US2010029942A1PendingUtilityA1

Process for the preparation of benzoimidazol-2-yl pyrimidine derivatives

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Assignee: CESCO-CANCIAN SERGIOPriority: Jun 30, 2008Filed: Jun 29, 2009Published: Feb 4, 2010
Est. expiryJun 30, 2028(~2 yrs left)· nominal 20-yr term from priority
A61P 37/06A61P 9/10A61P 37/00A61P 7/06A61P 37/08A61P 27/02A61P 29/00A61P 25/00A61P 1/16A61P 11/02A61P 17/06A61P 1/04A61P 11/06A61P 11/00A61P 15/00A61P 19/02A61P 19/08A61P 17/04A61P 17/00A61P 21/04C07D 403/04A61K 31/506C07D 401/12C07D 401/14
61
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Claims

Abstract

The present invention is directed to benzoimidazol-2-yl pyrimidine derivatives useful as histamine H 4 receptor modulators and processes for the preparation of such compounds.

Claims

exact text as granted — not AI-modified
1 . A process for the preparation of a compound of formula (I) 
     
       
         
         
             
             
         
       
       wherein 
       R 1 , R 2 , R 3  and R 4  are each independently selected from the group consisting of H, C 1-4 alkyl, C 2-4 alkenyl, C 2-4 alkynyl, phenyl, —CF 3 , —OCF 3 , —CN, halo, —NO 2 , —OC 1-4 alkyl, —SC 1-4 alkyl, —S(O)C 1-4 alkyl, —SO 2 C 1-4 alkyl, —C(O)C 1-4 alkyl, —C(O)phenyl, —C(O)NR a R b , —CO 2 C 1-4 alkyl, —CO 2 H, —C(O)NR a R b , and —NR a R b ; wherein R a  and R b  are each independently selected from the group consisting of H, C 1-4 alkyl, and C 3-7 cycloalkyl; 
       X 1  is C—R c ; wherein R c  is selected from the group consisting of H, methyl, hydroxymethyl, dimethylaminomethyl, ethyl, propyl, isopropyl, —CF 3 , cyclopropyl, and cyclobutyl; 
       X 2  is N; 
       n is 1 or 2; 
       Z is selected from the group consisting of N, CH, and C(C 1-4 alkyl); 
       R 6  is selected from the group consisting of H, C 1-6 alkyl, and a monocyclic cycloalkyl; 
       R 8  is selected from the group consisting of H and C 1-4 alkyl; 
       R 9 , R 10  and R 11  are each independently selected from the group consisting of H and C 1-4 alkyl; 
       or pharmaceutically acceptable salt, or pharmaceutically acceptable prodrug, or pharmaceutically active metabolite thereof; comprising 
     
     
       
         
         
             
             
         
       
       reacting a compound of formula (V) with a reducing agent system; in a solvent; at a temperature in the range of from about 0° C. to about 25° C., to yield compound of formula (VI); and 
     
     
       
         
         
             
             
         
       
       reacting compound of formula (VI) with a compound of formula (VII) in the presence of an oxidizing agent system, in a solvent, at a temperature in the range of from about 25° C. to about 100° C. 
     
   
   
       2 . A process for the preparation of a compound of formula (I-A) 
     
       
         
         
             
             
         
       
       or pharmaceutically acceptable salt, or pharmaceutically acceptable prodrug, or pharmaceutically active metabolite thereof; comprising 
     
     
       
         
         
             
             
         
       
       reacting a compound of formula (V-S) with a reducing agent system; in a solvent; at a temperature in the range of from about 0° C. to about 25° C., to yield compound of formula (VI-S); 
     
     
       
         
         
             
             
         
       
       reacting compound of formula (VI-S) with a compound of formula (VII-A) in the presence of an oxidizing agent system, in a solvent, at a temperature in the range of from about 25° C. to about 100° C., to yield compound of formula (I-A). 
     
   
   
       3 . A process as in  claim 2  wherein the reducing agent system is selected from the group consisting of Diabl-H, and RANEY® nickel and a source of hydrogen. 
   
   
       4 . A process as in  claim 2 , wherein the reducing agent system is DIBAL-H; wherein the DIBAL-His present in an amount in the range of from about 1.0 to about 5.0 molar equivalents; and wherein the solvent in said reacting a compound of formula (V-S) is selected from the group consisting of anhydrous toluene and anhydrous THF. 
   
