Edible oils to enhance delivery of orally administered steroids

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.

1 . A composition comprising a steroid and an edible oil. 
     
     
         2 . A composition consisting essentially of a steroid and an edible oil. 
     
     
         3 . The composition of  claim 1 , wherein the steroid is a neurosteroid. 
     
     
         4 . The composition of  claim 3 , wherein the neurosteroid is selected from the group consisting of allopregnanolone, allotetrahydrodeoxycorticosterone, ganaxolone, alphaxolone, alphadolone, hydroxydione, minaxolone, and Althesin. 
     
     
         5 . The composition of  claim 3 , wherein the neurosteroid is allopregnanolone. 
     
     
         6 . The composition of  claim 1 , wherein the steroid is suspended or dissolved in the edible oil. 
     
     
         7 . The composition of  claim 1 , wherein the edible oil comprises one or more vegetable oils. 
     
     
         8 . The composition of  claim 7 , wherein the vegetable oil is selected from the group consisting of coconut oil, corn oil, cottonseed oil, olive oil, palm oil, peanut oil, rapeseed oil, canola oil, safflower oil, sesame oil, soybean oil, sunflower oil, and mixtures thereof. 
     
     
         9 . The composition of  claim 1 , wherein the edible oil is canola oil. 
     
     
         10 . The composition of  claim 1 , wherein the edible oil is peanut oil. 
     
     
         11 . The composition of  claim 1 , wherein the edible oil comprises one or more nut oils. 
     
     
         12 . The composition of  claim 11 , wherein the nut oil is selected from the group consisting of almond oil, cashew oil, hazelnut oil, macadamia oil, mongongo nut oil, pecan oil, pine nut oil, pistachio oil, walnut oil, and mixtures thereof. 
     
     
         13 . The composition of  claim 1 , wherein the composition is contained within a soft gel capsule for oral delivery to a subject. 
     
     
         14 . The composition of  claim 1 , wherein the steroid is not progesterone. 
     
     
         15 . The composition of  claim 1 , wherein the composition comprises or consists essentially of allopregnanolone and canola oil. 
     
     
         16 . The composition of  claim 1 , wherein the composition comprises or consists essentially of allopregnanolone and peanut oil. 
     
     
         17 . A method of treating, reducing, and/or mitigating symptoms associated with and/or caused by traumatic brain injury, Alzheimer's disease, epilepsy, anxiety, fragile X syndrome, post-traumatic stress disorder, lysosomal storage disorders (Niemann-Pick type C disease), depression (including post-partum depression), premenstrual dysphoric disorder, alcohol craving, and smoking cessation in a subject in need thereof, comprising administration to the subject orally or transmucosally a composition of  claim 1 . 
     
     
         18 . The method of  claim 17 , wherein the composition is administered orally. 
     
     
         19 . A method of treating, reducing, and/or mitigating symptoms associated with and/or caused by epilepsy, in a subject in need thereof, comprising administration to the subject orally or transmucosally a composition of  claim 1 . 
     
     
         20 . A method of accelerating the termination or abortion of an impending seizure in a subject in need thereof, comprising administration to the subject orally or transmucosally a composition of  claim 1 . 
     
     
         21 . The method of  claim 19 , wherein the subject is experiencing aura. 
     
     
         22 . The method of  claim 19 , wherein the subject has been warned of an impending seizure. 
     
     
         23 . The method of  claim 19 , wherein the subject is experiencing a seizure. 
     
     
         24 . The method of  claim 19 , wherein the subject has status epilepticus. 
     
     
         25 . The method of  claim 19 , wherein the subject has myoclonic epilepsy. 
     
     
         26 . The method of  claim 19 , wherein the subject suffers from seizure clusters. 
     
     
         27 . The method of  claim 23 , wherein the seizure is a tonic seizure. 
     
     
         28 . The method of  claim 23 , wherein the seizure is a clonic seizure.