Patent ID: 11951111
Assignee: ALKERMES PHARMA IRELAND LIMITED
Field: Pharmaceuticals (Chemistry)
Classification: CPC A | IPC A

Claim 0:
1. A method of treating schizophrenia or bipolar I disorder in a patient in need thereof, the method comprising orally administering to the patient, once daily, a pharmaceutically acceptable coated immediate release bilayer tablet for orally delivering a fixed dose of olanzapine and 10 mg of samidorphan, wherein the bilayer tablet comprises:
a first tablet layer comprising:
10 mg samidorphan or a pharmaceutically acceptable salt of samidorphan in an amount to deliver 10 mg samidorphan;
about 35-43 wt % microcrystalline cellulose, based on the weight of the first tablet layer;
about 37-43 wt % lactose or a hydrate thereof, based on the weight of the first tablet layer; and
about 1.5 to about 2 wt % magnesium stearate;

a second tablet layer comprising:
a dose of olanzapine selected from the group consisting of 5 mg, 10 mg, 15 mg and 20 mg of the olanzapine;
about 38-42 wt % microcrystalline cellulose, based on the weight of the second tablet layer;
about 46-49 wt % lactose or a hydrate thereof, based on the weight of the second tablet layer; and
about 1.0 wt % magnesium stearate;

and
a film coating over the first and second tablet layer, wherein the tablet releases at least 97% of olanzapine and at least 97% of the samidorphan after 30 minutes when the tablet is tested in 500 mL USP acetate buffer at pH 1.0 using a USP Apparatus II (Paddle Method) at 37 with a paddle speed of 75 rpm and using a three-prong sinker.