US 11,707,466 B2
Immediate release multilayer tablet
Renato A. Chiarella, Dublin (IE); Hector Guzman, Dublin (IE); Paul Hurley, Dublin (IE); David Manser, Dublin (IE); and Kristopher Perkin, Dublin (IE)
Assigned to Alkermes Pharma Ireland Limited, Dublin (IE)
Filed by Alkermes Pharma Ireland Limited, Dublin (IE)
Filed on Jun. 30, 2022, as Appl. No. 17/855,242.
Application 17/855,242 is a continuation of application No. PCT/EP2021/081585, filed on Nov. 12, 2021.
Claims priority of provisional application 63/113,067, filed on Nov. 12, 2020.
Prior Publication US 2022/0354866 A1, Nov. 10, 2022
Int. Cl. A61K 9/24 (2006.01); A61K 31/5513 (2006.01); A61K 9/20 (2006.01); A61K 31/485 (2006.01)
CPC A61K 31/5513 (2013.01) [A61K 9/209 (2013.01); A61K 9/2013 (2013.01); A61K 9/2018 (2013.01); A61K 9/2027 (2013.01); A61K 9/2054 (2013.01); A61K 9/2095 (2013.01); A61K 31/485 (2013.01)] 15 Claims
 
1. 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.