# US 10,478,505 B2 · Edible oils to enhance delivery of orally administered steroids

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- Number: US 10,478,505 B2
- Document ID: US10478505B2
- Status: Granted
- Kind: B2
- Application number: 14/345,385
- Filed: 2012-09-21
- Published: 2014-11-20
- Granted: 2019-11-19
- Earliest claimed: 2011-09-23
- Assignees: The Regents of the University of California
- Applicants: The Regents of the University of California
- Inventors: Michael A. Rogawski
- Web page: https://patentgrep.com/patent/US10478505B2

## CPC

- A61K 47/46: Ingredients of undetermined constitution or reaction products thereof, e.g. skin, bone, milk, cotton fibre, eggshell, oxgall or plant extracts
- A61K 9/4816: {Wall or shell material}
- A61K 9/4833: {Encapsulating processes; Filling of capsules (mechanical aspects A61J3/07)}
- A61K 9/4858: {Organic compounds}
- A61K 31/57: substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
- A61K 47/44: Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin (synthetic glycerides, e.g. medium-chain triglycerides, A61K47/14)
- A61P 25/08: Antiepileptics; Anticonvulsants
- 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)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

The present invention relates to the formulation of steroids, including neurosteroids (e.g., allopregnanolone (ALP)) in edible oils to enhance their absorption when administered, e.g., orally or transmucosally to a patient.

## Claims

### Claim 1

A method of treating, reducing, and/or mitigating a seizure caused by epilepsy, in a subject in need thereof, comprising administration to the subject orally a therapeutic regimen comprising a composition comprising allopregnanolone formulated in an edible oil selected from the group consisting of canola oil, peanut oil, and mixtures thereof, wherein the composition does not comprise a surfactant, wherein the subject suffers from seizure clusters, and wherein the allopregnanolone is administered at a dose from about 50 mg/kg to about 250 mg/kg.

### Claim 2 (depends on 1)

The method of claim 1, wherein the composition consists essentially of allopregnanolone and the edible oil.

### Claim 3 (depends on 1)

The method of claim 1, wherein the allopregnanolone is suspended or dissolved in the edible oil.

### Claim 4 (depends on 1)

The method of claim 1, wherein the composition is contained within a soft gel capsule for oral delivery to a subject.

### Claim 5 (depends on 1)

The method of claim 1, wherein the composition consists essentially of allopregnanolone and canola oil.

### Claim 6 (depends on 1)

The method of claim 1, wherein the allopregnanolone is administered at a dose of about 50 mg/kg, 75 mg/kg, 100 mg/kg, 200 mg/kg or 250 mg/kg.

### Claim 7

A method of reducing the frequency, severity and/or duration of seizures caused by epilepsy, in a subject in need thereof, comprising administration to the subject orally a therapeutic regimen comprising a composition comprising allopregnanolone and an edible oil selected from the group consisting of canola oil, peanut oil, and mixtures thereof, wherein the composition does not comprise a surfactant, wherein the subject suffers from seizure clusters, and wherein the allopregnanolone is administered at a dose from about 50 mg/kg to about 250 mg/kg.

### Claim 8 (depends on 7)

The method of claim 7, wherein the subject is experiencing aura.

### Claim 9 (depends on 7)

The method of claim 7, wherein the composition consists essentially of allopregnanolone and the edible oil.

### Claim 10 (depends on 7)

The method of claim 7, wherein the allopregnanolone is suspended or dissolved in the edible oil.

### Claim 11 (depends on 7)

The method of claim 7, wherein the composition is contained within a soft gel capsule for oral delivery to a subject.

### Claim 12 (depends on 7)

The method of claim 7, wherein the composition consists essentially of allopregnanolone and canola oil.

### Claim 13 (depends on 7)

The method of claim 7, wherein the allopregnanolone is administered at a dose of about 50 mg/kg, 75 mg/kg 100 mg/kg, 200 mg/kg or 250 mg/kg.

### Claim 14 (depends on 7)

The method of claim 7, wherein the subject is a human.

### Claim 15 (depends on 1)

The method of claim 1, wherein the oral administration of allopregnanolone reduces the frequency, severity and/or duration of seizures caused by epilepsy.

### Claim 16 (depends on 1)

The method of claim 1, wherein the subject is a human.