	US 11,969,409 B2
	Formulations of apremilast
Nathan Bennette, Thousand Oaks, CA (US); William Brett Caldwell, Thousand Oaks, CA (US); Christi Hostetler, Thousand Oaks, CA (US); Kazden Ingram, Thousand Oaks, CA (US); Dory King, Thousand Oaks, CA (US); Kyle Kyburz, Thousand Oaks, CA (US); and Alison Viles, Thousand Oaks, CA (US)
Assigned to AMGEN INC., Thousand Oaks, CA (US)
Filed by AMGEN INC., Thousand Oaks, CA (US)
Filed on May 12, 2023, as Appl. No. 18/196,718.
Application 18/196,718 is a continuation of application No. 17/899,769, filed on Aug. 31, 2022, granted, now 11,752,129.
Application 17/899,769 is a continuation of application No. PCT/US2022/031325, filed on May 27, 2022.
Claims priority of provisional application 63/194,247, filed on May 28, 2021.
Prior Publication US 2023/0277502 A1, Sep. 7, 2023
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 9/20 (2006.01); A61K 9/00 (2006.01); A61K 9/28 (2006.01); A61K 31/4035 (2006.01)

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)]

19 Claims

1. An oral dosage form comprising:

a. a core tablet comprising

(i) a drug layer comprising a) amorphous apremilast and hypromellose acetate succinate (HPMCAS) in a solid dispersion and b) a water soluble polymer; and

(ii) a swellable layer comprising one or more swellable polymers; and

b. a coating layer disposed on the core tablet,

wherein the amorphous apremilast and HPMCAS are present in a weight ratio of 45:55 to 55:45 in the core tablet and the oral dosage form surface comprises at least one drug release orifice.