COMPOSITIONS COMPRISING KETAMINE, OPTIONALLY IN COMBINATION WITH N-ACYLETHANOLAMINES, AND USES THEREOF
The present disclosure relates to pharmaceutical compositions comprising ketamine, or a salt thereof, and combinations of ketamine, 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 depression, suicidal ideation, bipolar disorder, seizures, and pain by administrating said compositions to a subject in need thereof in a therapeutically effective amount.
1 . A pharmaceutical composition comprising ketamine, 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 25 mg to 500 mg of ketamine or a pharmaceutically acceptable salt thereof.
7 . The pharmaceutical composition of claim 2 , wherein the unit dosage form comprises from 0.25 mg/kg to 10 mg/kg of ketamine or a pharmaceutically acceptable salt thereof.
8 . The pharmaceutical composition of claim 2 , wherein the unit dosage form comprises from 10 mg/mL to 100 mg/mL of ketamine or a pharmaceutically acceptable salt thereof.
9 . The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition is formulated for oral administration, sublingual administration, or intravenous administration.
10 . A method of treating depression or suicidal ideation, comprising administrating to a subject in need thereof a therapeutically effective amount of a pharmaceutical composition comprising ketamine, or a pharmaceutically acceptable salt thereof.
11 . A method of treating pain, comprising administrating to a subject in need thereof a therapeutically effective amount of a pharmaceutical composition comprising ketamine, or a pharmaceutically acceptable salt thereof.
12 . A method of treating seizures, comprising administrating to a subject in need thereof a therapeutically effective amount of a pharmaceutical composition comprising ketamine, or a pharmaceutically acceptable salt thereof.
13 . A method of treating bipolar disorder, comprising administrating to a subject in need thereof a therapeutically effective amount of a pharmaceutical composition comprising ketamine, or a pharmaceutically acceptable salt thereof.
14 . The method of claim 10, 11, 12, or 13 , wherein the pharmaceutical composition further comprises at least on pharmaceutically acceptable carrier and/or excipient.
15 . The method of claim 10, 11, 12, or 13 , wherein the pharmaceutical composition is a free-flowing powder, a tablet, a capsule, a lozenge, a liquid, a liquid concentrate, or a syrup.
16 . The method of claim 10, 11, 12, or 13 , wherein the pharmaceutical composition is a unit dosage form composition.
17 . The method of claim 10, 11, 12, or 13 , wherein an amount of ketamine or a pharmaceutically acceptable salt thereof in the unit dosage form ranges from about 25 mg to about 500 mg.
18 . The method of claim 10, 11, 12, or 13 , wherein the amount of ketamine or a pharmaceutically acceptable salt thereof is about 0.25 mg/kg to about 10 mg/kg body weight.
19 . The pharmaceutical composition of claim 10, 11, 12, or 13 , wherein the unit dosage form comprises from 10 mg/mL to 100 mg/mL of ketamine or a pharmaceutically acceptable salt thereof.
20 . The method of claim 10, 11, 12, or 13 , wherein the pharmaceutical composition is administered orally, sublingually, or intravenously.
21 . A pharmaceutical composition comprising ketamine 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.
22 . The pharmaceutical composition of claim 21 , wherein the composition is a unit dosage from composition.
23 . The pharmaceutical composition of claim 22 , wherein the pharmaceutical composition is a solid unit dosage form composition.
24 . The pharmaceutical composition of claim 22 , wherein the pharmaceutical composition is a liquid unit dosage form composition.
25 . The pharmaceutical composition of claim 22 , wherein the pharmaceutical composition is packaged as a single unit dose or as a plurality of single unit doses.
26 . The pharmaceutical composition of claim 22 , wherein the unit dosage form comprises from 25 mg to 500 mg, 0.25 mg/kg to 10 mg/kg, or 10 mg/mL to 100 mg/mL of ketamine or a pharmaceutically acceptable salt thereof.
27 . The pharmaceutical composition of claim 22 , wherein the unit dosage form comprises from 50 mg to 1800 mg of N-acylethanolamine or a pharmaceutically acceptable salt thereof.
28 . The pharmaceutical composition of claim 21 , wherein the pharmaceutical composition is formulated for oral administration or intravenous administration.
29 . A method of treating depression, comprising administrating to a subject in need thereof a therapeutically effective amount of a pharmaceutical composition comprising ketamine, or a pharmaceutically acceptable salt thereof, and an N-acylethanolamine, or a pharmaceutically acceptable salt thereof.
30 . A method of treating suicidal ideation, comprising administrating to a subject in need thereof a therapeutically effective amount of a pharmaceutical composition comprising ketamine, or a pharmaceutically acceptable salt thereof, and an N-acylethanolamine, or a pharmaceutically acceptable salt thereof.
31 . A method of treating seizures, comprising administrating to a subject in need thereof a therapeutically effective amount of a pharmaceutical composition comprising ketamine, or a pharmaceutically acceptable salt thereof, and an N-acylethanolamine, or a pharmaceutically acceptable salt thereof.
32 . A method of treating bipolar disorder, comprising administrating to a subject in need thereof a therapeutically effective amount of a pharmaceutical composition comprising ketamine, or a pharmaceutically acceptable salt thereof, and an N-acylethanolamine, or a pharmaceutically acceptable salt thereof.
33 . The method of claim 29, 30, 31, or 32 , wherein the pharmaceutical composition further comprises at least on pharmaceutically acceptable carrier and/or excipient.
34 . The method of claim 29, 30, 31, or 32 , wherein the pharmaceutical composition is a free-flowing powder, a tablet, a capsule, a lozenge, a liquid, a liquid concentrate, or a syrup.
35 . The method of claim 29, 30, 31, or 32 , wherein the pharmaceutical composition is a unit dosage form composition.
36 . The method of claim 29, 30, 31, or 32 , wherein an amount of ketamine or a pharmaceutically acceptable salt thereof in the unit dosage form ranges from about 25 mg to about 500 mg, 0.25 mg/kg to 10 mg/kg, or 10 mg/mL to 100 mg/mL.
37 . The method of claim 29, 30, 31, or 32 , wherein the amount of N-acylethanolamine or a pharmaceutically acceptable salt thereof in the unit dosage form ranges from 50 mg to 1800 mg.
38 . The method of claim 29, 30, 31, or 32 , wherein the pharmaceutical composition is administered orally, sublingually, or intravenously.
39 . 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.
40 . 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.
41 . The pharmaceutical composition of any preceding claim , wherein the N-acylethanolamine is PEA or a pharmaceutically acceptable salt thereof.
42 . The method of any preceding claim , wherein the N-acylethanolamine is PEA or a pharmaceutically acceptable salt thereof.