Edible oils to enhance delivery of orally administered steroids
View Patent ↗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.
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.
2. The method of claim 1 , wherein the composition consists essentially of allopregnanolone and the edible oil.
3. The method of claim 1 , wherein the allopregnanolone is suspended or dissolved in the edible oil.
4. The method of claim 1 , wherein the composition is contained within a soft gel capsule for oral delivery to a subject.
5. The method of claim 1 , wherein the composition consists essentially of allopregnanolone and canola oil.
6. 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.
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.
8. The method of claim 7 , wherein the subject is experiencing aura.
9. The method of claim 7 , wherein the composition consists essentially of allopregnanolone and the edible oil.
10. The method of claim 7 , wherein the allopregnanolone is suspended or dissolved in the edible oil.
11. The method of claim 7 , wherein the composition is contained within a soft gel capsule for oral delivery to a subject.
12. The method of claim 7 , wherein the composition consists essentially of allopregnanolone and canola oil.
13. 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.
14. The method of claim 7 , wherein the subject is a human.
15. The method of claim 1 , wherein the oral administration of allopregnanolone reduces the frequency, severity and/or duration of seizures caused by epilepsy.
16. The method of claim 1 , wherein the subject is a human.