US2024016770A1PendingUtilityA1

Ghb formulation and method for its manufacture

84
Assignee: JAZZ PHARMACEUTICALS IRELAND LTDPriority: Feb 18, 2015Filed: Sep 25, 2023Published: Jan 18, 2024
Est. expiryFeb 18, 2035(~8.6 yrs left)· nominal 20-yr term from priority
Inventors:Clark AllphinScott Bura
A61K 31/19A61K 31/785A61K 9/5031A61K 38/02A61K 9/2846A61K 9/10A61K 9/1635
84
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Claims

Abstract

The present application relates to GHB formulations and methods for manufacturing the same.

Claims

exact text as granted — not AI-modified
We claim: 
     
         1 . An oral pharmaceutical composition for the treatment of narcolepsy, cataplexy, or excessive daytime sleepiness comprising gamma-hydroxybutyrate in a unit dose suitable for administration less than two hours after eating. 
     
     
         2 . The oral pharmaceutical composition of  claim 1 , wherein the composition is suitable for administration with food. 
     
     
         3 . The oral pharmaceutical composition of  claim 1 , wherein the composition is administered once daily. 
     
     
         4 . The oral pharmaceutical composition of  claim 1 , wherein the composition comprises gamma-hydroxybutyrate in an extended release or delayed release formulation. 
     
     
         5 . The oral pharmaceutical composition of  claim 1 , wherein the composition comprises gamma-hydroxybutyrate in a modified release formulation. 
     
     
         6 . The oral pharmaceutical composition of  claim 1 , wherein the composition comprises an immediate release component and an extended release component. 
     
     
         7 . The oral pharmaceutical composition of  claim 1 , wherein the composition comprises an amount of gamma-hydroxybutyrate equivalent to from 4.0 g to 12.0 g of sodium gamma-hydroxybutyrate. 
     
     
         8 . The oral pharmaceutical composition of  claim 1 , wherein the composition comprises an amount of gamma-hydroxybutyrate equivalent to about 4.0 g, about 6 g, about 7.5 g or about 9 g of sodium gamma-hydroxybutyrate. 
     
     
         9 . The oral pharmaceutical composition of  claim 1 , wherein the composition comprises an amount of gamma-hydroxybutyrate equivalent to about 6 g of sodium gamma-hydroxybutyrate. 
     
     
         10 . The oral pharmaceutical composition of  claim 1 , wherein the composition comprises an amount of gamma-hydroxybutyrate equivalent to about 7.5 g of sodium gamma-hydroxybutyrate. 
     
     
         11 . The oral pharmaceutical composition of  claim 1 , wherein the composition comprises an amount of gamma-hydroxybutyrate equivalent to about 9 g of sodium gamma-hydroxybutyrate. 
     
     
         12 . An oral pharmaceutical composition for the treatment of narcolepsy, cataplexy, or excessive daytime sleepiness comprising an amount of gamma-hydroxybutyrate in a unit dose form suitable for once a day administration less than two hours after eating protein or triglycerides or a mixture thereof, wherein the composition comprises gamma-hydroxybutyrate in an extended release or delayed release formulation. 
     
     
         13 . The oral pharmaceutical composition of  claim 12 , wherein the composition further comprises gamma-hydroxybutyrate in an immediate release component. 
     
     
         14 . The oral pharmaceutical composition of  claim 12 , wherein unit dose contains an amount of gamma-hydroxybutyrate equivalent to about 6 g of sodium gamma-hydroxybutyrate. 
     
     
         15 . The oral pharmaceutical composition of  claim 12 , wherein unit dose contains an amount of gamma-hydroxybutyrate equivalent to about 7.5 g of sodium gamma-hydroxybutyrate. 
     
     
         16 . The oral pharmaceutical composition of  claim 12 , wherein unit dose contains an amount of gamma-hydroxybutyrate equivalent to about 9 g of sodium gamma-hydroxybutyrate. 
     
     
         17 . The oral pharmaceutical composition of  claim 12 , wherein the unit dose is a sachet. 
     
     
         18 . An oral pharmaceutical composition for the treatment of narcolepsy, cataplexy, or excessive daytime sleepiness comprising gamma-hydroxybutyrate in a unit dose suitable for administration in combination with proteins, triglycerides or a mixture thereof. 
     
     
         19 . The oral pharmaceutical composition of  claim 18 , wherein the composition is suitable for co-administration with proteins, triglycerides or a mixture thereof. 
     
     
         20 . The oral pharmaceutical composition of  claim 18 , wherein the composition comprises gamma-hydroxybutyrate in an extended release formulation. 
     
     
         21 . The oral pharmaceutical composition of  claim 18 , wherein the composition comprises gamma-hydroxybutyrate in an immediate release formulation. 
     
     
         22 . The oral pharmaceutical composition of  claim 18 , wherein the composition comprises gamma-hydroxybutyrate in an immediate release component and an extended release component. 
     
     
         23 . The oral pharmaceutical composition of  claim 18 , wherein the composition is administered once daily. 
     
     
         24 . The oral pharmaceutical composition of  claim 18 , wherein the composition comprises an amount of gamma-hydroxybutyrate equivalent to from 4.0 g to 12.0 g of sodium gamma-hydroxybutyrate. 
     
     
         25 . A method of treating narcolepsy, cataplexy, or excessive daytime sleepiness in a patient in need thereof, the method comprising:
 administering a single daily dose to the patient less than two hours after eating, the single daily dose comprising controlled release particles and immediate release particles, wherein the single daily dose comprises an amount of gamma-hydroxybutyrate equivalent to from 4.0 g to 12.0 g of sodium gamma-hydroxybutyrate; and wherein the single daily dose provides therapeutically effective levels of gamma-hydroxybutyrate for about 6-8 hours after administration of the single daily dose to the patient.   
     
     
         26 . The method of  claim 25 , further comprising administering to the patient (a) a pro-anion compound selected from the group consisting of one or more proteins and triglycerides; or (b) a supplemental anion compound. 
     
     
         27 . The method of  claim 25 , further comprising administering to the patient a quantity of protein providing an amount of amino acid after administration ranging from about 40 to about 200 mmoles. 
     
     
         28 . The method of  claim 25 , wherein the single daily dose comprises an amount of gamma-hydroxybutyrate equivalent to about 4.0 g, about 6 g, about 7.5 g or about 9 g of sodium gamma-hydroxybutyrate. 
     
     
         29 . The method of  claim 25 , wherein the single daily dose is in a unit dose. 
     
     
         30 . The method of  claim 29 , wherein the unit dose is a sachet.

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