dow Pharmaceutical Sciences Incorporated (Bausch Health Cos., Inc.)
• Inventors: Winckle, Gareth, Fieldson, Gregory T.
• Primary Examiner(s): Stevens, Mark V
• Application Number:
  US15/849,414
• Publication Number:
  US 20180117028A1
• Time in Patent Office: 734 Days
• 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 31/454 containing a five-membered ring with nitrogen as a ring hetero atom, e.g. pimozide, domperidone
• CPC Class Codes: A61K 47/10 Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
• CPC Class Codes: A61K 47/14 Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
• CPC Class Codes: A61K 47/24 containing atoms other than carbon, hydrogen, oxygen, halogen, nitrogen or sulfur, e.g. cyclomethicone or phospholipids
• CPC Class Codes: A61K 8/34 Alcohols
• CPC Class Codes: A61K 8/496 Triazoles or their condensed derivatives, e.g. benzotriazoles
• 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: A61P 17/00 Drugs for dermatological disorders
• CPC Class Codes: A61P 17/06 Antipsoriatics
• CPC Class Codes: A61P 31/04 Antibacterial agents
• CPC Class Codes: A61P 31/10 Antimycotics

Abstract

Methods and compositions for treating disorders of the nail and nail bed. Such compositions contain a vehicle in which all components of the composition are dissolved, suspended, dispersed, or emulsified, a non-volatile solvent, a wetting agent, and a pharmaceutically active ingredient that is soluble in the non-volatile solvent and/or a mixture of the vehicle and the non-volatile solvent, and which composition is effective in treating a disorder of the nail or nail bed.

Claims

1. A method for the treatment of onychomycosis comprising topically applying to the surface of the nail of an individual suffering from onychomycosis a pharmaceutical composition comprising ethanol, diisopropyl adipate, C12-15 alkyl lactate, cyclomethicone, and a triazole antifungal agent;

wherein the composition is formulated as a solution;

wherein the ethanol is present in the composition at a concentration of at least 50% w/w;

wherein the cyclomethicone is present in the composition at a concentration between 10% and 15% w/w;

wherein the diisopropyl adipate is present in the composition at a concentration between 8% and 15% w/w;

wherein the C12-15 alkyl lactate is present in the composition at a concentration between 8% and 15% w/w;

wherein the composition does not comprise a polymeric film forming compound; and

wherein the application of the composition is in an amount and for a time sufficient to ameliorate the symptoms of the onychomycosis.

2. The method of claim 1, wherein the triazole antifungal agent is (2R,3R)-2-(2,4-difluorophenyl)-3-(4-methylenepiperidine-1-yl)-1-(1H-1,2,4-triazole-1-yl)butane-2-ol.

3. The method of claim 1, wherein the concentration of the triazole antifungal agent is between 2% and 15%.

4. The method of claim 1, wherein the concentration of ethanol is at least 80% w/w.

5. The method of claim 1, wherein the pharmaceutical composition is applied once daily.