IP Library › Granted Patent US 10,195,168
Granted Patent B2
US 10,195,168 · App. 15/385,447 · Granted Feb 5, 2019

Gamma-hydroxybutyrate compositions and their uses for the treatment of disorders

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Quick Facts
Patent No.
US 10,195,168
App. No.
15/385,447
Granted
Feb 5, 2019
Kind
B2
Abstract

Provided herein are pharmaceutical compositions and formulations comprising mixed salts of gamma-hydroxybutyrate (GHB). Also provided herein are methods of making the pharmaceutical compositions and formulations, and methods of their use for the treatment of sleep disorders such as apnea, sleep time disturbances, narcolepsy, cataplexy, sleep paralysis, hypnagogic hallucination, sleep arousal, insomnia, and nocturnal myoclonus.

Claims (7)

1. A pharmaceutical composition of gamma-hydroxybutyrate (GHB) comprising a mixture of salts of GHB, wherein the mixture consists of a sodium salt of gamma-hydroxybutyrate (Na·GHB), a potassium salt of gamma-hydroxybutyrate (K·GHB), a magnesium salt of gamma-hydroxybutyrate (Mg·(GHB) 2 ), and a calcium salt of gamma-hydroxybutyrate (Ca·(GHB) 2 ), wherein the Na·GHB, K·GHB, Mg·(GHB) 2 , and Ca·(GHB) 2 salts are present in a wt/wt % ratio of about 8%:23%:21%:48%, respectively, wherein the composition is formulated as a liquid formulation, and wherein the liquid formulation has a total concentration of GHB salts of about 350 mg/mL to about 650 mg/mL.

2. The pharmaceutical composition of claim 1 , wherein the total concentration of GHB salts is about 500 mg/mL.

3. The pharmaceutical composition of claim 1 , wherein the composition has a pH of about 7.0 to about 9.0.

4. The pharmaceutical composition of claim 1 , wherein the composition is chemically stable and resistant to microbial growth, and wherein the composition is free of preservatives.

5. A pharmaceutical composition of gamma-hydroxybutyrate (GHB) comprising a mixture of salts of GHB, wherein the mixture consists of a sodium salt of gamma-hydroxybutyrate (Na·GHB), a potassium salt of gamma-hydroxybutyrate (K·GHB), a magnesium salt of gamma-hydroxybutyrate (Mg·(GHB) 2 ), and a calcium salt of gamma-hydroxybutyrate (Ca·(GHB) 2 ), wherein the Na·GHB, K·GHB, Mg·(GHB) 2, and Ca·(GHB) 2 salts are present in a wt/wt % ratio of about 8%:23%:21%:48%, respectively, wherein the composition is in a solid formulation.

6. The pharmaceutical composition of claim 5 , wherein the solid formulation is a tablet, pill, capsule or powder.

7. The pharmaceutical composition of claim 6 , wherein the capsule is a time release capsule.

Assignments (5)
RELEASE OF SECURITY INTEREST Recorded May 5, 2021
From: BANK OF AMERICA, N.A.
To: JAZZ PHARMACEUTICALS, INC.; JAZZ PHARMACEUTICALS IRELAND LIMITED; JAZZ PHARMACEUTICALS INTERNATIONAL LIMITED; JAZZ PHARMACEUTICALS INTERNATIONAL III LIMITED; CELATOR PHARMACEUTICALS, INC.; CAVION, INC.
Reel/Frame 056150/0708 →
SECURITY AGREEMENT Recorded May 5, 2021
From: CAVION, INC.; CELATOR PHARMACEUTICALS, INC.; JAZZ PHARMACEUTICALS IRELAND LIMITED; JAZZ PHARMACEUTICALS, INC.
To: U.S. BANK NATIONAL ASSOCIATION
Reel/Frame 056151/0010 →
SUPPL. NO. 3 TO SECURITY AGREEMENT Recorded Feb 1, 2019
From: JAZZ PHARMACEUTICALS IRELAND LIMITED; JAZZ PHARMACEUTICALS INTERNATIONAL LIMITED; JAZZ PHARMACEUTICALS INTERNATIONAL III LIMITED; JAZZ PHARMACEUTICALS, INC.
To: BANK OF AMERICA, N.A.
Reel/Frame 048208/0585 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 15, 2017
From: ALLPHIN, CLARK P.; DESJARDIN, MICHAEL
To: JAZZ PHARMACEUTICALS, INC.
Reel/Frame 042381/0997 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 15, 2017
From: JAZZ PHARMACEUTICALS, INC.
To: JAZZ PHARMACEUTICALS IRELAND LIMITED
Reel/Frame 042382/0014 →
Cited By (4)
US 12,440,449 US 12,478,604 US 12,551,457 US 12,582,622