US2014147486A1PendingUtilityA1

Implants for the treatment of dopamine associated states

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Assignee: UNIV PENNSYLVANIAPriority: Apr 6, 2006Filed: Jun 6, 2013Published: May 29, 2014
Est. expiryApr 6, 2026(expired)· nominal 20-yr term from priority
Inventors:Terri SebreeSteven Siegel
A61P 5/00A61P 43/00A61P 5/06A61P 25/16A61P 25/00A61P 25/28A61P 25/14A61P 21/00A61P 15/00A61P 15/10A61K 31/403A61L 2300/40A61L 31/16A61K 31/4045A61L 31/06A61K 9/0024A61L 27/34A61L 27/18A61L 31/148A61K 9/204A61L 27/54A61L 31/10A61K 31/517
61
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Claims

Abstract

Biodegradable implants comprising dopamine modulating compounds are described.

Claims

exact text as granted — not AI-modified
1 . A method for treating a subject for a dopamine associated state, comprising administering to said subject a biodegradable implant, wherein said implant comprises an effective amount of a dopamine modulating compound, such that said subject is treated for said dopamine associated state. 
     
     
         2 . The method of  claim 1 , wherein said dopamine associated state is Parkinson's to disease, attention deficit disorder (ADD), attention deficit hyperactivity disorder (ADHD), autism, pervasive development disorder (PDD), Asberger's syndrome, toxin-induced parkinsonism, disease-induced parkinsonism, erectile dysfunction, restless leg syndrome, or hyperprolactinemia. 
     
     
         3 . The method of  claim 2 , wherein said dopamine associated state is Parkinson's disease. 
     
     
         4 . The method of any one of  claims 1 - 3 , wherein said dopamine modulating compound is a dopamine agonist. 
     
     
         5 . The method of  claim 4 , wherein said dopamine agonist is apomorphine, lisuride, pergolide, bromocriptine, pramipexole, rotigotine, docarpamine, terguride, cabergoline, levodopa, spheramine, romergoline, carmoxirole, zelandopam, sumanirole, sibenadet a 4-alkylamino-2(3H)-indolone compound or a combination thereof. 
     
     
         6 . The method of  claim 5 , wherein said 4-alkylamino-2(3H)-indolone compound is of formula (I): 
       
         
           
           
               
               
           
         
       
       wherein:
 R is amino, alkylamino, di-alkylamino, alkenylamino, dialkenylamino, N-alkyl-N-alkenylamino, benzylamino, dibenzylamino, arylalkylamino, or diarylalkylamino; 
 R 1 , R 2  and R 3  are each independently hydrogen or alkyl; and 
 n is 1, 2, or 3, and pharmaceutically acceptable salts thereof. 
 
     
     
         7 . The method of  claim 6 , wherein said dopamine modulating compound is ropinirole. 
     
     
         8 . The method of any one of  claims 1 - 7 , wherein said effective amount results in a plasma level of said dopamine modulating compound between about 1 ng/mL and about 40 ng/mL in said subject for at least one day. 
     
     
         9 . The method of  claim 8 , wherein said effective amount results in a plasma level to of between about 1 ng/mL and about 20 ng/mL. 
     
     
         10 . The method of  claim 9 , wherein said effective amount results in a plasma level of between about 1 ng/mL and about 15 ng/mL. 
     
     
         11 . The method of any one of  claims 8 - 10 , wherein said plasma level of said dopamine modulating compound in said subject is maintained for at least one week. 
     
     
         12 . The method of  claim 11 , wherein said plasma level is maintained for at least one month. 
     
     
         13 . The method of  claim 12 , wherein said plasma level is maintained for at least three months. 
     
     
         14 . The method of  claim 13 , wherein said plasma level is maintained for at least six or more months. 
     
     
         15 . The method of anyone of  claims 1 - 14 , wherein said polymer comprises poly(glycolic acid), poly-D,L-lactic acid, poly-L-lactic acid, copolymers of the foregoing, poly(aliphatic carboxylic acids), copolyoxalates, polycaprolactone, polydioxonone, poly(ortho carbonates), poly(acetals), poly(lactic acid-caprolactone), polyorthoesters, poly(glycolic acid-caprolactone), polyanhydrides, natural polymers, or mixtures thereof. 
     
