US2006275230A1PendingUtilityA1

Compositions and methods for treating conditions of the nail unit

57
Assignee: KOCHINKE FRANKPriority: Dec 10, 2004Filed: May 25, 2006Published: Dec 7, 2006
Est. expiryDec 10, 2024(expired)· nominal 20-yr term from priority
Inventors:Frank KochinkeCorinne Bright
A61P 31/10A61P 43/00A61P 31/02A61K 9/7007A61K 9/1647A61Q 17/005A61K 9/0024A61K 31/4196A61Q 3/00A61K 8/494A61K 31/137A61K 31/7048A61K 9/0019A61K 31/4184A61K 9/08A61P 17/00A61K 9/10A61K 31/496
57
PatentIndex Score
0
Cited by
0
References
0
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 non-temperature dependent phase change compositions that may be formulated as solutions, solids, semisolids, microparticles, or crystals.

Claims

exact text as granted — not AI-modified
1 . A drug delivery system for treating a nail unit condition comprising a composition having a therapeutically effective amount of an active agent for sustained release, wherein the composition is a non-temperature dependent phase change composition configured for local administration within a digit.  
   
   
       2 . The drug delivery system of  claim 1  wherein the nail unit condition is a fungal infection.  
   
   
       3 . The drug delivery system of  claim 2  wherein the fungal infection is onychomycosis.  
   
   
       4 . The drug delivery system of  claim 1  wherein the composition comprises microparticles.  
   
   
       5 . The drug delivery system of  claim 1  wherein the composition is formulated as a liquid.  
   
   
       6 . The drug delivery system of  claim 5  wherein the liquid is an aqueous solution.  
   
   
       7 . The drug delivery system of  claim 5  wherein the liquid is a nonaqueous solution.  
   
   
       8 . The drug delivery system of  claim 5  wherein the liquid is a suspension.  
   
   
       9 . The drug delivery system of  claim 1  wherein the composition is formulated as a semi-solid.  
   
   
       10 . The drug delivery system of  claim 9  wherein the semi-solid is a gel or paste.  
   
   
       11 . The drug delivery system of  claim 1  wherein the composition is formulated as a solid.  
   
   
       12 . The drug delivery system of  claim 1  wherein the composition comprises the active agent in crystalline form.  
   
   
       13 . The drug delivery system of  claim 1  wherein the active agent is selected from the group consisting of analgesics, anesthetics, anti-infective agents, anti-inflammatory agents, chemotherapeutic agents, nucleic acids, peptides, proteins, and combinations thereof.  
   
   
       14 . The drug delivery system of  claim 13  wherein the active agent comprises an anti-infective agent.  
   
   
       15 . The drug delivery system of  claim 14  wherein the anti-infective agent is selected from the group consisting of antibacterial agents, antifungal agents, antiviral agents, antiseptics, and combinations thereof.  
   
   
       16 . The drug delivery system of  claim 15  wherein the active agent comprises an antifungal agent.  
   
   
       17 . The drug delivery system of  claim 16  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.  
   
   
       18 . The drug delivery system of  claim 17  wherein the imidazole derivative is selected from the group consisting of bifonazole, butoconazole, clotrimazole, econazole, ketoconazole, miconazole, oxiconazole, sulconazole, and combinations thereof.  
   
   
       19 . The drug delivery system of  claim 17  wherein the triazole derivative is selected from the group consisting of itraconazole, fluconazole, terconazole, and combinations thereof.  
   
   
       20 . The drug delivery system of  claim 17  wherein the allylamine comprises naftine.  
   
   
       21 . The drug delivery system of  claim 20  wherein the allylamine comprises terbinafine.  
   
   
       22 . The drug delivery system of  claim 17  wherein the polyene antifungal antibiotic comprises amphotericin B or nystatin.  
   
   
       23 . The drug delivery system of  claim 17  wherein the antifungal organic acid is selected from the group consisting of benzoic acid, salicylic acid, propionic acid, caprylic acid, and combinations thereof.  
   
   
       24 . The drug delivery system of  claim 16  wherein the active agent comprises an anti-inflammatory agent.  
   
   
       25 . The drug delivery system of  claim 1  wherein the active agent comprises an antifungal agent and an anti-inflammatory agent.  
   
   
       26 . The drug delivery system of  claim 25  wherein the antifungal agent comprises itraconazole and the anti-inflammatory agent comprises dexamethasone.  
   
   
       27 . The drug delivery system of  claim 1  comprising less than 30% active agent by weight.  
   
   
       28 . The drug delivery system of  claim 1  further comprising a pharmaceutically acceptable carrier.  
   
   
       29 . The drug delivery system of  claim 1  wherein the pharmaceutically acceptable carrier comprises a biocompatible polymer.  
   
   
       30 . The drug delivery system of  claim 29  wherein the biocompatible 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; polyethylene glycols; biodegradable polyurethanes; poly(amino acid)s; polyetheresters; polyacetals; polycyanoacrylates; poly(oxyethylene)/poly(oxypropylene) copolymers; and blends and copolymers thereof.  
   
   
       31 . The drug delivery system of  claim 30  wherein the biocompatible polymer comprises a polyethylene glycol.  
   
