CPC A61K 31/4035 (2013.01) [A61K 9/0065 (2013.01); A61K 9/2009 (2013.01); A61K 9/2054 (2013.01); A61K 9/2086 (2013.01); A61K 9/2853 (2013.01); A61K 9/2866 (2013.01)] | 17 Claims |
1. An oral dosage form comprising:
a core tablet comprising
(i) a drug layer comprising 8-11 wt % apremilast based upon total core tablet weight, 8-11 wt % hypromellose acetate succinate (HPMCAS) based upon total core tablet weight, 2-7 wt % mannitol based upon total core tablet weight, 40-45 wt % polyethylene oxide with molecular weight of 200,000 Da based upon total core tablet weight, 0.1-0.5 wt % magnesium stearate based upon total core tablet weight, and 0.1-0.5 wt % colloidal silicon dioxide based upon total core tablet weight, wherein the apremilast and HPMCAS are in a solid dispersion; and
(ii) a swellable layer comprising 18-25 wt % polyethylene oxide with molecular weight of 5,000,000 Da based upon total core tablet weight, 7-10 wt % microcrystalline cellulose based upon total core tablet weight, 1.5-3.5 wt. % sodium chloride based upon total core tablet weight, 0.01-0.2 wt % iron oxide based upon total core tablet weight, and 0.05-0.3 wt % magnesium stearate based upon total core tablet weight; and
a coating layer disposed on the core tablet and comprising cellulose acetate and polyethylene glycol; and
the oral dosage form surface comprises at least one drug release orifice.
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