US2006153786A1PendingUtilityA1

Compositions and methods for treating conditions of the nail unit

Assignee: TALIMA THERAPEUTICS INCPriority: Dec 10, 2004Filed: Dec 12, 2005Published: Jul 13, 2006
Est. expiryDec 10, 2024(expired)· nominal 20-yr term from priority
A61P 31/00A61P 31/10A61K 31/496A61K 9/06A61K 9/08A61K 31/137A61K 9/7007A61P 17/00A61K 47/34A61K 9/107A61K 9/2063A61K 9/0024A61K 9/0092A61K 9/7015A61K 9/10A61K 31/00A61K 9/2031A61K 45/06A61K 47/38A61K 9/1647A61K 47/36A61K 9/0014A61K 31/7052A61K 31/351A61K 9/2054A61K 9/70A61K 9/0019A61K 31/4184A61K 31/4196A61K 8/49A61K 31/7034
51
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Claims

Abstract

The biodegradable drug delivery systems described here are formulated for implantation into the nail unit and its surrounding tissues for the treatment of various nail unit conditions. The systems include greater than 30% by weight of the active agent, and may be formulated as solutions, solids, semisolids, microparticles, or crystals.

Claims

exact text as granted — not AI-modified
1 . A method for treating a nail unit condition comprising administering locally within a digit having a distal portion, a middle portion, and a proximal portion, a composition comprising greater than 30% by weight of an active agent.  
     
     
         2 . The method of  claim 1  wherein the nail unit condition is a fungal infection.  
     
     
         3 . The method of  claim 2  wherein the fungal infection is onychomycosis.  
     
     
         4 . The method of  claim 1  wherein the composition is administered to the distal portion of the digit.  
     
     
         5 . The method of  claim 1  wherein the distal portion of the digit comprises a nail unit having a nail plate, a nail bed, a nail fold, and a matrix.  
     
     
         6 . The method of  claim 5  wherein the composition is administered to the matrix.  
     
     
         7 . The method of  claim 5  wherein the composition is administered to the nail fold.  
     
     
         8 . The method of  claim 1  wherein the composition is administered to the middle portion of the digit.  
     
     
         9 . The method of  claim 1  wherein the composition is administered to the proximal portion of the digit.  
     
     
         10 . The method of  claim 1  wherein the digit is a finger.  
     
     
         11 . The method of  claim 1  wherein the digit is a toe.  
     
     
         12 . The method of  claim 1  wherein the composition is administered by injection through a conduit.  
     
     
         13 . The method of  claim 12  wherein the conduit comprises a needle.  
     
     
         14 . The method of  claim 13  wherein a portion of the needle is configured to remain in the digit after injection of the composition.  
     
     
         15 . The method of  claim 1  wherein the composition comprises a liquid solution.  
     
     
         16 . The method of  claim 1  wherein the composition comprises a suspension.  
     
     
         17 . The method of  claim 1  wherein the composition comprises an emulsion.  
     
     
         18 . The method of  claim 1  wherein the composition comprises a solid implant.  
     
     
         19 . The method of  claim 1  wherein the composition comprises a semisolid implant.  
     
     
         20 . The method of  claim 19  wherein the semisolid implant comprises a gel.  
     
     
         21 . The method of  claim 19  wherein the semisolid implant comprises a paste.  
     
     
         22 . The method of  claim 1  wherein the active agent is selected from the group consisting of analgesics, anesthetics, anti-infective agents, anti-inflammatory agents, chemotherapeutic agents, other small molecules, and combinations thereof.  
     
     
         23 . The method of  claim 22  wherein the active agent comprises an anti-infective agent.  
     
     
         24 . The method of  claim 23  wherein the anti-infective agent is selected from the group consisting of antibacterial agents, antifungal agents, antiviral agents, and antiseptics.  
     
     
         25 . The method of  claim 24  wherein the active agent comprises an antifungal agent.  
     
