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US 11,992,559 B2Granted
Microsphere formulations comprising lurasidone and methods for making and using the same
AssigneeOakwood Laboratories, LLC
InventorsColin Spencer, Griffin Beyer, Tracy Richey, Mark Smith, Nicholas DeLucia
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Abstract
Extended-release microsphere formulations comprising lurasidone are provided. In one aspect, the microsphere formulations are characterized in that the lurasidone is released in vivo in humans over a period of about 30 days. Methods for making and using the formulations are also provided.
Claims16
A microsphere formulation, comprising:
- polymer microspheres, each polymer microsphere comprising:
- an active pharmaceutical ingredient consisting of lurasidone or a pharmaceutically acceptable salt thereof;
- and
- a biodegradable polymer wherein the biodegradable polymer comprises an acid terminated poly(D,L-lactide-co-glycolide) with lactide:glycolide ratio of about 75 to about 25, and wherein the biodegradable polymer has an inherent viscosity of about 0.14 dL/g to about 0.56 dL/g,
- wherein each polymer microsphere comprises a drug load of lurasidone of greater than or equal to 55% by weight of the polymer microsphere, and
- wherein the polymer microspheres have a particle size of less than or equal to 25 μm (D50).
3 more elements
A microsphere formulation, comprising:
- polymer microspheres, each polymer microsphere comprising:
- an active pharmaceutical ingredient consisting of lurasidone HCl;
- and
- a biodegradable polymer comprising an acid terminated poly(D,L-lactide-co-glycolide) (“PLGA”) with lactide:glycolide of about 75:
- about 25 and an inherent viscosity of from about 0.14 dL/g to about 0.56 dL/g,
- wherein each polymer microsphere has a lurasidone drug load of from 55% to about 70% by weight of the polymer microsphere;
- wherein the polymer microspheres have a particle size of about 14 μm (D50) to about 25 μm (D50);
- and
- wherein the microsphere formulation is characterized in that about 75% to 100% of the lurasidone is released over a period of about 30 days of injection into a subject, but not more than about 20% of the lurasidone has been released within about 24 hours of injection into the subject.
6 more elements
Dependencies are inferred from the claim text.