IP Library › Granted Patent US 12,440,449
Granted Patent B2
US 12,440,449 · App. 17/670,078 · Granted Oct 14, 2025

Alcohol-resistant drug formulations

Inventors: Edwin Walsh (Dublin, IE); Clark Patrick Allphin (Seattle, WA)
Assignee: Jazz Pharmaceuticals Ireland Limited
A61K9/2866A61K9/2846A61K45/06
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Quick Facts
Patent No.
US 12,440,449
App. No.
17/670,078
Granted
Oct 14, 2025
Kind
B2
Abstract

The invention relates to modified release oral formulations of therapeutic agents, including gamma hydroxybutyrate (GHB), paracetamol, codeine or oxycodone, which are resistant to alcohol induced dose dumping. Provided are formulations that have improved resistance to rapid release of the active ingredient in the presence of increasing amounts of alcohol. Also provided are formulations that can reduce or prevent the release of the active ingredient following exposure to alcohol-containing media. The invention also relates to methods of making the 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 (31)

1. A pharmaceutical formulation comprising a film coated drug carrier core, wherein the drug carrier core comprises at least one therapeutic agent selected from gamma hydroxybutyrate (GHB), a pharmaceutically acceptable salt of GHB, or a prodrug of GHB, and wherein the film coating comprises a polymer blend of ethyl cellulose and a polymethacrylate polymer disposed over the drug carrier core; and

wherein the polymer blend provides an enteric dissolution.

2. The formulation of claim 1 , wherein the polymethacrylate polymer in the polymer blend is methacrylic acid-ethyl acrylate co-polymer, methacrylic acid methyl methacrylate co-polymer, or methyl acrylate-methyl methacrylate-methacrylic acid co-polymer.

3. The formulation of claim 2 , wherein the polymethacrylate polymer in the polymer blend is methacrylic acid-ethyl acrylate co-polymer, and wherein the ratio of methacrylic acid to ethyl acrylate is about 1:1.

4. The formulation of claim 1 , wherein the ethyl cellulose and the polymethacrylate polymer are present at a weight ratio of ethyl cellulose:polymethacrylate polymer from 50:1 to 1:50, 25:1 to 1:25, 10:1 to 1:10, 5:1 to 1:5 or 3:1 to 1:3.

5. The formulation of claim 1 , wherein the film coating is a first coating and the formulation further comprises a second coating comprising at least one polymer, wherein the second coating is disposed over the first coating.

6. The formulation of claim 5 , wherein the second coating comprises ethyl cellulose and methacrylic acid-ethyl acrylate co-polymer.

7. The formulation of claim 5 , wherein the second coating further comprises a polysaccharide gum selected from the group consisting of acacia gum, guar gum, tragacanth gum, xanthan gum, and mixtures thereof.

8. The formulation of claim 5 , wherein the polymer in the second coating is a cellulose polymer, and wherein the second coating further comprises guar gum, which is present at 1-15% w/w of the cellulose polymer.

9. The formulation of claim 1 , wherein the pharmaceutically acceptable salt of GHB is selected from the group consisting of sodium oxybate, calcium oxybate, potassium oxybate, magnesium oxybate, and combinations thereof.

10. The formulation of claim 1 , wherein:

a) a release rate of the at least one therapeutic agent from the formulation in a second stage of a two-stage dissolution test is decreased after the formulation is exposed to about 5% to about 40% v/v ethanol in a first stage as compared to the release rate of the at least one therapeutic agent from the formulation in the second stage when the formulation is not exposed to ethanol in the first stage; wherein the first stage of the two-stage dissolution test is in 0.1N HCl buffer and the second stage is in Tris pH 6.8 buffer; or

b) not more than 0% to about 40% of the at least one therapeutic agent is released from the formulation within about 1 hour of exposure to an acidic aqueous buffer comprising about 5% v/v to about 20% v/v ethanol; or

c) a release rate of the at least one therapeutic agent from the formulation when about 5% v/v to about 35% v/v ethanol is present in 0.1N HCl buffer dissolution media is within about 1% to about 10% of the release rate of the at least one therapeutic agent from the formulation in the absence of ethanol for about 60 minutes in 0.1N HCl buffer dissolution media.

11. A pharmaceutical formulation comprising a film coated drug carrier core, wherein the drug carrier core comprises at least one therapeutic agent selected from gamma hydroxybutyrate (GHB), a pharmaceutically acceptable salt of GHB, or a prodrug of GHB, and wherein the film coating comprises a polymer blend of ethyl cellulose and a polymethacrylate polymer disposed over the drug carrier core; and

wherein the polymethacrylate polymer in the polymer blend is methacrylic acid-ethyl acrylate co-polymer, methacrylic acid methyl methacrylate co-polymer, or methyl acrylate-methyl methacrylate-methacrylic acid co-polymer.

12. The formulation of claim 11 , wherein the polymethacrylate polymer in the polymer blend is methacrylic acid-ethyl acrylate co-polymer, and wherein the ratio of methacrylic acid to ethyl acrylate is about 1:1.

