Methods for treating major depressive disorder and treatment-resistant depression
AssigneeiX Biopharma Ltd.
InventorsYip Hang Eddy LEE, Chin Beng Stephen LIM
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Abstract
The invention concerns methods of using a ketamine dosage form in treating depression and, in particular, major depressive disorder and treatment-resistant depression, comprising administering to a patient in need thereof, a fast dissolving freeze-dried wafer solid dosage form with a matrix for rapid release and absorption of ketamine in the oral cavity of the said patient.
Claims21
1-20. (canceled)
A method of treating major depressive disorder or treatment-resistant depression comprising sublingually administering to a patient in need thereof, a wafer solid dosage form, wherein said dosage form comprises:
- (a) ketamine or a salt form thereof at a dose of about 25 mg to about 150 mg;
- (b) about 2 to about 20% w/w amorphous, non-ionic matrix forming agent;
- and
- (c) about 40% to about 80% w/w crystalline matrix forming agent;
- wherein the dosage form dissolves in the oral cavity;
- and wherein said dosage form disintegrates in the oral cavity in a time of less than 15 seconds and dissolves in the oral cavity in a time of less than 60 seconds, and wherein ketamine is detected in vivo within 5 minutes.
A method for improving uptake of ketamine in a patient suffering from major depressive disorder or treatment-resistant depression, said method comprising administering sublingually to a patient in need thereof, a fast-dissolving wafer solid dosage form, wherein said dosage form comprises:
- (a) ketamine or a salt form thereof at a dose of about 25 mg to about 150 mg;
- and
- (b) about 2 to about 20% w/w amorphous matrix forming agent;
- and
- (c) about 40% to about 80% w/w crystalline matrix forming agent;
- wherein the dosage form dissolves in the oral cavity without leaving a residue of said dosage form;
- and wherein said dosage form disintegrates in the oral cavity in a time of less than 15 seconds and dissolves in the oral cavity in a time of less than 60 seconds;
- and wherein ketamine is detected in vivo within 5 minutes.
A method of treating depression-related suicidal ideation comprising sublingually administering to an oral cavity of a patient in need thereof, a wafer solid dosage form, wherein said dosage form comprises:
- (a) ketamine or a salt form thereof at a dose of about 25 mg to about 150 mg;
- (b) about 2 to about 20% w/w amorphous, non-ionic matrix forming agent;
- and
- (c) about 40% to about 80% w/w crystalline matrix forming agent;
- wherein the dosage form dissolves in the oral cavity;
- and wherein said dosage form disintegrates in the oral cavity in a time of less than 15 seconds and dissolves in the oral cavity in a time of less than 60 seconds, and wherein ketamine is detected in vivo within 5 minutes.
A method for improving uptake of ketamine in a patient suffering from suicidal ideation and/or drug-resistant depression, said method comprising administering sublingually to a patient in need thereof, a fast-dissolving wafer solid dosage form,
- wherein the dosage form comprises:
- (a) ketamine or a salt form thereof at a dose of about 25 mg to about 150 mg;
- and
- (b) about 2 to about 20% w/w amorphous matrix forming agent;
- and
- (c) about 40% to about 80% w/w crystalline matrix forming agent;
- wherein the dosage form dissolves in the oral cavity without leaving a residue of said dosage form;
- wherein the dosage form disintegrates in the oral cavity in a time of less than 15 seconds and dissolves in the oral cavity in a time of less than 60 seconds;
- wherein the ketamine is detected in vivo within 5 minutes;
- wherein the ketamine is rapidly absorbed with detectable concentrations at a first sampling time of 3 minutes;
- and
- wherein the rapid therapeutic action of the ketamine is caused by a detectable blood ketamine concentration within minutes of sublingual administration;
- and
- wherein the rapid therapeutic action of the ketamine results in action in the brain;
- and
- wherein the first exposure effect causes at least one of the following effects:
- glutamate modulation;
- synaptic repair;
- inflammation reduction;
- and network resetting.
Dependencies are inferred from the claim text.