US2005288481A1PendingUtilityA1

Design of poly(ester amides) for the control of agent-release from polymeric compositions

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Individually held — no corporate assignee on recordPriority: Apr 30, 2004Filed: Jul 22, 2005Published: Dec 29, 2005
Est. expiryApr 30, 2024(expired)· nominal 20-yr term from priority
Inventors:Jessica DesnoyerStephen D. PacettiLothar W. KleinerSyed Faiyaz Ahmed HossainyYung-Ming ChenGordon StewartGina Zhang
A61P 9/10A61L 27/34A61L 31/06A61L 2300/416A61L 31/10A61L 27/18A61L 2300/604A61L 31/16
47
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Claims

Abstract

The present invention generally encompasses a medical article, such as a medical device or coating comprising an agent or combination of agents, wherein the agent is distributed throughout a polymeric matrix. The polymeric matrix comprises an agent and a poly(ester amide) having a design that was preselected to provide a predetermined release rate of the combination of agents from the medical article.

Claims

exact text as granted — not AI-modified
1 . A medical article comprising: 
 a combination of agents; and    a polymeric matrix comprising an agent and a poly(ester amide) having a design that was preselected to provide a predetermined release rate of the combination of agents from the medical article, wherein the design provides a predetermined diffusion coefficient, a predetermined rate of degradation of the polymeric matrix, or a combination thereof.    
     
     
         2 . The medical article of  claim 1  comprising a medical device, a coating for a medical device, or a combination thereof.  
     
     
         3 . The medical article of  claim 1  comprising a stent.  
     
     
         4 . The medical article of  claim 1 , wherein the agent comprises a component selected from a group consisting of bioactive agents, biobeneficial agents, diagnostic agents, plasticizing agents, and any prodrugs, codrugs, metabolites, analogs, homologues, congeners, derivatives, salts, and combinations thereof.  
     
     
         5 . The medical article of  claim 1 , wherein the agent comprises a component selected from a group consisting of poly(alkylene glycols), phosphorylcholine, poly(N-vinyl pyrrolidone), poly(ethylene oxide), poly(acrylamide methyl propane sulfonic acid), poly(styrene sulfonate), polysaccharides, poly(ester amides), peptides, non-thrombotics, antimicrobials, nitric oxide donors, free radical scavengers, and any prodrugs, codrugs, metabolites, analogs, homologues, congeners, derivatives, salts, and combinations thereof.  
     
     
         6 . The medical article of  claim 5 , wherein the poly(alkylene glycol) comprises a component selected from a group consisting of poly(ethylene glycol), poly(propylene glycol), and any prodrugs, codrugs, metabolites, analogs, homologues, congeners, derivatives, salts, and combinations thereof.  
     
     
         7 . The medical article of  claim 5 , wherein the polysaccharide comprises a component selected from a group consisting of carboxymethylcellulose, sulfonated dextran, sulfated dextran, dermatan sulfate, chondroitin sulfate, hyaluronic acid, heparin, hirudin, and any prodrugs, codrugs, metabolites, analogs, homologues, congeners, derivatives, salts, and combinations thereof.  
     
     
         8 . The medical article of  claim 5 , wherein the peptide comprises a component selected from a group consisting of elastin, silk-elastin, collagen, atrial natriuretic peptide (ANP), Arg-Gly-Asp (RGD), and any prodrugs, codrugs, metabolites, analogs, homologues, congeners, derivatives, salts, and combinations thereof.  
     
     
         9 . The medical article of  claim 5 , wherein the free radical scavenger comprises a component selected from a group consisting of 2,2′,6,6′-tetramethyl-1-piperinyloxy, free radical; 4-amino-2,2′,6,6′-tetramethyl-1-piperinyloxy, free radical; 4-hydroxy-2,2′,6,6′-tetramethyl-piperidene-1-oxy, free radical; 2,2′,3,4,5,5′-hexamethyl-3-imidazolinium-1-yloxy methyl sulfate, free radical; 16-doxyl-stearic acid, free radical; superoxide dismutase mimic; and any prodrugs, codrugs, metabolites, analogs, homologues, congeners, derivatives, salts, and combinations thereof.  
     
     
         10 . The medical article of  claim 5 , wherein the nitric oxide donor comprises a component selected from the group consisting of S-nitrosothiols, nitrites, N-oxo-N-nitrosamines, substrates of nitric oxide synthase, diazenium diolates, and any prodrugs, codrugs, metabolites, analogs, homologues, congeners, derivatives, salts, and combinations thereof.  
     
