COMPOSITIONS COMPRISING IBOGAINE, OPTIONALLY IN COMBINATION WITH N-ACYLETHANOLAMINES, AND USES THEREOF
The present disclosure relates to pharmaceutical compositions comprising ibogaine, or a salt thereof, and combinations of ibogaine, or a pharmaceutically acceptable salt thereof and an N-acylethanolamine, or a salt thereof, and at least one pharmaceutically acceptable carrier and/or excipient, and their use in methods of treating substance addiction and opioid dependence by administrating said compositions to a subject in need thereof in a therapeutically effective amount.
1 . A pharmaceutical composition comprising ibogaine, or a pharmaceutically acceptable salt thereof, and at least one pharmaceutically acceptable carrier and/or excipient.
2 . The pharmaceutical composition of claim 1 , wherein the composition is a unit dosage from composition.
3 . The pharmaceutical composition of claim 2 , wherein the pharmaceutical composition is a solid unit dosage form composition.
4 . The pharmaceutical composition of claim 2 , wherein the pharmaceutical composition is a liquid unit dosage form composition.
5 . The pharmaceutical composition of claim 2 , wherein the pharmaceutical composition is packaged as a single unit dose or as a plurality of single unit doses.
6 . The pharmaceutical composition of claim 2 , wherein the unit dosage form comprises from 200 mg to 1000 mg of ibogaine or a pharmaceutically acceptable salt thereof.
7 . The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition is formulated for oral administration or intravenous administration.
8 . A method of treating substance addiction, comprising administrating to a subject in need thereof a therapeutically effective amount of a pharmaceutical composition comprising ibogaine, or a pharmaceutically acceptable salt thereof.
9 . A method of treating opioid dependence, comprising administrating to a subject in need thereof a therapeutically effective amount of a pharmaceutical composition comprising ibogaine, or a pharmaceutically acceptable salt thereof.
10 . The method of claim 8 or 9 , wherein the pharmaceutical composition further comprises at least on pharmaceutically acceptable carrier and/or excipient.
11 . The method of claim 8 or 9 , wherein the pharmaceutical composition is a free-flowing powder, a tablet, a capsule, a lozenge, a liquid, a liquid concentrate, or a syrup.
12 . The method of claim 8 or 9 , wherein the pharmaceutical composition is a unit dosage form composition.
13 . The method of claim 8 or 9 , wherein an amount of ibogaine or a pharmaceutically acceptable salt thereof in the unit dosage form ranges from about 200 mg to about 1000 mg.
14 . The method of claim 8 or 9 , wherein the amount of ibogaine or a pharmaceutically acceptable salt thereof is about 0.5-2 mg/kg, 2-5 mg/kg, 5-10 mg/kg, 10-15 mg/kg, and 15-30 mg/kg body weight.
15 . The method of claim 8 or 9 , wherein the pharmaceutical composition is administered orally or intravenously.
16 . A pharmaceutical composition comprising ibogaine or a pharmaceutically acceptable salt thereof, and an N-acylethanolamine or a pharmaceutically acceptable salt thereof, and at least one pharmaceutically acceptable carrier and/or excipient.
17 . The pharmaceutical composition of claim 16 , wherein the composition is a unit dosage from composition.
18 . The pharmaceutical composition of claim 17 , wherein the pharmaceutical composition is a solid unit dosage form composition.
19 . The pharmaceutical composition of claim 17 , wherein the pharmaceutical composition is a liquid unit dosage form composition.
20 . The pharmaceutical composition of claim 17 , wherein the pharmaceutical composition is packaged as a single unit dose or as a plurality of single unit doses.
21 . The pharmaceutical composition of claim 17 , wherein the unit dosage form comprises from 200 mg to 1000 mg of ibogaine or a pharmaceutically acceptable salt thereof.
22 . The pharmaceutical composition of claim 17 , wherein the unit dosage form comprises from 50 mg to 1800 mg of N-acylethanolamine or a pharmaceutically acceptable salt thereof.
23 . The pharmaceutical composition of claim 16 , wherein the pharmaceutical composition is formulated for oral administration or intravenous administration.
24 . A method of treating substance addiction, comprising administrating to a subject in need thereof a therapeutically effective amount of a pharmaceutical composition comprising ibogaine, or a pharmaceutically acceptable salt thereof, and an N-acylethanolamine, or a pharmaceutically acceptable salt thereof.
25 . A method of treating opioid dependence, comprising administrating to a subject in need thereof a therapeutically effective amount of a pharmaceutical composition comprising ibogaine, or a pharmaceutically acceptable salt thereof, and an N-acylethanolamine, or a pharmaceutically acceptable salt thereof.
26 . The method of claim 24 or 25 , wherein the pharmaceutical composition further comprises at least on pharmaceutically acceptable carrier and/or excipient.
27 . The method of claim 24 or 25 , wherein the pharmaceutical composition is a free-flowing powder, a tablet, a capsule, a lozenge, a liquid, a liquid concentrate, or a syrup.
28 . The method of claim 24 or 25 , wherein the pharmaceutical composition is a unit dosage form composition.
29 . The method of claim 24 or 25 , wherein an amount of ibogaine or a pharmaceutically acceptable salt thereof in the unit dosage form ranges from about 200 mg to about 1000 mg.
30 . The method of claim 24 or 25 , wherein the amount of N-acylethanolamine or a pharmaceutically acceptable salt thereof in the unit dosage form ranges from 50 mg to 1800 mg.
31 . The method of claim 24 or 25 , wherein the amount of ibogaine or a pharmaceutically acceptable salt thereof is about 0.5-2 mg/kg, 2-5 mg/kg, 5-10 mg/kg, 10-15 mg/kg, and 15-30 mg/kg body weight.
32 . The method of claim 24 or 25 , wherein the pharmaceutical composition is administered orally or intravenously.
33 . The pharmaceutical composition of any preceding claim , wherein the N-acylethanolamine is selected from the group consisting of N-palmitoylethanolamine (PEA), Me-palmitoylethanolamide (Me-PEA), palmitoylcyclohexamide, palmitoylbutylamide, palmitoylisopropylamide, oleoylethanolamine (OEA), palmitoylisopropylamide (PIA), salts thereof and any combination thereof.
34 . The method of any preceding claim , wherein the N-acylethanolamine is selected from the group consisting of N-palmitoylethanolamine (PEA), Me-palmitoylethanolamide (Me-PEA), palmitoylcyclohexamide, palmitoylbutylamide, palmitoylisopropylamide, oleoylethanolamine (OEA), palmitoylisopropylamide (PIA), salts thereof and any combination thereof.
35 . The pharmaceutical composition of any preceding claim , wherein the N-acylethanolamine is PEA or a pharmaceutically acceptable salt thereof.
36 . The method of any preceding claim , wherein the N-acylethanolamine is PEA or a pharmaceutically acceptable salt thereof.