   
       5 . A process as in  claim 4 , wherein DIBAL-His present in an amount of about 2.5 molar equivalents. 
   
   
       6 . A process as in  claim 2 , wherein the reducing agent system is RANEY® nickel and a source of hydrogen; wherein the source of hydrogen is formic acid; and wherein the solvent in said reacting a compound of formula (V-S) is water. 
   
   
       7 . A process as in  claim 6 , wherein the RANEY® nickel is present in an amount in of about 200% by weight and wherein the formic acid is present in an excess amount. 
   
   
       8 . A process as in  claim 2 , wherein compound of formula (V-S) is reacted with the reducing agent system at a temperature of about 5 to about 25° C. 
   
   
       9 . A process as in  claim 2 , wherein compound of formula (VII-A) is present as its corresponding free base. 
   
   
       10 . A process as in  claim 2 , wherein the compound of formula (VII-A) is present in an amount in the range of from about 1.0 to about 1.25 molar equivalents. 
   
   
       11 . A process as in  claim 10 , wherein the compound of formula (VII-A) is present in an amount in the range of from about 1.0 to about 1.1 molar equivalents. 
   
   
       12 . A process as in  claim 2 , wherein the oxidizing agent system is selected from the group consisting of Na 2 S 2 O 5 /air and Na 2 SO 3 /air. 
   
   
       13 . A process as in  claim 2 , wherein the oxidizing agent or oxidizing agent system is present in an amount in the range of from about 0.90 to about 1.5 molar equivalents. 
   
   
       14 . A process as in  claim 13 , wherein the oxidizing agent system is present in an amount of about 1.0 molar equivalents. 
   
   
       15 . A process as in  claim 2 , wherein the compound of formula (VI-S) is reacted with compound of formula (VII-A) in water. 
   
   
       16 . A process as in  claim 2 , wherein the compound of formula (VI-S) is reacted with compound of formula (VII-A) at a temperature in the range of from about 55° C. to about 65° C. 
   
   
       17 . A process for the preparation of a compound of formula (I-B) 
     
       
         
         
             
             
         
       
       or pharmaceutically acceptable salt, or pharmaceutically acceptable prodrug, or pharmaceutically active metabolite thereof; comprising 
     
     
       
         
         
             
             
         
       
       reacting a compound of formula (V-S) with a reducing agent system; in a solvent; at a temperature in the range of from about 0° C. to about 25° C.; to yield compound of formula (VI-S); and 
     
     
       
         
         
             
             
         
       
       reacting the compound of formula (VI-S) with a compound of formula (VII-B) in the presence of an oxidizing agent system, in a solvent at a temperature in the range of from about 25° C. to about 100° C., to yield compound of formula (I-B). 
     
   
   
       18 . A process as in  claim 17 , wherein the reducing agent system is selected from the group consisting of DIBAL-H, and RANEY® nickel and a source of hydrogen. 
   
   
       19 . A process as in  claim 17 , wherein the reducing agent system is DIBAL-H; wherein the DIBAL-His present in an amount in the range of from about 1.0 to about 5.0 molar equivalents; and wherein the solvent in said reacting a compound of formula (V-S) is selected from the group consisting of anhydrous THF and anhydrous toluene. 
   
   
       20 . A process as in  claim 19 , wherein the DIBAL-His present in an amount of about 2.5 molar equivalents. 
   
   
       21 . A process as in  claim 17 , wherein the reducing agent system is RANEY® nickel and a source of hydrogen; wherein the source of hydrogen is formic acid; and wherein the solvent in said reacting a compound of formula (V-S) is water. 
   
   
       22 . A process as in  claim 21 , wherein the RANEY® nickel is present in an amount of about 20% by weight and wherein the formic acid is present in an excess amount. 
   
   
       23 . A process as in  claim 17 , wherein the compound of formula (V-S) is reacted with the reducing agent system at a temperature of from about 5° C. to about 25° C. 
   
   
       24 . A process as in  claim 17 , wherein the compound of formula (VII-B) is present as its corresponding free base. 
   
   
       25 . A process as in  claim 17 , wherein the compound of formula (VII-B) is present in an amount in the range of from about 1.0 to about 1.25 molar equivalents. 
   
