US2003133979A1PendingUtilityA1

Device for the sustained release of aggregation-stabilized, biologically active agent

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Assignee: ALKERMES INCPriority: Jun 11, 1992Filed: Oct 22, 2002Published: Jul 17, 2003
Est. expiryJun 11, 2012(expired)· nominal 20-yr term from priority
Inventors:Paul A. BurkeStephen E. ZaleMark TracyOlufunmi L. JohnsonHoward BernsteinM. Amin KhanAvram BricknerHenry Auer
C07K 14/56A61K 9/1658A61K 9/5052A61K 47/02A61K 38/1816A61K 47/26A61K 9/5031A61K 9/5153A61K 9/0019A61K 9/1694A61K 9/1611A61K 38/212A61K 9/1647A61K 38/27
56
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Claims

Abstract

A device for the sustained release in vivo of a water soluble, biologically active agent wherein the agent is susceptible to aggregation comprising a drug delivery device and aggregation-stabilized, biologically active agent wherein the aggregation-stabilized agent is disposed within the drug delivery device.

Claims

exact text as granted — not AI-modified
What is claimed is:  
     
         1 . A device for the sustained release in vivo of a water soluble, biologically active agent wherein said agent is susceptible to aggregation, comprising: 
 a) a drug delivery device; and    b) aggregation-stabilized, biologically active agent wherein said aggregation-stabilized agent is disposed within the drug delivery device.    
     
     
         2 . A sustained release device of  claim 1  wherein the drug delivery device is a biocompatible polymeric matrix.  
     
     
         3 . A sustained release device of  claim 1  wherein the aggregation-stabilized, biologically active agent includes a biologically active agent and an aggregation-stabilizer.  
     
     
         4 . A sustained release device of  claim 3  wherein the aggregation-stabilizer is at least one salting-out salt.  
     
     
         5 . A sustained release device of  claim 3  wherein the aggregation-stabilizer is a metal cation component.  
     
     
         6 . A sustained release device of  claim 5  wherein the aggregation-stabilizer and a metal cation of the metal cation component are complexed.  
     
     
         7 . A sustained release device of  claim 3  wherein the aggregation-stabilizer is a buffer.  
     
     
         8 . A sustained release device of  claim 3  wherein the aggregation-stabilizer is polyethylene glycol.  
     
     
         9 . A sustained release device of  claim 3  wherein the aggregation-stabilized, biologically active agent is in particulate form.  
     
     
         10 . A composition for the sustained release in vivo of a water soluble, biologically active agent wherein said agent is susceptible to aggregation, comprising: 
 a) a biocompatible polymer; and    b) aggregation-stabilized, biologically active agent wherein said aggregation-stabilized agent is disposed within the polymer.    
     
     
         11 . A sustained release composition of  claim 10  wherein the aggregation-stabilized, biologically active agent includes a biologically active agent and an aggregation-stabilizer.  
     
     
         12 . A sustained release composition of  claim 10  wherein the biologically active agent and the aggregation-stabilizer are mixed.  
     
     
         13 . A sustained release composition of  claim 10  wherein the aggregation-stabilizer reduces the solubility of the protein in an aqueous fluid.  
     
     
         14 . A composition of  claim 13  wherein the anti-aggregation agent is a salting-out salt.  
     
     
         15 . A composition of  claim 14  wherein the salting-out salt comprises a salt containing a cation selected from the group consisting Mg +2 , Li + , Na + , K + , NH 4   +  and combinations thereof.  
     
     
         16 . A composition of  claim 13  wherein the salting-out salt comprises a salt containing an anion selected from the group consisting of SO 4   −2 , HPO 4   −2 , acetate, citrate, tartrate, CL − , NO 3   − , CLO 3   − , I − , CLO 4   − , SCN −  and combinations thereof.  
     
     
         17 . A composition of  claim 13  wherein the salting-out salt is ammonium sulfate.  
     
     
         18 . A composition of  claim 11  wherein the aggregation stabilizer is mannitol.  
     
     
         19 . A sustained release composition of  claim 11  wherein the aggregation-stabilizer is a buffer.  
     
     
         20 . A sustained release composition of  claim 11  wherein the aggregation-stabilizer is a metal cation from a metal cation component.  
     
     
         21 . A sustained release composition of  claim 11  wherein the metal cation of said metal cation component is a biocompatible multivalent cation.  
     
     
         22 . A sustained release composition of  claim 12  wherein the multivalent metal cation is selected from the group consisting of Zn +2 , Ca +2 , Cu +2 , Mg +2  and combinations thereof.  
     
     
         23 . A sustained release composition of  claim 10  wherein the biocompatible polymeric matrix is formed of a biodegradable polymer.  
     
     
         24 . A sustained release composition of  claim 20  further comprising a second metal cation component, wherein the second metal cation component is dispersed within the biocompatible polymeric matrix.  
     
     
         25 . A sustained release composition of  claim 24  wherein the second metal cation component is selected from the group consisting of magnesium hydroxide, magnesium carbonate, calcium carbonate, zinc carbonate, magnesium acetate, zinc acetate, magnesium sulfate, zinc sulfate, magnesium chloride, zinc chloride, zinc citrate, magnesium citrate and a combination thereof.  
     
     
         26 . A composition for the sustained release in vivo of a water soluble, biologically active agent aggregation, comprising: 
 a) a biodegradable polymer; and    b) aggregation-stabilized, biologically active agent wherein said aggregation-stabilized agent is disposed within the biodegradable polymer.    
     
     
         27 . A sustained release composition of  claim 26  wherein the biodegradable polymer is poly(lactide-co-glycolide).

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