Gamma-hydroxybutyrate compositions and their use for the treatment of disorders
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First Claim
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1. A pharmaceutical composition of gamma-hydroxybutyrate (GHB) comprising a mixture of at least three salts of GHB, wherein the mixture comprises a calcium salt of gamma-hydroxybutyrate (Ca•
- (GHB)2), a magnesium salt of gamma-hydroxybutyrate (Mg•
(GHB)2), and one or more salts selected from the group consisting of a sodium salt of gamma-hydroxybutyrate (Na•
GHB) and a potassium salt of gamma-hydroxybutyrate (K•
GHB).
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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.
68 Citations
29 Claims
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1. A pharmaceutical composition of gamma-hydroxybutyrate (GHB) comprising a mixture of at least three salts of GHB, wherein the mixture comprises a calcium salt of gamma-hydroxybutyrate (Ca•
- (GHB)2), a magnesium salt of gamma-hydroxybutyrate (Mg•
(GHB)2), and one or more salts selected from the group consisting of a sodium salt of gamma-hydroxybutyrate (Na•
GHB) and a potassium salt of gamma-hydroxybutyrate (K•
GHB).
- (GHB)2), a magnesium salt of gamma-hydroxybutyrate (Mg•
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2. The pharmaceutical composition of claim 1, wherein the mixture comprises Na•
- GHB, K•
GHB, Mg•
(GHB)2, and Ca•
(GHB)2, and wherein the amount of Na•
GHB is present at a wt/wt % of about 5% to about 40%.
- GHB, K•
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3. The pharmaceutical composition of claim 1, wherein a Na•
- GHB salt is present in a wt/wt % of about 5% to about 10%.
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4. The pharmaceutical composition of claim 1, wherein a K•
- GHB salt is present in a wt/wt % of about 10% to about 15%, about 15% to about 20%, about 20% to about 25%, about 25% to about 30%, about 30% to about 35%, or about 35% to about 40%.
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5. The pharmaceutical composition of claim 1, wherein the Mg•
- (GHB)2 salt is present in a wt/wt % of about 5% to about 10%, about 10% to about 15%, about 15% to about 20%, about 20% to about 25%, or about 25% to about 30%.
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6. The pharmaceutical composition of claim 1, wherein the Ca•
- (GHB)2 salt is present in a wt/wt % of about 20% to about 25%, about 25% to about 30%, about 30% to about 35%, about 35% to about 40%, about 40% to about 45%, about 45% to about 50%, or about 50% to about 55%.
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7. The pharmaceutical composition of claim 2, wherein the Na•
- GHB salt is present in a wt/wt % of about 5% to about 10%.
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8. The pharmaceutical composition of claim 2, wherein the K•
- GHB salt is present in a wt/wt % of about 10%, about 15%, about 20%, about 25%, about 30%, about 35%, or about 40%.
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9. The pharmaceutical composition of claim 2, wherein the Mg•
- (GHB)2 salt is present in a wt/wt % of about 5%, about 10%, about 15%, about 20%, about 25%, or about 30%.
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10. The pharmaceutical composition of claim 2, wherein the Ca•
- (GHB)2 salt is present in a wt/wt % of about 20%, about 25%, about 30%, about 35%, about 40%, about 45%, about 50%, or about 55%.
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11. The pharmaceutical composition of claim 2, wherein the Na•
- GHB salt is present in a wt/wt % of about 5% to about 40%, the K•
GHB salt is present in a wt/wt % of about 10% to about 40%, the Mg•
(GHB)2 salt is present in a wt/wt % of about 5% to about 30%, and the Ca•
(GHB)2 salt is present in a wt/wt % of about 20% to about 80%.
- GHB salt is present in a wt/wt % of about 5% to about 40%, the K•
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12. The pharmaceutical composition of claim 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%;
32%;
20%;
40%, respectively.
- GHB, K•
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13. The pharmaceutical composition of claim 2, wherein the Na•
- GHB, K•
GHB, Mg•
(GHB)2, and Ca•
(GHB)2 salts are present in a wt/wt % ratio of about 29%;
31%;
13%;
27%, respectively.