     
         26 . The method of  claim 25  wherein the antifungal agent is selected from the group consisting of amorolfine, ciclopirox, flucytosine, griseofulvin, haloprogrin, potassium iodide sodium pyrithione, undecylenic acid, imidazole derivatives, triazole derivatives, allylamines, polyene antifungal antibiotics, antifungal organic acids, and combinations thereof.  
     
     
         27 . The method of  claim 26  wherein the imidazole derivative is selected from the group consisting of bifonazole, butoconazole, clotrimazole, econazole, ketoconazole, miconazole, oxiconazole, and sulconazole.  
     
     
         28 . The method of  claim 26  wherein the triazole derivative is selected from the group consisting of itraconazole, fluconazole, and terconazole.  
     
     
         29 . The method of  claim 26  wherein the allylamine comprises naftifine or terbinafine.  
     
     
         30 . The method of  claim 29  wherein the allylamine comprises terbinafine.  
     
     
         31 . The method of  claim 26  wherein the polyene antifungal antibiotic comprises amphotericin B or nystatin.  
     
     
         32 . The method of  claim 26  wherein the antifungal organic acid is selected from the group consisting of benzoic acid, salicylic acid, propionic acid, and caprylic acid.  
     
     
         33 . The method of  claim 22  wherein the active agent comprises an anti-inflammatory agent.  
     
     
         34 . The method of  claim 33  wherein the anti-inflammatory agent comprises a steroidal or nonsteroidal anti-inflammatory agent.  
     
     
         35 . The method of  claim 22  wherein the active agent comprises a chemotherapeutic agent.  
     
     
         36 . The method of  claim 35  wherein the chemotherapeutic agent is selected from the group consisting of alkaloids, alkylating agents, antineoplastic antibiotics, and antimetabolites.  
     
     
         37 . The method of  claim 1  wherein the active agent comprises a nucleic acid, peptide, or protein.  
     
     
         38 . A drug delivery system comprising a therapeutically effective amount of a composition having greater than 30% by weight of an active agent for local sustained release useful for treating a nail unit condition, wherein the composition is configured for implantation in a nail unit.  
     
     
         39 . The drug delivery system of  claim 38  wherein the nail unit condition is a fungal infection.  
     
     
         40 . The drug delivery system of  claim 39  wherein the fungal infection is onychomycosis.  
     
     
         41 . The drug delivery system of  claim 38  wherein the active agent is selected from the group consisting of analgesics, anesthetics, anti-infective agents, anti-inflammatory agents, chemotherapeutic agents, other small molecules, and combinations thereof.  
     
     
         42 . The drug delivery system of  claim 41  wherein the active agent comprises an anti-infective agent.  
     
     
         43 . The drug delivery system of  claim 42  wherein the anti-infective agent is selected from the group consisting of antibacterial agents, antifungal agents, antiviral agents, and antiseptics.  
     
     
         44 . The drug delivery system of  claim 43  wherein the active agent comprises an antifungal agent.  
     
     
         45 . The drug delivery system of  claim 44  wherein the antifungal agent is selected from the group consisting of amorolfine, ciclopirox, flucytosine, griseofulvin, haloprogrin, potassium iodide sodium pyrithione, undecylenic acid, imidazole derivatives, triazole derivatives, allylamines, polyene antifungal antibiotics, antifungal organic acids, and combinations thereof.  
     
     
         46 . The drug delivery system of  claim 45  wherein the imidazole derivative is selected from the group consisting of bifonazole, butoconazole, clotrimazole, econazole, ketoconazole, miconazole, oxiconazole, and sulconazole.  
     
     
         47 . The drug delivery system of  claim 45  wherein the triazole derivative is selected from the group consisting of itraconazole, fluconazole, and terconazole.  
     
     
         48 . The drug delivery system of  claim 45  wherein the allylamine comprises naftifine or terbinafine.  
     
     
         49 . The drug delivery system of  claim 48  wherein the allylamine comprises terbinafine.  
     
