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US 2022/0054420 A1Published application
Microsphere formulations comprising ketamine and methods for making and using the same
AssigneeOakwood Laboratories, LLC
InventorsRachel Galaska, Kelsey Kaht, Tracy Richey
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Abstract
Extended-release, injectable microsphere formulations comprising ketamine are provided. Methods for making and using the microsphere formulations are also provided.
Claims26
A microsphere formulation, comprising:
- polymer microspheres, each polymer microsphere comprising:
- (i) esketamine;
- and
- (ii) a biodegradable poly(lactide) polymer having an inherent viscosity of about 0.6 dL/g to about 0.7 dL/g,
- wherein each polymer microsphere has a ketamine drug load of about 12 wt/wt % to about 17 wt/wt %;
- wherein the polymer microspheres have an average particle size of about 80 μm (D50) to about 110 μm (D50);
- and
- wherein the polymer microspheres are characterized in that each of the polymer microspheres comprises a plurality of internal macrovoids.
5 more elements
A microsphere formulation, comprising:
- polymer microspheres, each polymer microsphere comprising:
- (i) ketamine;
- and
- (ii) a biodegradable poly(lactide) polymer;
- wherein each polymer microsphere has a ketamine drug load of about 10 wt/wt % to about 30 wt/wt %, and
- wherein the polymer microspheres have an average particle size greater than 60 μm (D50).
3 more elements
A method for making polymer microspheres, the method comprising:
- (i) contacting ketamine with a biodegradable poly(lactide) polymer in the presence of a solvent to form an organic component and providing the organic component to a first homogenizer;
- (ii) providing an inner aqueous component comprising water and a first surfactant to the first homogenizer;
- (iii) homogenizing the organic component with the inner aqueous component to form a primary emulsion;
- (iv) providing the primary emulsion to a second homogenizer at a first flow rate;
- (v) providing a continuous phase comprising water and a second surfactant to the second homogenizer at a second flow rate;
- (vi) homogenizing the primary emulsion and the continuous phase;
- and
- (iv) removing the solvent to form the polymer microspheres,
- wherein each of the formed polymer microspheres incorporates at least a portion of the inner aqueous component in the form of a plurality of emulsions.
6 more elements
A method for treating depression, the method comprising intramuscularly or subcutaneously injecting a patient in need thereof with a therapeutically effective amount of a microsphere formulation, the microsphere formulation comprising:
- polymer microspheres, each polymer microsphere comprising:
- (i) esketamine;
- and
- (ii) a biodegradable poly(lactide) polymer;
- wherein each polymer microsphere has a ketamine drug load of between about 10 wt/wt % to about 30 wt/wt %, and
- wherein the polymer microspheres have an average particle size greater than 60 μm (D50).
3 more elements
Dependencies are inferred from the claim text.