US2021267928A1PendingUtilityA1

Modified release gamma- hydroxybutyrate formulations having improved pharmacokinetics

79
Assignee: FLAMEL IRELAND LTDPriority: Jul 22, 2016Filed: May 17, 2021Published: Sep 2, 2021
Est. expiryJul 22, 2036(~10 yrs left)· nominal 20-yr term from priority
Inventors:Claire MégretHervé GuillardJean-François Dubuisson
A61P 43/00A61P 25/20A61P 25/00A61K 31/19A61K 9/5084A61K 9/5078A61K 9/5042A61K 9/5026A61K 9/5015A61K 9/1676A61K 9/146A61K 31/22A61K 9/14
79
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Claims

Abstract

Modified release formulations of gamma-hydroxybutyrate having improved dissolution and pharmacokinetic properties are provided, and therapeutic uses thereof.

Claims

exact text as granted — not AI-modified
1 . A method of treating narcolepsy or at least one symptom thereof, the method comprising:
 opening a sachet containing a pharmaceutical composition;   orally administering the composition to a human subject in need thereof, wherein the orally administering occurs only once per night;   releasing gamma-hydroxybutyrate into the blood stream of the human subject as a result of the orally administering; and   inducing the human subject to sleep for at least six consecutive hours as a result of the orally administering and releasing.   
     
     
         2 . The method of  claim 1 , wherein, when the orally administering comprises administering to the human subject a dose of the composition equivalent to 4.5 g or 6.0 g of sodium oxybate, the composition yields a plasma concentration versus time curve bioequivalent to the plasma concentration versus time curve depicted in  FIG. 12  for the corresponding dose. 
     
     
         3 . The method of  claim 1 , wherein, when the orally administering comprises administering to the human subject a dose of the composition equivalent to 4.5 g, 6.0 g, or 7.5 g of sodium oxybate, the composition yields a plasma concentration versus time curve bioequivalent to the plasma concentration versus time curve depicted in  FIG. 13  for the corresponding dose. 
     
     
         4 . The method of  claim 1 , wherein, when the orally administering comprises administering to the human subject a dose of the composition equivalent to 4.5 g, 7.5 g, or 9.0 g of sodium oxybate, the composition yields a plasma concentration versus time curve bioequivalent to the plasma concentration versus time curve depicted in  FIG. 90  for the corresponding dose. 
     
     
         5 . The method of  claim 1 , wherein the orally administering occurs approximately 2 hours after the human subject has eaten a meal. 
     
     
         6 . The method of  claim 1 , wherein the inducing comprises inducing the human subject to sleep for 6 to 8 consecutive hours. 
     
     
         7 . The method of  claim 1 , wherein the inducing comprises inducing the human subject to sleep for 8 consecutive hours. 
     
     
         8 . The method of  claim 1 , wherein the orally administering comprises administering to the human subject a dose of the composition equivalent to 3.0 g to 12.0 g of sodium oxybate. 
     
     
         9 . The method of  claim 1 , wherein the orally administering comprises administering to the human subject a dose of the composition equivalent to 4.5 g, 6.0 g, 7.5 g, or 9.0 g of sodium oxybate. 
     
     
         10 . The method of  claim 1 , wherein the pharmaceutical composition comprises the free base of gamma-hydroxybutyrate, a pharmaceutically acceptable salt of gamma-hydroxybutyric acid, any combination thereof, or any hydrate, solvate, complex or tautomer thereof. 
     
     
         11 . The method of  claim 1 , wherein the pharmaceutical composition comprises one or more salts of gamma-hydroxybutyric acid selected from sodium salt of gamma-hydroxybutyric acid, potassium salt of gamma-hydroxybutyric acid, magnesium salt of gamma-hydroxybutyric acid, calcium salt of gamma-hydroxybutyric acid, lithium salt of gamma-hydroxybutyric, or tetra ammonium salt of gamma-hydroxybutyric acid. 
     
     
         12 . The method of  claim 1 , wherein the pharmaceutical composition comprises sodium oxybate. 
     
     
         13 . The method of  claim 1 , further comprising mixing the pharmaceutical composition with water after the opening and prior to the orally administering. 
     
     
         14 . The method of  claim 13 , wherein the mixing results in the pharmaceutical composition being suspended in the water. 
     
     
         15 . The method of  claim 13 , wherein the mixing comprises pouring pharmaceutical composition from the sachet into a container containing the water. 
     
     
         16 . The method of  claim 1 , wherein the pharmaceutical composition comprises a modified release formulation of gamma-hydroxybutyrate. 
     
     
         17 . The method of  claim 16 , wherein the modified release formulation comprises immediate release and modified release portions. 
     
     
         18 . The method of  claim 16 , wherein the modified release formulation of gamma-hydroxybutyrate comprises particles with a volume mean diameter of from 100 to 1200 microns. 
     
     
         19 . The method of  claim 16 , wherein the modified release formulation of gamma-hydroxybutyrate comprises particles with a volume mean diameter of from 200 to 800 microns. 
     
     
         20 . The method of  claim 16 , wherein the modified release formulation of gamma-hydroxybutyrate comprises particles with a volume mean diameter of from 100 to 500 microns. 
     
     
         21 . The method of  claim 16 , wherein the modified release formulation of gamma-hydroxybutyrate comprises particles with a volume mean diameter of about 320 microns. 
     
     
         22 . The method of  claim 17 , wherein the immediate release portion comprises particles with a volume mean diameter of from 10 to 1000 microns. 
     
     
         23 . The method of  claim 17 , wherein the immediate release portion comprises particles with a volume mean diameter of from 150 to 400 microns. 
     
     
         24 . The method of  claim 17 , wherein the immediate release portion comprises particles with a volume mean diameter of about 270 microns. 
     
     
         25 . The method of  claim 17 , wherein the immediate release portion comprises particles with a volume mean diameter of from 95 to 600 microns. 
     
     
         26 . The method of  claim 17 , wherein the immediate release portion comprises particles with a volume mean diameter of from 95 to 450 microns. 
     
     
         27 . The method of  claim 17 , wherein the immediate release portion comprises particles with a volume mean diameter of from 95 to 170 microns. 
     
     
         28 . The method of  claim 17 , wherein the immediate release portion comprises particles with a volume mean diameter of about 140 microns. 
     
     
         29 . The method of  claim 22 , wherein the immediate release portion comprises extruded particles. 
     
     
         30 . The method of  claim 29 , wherein the extruded particles are spheronized.

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