   
       32 . The drug delivery system of  claim 31  wherein the polyethylene glycol comprises polyethylene glycol 3350.  
   
   
       33 . The drug delivery system of  claim 28  wherein the pharmaceutically acceptable carrier comprises a biodegradable polymer.  
   
   
       34 . The drug delivery system of  claim 33  wherein the biodegradable polymer comprises a poly(lactic acid-co-glycolic acid) (PLGA ) copolymer.  
   
   
       35 . The drug delivery system of  claim 1  wherein the composition is adapted for injection into the digit.  
   
   
       36 . A method for treating a nail unit condition comprising administering within a digit a non-temperature dependent phase change composition having a therapeutically effective amount of an active agent for sustained release.  
   
   
       37 . The method of  claim 36  wherein the nail unit condition is a fungal infection.  
   
   
       38 . The method of  claim 37  wherein the fungal infection is onychomycosis.  
   
   
       39 . The method of  claim 36  wherein the digit comprises a distal portion and a proximal portion.  
   
   
       40 . The method of  claim 39  wherein the distal portion comprises a nail unit having a nail plate, a nail fold, and a matrix.  
   
   
       41 . The method of  claim 40  wherein the composition is administered within the matrix.  
   
   
       42 . The method of  claim 40  wherein the composition is administered within the nail fold.  
   
   
       43 . The method of  claim 39  wherein the digit further comprises a middle portion.  
   
   
       44 . The method of  claim 43  wherein the composition is administered within the middle portion of the digit.  
   
   
       45 . The method of  claim 36  wherein the digit is a finger.  
   
   
       46 . The method of  claim 36  wherein the digit is a toe.  
   
   
       47 . The method of  claim 36  wherein the composition is administered by injection through a conduit.  
   
   
       48 . The method of  claim 47  wherein the conduit comprises a needle.  
   
   
       49 . The method of  claim 48  wherein a portion of the needle is configured to remain in the digit after injection of the composition.  
   
   
       50 . The method of  claim 36  wherein the composition is administered using a pressurized gas.  
   
   
       51 . The method of  claim 36  wherein an applicator is used to push the composition into the digit.  
   
   
       52 . The method of  claim 36  wherein the composition comprises microparticles.  
   
   
       53 . The method of  claim 52  wherein the microparticles are administered using a pressurized gas.  
   
   
       54 . The method of  claim 36  wherein the composition is formulated as a liquid.  
   
   
       55 . The method of  claim 54  wherein the liquid comprises an aqueous solution.  
   
   
       56 . The method of  claim 54  wherein the liquid comprises a nonaqueous solution.  
   
   
       57 . The method of  claim 54  wherein the liquid comprises a suspension.  
   
   
       58 . The method of  claim 36  wherein the composition is formulated as a semi-solid.  
   
   
       59 . The method of  claim 58  wherein the semi-solid is a gel or paste.  
   
   
       60 . The method of  claim 36  wherein the composition is formulated as a solid.  
   
   
       61 . The method of  claim 36  wherein the composition comprises the active agent in crystalline form.  
   
   
       62 . The method of  claim 36  wherein the active agent is selected from the group consisting of analgesics, anesthetics, anti-infective agents, anti-inflammatory agents, chemotherapeutic agents, nucleic acids, peptides, proteins, and combinations thereof.  
   
   
       63 . The method of  claim 62  wherein the active agent comprises an anti-infective agent.  
   
   
       64 . The method of  claim 63  wherein the anti-infective agent is selected from the group consisting of antibacterial agents, antifungal agents, antiviral agents, antiseptics, and combinations thereof.  
   
   
       65 . The method of  claim 64  wherein the active agent comprises an antifungal agent.  
   
   
       66 . The method of  claim 65  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.  
   
   
       67 . The method of  claim 66  wherein the imidazole derivative is selected from the group consisting of bifonazole, butoconazole, clotrimazole, econazole, ketoconazole, miconazole, oxiconazole, sulconazole, and combinations thereof.  
   
   
       68 . The method of  claim 66  wherein the triazole derivative is selected from the group consisting of itraconazole, fluconazole, terconazole, and combinations thereof.  
   
   
       69 . The method of  claim 66  wherein the allylamine comprises naftine.  
   
   
       70 . The method of  claim 66  wherein the allylamine comprises terbinafine.  
   
   
       71 . The method of  claim 66  wherein the polyene antifungal antibiotic comprises amphotericin B or nystatin.  
   
   
       72 . The method of  claim 66  wherein the antifungal organic acid is selected from the group consisting of benzoic acid, salicylic acid, propionic acid, caprylic acid, and combinations thereof.  
   
   
       73 . The method of  claim 62  wherein the active agent comprises an anti-inflammatory agent.  
   
   
       74 . The method of  claim 62  wherein the active agent comprises an antifungal agent and an anti-inflammatory agent.  
   
   
       75 . The method of  claim 74  wherein the antifungal agent comprises terbinafine and the anti-inflammatory agent comprises dexamethasone.  
   
   
       76 . The method of  claim 36  wherein the composition comprises less than 30% active agent by weight.

Join the waitlist — get patent alerts

Track US2006275230A1 — get alerts on status changes and closely related new filings.

We store only your email — no account needed. See our privacy policy.