     
         50 . The drug delivery system of  claim 45  wherein the polyene antifungal antibiotic comprises amphotericin B or nystatin.  
     
     
         51 . The drug delivery system of  claim 45  wherein the antifungal organic acid is selected from the group consisting of benzoic acid, salicylic acid, propionic acid, and caprylic acid.  
     
     
         52 . The drug delivery system of  claim 41  wherein the active agent comprises an anti-inflammatory agent.  
     
     
         53 . The drug delivery system of  claim 52  wherein the anti-inflammatory agent comprises a steroidal or nonsteroidal anti-inflammatory agent.  
     
     
         54 . The drug delivery system of  claim 41  wherein the active agent comprises a chemotherapeutic agent.  
     
     
         55 . The drug delivery system of  claim 54  wherein the chemotherapeutic agent is selected from the group consisting of alkaloids, alkylating agents, antineoplastic antibiotics, and antimetabolites.  
     
     
         56 . The drug delivery system of  claim 38  wherein the active agent is a nucleic acid, peptide, or protein.  
     
     
         57 . The drug delivery system of  claim 38  wherein the composition comprises the active agent in crystalline form.  
     
     
         58 . The drug delivery system of  claim 38  wherein the composition comprises a solid.  
     
     
         59 . The drug delivery system of  claim 38  wherein the composition comprises a liquid solution.  
     
     
         60 . The drug delivery system of  claim 38  wherein the composition comprises a semisolid.  
     
     
         61 . The drug delivery system of  claim 38  wherein the composition comprises a suspension.  
     
     
         62 . The drug delivery system of  claim 38  wherein the composition comprises an emulsion.  
     
     
         63 . The drug delivery system of  claim 38  further comprising a pharmaceutically acceptable carrier.  
     
     
         64 . The drug delivery system of  claim 63  wherein the pharmaceutically acceptable carrier comprises a polymer.  
     
     
         65 . The drug delivery system of  claim 64  wherein the polymer is selected from the group consisting of poly(lactide)s; poly(glycolide)s; poly(lactide-co-glycolide)s; poly(lactic acid)s; poly(glycolic acid)s; poly(lactic acid-co-glycolic acid)s; poly(caprolactone)s; poly(orthoester)s; poly(phosphoester)s; poly(phosphazene)s; poly(hydroxybutyrate)s or copolymers including poly(hydroxybutyrate); poly(lactide-co-caprolactone)s; polycarbonates; polyesteramides; polyanhidrides; poly(dioxanone)s; poly(alkylene alkylate)s; copolymers of polyethylene glycol and a polyorthoester; biodegradable polyurethanes; poly(amino acid)s; polyetheresters; polyacetals; polycyanoacrylates; poly(oxyethylene)/poly(oxypropylene) copolymers; or blends or copolymers thereof.  
     
     
         66 . The drug delivery system of  claim 63  wherein the pharmaceutically acceptable carrier comprises a biodegradable polymer.  
     
     
         67 . The drug delivery system of  claim 66  wherein the biodegradable polymer comprises a poly(lactic acid-co-glycolic acid) (PLGA) copolymer.  
     
     
         68 . The drug delivery system of  claim 63  wherein the pharmaceutically acceptable carrier comprises polyethylene glycol.  
     
     
         69 . The drug delivery system of  claim 38  wherein the active agent comprises 70% or more of the composition by weight.  
     
     
         70 . The drug delivery system of  claim 38  wherein the composition is a liquid solution and the active agent comprises an antifungal agent.  
     
     
         71 . The drug delivery system of  claim 38  wherein the composition is a semisolid and the active agent comprises an antifungal agent.  
     
     
         72 . The drug delivery system of  claim 38  wherein the composition comprises crystals of an antifungal agent.  
     
     
         73 . The drug delivery system of  claim 38  wherein the composition comprises a suspension and the active agent comprises an antifungal agent.  
     
     
         74 . The drug delivery system of  claim 38  wherein the composition comprises an emulsion and the active agent comprises an antifungal agent.

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