Method for decreasing symptoms of alcohol consumption

Abstract

The present invention relates to methods and compositions of metadoxine and physiologically compatible active derivatives thereof, and their use for decreasing symptoms of alcohol consumption as well as in the prevention of alcohol consumption related symptoms in subjects in need thereof.

1 . A method for decreasing or preventing symptoms or effects of alcohol consumption in a subject in need thereof, wherein said subject has not reached intoxication, comprising non-chronic administration of a composition comprising metadoxine. 
     
     
         2 . A method for preventing alcohol intoxication in a subject in need thereof, wherein said subject has not reached intoxication, comprising administering a composition comprising metadoxine. 
     
     
         3 . A method for reducing or eliminating blood alcohol levels in a subject in need thereof, wherein said subject has not reached intoxication, comprising administering a composition comprising metadoxine. 
     
     
         4 . The method according to  claim 2  or  3 , wherein said composition is administered by non-chronic administration. 
     
     
         5 . The method according to  claim 1 , wherein said subject is or will be social drinking, session drinking or binge drinking. 
     
     
         6 . The method according to  claim 1 , wherein said composition is administered in a single dosage form or portion thereof. 
     
     
         7 . The method of  claim 1 , wherein the mode of administration is oral, sublingual, buccal, nasal, transdermal, transmucosal, rectal or subcutaneous administration. 
     
     
         8 . A composition comprising metadoxine formulated for sustained or controlled release upon administration to a subject. 
     
     
         9 . A composition comprising metadoxine, wherein a portion of the metadoxine is formulated for sustained release and a portion of the metadoxine is formulated for immediate release upon administration to a subject. 
     
     
         10 . The composition according to  claim 8 , wherein the relative proportion of sustained release metadoxine to immediate release metadoxine is in a range of from 1-to-99 to 99-to-1, in whole integers. 
     
     
         11 . The composition according to  claim 8 , selected from a pharmaceutical composition, a dietary supplement, a food and a beverage. 
     
     
         12 . The composition according to  claim 8 , wherein said metadoxine is a physiologically compatible derivative. 
     
     
         13 . The composition according to  claim 8 , wherein said composition is formulated for non-chronic administration. 
     
     
         14 . The composition according to  claim 13 , wherein said composition is administered in a single dosage form or portion thereof. 
     
     
         15 . The composition according to  claim 8 , wherein said composition is formulated to release not less than 50% of the total metadoxine within 8 hours. 
     
     
         16 . The composition according to  claim 8 , wherein said composition is formulated to release not less than 50% of the total metadoxine within 6 hours. 
     
     
         17 . The composition according to  claim 8 , wherein said composition has a t max  of metadoxine in the blood greater than about 1 hour. 
     
     
         18 . The composition according to  claim 17 , wherein said composition has a t max  of metadoxine in the blood that is about 2-fold greater than in an immediate release composition. 
     
     
         19 . The composition according to  claim 8 , wherein said composition is formulated to deliver up to 3000 mg of metadoxine in a single dose administration or portion thereof. 
     
     
         20 . The composition according to  claim 8 , wherein said composition further comprises a polymeric material. 
     
     
         21 . The composition according to  claim 8 , wherein said composition further comprises an absorption enhancer. 
     
     
         22 . The composition according to  claim 8 , wherein said composition further comprises an acceptable excipient. 
     
     
         23 . The composition according to  claim 8 , wherein said composition comprises or consists essentially of Formula 1. 
     
     
         24 . The composition according to  claim 8 , wherein said composition comprises or consists essentially of Formula 2. 
     
     
         25 . The composition according to  claim 8 , wherein said composition comprises or consists essentially of Formula 3. 
     
     
         26 . The composition according to  claim 8 , wherein said sustained release is controlled release. 
     
     
         27 . A method for increasing the mean t max  of metadoxine in the blood of a subject in need thereof comprising administering a composition according to  claim 8 . 
     
     
         28 . The method according to  claim 27 , wherein said composition has a t max  of metadoxine in the blood that is about 2-fold greater than in an immediate release composition. 
     
     
         29 . The method according to  claim 1 , wherein said composition is a composition according to  claim 8 . 
     
     
         30 . The method according to  claim 28 , wherein said subject is or will be social drinking, session drinking or binge drinking. 
     
     
         31 . The method according to  claim 28 , wherein said composition is administered by non-chronic administration. 
     
     
         32 . The method according to  claim 31 , wherein said composition is administered in a single dosage form or portion thereof. 
     
     
         33 . The method of  claim 28 , wherein said mode of administration is oral, nasal, rectal, subcutaneous, transmucosal, sublingual, buccal or transdermal administration. 
     
     
         34 - 37 . (canceled) 
     
     
         38 . A drug delivery device comprising a metadoxine composition according to  claim 8 .