     
         11 . The medical article of  claim 1 , wherein the agent comprises a component selected from a group consisting of rapamycin, methyl rapamycin, everolimus, pimecrolimus, 42-Epi-(tetrazoylyl)rapamycin (ABT-578), tacrolimus, and any prodrugs, codrugs, metabolites, analogs, homologues, congeners, derivatives, salts, and combinations thereof.  
     
     
         12 . The medical article of  claim 1 , wherein the agent comprises a component selected from a group consisting of imatinib mesylate, paclitaxel, docetaxel, midostaurin, and any prodrugs, codrugs, metabolites, analogs, homologues, congeners, derivatives, salts, and combinations thereof.  
     
     
         13 . The medical article of  claim 1 , wherein the agent comprises a component selected from a group consisting of estradiol, clobetasol, idoxifen, tazarotene, and any prodrugs, codrugs, metabolites, analogs, homologues, congeners, derivatives, salts, and combinations thereof.  
     
     
         14 . The medical article of  claim 1  comprising a combination of agents selected from a group consisting of everolimus and clobetasol; tacrolimus and rapamycin; tacrolimus and everolimus; rapamycin and paclitaxel; and, combinations thereof.  
     
     
         15 . The medical article of  claim 1 , wherein the design comprises 
 a preselected linker or combination of linkers for combining the agent or combination of agents to the polymeric matrix;    a preselected electron-donating group, electron-withdrawing group, or a combination thereof for controlling the rate of degradation of the polymeric matrix;    a preselected glass-transition temperature of a polymer in the polymeric matrix;    a preselected initial concentration gradient profile of an agent across the polymeric matrix; or    a combination thereof, to provide for a controlled-release of the combination of agents.    
     
     
         16 . The medical article of  claim 1 , wherein the design comprises 
 a polymeric matrix having a preselected hydrophilicity/hydrophobicity;    a polymeric matrix having a preselected porosity;    a polymeric matrix having a preselected glass-transition temperature;    a polymeric matrix comprising controlled-volumes;    an agent having a preselected hydrophilicity/hydrophobicity;    an encapsulating polymer having a preselected hydrophilicity/hydrophobicity; or    a combination thereof, to provide for a controlled-release of the combination of agents.    
     
     
         17 . The medical article of  claim 1  further comprising a second polymeric matrix.  
     
     
         18 . The medical article of  claim 1 , wherein the medical article comprises a layer, a controlled volume, an initial concentration gradient profile, or a combination thereof.  
     
     
         19 . A method of creating a medical article comprising: 
 selecting a combination of agents and a predetermined release rate for an agent;    designing a polymeric matrix comprising a poly(ester amide) having a design that was preselected to provide a predetermined release rate of the combination of agents from the medical article, wherein the design provides a predetermined diffusion coefficient, a predetermined rate of degradation of the polymeric matrix, or a combination thereof; and    forming the medical article.    
     
     
         20 . The method of  claim 19 , wherein the medical article comprises a medical device, a coating for a medical device, or a combination thereof.  
     
     
         21 . The method of  claim 19 , wherein the medical article comprises a stent.  
     
     
         22 . The method of  claim 19 , wherein the agent comprises a component selected from a group consisting of bioactive agents, biobeneficial agents, diagnostic agents, plasticizing agents, and combinations thereof.  
     
     
         23 . The method of  claim 19 , wherein the agent comprises a component selected from a group consisting of poly(alkylene glycols), phosphorylcholine, poly(N-vinyl pyrrolidone), poly(ethylene oxide), poly(acrylamide methyl propane sulfonic acid), poly(styrene sulfonate), polysaccharides, poly(ester amides), peptides, non-thrombotics, antimicrobials, nitric oxide donors, free radical scavengers, and any prodrugs, codrugs, metabolites, analogs, homologues, congeners, derivatives, salts, and combinations thereof.  
     
     
         24 . The method of  claim 23 , wherein the poly(alkylene glycol) comprises a component selected from a group consisting of poly(ethylene glycol), poly(propylene glycol), and any prodrugs, codrugs, metabolites, analogs, homologues, congeners, derivatives, salts, and combinations thereof.  
     
     
         25 . The method of  claim 23 , wherein the polysaccharide comprises a component selected from a group consisting of carboxymethylcellulose, sulfonated dextran, sulfated dextran, dermatan sulfate, chondroitin sulfate, hyaluronic acid, heparin, hirudin, and any prodrugs, codrugs, metabolites, analogs, homologues, congeners, derivatives, salts, and combinations thereof.  
     