     
         16 . The method of  claim 15 , wherein said natural polymer is albumin, casein, or a wax. 
     
     
         17 . The method of any one of  claims 1 - 16 , wherein said polymer is charged. 
     
     
         18 . The method of  claim 15 , wherein said polymer is a polyglycolide/polylactide co polymer or polycaprolactone. 
     
     
         19 . The method of any one of  claims 1 - 18 , wherein said implant comprises one or more sections. 
     
     
         20 . The method of  claim 19 , wherein said implant comprises two or more sections. 
     
     
         21 . The method of  claim 20 , wherein said sections have different rates of degradation. 
     
     
         22 . The method of any one of  claims 1 - 21 , wherein at least one symptom of Parkinson's disease is treated. 
     
     
         23 . The method of any one of  claims 1 - 22 , wherein said implant comprises a hydrophobic coating. 
     
     
         24 . The method of  claim 23 , wherein said hydrophobic coating is PLA. 
     
     
         25 . The method of  claim 15 , wherein said polymer is PLA. 
     
     
         26 . A biodegradable implant, comprising a dopamine modulating compound and a biodegradable polymer. 
     
     
         27 . The implant of  claim 26 , wherein said dopamine modulating compound is a dopamine agonist. 
     
     
         28 . The implant of  claim 27 , wherein said dopamine agonist is apomorphine, lisuride, pergolide, bromocriptine, pramipexole, rotigotine, docarpamine, terguride, cabergoline, levodopa, spheramine, romergoline, carmoxirole, zelandopam, sumanirole, sibenadet, a 4-alkylamino-2(3H)-indolone compound or a combination thereof. 
     
     
         29 . The implant of  claim 28 , wherein said 4-alkylamino-2(3H)-indolone compound is of formula (I): 
       
         
           
           
               
               
           
         
       
       wherein:
 R is amino, alkylamino, di-alkylamino, alkenylamino, dialkenylamino, N-alkyl-N-alkenylamino, benzylamino, dibenzylamino, arylalkylamino, or diarylalkylamino; 
 R 1 , R 2  and R 3  are each independently hydrogen or alkyl; and 
 n is 1, 2, or 3, and pharmaceutically acceptable salts thereof. 
 
     
     
         30 . The implant of  claim 29 , wherein said dopamine modulating compound is ropinirole. 
     
     
         31 . The implant of anyone of  claims 27 - 30 , wherein said polymer comprises poly(glycolic acid), poly-D,L-lactic acid, poly-L-lactic acid, copolymers of the foregoing, poly(aliphatic carboxylic acids), copolyoxalates, polycaprolactone, polydioxonone, poly(ortho carbonates), poly(acetals), poly(lactic acid-caprolactone), polyorthoesters, poly(glycolic acid-caprolactone), polyanhydrides, natural polymers, or mixtures thereof. 
     
     
         32 . The implant of  claim 31 , wherein said polymer is a polyglycolide/polylactide co polymer or polycaprolactone. 
     
     
         33 . The implant of any one of  claims 27 - 32 , wherein said dopamine modulating compound is present in an amount which is effective to treat a subject for a dopamine associated state. 
     
     
         34 . The implant of  claim 33 , wherein said dopamine associated state is Parkinson's disease, attention deficit disorder (ADD), attention deficit hyperactivity disorder (ADHD), autism, pervasive development disorder (PDD), Asberger's syndrome, toxin-induced parkinsonism, disease-induced parkinsonism, erectile dysfunction, restless leg syndrome, or hyperprolactinemia. 
     
     
         35 . The implant of any one of  claims 27 - 34 , wherein said dopamine modulating compound is present in an amount which is effective to maintain a dopamine modulating compound level of between about 1 ng/ml and about 40 ng/ml in a subject for at least one day. 
     
     
         36 . The implant of  claim 35 , wherein said dopamine modulating compound levels are maintained for at least one week. 
     
