Povidone-iodine topical composition

Abstract

The present invention relates to a topical pharmaceutical composition comprising povidone-iodine, a tertiary amide, surfactant and coconut oil, useful for killing microbes and treating wounds or sores on the surface of the skin.

1 - 36 . (canceled) 
     
     
         37 . A composition comprising:
 a povidone-iodine complex, wherein the amount of complexed iodine in the povidone-iodine complex is within a range of about 4% to about 12% by weight of the povidone-iodine complex;   a tertiary amide or a salt or hydrate thereof, wherein the amount of tertiary amide is within a range of about 0.1% to about 2% by weight of the composition;   wherein the composition has a pH within a range of about 2.0 to about 3.5 and has a specific gravity within a range of about 0.9 to about 1.1; and   wherein the composition contains less than 5% by weight of an ingredient that reacts with iodine.   
     
     
         38 . The composition of  claim 37 , further comprising coconut oil. 
     
     
         39 . The composition of  claim 38 , wherein the amount of coconut oil is within a range of about 0.5% to about 2% by weight of the composition. 
     
     
         40 . The composition of  claim 37 , further comprising a surfactant. 
     
     
         41 . The compositions of  claim 40 , wherein the surfactant is a polyethylene glycol of 4-(1,1,3,3-tetramethylbutyl)-phenyl, or Nonoxynol 9, or combination thereof. 
     
     
         42 . The composition of  claim 37 , wherein the amount of povidone-iodine complex is within a range of about 5% to about 10% by weight of the composition. 
     
     
         43 . The composition of  claim 41 , wherein the amount of povidone-iodine complex is within a range of about 5% to about 10% by weight of the composition. 
     
     
         44 . The composition of  claim 37 , wherein the composition further comprises beeswax. 
     
     
         45 . The composition of  claim 37 , wherein the tertiary amide has the formula 
       
         
           
           
               
               
           
         
         wherein R 4  is a saturated fatty group of 11-29 carbon atoms; 
         R 5  and R 6  are independently lower alkyl aryl, aryl lower alkyl, or saturated fatty group containing 11-29 carbon atoms or R 7 :
 R 7  is
   R 1 —Ar—O—R 2 —O—R 3 —;
 
 
 R 2  and R 3  are independently alkylene groups containing 1-6 carbon atoms, 
 R 1  is a lower alkyl, and 
 Ar is aryl. 
 
       
     
     
         46 . The composition of  claim 45 , wherein R 4  is a saturated fatty group containing 15-21 carbon atoms. 
     
     
         47 . The composition of  claim 45 , wherein R 5  is aryl or aryl lower alkyl; and R 6  is
   R 1 —Ar—O—R 2 —O—R 3 —;
   R 2  and R 3  are independently alkylene containing 1-3 carbon atoms; and   Ar is aryl.   
     
     
         48 . The composition of  claim 45 , wherein Ar is phenyl. 
     
     
         49 . The composition of  claim 45 , wherein R 5  is aryl lower alkyl. 
     
     
         50 . The composition of  claim 45 , wherein R 5  is benzyl. 
     
     
         51 . The composition of  claim 50 , wherein R 4  is a saturated fatty group containing 15-21 carbon atoms. 
     
     
         52 . The composition of  claim 45 , wherein the tertiary amide is benzethonium stearamide or benzalkonium stearamide. 
     
     
         53 . The composition of  claim 37 , wherein the tertiary amide is a hydrate of the tertiary amide, and wherein the hydrate of the tertiary amide is of the formula 
       
         
           
           
               
               
           
         
         R 4  is a saturated fatty group of 11-29 carbon atoms; 
         R 5  and R 6  are independently lower alkyl, aryl, aryl lower alkyl, or fatty group containing 11-29 carbon atoms or R 7 ; 
         R 7  is
   R 1 —Ar—O—R 2 —O—R 3 —;
 
 
         R 2  and R 3  are independently alkylene groups containing 1-6 carbon atoms; 
         R 1  is an alkyl group containing 1-15 carbon atoms; and 
         Ar is aryl. 
       
     
     
         54 . The composition of  claim 37 , wherein the composition is in the form of a paste, cream or ointment. 
     
     
         55 . The composition of  claim 37 , wherein the composition is in the form of an aerosol spray. 
     
     
         56 . A method for treating a wound or open sore on a subject which comprises
 placing a microbicidal effective amount of a topical pharmaceutical composition onto the wound or open sore and rubbing the composition thereon thoroughly,   said composition comprising:   an antiseptic effective amount of povidone-iodine complex wherein the amount of complexed iodine in the povidone-iodine complex is from about 4% to about 12% by weight of the povidone-iodine complex;   a second component comprising a tertiary amide or a salt thereof or a hydrate thereof, said second component present in an amount from about 0.1% to about 2% by weight of the composition;   coconut oil in an amount from about 0.5% to about 2% by weight of the composition;   an emulsifying effective amount of a surfactant; and   water;   said composition having a pH of about 2.0 to about 3.5 and having a specific gravity from about 0.9 to about 1.1; and   said composition containing less than 5% by weight of an ingredient that reacts with iodine.