     
         26 . The method of  claim 23 , wherein the peptide comprises a component selected from a group consisting of elastin, silk-elastin, collagen, atrial natriuretic peptide (ANP), Arg-Gly-Asp (RGD), and any prodrugs, codrugs, metabolites, analogs, homologues, congeners, derivatives, salts, and combinations thereof.  
     
     
         27 . The method of  claim 23 , wherein the free radical scavenger comprises a component selected from a group consisting of 2,2′,6,6′-tetramethyl-1-piperinyloxy, free radical; 4-amino-2,2′,6,6′-tetramethyl-1-piperinyloxy, free radical; 4-hydroxy-2,2′,6,6′-tetramethyl-piperidene-1-oxy, free radical; 2,2′,3,4,5,5′-hexamethyl-3-imidazolinium-1-yloxy methyl sulfate, free radical; 16-doxyl-stearic acid, free radical; superoxide dismutase mimic; and any prodrugs, codrugs, metabolites, analogs, homologues, congeners, derivatives, salts, and combinations thereof.  
     
     
         28 . The method of  claim 23 , wherein the nitric oxide donor comprises a component selected from the group consisting of S-nitrosothiols, nitrites, N-oxo-N-nitrosamines, substrates of nitric oxide synthase, diazenium diolates, and any prodrugs, codrugs, metabolites, analogs, homologues, congeners, derivatives, salts, and combinations thereof.  
     
     
         29 . The method of  claim 19 , wherein the agent comprises a component selected from a group consisting of rapamycin, methyl rapamycin, everolimus, pimecrolimus, 42-Epi-(tetrazoylyl)rapamycin (ABT-578), tacrolimus, and any prodrugs, codrugs, metabolites, analogs, homologues, congeners, derivatives, salts, and combinations thereof.  
     
     
         30 . The method of  claim 19 , wherein the agent comprises a component selected from a group consisting of imatinib mesylate, paclitaxel, docetaxel, midostaurin, and any pro drugs, codrugs, metabolites, analogs, homologues, congeners, derivatives, salts, and combinations thereof.  
     
     
         31 . The method of  claim 19 , wherein the agent comprises a component selected from a group consisting of estradiol, clobetasol, idoxifen, tazarotene, and any prodrugs, codrugs, metabolites, analogs, homologues, congeners, derivatives, salts, and combinations thereof.  
     
     
         32 . The method of  claim 19 , wherein the combination of agents comprises a combination selected from a group consisting of everolimus and clobetasol; tacrolimus and rapamycin; tacrolimus and everolimus; rapamycin and paclitaxel; and, combinations thereof.  
     
     
         33 . The method of  claim 19 , wherein the degradation comprises degradation of a linker or combination of linkers used to attach an agent to the polymeric matrix, wherein the degradation of the combination of linkers provides for control of the release of the combination of agents.  
     
     
         34 . The method of  claim 19  further comprising a second polymeric matrix.  
     
     
         35 . The method of  claim 34 , wherein the medical article comprises a layer, a controlled volume, an initial concentration gradient profile, or a combination thereof.  
     
     
         36 . The method of  claim 19 , wherein the designing comprises 
 preselecting linker or combination of linkers for combining the agent or combination of agents to the polymeric matrix;    preselecting an electron-donating group, electron-withdrawing group, or a combination thereof for controlling the rate of degradation of the polymeric matrix;    preselecting a glass-transition temperature of a polymer in the polymeric matrix;    preselecting an initial concentration gradient profile of an agent across the polymeric matrix; or    a combination thereof, to provide for a controlled-release of the combination of agents.    
     
     
         37 . The method of  claim 19 , wherein the designing comprises 
 preselecting a polymer having a desired hydrophilicity/hydrophobicity;    preselecting an agent having a desired hydrophilicity/hydrophobicity;    preselecting a pore-forming agent to form a polymeric matrix having a desired porosity;    preselecting a polymeric matrix having a desired glass-transition temperature;    preselecting a polymeric matrix comprising controlled-volumes;    preselecting an encapsulating polymer having a preselected hydrophilicity/hydrophobicity; or    a combination thereof, to provide for a controlled-release of the combination of agents.    
     
     
         38 . A method of delivering a combination of agents to a mammalian tissue, wherein the method comprises contacting the medical article of  claim 1  with the mammalian tissue under in vivo conditions.  
     
     
         39 . The method of  claim 38 , wherein the tissue comprises a vascular tissue.  
     
     
         40 . A method of preventing or treating a disease comprising implanting the medical article of  claim 1  in a subject.  
     
     
         41 . The method of  claim 40 , wherein the disease comprises a vascular disease comprising restenosis, vulnerable plaque, or a combination thereof.

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