13. The formulation of claim 11 , wherein the ethyl cellulose and the polymethacrylate polymer are present at a weight ratio of ethyl cellulose:polymethacrylate polymer from 50:1 to 1:50, 25:1 to 1:25, 10:1 to 1:10, 5:1 to 1:5 or 3:1 to 1:3.

14. The formulation of claim 11 , wherein the film coating is a first coating and the formulation further comprises a second coating comprising at least one polymer, wherein the second coating is disposed over the first coating.

15. The formulation of claim 14 , wherein the second coating comprises ethyl cellulose and methacrylic acid-ethyl acrylate co-polymer.

16. The formulation of claim 14 , wherein the second coating further comprises a polysaccharide gum selected from the group consisting of acacia gum, guar gum, tragacanth gum, xanthan gum, and mixtures thereof.

17. The formulation of claim 14 , wherein the polymer in the second coating is a cellulose polymer, and wherein the second coating further comprises guar gum, which is present at 1-15% w/w of the cellulose polymer.

18. The formulation of claim 11 , wherein the pharmaceutically acceptable salt of GHB is selected from the group consisting of sodium oxybate, calcium oxybate, potassium oxybate, magnesium oxybate, and combinations thereof.

19. The formulation of claim 11 , wherein:

a) a release rate of the at least one therapeutic agent from the formulation in a second stage of a two-stage dissolution test is decreased after the formulation is exposed to about 5% to about 40% v/v ethanol in a first stage as compared to the release rate of the at least one therapeutic agent from the formulation in the second stage when the formulation is not exposed to ethanol in the first stage; wherein the first stage of the two-stage dissolution test is in 0.1N HCl buffer and the second stage is in Tris pH 6.8 buffer; or

b) not more than 0% to about 40% of the at least one therapeutic agent is released from the formulation within about 1 hour of exposure to an acidic aqueous buffer comprising about 5% v/v to about 20% v/v ethanol; or

c) a release rate of the at least one therapeutic agent from the formulation when about 5% v/v to about 35% v/v ethanol is present in 0.1N HCl buffer dissolution media is within about 1% to about 10% of the release rate of the at least one therapeutic agent from the formulation in the absence of ethanol for about 60 minutes in 0.1N HCl buffer dissolution media.

20. A method of treatment of a disease, disorder or symptom comprising administration of a formulation of claim 1 to a patient in need thereof, wherein the disease, disorder or symptom is selected from the group consisting of sleeping disorders, drug abuse, alcohol and/or opiate withdrawal, a reduced level of growth hormone, anxiety, analgesia, Parkinson's Disease, depression, fibromyalgia, endocrine disturbances and tissue protection following hypoxia/anoxia, stroke, myocardial infarction, an increased level of intracranial pressure, excessive daytime sleepiness, cataplexy, sleep paralysis, apnea, narcolepsy, sleep time disturbances, rapid eye movement (REM) sleep behavior disorder (RBD), hypnagogic hallucinations, sleep arousal, insomnia, idiopathic hypersomnia, essential tremor and nocturnal myoclonus.

21. A method of treatment of a disease, disorder or symptom comprising administration of a formulation of claim 11 to a patient in need thereof, wherein the disease, disorder or symptom is selected from the group consisting of sleeping disorders, drug abuse, alcohol and/or opiate withdrawal, a reduced level of growth hormone, anxiety, analgesia, Parkinson's Disease, depression, fibromyalgia, endocrine disturbances and tissue protection following hypoxia/anoxia, stroke, myocardial infarction, an increased level of intracranial pressure, excessive daytime sleepiness, cataplexy, sleep paralysis, apnea, narcolepsy, sleep time disturbances, rapid eye movement (REM) sleep behavior disorder (RBD), hypnagogic hallucinations, sleep arousal, insomnia, idiopathic hypersomnia, essential tremor and nocturnal myoclonus.

22. The formulation of claim 1 , wherein the film coating is alcohol-resistant.

23. The formulation of claim 11 , wherein the film coating is alcohol-resistant.

Assignments (2)
SECURITY AGREEMENT Recorded Jul 26, 2024
From: CAVION, INC.; CELATOR PHARMACEUTICALS, INC.; GW PHARMA LIMITED; JAZZ PHARMACEUTICALS, INC.; JAZZ PHARMACEUTICALS IRELAND LIMITED; JAZZ PHARMACEUTICALS RESEARCH UK LIMITED (F/K/A GW RESEARCH LIMITED)
To: U.S. BANK TRUST COMPANY, NATIONAL ASSOCIATION, AS COLLATERAL TRUSTEE
Reel/Frame 068173/0155 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 11, 2022
From: WALSH, EDWIN; ALLPHIN, CLARK
To: JAZZ PHARMACEUTICALS IRELAND LIMITED
Reel/Frame 060471/0779 →
Continuity (4)
Continuation 16688797 · Nov 19, 2019
Provisional Application 62769380 · Nov 19, 2018
Provisional Application 62769382 · Nov 19, 2018
Related Publication 20220160640A1 · May 26, 2022
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