Back to results
US 2024/0189259 A2Published application
Extended Release Pharmaceutical Formulation
AssigneeDouglas Pharmaceuticals Limited
InventorsPaul Glue, Natalie Medlicott, Peter Surman, Yuefeng Long
Life of this patent
Estimating the term…
Abstract
The disclosure provides a dosing regimen utilizing an oral extended release formulation for the treatment of treatment-resistant depression and treatment-resistant anxiety.
Claims48
A method for the prevention, treatment, and/or management in a patient of a condition selected from the group consisting of depression;
- treatment-resistant depression;
- and treatment-resistant anxiety, including but not limited to DSM-V Generalized Anxiety Disorder, Social Anxiety Disorder, Panic Disorder, Post-Traumatic Stress Disorder and/or Obsessive-Compulsive Disorder, comprising:
- selecting a patient in need of the prevention, treatment, alleviation and/or management of said condition;
- administering to said patient a treatment regimen comprising:
- a first dosage course of about 60 mg daily, about 120 mg daily, or about 180 mg daily, of an active agent selected from the group consisting of ketamine, norketamine, and combinations thereof, administered as an oral dosage form,
- optionally, after said first dosage course, administering to the patient a maintenance course comprising a second dosage course of active agent selected from the group consisting of ketamine, norketamine, and combinations thereof, administered as an oral dosage form,
- further wherein the condition is prevented, treated, alleviated and/or managed in said patient.
4 more elements
A solid, oral, extended release pharmaceutical tablet comprising:
- (A) a core comprising:
- i) a therapeutically effective amount of an active agent selected from the group consisting of ketamine, norketamine, pharmaceutically acceptable salts thereof, and combinations thereof, wherein the active agent is present at a concentration of about 6% to about 20%, or at least about 10%, at least about 12% or at least about 15% by weight;
- ii) at least one matrix polymer comprising at least one high molecular weight polyethylene oxide (PEO) that is cured, wherein said high molecular weight PEO has an approximate molecular weight of from about 2 million to about 7 million, based upon rheological measurements, optionally in combination with at least one additional matrix polymer selected from the group consisting of hydroxypropyl methyl cellulose (HPMC), ethyl cellulose (EC), polyvinyl pyrrolidone, xanthan gum, pullulan, polyvinyl alcohol, polyvinyl acetate, glycerol fatty acid esters, polyacrylamide, polyacrylic acid, and copolymers of ethacrylic acid or methacrylic acid;
- and
- iii) a lubricant selected from the group consisting of magnesium stearate, calcium stearate, zinc stearate, colloidal silicon dioxide, hydrogenated vegetable oils, polyoxyethylene monostearate, polyethylene glycol, sodium stearyl fumarate, sodium benzoate, sodium lauryl sulfate, magnesium lauryl sulfate, and light mineral oil,
- (B) a coating on said core,
- optionally, wherein said tablet is crush resistant and has a breaking strength of at least about 200 N.
4 more elements
A solid, oral, extended release pharmaceutical tablet comprising a core, wherein the core comprises:
- i) a therapeutically effective amount of an active agent selected from the group consisting of ketamine, norketamine, pharmaceutically acceptable salts thereof, and combinations thereof, wherein the active agent is present at a concentration of about 6% to about 20%, or at least about 10%, at least about 12% or at least about 15% by weight of the core;
- and
- ii) a matrix polymer, wherein the matrix polymer is a high molecular weight polyethylene oxide (PEO) that is cured, wherein said high molecular weight PEO has an approximate molecular weight of from about 2 million to about 7 million, based upon rheological measurements.
A solid, oral, extended release pharmaceutical tablet comprising:
- (A) a core comprising:
- i) a therapeutically effective amount of an active agent selected from the group consisting of ketamine, norketamine, pharmaceutically acceptable salts thereof, and combinations thereof, wherein the active agent is present at a concentration of about 6% to about 20%, or at least about 10%, at least about 12% or at least about 15% by weight;
- ii) at least one matrix polymer comprising at least one high molecular weight polyethylene oxide (PEO) that is cured, wherein said high molecular weight PEO has an approximate molecular weight of from about 2 million to about 7 million, based upon rheological measurements, optionally in combination with at least one additional matrix polymer selected from the group consisting of hydroxypropyl methyl cellulose (HPMC), ethyl cellulose (EC), polyvinyl pyrrolidone, xanthan gum, pullulan, polyvinyl alcohol, polyvinyl acetate, glycerol fatty acid esters, polyacrylamide, polyacrylic acid, and copolymers of ethacrylic acid or methacrylic acid;
- and
- iii) a lubricant selected from the group consisting of magnesium stearate, calcium stearate, zinc stearate, colloidal silicon dioxide, hydrogenated vegetable oils, polyoxyethylene monostearate, polyethylene glycol, sodium stearyl fumarate, sodium benzoate, sodium lauryl sulfate, magnesium lauryl sulfate, and light mineral oil,
- (B) a coating on said core,
- optionally, wherein said tablet is crush resistant and has a breaking strength of at least about 200 N,
- prepared by a process comprising the steps of
- (i) applying an initial coating to the tablet;
- (ii) curing the coated tablet;
- and
- (iii) optionally applying an additional coating to the tablet.
9 more elements
Dependencies are inferred from the claim text.