Ghb pharmaceutical compositions comprising a floating interpenetrating polymer network forming system

Abstract

GHB drug delivery systems comprising a floating interpenetrating network (IPN) are provided. The pharmaceutical compositions contain at least one IPN forming system, at least GHB drug, and at least one gas generating agent, such that upon oral ingestion of the compositions, a floating IPN is formed in situ. These floating IPN provide extended release of the GHB drug entrapped therein for at least about 3 hours.

1 . An orally administrable gamma hydroxybutyrate drug composition which comprises a floating inter-penetrating network (IPN) forming system comprises:
 (a) at least one gamma hydroxybutyrate or a salt, hydrate, tautomer, or solvate, or complex thereof as the active pharmaceutical ingredient;   (b) an inter-penetrating network (IPN) forming blend which self-assembles into a floating IPN in situ following oral ingestion, which comprises:
 (i) at least two polymers comprising at least one IPN forming anionic polymer and/or at least one IPN forming galactomannan polysaccharide; 
 (ii) at least one cross-linking agent which interacts with the at least one IPN forming anionic polymer or galactomannan (i) to form an IPN and/or a further crosslinked IPN; and 
   (c) a non-toxic gas generating agent, wherein the gas generating agent forms a non-toxic gas when exposed to stomach acid,   wherein following oral ingestion, the composition provides a floating IPN which comprises the gamma hydroxybutyrate drug and the non-toxic gas entrapped therein, thereby providing a floating IPN.