     
         37 . The implant of  claim 36 , wherein said dopamine modulating compound levels are maintained for at least one month. 
     
     
         38 . The implant of  claim 37 , wherein said dopamine modulating compound levels are maintained for at least three months. 
     
     
         39 . The implant of any one of  claims 27 - 38 , wherein said implant comprises a hydrophobic coating. 
     
     
         40 . The implant of  claim 39 , wherein said hydrophobic coating is PLA. 
     
     
         41 . The implant of  claim 31 , wherein said polymer is PLA. 
     
     
         42 . The implant of any one of  claims 27 - 41 , wherein said implant is manufactured using a melt mix procedure. 
     
     
         43 . A method for maintaining a plasma level of between about 1 and 40 of a dopamine modulating compound in a subject, comprising administering to said subject an implant comprising a biodegradable polymer and said dopamine modulating compound, such that the plasma level of said compound is maintained for at least one day. 
     
     
         44 . The method of  claim 43 , wherein said plasma level is maintained for at least one month. 
     
     
         45 . The method of  claim 44 , wherein said plasma level is maintained for at least three months. 
     
     
         46 . The method of any one of  claims 43 - 45 , wherein said subject is suffering from a dopamine associated state selected from Parkinson's disease, attention deficit disorder (ADD), attention deficit hyperactivity disorder (ADHD), autism, pervasive development disorder (PDD), Asberger's syndrome, toxin-induced parkinsonism, disease-induced parkinsonism, erectile dysfunction, restless leg syndrome, or hyperprolactinemia. 
     
     
         47 . The method of  claim 46 , wherein said dopamine associated state is Parkinson's disease. 
     
     
         48 . The method of any one of  claims 43 - 47 , wherein said dopamine modulating compound is a dopamine agonist. 
     
     
         49 . The method of  claim 48 , wherein said dopamine agonist is apomorphine, lisuride, pergolide, bromocriptine, pramipexole, rotigotine, docarpamine, terguride, cabergoline, levodopa, spheramine, romergoline, carmoxirole, zelandopam, sumanirole, sibenadet, a 4-alkylamino-2(3H)-indolone compound, or a combination thereof. 
     
     
         50 . The method of  claim 49 , wherein said a 4-alkylamino-2(3H)-indolone compound is of formula (I): 
       
         
           
           
               
               
           
         
       
       wherein:
 R is amino, alkylamino, di-alkylamino, alkenylamino, dialkenylamino, N-alkyl-N-alkenylamino, benzylamino, dibenzylamino, arylalkylamino, or diarylalkylamino; 
 R 1 , R 2  and R 3  are each independently hydrogen or alkyl; and 
 n is 1, 2, or 3, and pharmaceutically acceptable salts thereof. 
 
     
     
         51 . The method of  claim 50 , wherein said dopamine modulating compound is ropinirole. 
     
     
         52 . The method of anyone of  claims 43 - 51 , wherein said polymer comprises poly(glycolic acid), poly-D,L-lactic acid, poly-L-lactic acid, copolymers of the foregoing, poly(aliphatic carboxylic acids), copolyoxalates, polycaprolactone, polydioxonone, poly(ortho carbonates), poly(acetals), poly(lactic acid-caprolactone), polyorthoesters, poly(glycolic acid-caprolactone), polyanhydrides, natural polymers, or mixtures thereof. 
     
     
         53 . The method of  claim 52 , wherein said polymer is a polyglycolide/polylactide co polymer or polycaprolactone. 
     
     
         54 . The method of any one of  claims 43 - 53 , wherein said implant comprises a hydrophobic coating. 
     
     
         55 . The method of  claim 54 , wherein said hydrophobic coating comprises PLA. 
     
     
         56 . The implant of  claim 52 , wherein said polymer is PLA. 
     
     
         57 . A method for treating a subject for Parkinson's disease, comprising administering to said subject a biodegradable implant, wherein said implant comprises an effective amount of ropinirole to treat Parkinson's disease. 
     
     
         58 . A biodegradable implant, comprising ropinirole and a biodegradable polymer. 
     
     
         59 . The implant of  claim 58 , wherein said implant comprises a hydrophobic coating.

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