# US 11,077,079 B1 · GHB formulation and method for its manufacture

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- Number: US 11,077,079 B1
- Document ID: US11077079B1
- Status: Granted
- Kind: B1
- Application number: 17/118,041
- Filed: 2020-12-10
- Granted: 2021-08-03
- Earliest claimed: 2015-02-18
- Assignees: Jazz Pharmaceuticals Ireland Limited
- Applicants: Jazz Pharmaceuticals Ireland Limited
- Inventors: Clark Allphin; Scott Bura
- Web page: https://patentgrep.com/patent/US11077079B1

## CPC

- A61K 31/19: Carboxylic acids, e.g. valproic acid (salicylic acid A61K31/60)
- A61K 9/10: Dispersions; Emulsions
- A61K 9/1635: {obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates}
- A61K 9/2846: {Poly(meth)acrylates}
- A61K 9/5031: {obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poly(lactide-co-glycolide)}
- A61K 31/785: Polymers containing nitrogen
- A61K 38/02: Peptides of undefined number of amino acids; Derivatives thereof
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)

## Abstract

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

## Claims

### Claim 1

A method of treating narcolepsy in a patient in need thereof, the method comprising:
administering a single daily dose to the patient, the single daily dose comprising an amount of oxybate equivalent to from 4.0 g to 12.0 g of sodium oxybate, wherein the administering comprises:
opening a sachet containing a solid oxybate formulation,
mixing the formulation with water, and
orally administering the mixture to the patient, wherein the oxybate formulation comprises an immediate release component and a controlled release component.

### Claim 2 (depends on 1)

The method of claim 1, wherein the orally administering occurs at night.

### Claim 3 (depends on 1)

The method of claim 1, wherein the oxybate formulation is mixed with water immediately prior to administration.

### Claim 4 (depends on 1)

The method of claim 1, wherein the oxybate is administered with food.

### Claim 5 (depends on 1)

The method of claim 1, wherein the administering promotes the patient to sleep for 6 to 8 hours.

### Claim 6 (depends on 1)

The method of claim 1, wherein the amount of oxybate administered to the patient is 35 mEq, 45 mEq, 60 mEq, or 70 mEq of oxybate.

### Claim 7 (depends on 1)

The method of claim 1, wherein the mixture is a suspension.

### Claim 8 (depends on 1)

The method of claim 1, wherein the oxybate formulation further comprises an acid.

### Claim 9 (depends on 8)

The method of claim 8, wherein the acid is selected from the group consisting of malic acid, citric acid, tartaric acid, boric acid, maleic acid, phosphoric acid, and benzoic acid.

### Claim 10

A method of treating cataplexy or excessive daytime sleepiness associated with narcolepsy in a patient in need thereof, the method comprising:
administering a single daily dose to the patient, the single daily dose comprising an amount of oxybate equivalent to from 4.0 g to 12.0 g of sodium oxybate, wherein the administering comprises:
opening a sachet containing a solid oxybate formulation,
mixing the formulation with water, and
orally administering the mixture to the patient, wherein the oxybate formulation comprises an immediate release component and a controlled release component.

### Claim 11 (depends on 10)

The method of claim 10, wherein the orally administering occurs at night.

### Claim 12 (depends on 10)

The method of claim 10, wherein the oxybate formulation is mixed with water immediately prior to administration.

### Claim 13 (depends on 10)

The method of claim 10, wherein the oxybate is administered with food.

### Claim 14 (depends on 10)

The method of claim 10, wherein the administering promotes the patient to sleep for 6 to 8 hours.

### Claim 15 (depends on 10)

The method of claim 10, wherein the amount of oxybate administered to the patient is 35 mEq, 45 mEq, 60 mEq, or 70 mEq of oxybate.

### Claim 16 (depends on 10)

The method of claim 10, wherein the mixture is a suspension.

### Claim 17 (depends on 16)

The method of claim 16, wherein the oxybate formulation further comprises an acid.

### Claim 18 (depends on 17)

The method of claim 17, wherein the acid is selected from the group consisting of malic acid, citric acid, tartaric acid, boric acid, maleic acid, phosphoric acid, and benzoic acid.