US2005048123A1PendingUtilityA1

In situ gelling drug delivery system

57
Assignee: CONTROL DELIVERY SYS INCPriority: Jun 26, 2003Filed: Jun 25, 2004Published: Mar 3, 2005
Est. expiryJun 26, 2023(expired)· nominal 20-yr term from priority
Inventors:Dongling SuPaul AshtonJianbing Chen
A61P 43/00A61P 25/04A61K 9/06A61K 31/542A61K 31/382A61K 47/6903A61K 9/0024A61K 47/60A61K 9/0051A61K 47/34A61K 31/485A61K 47/55A61K 9/0092A61K 31/196
57
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Claims

Abstract

The invention provides liquid controlled-release drug delivery compositions which gel upon injection into the body to form, in situ, controlled-release drug implants. The compositions of the invention feature a gel-forming polymer that is insoluble in water, a polyethylene glycol solvent in which the polymer is dissolved, and the drug substance to be delivered.

Claims

exact text as granted — not AI-modified
1 . An injectable pharmaceutical composition comprising: 
 (a) a drug substance;    (b) a polyethylene glycol; and    (c) a biocompatible and bioerodable poly(DL-lactide-glycolide) (PLGA) polymer;    wherein the bioerodable PLGA polymer is dissolved, dispersed or suspended in the polyethylene glycol.    
     
     
         2 . The composition of  claim 1 , wherein the average MW of the polyethylene glycol is between about 100 and about 6000.  
     
     
         3 . The composition of  claim 2 , wherein the average MW of the polyethylene glycol is between about 200 and about 400.  
     
     
         4 . The composition of any one of claims  1 - 3 , wherein the drug substance is dissolved in the polyethylene glycol.  
     
     
         5 . The composition of any one of claims  1 - 3 , wherein the PLGA polymer is dissolved in the polyethylene glycol.  
     
     
         6 . The composition of  claim 4 , wherein the PLGA polymer is dissolved in the polyethylene glycol.  
     
     
         7 . A composition according to any one of claims  1 - 6 , wherein the drug substance is selected from the group consisting of peptides, proteins, pegylated peptides, and pegylated proteins.  
     
     
         8 . A composition according to any one of claims  1 - 6 , wherein the drug substance is a prodrug.  
     
     
         9 . A composition according to any one of claims  1 - 6 , wherein the drug substance is a co-drug.  
     
     
         10 . A composition according to  claim 9 , wherein the co-drug comprises morphine linked to diclofenac.  
     
     
         11 . A method for administering a drug substance to a subject, comprising injecting into the subject a composition according to any one of claims  1 - 10 .  
     
     
         12 . A method for forming a polymeric sustained-release drug delivery gel in a subject, comprising injecting into the subject a composition according to any one of claims  1 - 10 .  
     
     
         13 . A method of administering a composition according to claims  1 - 10  wherein the composition is co-administered with an aqueous fluid.  
     
     
         14 . The method according to  claim 13  wherein the aqueous fluid is buffered saline.  
     
     
         15 . The method according to  claim 13  wherein the aqueous fluid is a hydrogel.  
     
     
         16 . The method according to  claim 13  wherein the aqueous fluid and the composition are administered via a double lumen needle.  
     
     
         17 . The method according to  claim 15  wherein the aqueous fluid and the composition are administered via a double lumen syringe.  
     
     
         18 . The method according to  claim 13  wherein the aqueous fluid and the polymer gel are mixed immediately before administration.  
     
     
         19 . The method according to  claim 15  wherein the aqueous fluid and the polymer gel are each contained in a separate syringe.  
     
     
         20 . A drug delivery device containing a composition according to any one of claims  1 - 10 .  
     
     
         21 . A device according to  claim 20  wherein the device has at least one opening.  
     
     
         22 . A device according to  claim 20  wherein the device is an open tube.  
     
     
         23 . An injectable pharmaceutical composition comprising: 
 (a) a prodrug, comprising a drug substance covalently linked to a polyoxyethylene ether; and    (b) a biocompatible and bioerodable poly(DL-lactide-glycolide) (PLGA) polymer;    wherein the bioerodable PLGA polymer is dissolved, dispersed or suspended in the drug substance—polyoxyethylene ether complex.    
     
     
         24 . The composition of  claim 23 , wherein the average MW of the polyethylene glycol is between about 100 and about 6000.  
     
     
         25 . The composition of  claim 23 , wherein the average MW of the polyethylene glycol is between about 200 and about 400.  
     
     
         26 . A method for forming a polymeric sustained-release drug delivery gel in a subject, comprising injecting into the subject a composition according to any one of claims  23 - 25 .  
     
     
         27 . A method of administering a composition according to claims  23 - 25  wherein the composition is co-administered with an aqueous fluid.  
     
     
         28 . The method according to  claim 27  wherein the aqueous fluid is buffered saline.  
     
     
         29 . A drug delivery device containing a composition according to any one of claims  23 - 25 .  
     
     
         30 . A device according to  claim 29  wherein the device has at least one opening.  
     
     
         31 . A device according to  claim 29  wherein the device is an open tube.

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