US2019008792A1PendingUtilityA1

Bioerodible drug delivery implants

Assignee: HERA HEALTH SOLUTIONS INCPriority: Jul 8, 2017Filed: Jul 8, 2018Published: Jan 10, 2019
Est. expiryJul 8, 2037(~10.9 yrs left)· nominal 20-yr term from priority
D04H 1/728D10B 2509/00A61K 9/7007A61K 31/57D01D 7/00D01D 5/003D10B 2331/041D10B 2401/12A61K 47/34A61P 15/18A61K 45/00D04H 1/4258D04H 1/4282D04H 1/4291D04H 1/4358D04H 1/4334D04H 1/4326D04H 1/435A61K 31/137A61K 31/567A61K 38/24A61K 31/485A61K 9/0024
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Claims

Abstract

Disclosed herein are bioerodible drug delivery devices including one or more active agents, and related methods. The devices are useful for administering a wide variety of agents over prolonged periods of time.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         1 . A bioerodible drug delivery device comprising a non-woven sheet having a length, width and thickness, said sheet in a rolled configuration comprising multiple turns along an axis parallel to the sheet length and perpendicular to the sheet width, wherein the non-woven sheet comprises an electrospun bioerodible polymer and at least one active agent. 
     
     
         2 . The device according to  claim 1 , wherein the sheet has a width of 20-500 mm and comprises at least 2 turns per 50 mm of width. 
     
     
         3 . The device according to  claim 1 , wherein the bioerodible polymer comprises a polyester, polycarbonate, polyanhydride, polyamide, polyurethane, polyketal, polyacetal, polydioxanone, polyesteramide, polyorthoester, polyorthocarbonate, polyphosphazene, polypeptide, polyvinyl, polyalkylene oxide, polysaccharide, copolymer thereof, or combination thereof. 
     
     
         4 . The device according to  claim 3 , wherein the bioerodible polymer comprises a poly(lactic acid) selected from poly(L-lactic acid), poly(D-lactic acid), poly(D/L-lactic acid), copolymers thereof, and combinations thereof. 
     
     
         5 . The device according to  claim 1 , wherein after implantation into a patient, the device releases a therapeutic amount of active agent for a period of 3-60 months. 
     
     
         6 . The device according to  claim 1 , wherein the active agent comprises one or more analgesic agents; anti-anxiety agents; anti-arthritic agents; anti-asthmatic agents; anticancer agents; anticholinergic agents; anticholinesterases; anticonvulsants; antidepressants; a progestogen, a contraceptive, an antidiabetic agents; antidiarrheal agents; anti-emetic agents; antihistamines; antihyperlipidemic agents; anti-infective agents; anti-inflammatory agents; antimigraine agents; anti-obesity agents; antipruritic agents; antipsychotic agents; antispasmodic agents; an estrogenic compound, neurological agents; cardiovascular medicaments; diuretic agents; gastrointestinal medications; hormones; anti-hormones; hypnotic agents; immunosuppressive agents; leukotriene inhibitors; narcotic agonists, narcotic antagonists; neurotransmitters; nicotine; nucleic acids; peptide drugs; thrombolytic agents; vasodilators; or a combination thereof. 
     
     
         7 . The device according to  claim 6 , wherein the active agent comprises a progestogen selected from the group consisting of 21-acetoxypregnenolone; allylestrenol; anagestone (17α-hydroxy-6α-methylpregn-4-en-20-one); anagestone 17α-acetate; chlormadinone; chlormadinone 17α-acetate; chloroethynyl norgestrel; cyproterone; cyproterone 17α-acetate; desogestrel; dienogest; dimethisterone (6α,21-dimethylethisterone); drospirenone (1,2-dihydrospirorenone); ethisterone (17α-ethinyltestosterone or pregneninolone); ethynerone; etynodiol diacetate (norethindrol diacetate); etonogestrel (11-methylene-levo-norgestrel; 3-keto-desogestrel); gestodene; hydroxyprogesterone (17α-hydroxyprogesterone); hydroxyprogesterone caproate; hydroxyprogesterone acetate; hydroxyprogesterone heptanoate; levonorgestrel; lynestrenol; medrogestone (6,17α-dimethyl-6-dehydroprogesterone); medroxyprogesterone; medroxyprogesterone acetate; megestrol; megestrol acetate; segesterone acetate; nomegestrol; nomegestrol acetate; norethindrone (norethisterone; 19-nor-17α-ethynyltestosterone); norelgestromin (17-deacetylnorgestimate); noretynodrel; norgestrienone; progesterone; retroprogesterone, and combinations thereof. 
     