- GHB, K•
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14. The pharmaceutical composition of claim 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.
- GHB, K•
-
15. The pharmaceutical composition of claim 1, wherein the mixture comprises Mg•
- GHB2, Na•
GHB, and Ca•
(GHB)2.
- GHB2, Na•
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16. The pharmaceutical composition of claim 15, wherein the Na•
- GHB salt is present in a wt/wt % of about 5% to about 10%, the Mg•
GHB2 salt is present in a wt/wt % of about 20% to about 25%, and the Ca•
(GHB)2 salt is present in a wt/wt % of about 40% to about 50%.
- GHB salt is present in a wt/wt % of about 5% to about 10%, the Mg•
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17. The pharmaceutical composition of claim 1, wherein the mixture comprises K•
- GHB, Mg•
(GHB)2, and Ca•
(GHB)2.
- GHB, Mg•
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18. The pharmaceutical composition of claim 17, wherein the K•
- GHB salt is present in a wt/wt % of about 10% to about 40%, the M•
(GHB)2 salt is present in a wt/wt % of about 20% to about 30%, and the Ca•
(GHB)2 salt is present in a wt/wt % of about 40% to about 55%.
- GHB salt is present in a wt/wt % of about 10% to about 40%, the M•
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19. The pharmaceutical composition of claim 17, wherein the K•
- GHB, M•
(GHB)2 and Ca•
(GHB)2 salts are present in a wt/wt % ratio of about 33%;
42%;
25%, respectively.
- GHB, M•
-
20. The pharmaceutical composition of claim 1, comprising an aqueous solution of about 250 mg/mL to about 750 mg/mL of the mixture of salts of GHB, wherein the composition has a pH of about 7.0 to about 9.0, wherein the composition is chemically stable and resistant to microbial growth, and wherein the composition is free of preservatives.
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21. The pharmaceutical composition of claim 20, wherein the composition has a pH of about 7.3 to about 8.5.
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22. The pharmaceutical composition of claim 20, wherein the composition additionally comprises a pH adjusting or buffering agent.
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23. The pharmaceutical composition of claim 22, wherein the pH adjusting or buffering agent is an acid.
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24. The pharmaceutical composition of claim 23, wherein acid is an inorganic acid or an organic acid, wherein acid is selected from the group consisting of malic acid, citric acid, acetic acid, boric acid, lactic acid, hydrochloric acid, phosphoric acid, sulfuric acid, sulfonic acid, and nitric acid.
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25. The pharmaceutical composition of claim 24, wherein acid is malic acid.
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26. The pharmaceutical composition of claim 1, wherein the composition is formulated as a liquid formulation.
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27. The formulation of claim 26, wherein the formulation is chemically stable and resistant to microbial growth, and wherein the formulation is free of preservatives.
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28. The formulation of claim 26, which is suitable for oral administration.
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29. The formulation of claim 26, wherein the formulation is chemically stable and resistant to microbial growth, and wherein the formulation contains at least one preservative.
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Litigation Data
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Current AssigneeJazz Pharmaceuticals Ireland Limited (Jazz Pharmaceuticals Plc)
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Original AssigneeJazz Pharmaceuticals Ireland Limited (Jazz Pharmaceuticals Plc)
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InventorsAllphin, Clark P., DesJardin, Michael
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Primary Examiner(s)Richter, Johann R
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Assistant Examiner(s)Zhang, Yanzhi
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Application NumberUS14/045,673Publication NumberTime in Patent Office712 DaysField of Search514/557, 562/579US Class Current1/1CPC Class CodesA61K 2300/00 Mixtures or combinations of...A61K 31/19 Carboxylic acids, e.g. valp...A61K 31/554 having at least one nitroge...A61K 9/0053 Mouth and digestive tract, ...A61K 9/08 Solutions composition of so...A61P 25/00 Drugs for disorders of the ...A61P 25/04 Centrally acting analgesics...A61P 25/20 Hypnotics; Sedatives
