US2007037982A1PendingUtilityA1

Preparation of oxycodone

59
Individually held — no corporate assignee on recordPriority: Sep 23, 2004Filed: Oct 25, 2006Published: Feb 15, 2007
Est. expirySep 23, 2024(expired)· nominal 20-yr term from priority
Inventors:Michael CasnerJen-Sen DungErno M. KeskenyJin Luo
C07D 489/08C07D 489/04C07D 489/02A61P 43/00
59
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Claims

Abstract

A method of purifying oxycodone or a salt thereof includes the steps of: a) preparing a solution including the oxycodone or salt thereof in a solvent, the solution having a pH less than 6, and; b) maintaining the solution at a temperature of at least 55° C. for a period of at least 1 hour; wherein the step of maintaining is performed in the absence of hydrogenation reagents.

Claims

exact text as granted — not AI-modified
1 . A method of purifying oxycodone or a salt thereof, comprising the steps of: 
 a) preparing a solution comprising the oxycodone or salt thereof in a solvent, said solution having a pH less than 6, and;    b) maintaining the solution at a temperature of at least 55° C. for a period of at least 1 hour;    wherein the step of maintaining is performed in the absence of hydrogenation reagents.    
     
     
         2 . The method of  claim 1 , wherein the solution comprises oxycodone hydrochloride.  
     
     
         3 . The method of  claim 1 , wherein the pH is less than 5.  
     
     
         4 . The method of  claim 1 , wherein the pH is less than 3.  
     
     
         5 . The method of  claim 1 , wherein the temperature is at least 60° C.  
     
     
         6 . The method of  claim 1 , wherein the temperature is from about 70° C. to 75° C.  
     
     
         7 . The method of  claim 1 , wherein the period is at least 3 hours.  
     
     
         8 . The method of  claim 1 , wherein the period is at least 5 hours.  
     
     
         9 . The method of  claim 1 , wherein the period is from 5 to 10 hours.  
     
     
         10 . The method of  claim 1 , further comprising after step (b) the steps of: 
 c) contacting the solution with hydrogenation reagents for a period of at least 1 hour; and    d) crystallizing the product of step (c) to form the purified oxycodone or salt thereof;    wherein the purified oxycodone or salt thereof comprises less than 2 ppm of 14-hydroxycodeinone.    
     
     
         11 . The method of  claim 10 , wherein the purified oxycodone or salt thereof is oxycodone hydrochloride.  
     
     
         12 . The method of  claim 10 , wherein the hydrogenation reagents comprise a hydrogenation catalyst and either hydrogen or a hydrogen transfer reagent.  
     
     
         13 . A method of purifying oxycodone or a salt thereof, comprising the steps of: 
 a) preparing a solution comprising the oxycodone or salt thereof in a solvent, said solution having a pH less than 6, and;    b) maintaining the solution at a temperature of at least 55° C. for a period of at least 1 hour;    wherein the solution comprises, after the maintaining step, a level of 14-hydroxycodeinone that is higher than a level of 14-hydroxycodeinone before the maintaining step.    
     
     
         14 . The method of  claim 13 , wherein the solution comprises oxycodone hydrochloride.  
     
     
         15 . The method of  claim 13 , wherein the pH is less than 5.  
     
     
         16 . The method of  claim 13 , wherein the pH is less than 3.  
     
     
         17 . The method of  claim 13 , wherein the temperature is at least 60° C.  
     
     
         18 . The method of  claim 13 , wherein the temperature is from about 70° C. to 75° C.  
     
     
         19 . The method of  claim 13 , wherein the period is at least 3 hours.  
     
     
         20 . The method of  claim 13 , wherein the period is at least 5 hours.  
     
     
         21 . The method of  claim 13 , wherein the period is from 5 to 10 hours.  
     
     
         22 . The method of  claim 13 , wherein the step of maintaining is performed in the absence of hydrogenation reagents.  
     
     
         23 . The method of  claim 13 , further comprising after step (b) the steps of: 
 c) contacting the solution with hydrogenation reagents for a period of at least 1 hour; and    d) crystallizing the product of step (c) to form the purified oxycodone or salt thereof;    wherein the purified oxycodone or salt thereof comprises less than 2 ppm of 14-hydroxycodeinone.    
     
     
         24 . The method of  claim 23 , wherein the purified oxycodone or salt thereof is oxycodone hydrochloride.  
     
     
         25 . The method of  claim 23 , wherein the hydrogenation reagents comprise a hydrogenation catalyst and either hydrogen or a hydrogen transfer reagent.  
     
     
         26 . Crystalline oxycodone hydrochloride comprising less than 2 ppm of 14-hydroxycodeinone.  
     
     
         27 . The crystalline oxycodone hydrochloride of  claim 26 , comprising about 0 ppm of 14-hydroxycodeinone.

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