Immediate release formulations and dosage forms of gamma-hydroxybutyrate

Abstract

The present invention provides a solid immediate release dosage form adapted for oral administration of GHB. The solid immediate release dosage form includes an immediate release formulation comprising a relatively high weight-percentage of GHB with a bioavailability similar to that of a liquid GHB dosage form.

1 - 10 . (canceled) 
     
     
         11 . A unit dosage form for oral delivery of GHB, comprising an immediate release formulation, wherein said immediate release formulation comprises:
 GHB or a pharmaceutically acceptable salt thereof, in an amount of about 80-84% by weight of the immediate release formulation;   microcrystalline cellulose (MCC) in an amount of about 1-15% by weight of the immediate release formulation; and   povidone in an amount of about 1-5% by weight of the immediate release formulation.   
     
     
         12 . The unit dosage form of  claim 11 , wherein said povidone is in an amount of about 4% by weight of the immediate release formulation. 
     
     
         13 . The unit dosage form of  claim 11 , wherein said microcrystalline cellulose is in an amount of about 15% by weight of the immediate release formulation. 
     
     
         14 . The unit dosage form of  claim 11 , wherein said GHB or a pharmaceutically acceptable salt thereof is in an amount of about 81% by weight of the immediate release formulation. 
     
     
         15 . The unit dosage form of  claim 11 , wherein GHB or a pharmaceutically acceptable salt thereof, is in an amount of about 81% by weight of the immediate release formulation, microcrystalline cellulose is in an amount of about 15% by weight of the immediate release formulation, and povidone is in an amount of about 4% by weight of the immediate release formulation. 
     
     
         16 . The unit dosage form of  claim 11 , wherein the immediate release formulation releases more than 80% of the GHB or a pharmaceutically acceptable salt thereof contained therein within 30 minutes after administration. 
     
     
         17 . The unit dosage form of  claim 11 , wherein said immediate release formulation releases more than 95% of the GHB or a pharmaceutically acceptable salt thereof contained therein within 45 minutes after administration.