   
       26 . A process as in  claim 25 , wherein the compound of formula (VII-B) is present in an amount in the range of from about 1.0 to about 1.1 molar equivalents. 
   
   
       27 . A process as in  claim 17 , wherein the oxidizing agent system is selected from the group consisting of Na 2 S 2 O 5 /air and Na 2 SO 3 /air. 
   
   
       28 . A process as in  claim 17 , wherein the oxidizing agent system is present in an amount in the range of from about 0.90 to about 1.5 molar equivalents. 
   
   
       29 . A process as in  claim 28 , wherein the oxidizing agent system is present in an amount of about 1.0 molar equivalents. 
   
   
       30 . A process as in  claim 17 , wherein the compound of formula (VI-S) is reacted with the compound of formula (VII-B) in water. 
   
   
       31 . A process as in  claim 17 , wherein the compound of formula (VI-S) is reacted with the compound of formula (VII-B) at a temperature in the range of from about 55° C. to about 65° C. 
   
   
       32 . A crystalline hemi-tartrate of compound of formula (I-A) 
     
       
         
         
             
             
         
       
     
   
   
       33 . A crystalline hemi-tartrate of compound of formula (I-A) 
     
       
         
         
             
             
         
       
       whose powder X-ray diffraction spectrum comprises the following powder X-ray diffraction peaks: 
     
     
       
         
               
               
               
             
                   
                   
               
                   
                 Pos. [°2θ] 
                 d-spacing [Å] 
               
                   
                   
               
                   
               
               
               
               
             
                   
                 6.49 
                 13.62 
               
                   
                 8.58 
                 10.30 
               
                   
                 9.17 
                 9.64 
               
                   
                 10.35 
                 8.55 
               
                   
                 10.75 
                 8.23 
               
                   
                 16.72 
                 5.30 
               
                   
                 17.46 
                 5.08 
               
                   
                 18.89 
                 4.70 
               
                   
                 23.60 
                 3.77 
               
                   
                   
               
           
              
              
              
             
             
              
             
          
           
              
              
              
              
              
              
              
              
              
              
             
          
         
       
     
   
   
       34 . A process for the preparation of a hemi-tartrate of compound of formula (I-A) 
     
       
         
         
             
             
         
       
       comprising: 
       dissolving the compound of formula (I-A) in an organic solvent forming a solution; 
       heating said solution to a first temperature in the range of from about 35° C. to about reflux; 
       adding L-tartaric acid to form a tartrate solution; and 
       heating said tartrate solution to a second temperature in the range of from about 50° C. to about reflux to form a heated mixture. 
     
   
   
       35 . A process as in  claim 34 , wherein said heating said first temperature is about 50° C. 
   
   
       36 . A process as in  claim 34 , wherein the L-tartaric acid is added in an amount of about 0.5 molar equivalents. 
   
   
       37 . A process as in  claim 34 , wherein said second temperature is a temperature of about 70° C. to about 75° C. 
   
   
       38 . A process as in  claim 34 , further comprising cooling said heated mixture to a temperature in the range of from about 0° C. to about −5° C. 
   
   
       39 . A process for the recrystallization of a hemi-tartrate of compound of formula (I-A) 
     
       
         
         
             
             
         
       
       comprising: 
       dissolving the hemi-tartrate of compound of formula (I-A) in a mixture of water and an organic solvent, or in a mixture of organic solvents; and 
       removing a sufficient amount of water to yield a mixture with boiling point of between about 78° C. and about 80° C. 
     
   
   
       40 . A process as in  claim 39 , wherein the hemi-tartrate of compound of formula (I-A) is dissolved in one of the following mixtures: a mixture of water and denatured ethanol, and a mixture of methanol and denatured ethanol. 
   
   
       41 . A process as in  claim 40 , wherein the hemi-tartrate of compound of formula (I-A) is dissolved in a mixture of water and denatured ethanol; and wherein the water in the mixture is present in an amount of from about 1% to about 1.5% by weight. 
   
   
       42 . A process as in  claim 41 , wherein said water is present in an amount of about 1.4% by weight. 
   
   
       43 . A process as in  claim 39 , wherein said dissolving is made in a mixture of water and an organic solvent, and further comprising heating said hemi-tartrate of the compound of formula (I-A) in said mixture of water and an organic solvent to azeotropically remove the water.

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