Osmotic dosage forms comprising deutetrabenazine and methods of use thereof
AssigneeAuspex Pharmaceuticals, Inc.
InventorsParag Shah, Mayank Joshi, Soumen Pattanayek, Divyang Patel, Sandeep Pandita
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Abstract
Provided herein are osmotic dosage forms containing deutetrabenazine for use in the treatment of, e.g., hyperkinetic movement disorders. When orally administered to a subject on a once-daily basis, the dosage forms provide a favorable pharmacokinetic profile for the active agent indicating treatment efficacy over an extended period of time.
Claims31
A method of administering a once-daily dose of deutetrabenazine in an osmotic dosage form for treating a hyperkinetic movement disorder in a subject in need thereof comprising:
- orally administering to the subject, on a once daily basis, the osmotic dosage form, wherein the dosage form comprises
- a. a tablet core comprising an active layer and a push layer, wherein the active layer comprises an amount of deutetrabenazine microparticles and an active layer control release agent, and wherein the push layer comprises an osmotic agent and a push layer control release agent, and an optional tablet seal coat on the outer surface of the tablet core;
- b. a semipermeable layer surrounding the tablet core;
- c. a port extending through the semipermeable layer into the tablet core;
- and
- d. an immediate release coating external to the semipermeable layer comprising a second amount of deutetrabenazine microparticles,
- wherein the dosage comprises from about 6 mg to about 48 mg deutetrabenazine in the form of deutetrabenzine microparticles and wherein about 70%-80% of the total amount of deutetrabenazine microparticles present in the dosage form is present within the active layer and wherein about 20%-30% of the total amount of deutetrabenazine microparticles present in the dosage form, is present within the immediate release coating;
- and
- wherein the deutetrabenazine microparticles have a D90 of 15 μm, a D50 10 μm, and/or a D10 of 3 μm.
A method of administering a once-daily dose of deutetrabenazine in an osmotic dosage form for treating a hyperkinetic movement disorder in a subject in need thereof comprising:
- orally administering to the subject, on a once daily basis, the osmotic dosage form, wherein the dosage form comprises,
- a. a tablet core comprising an active layer and a push layer, wherein the active layer comprises an amount of deutetrabenazine microparticles and an active layer control release agent, and wherein the push layer comprises an osmotic agent and a push layer control release agent, and an optional tablet seal coat on the outer surface of the tablet core;
- b. a semipermeable layer surrounding the tablet core;
- c. a port extending through the semipermeable layer into the tablet core;
- and
- d. an immediate release coating external to the semipermeable layer comprising a second amount of deutetrabenazine microparticles,
- wherein the dosage comprises from about 6 mg to about 48 mg deutetrabenazine in the form of deutetrabenzine microparticles and wherein about 70%-80% of the total amount of deutetrabenazine microparticles present in the dosage form is present within the active layer and wherein about 20%-30% of the total amount of deutetrabenazine microparticles present in the dosage form, is present within the immediate release coating;
- wherein the deutetrabenazine microparticles have a D90 of 15 μm, a D50 10 μm, and/or a D10 of 3 μm, and
- wherein the subject is in a fasted state at the time of the oral administration.
Dependencies are inferred from the claim text.