     
         8 . The device according to  claim 6 , wherein the active agent comprises gonadotropin-releasing hormone. 
     
     
         9 . The device according to  claim 6 , wherein the active agent comprises lofexidine, methadone, buprenorphine, or naltrextone 
     
     
         10 . The device according to any of  claim 6 , wherein the active agent comprises one or more veterinary drugs. 
     
     
         11 . A method for preparing the device according to  claim 1 , comprising:
 (a) applying an electric voltage from a voltage source to a solution to form a charged solution,   (b) forming at least one drop of charged solution,   (c) forming non-woven fibers on a grounded collector spaced apart from the drop along a first axis, and   (d) converting the collected fibers to a rolled configuration.   
     
     
         12 . The method according to  claim 11 , wherein the at least one drop is formed by passing the solution through a needle. 
     
     
         13 . The method according to  claim 11 , wherein the at least one drop is formed by passing the charged solution through a needle at a rate of 0.05-0.5 ml/hr. 
     
     
         14 . The method according to  claim 11 , wherein the at least one drop is formed by temporarily passing a wire through the solution. 
     
     
         15 . The method according to  claim 14 , wherein the wire is repeatedly passed through the solution 2-30 times per minute. 
     
     
         16 . The method according to  claim 11 , wherein the grounded collector is a flat surface. 
     
     
         17 . The method according to  claim 11 , wherein the collector is a rotating rod. 
     
     
         18 . A drug delivery device prepared by the method of  claim 11 . 
     
     
         19 . A method of treating or preventing a medical condition in a mammal, comprising implanting the drug delivery device of  claim 1  into the mammal. 
     
     
         20 . A method for preventing pregnancy in a mammal, comprising implanting a bioerodible drug delivery device in said mammal, the device comprising a non-woven sheet having a length, width and thickness, said sheet in a rolled configuration comprising multiple turns along an axis parallel to the sheet length and perpendicular to the sheet width, wherein the non-woven sheet comprises a bioerodible polymer and at least one contraceptive drug. 
     
     
         21 . The method according to  claim 20 , wherein the contraceptive drug comprises comprises a progestogen selected from the group consisting of 21-acetoxypregnenolone; allylestrenol; anagestone (17α-hydroxy-6α-methylpregn-4-en-20-one); anagestone 17α-acetate; chlormadinone; chlormadinone 17α-acetate; chloroethynyl norgestrel; cyproterone; cyproterone 17α-acetate; desogestrel; dienogest; dimethisterone (6α,21-dimethylethisterone); drospirenone (1,2-dihydrospirorenone); ethisterone (17α-ethinyltestosterone or pregneninolone); ethynerone; etynodiol diacetate (norethindrol diacetate); etonogestrel (11-methylene-levo-norgestrel; 3-keto-desogestrel); gestodene; hydroxyprogesterone (17α-hydroxyprogesterone); hydroxyprogesterone caproate; hydroxyprogesterone acetate; hydroxyprogesterone heptanoate; levonorgestrel; lynestrenol; medrogestone (6,17α-dimethyl-6-dehydroprogesterone); medroxyprogesterone; medroxyprogesterone acetate; megestrol; megestrol acetate; segesterone acetate; nomegestrol; nomegestrol acetate; norethindrone (norethisterone; 19-nor-17α-ethynyltestosterone); norelgestromin (17-deacetylnorgestimate); noretynodrel; norgestrienone; progesterone; retroprogesterone, and combinations thereof.

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