	US 12,427,136 B2
	Formulations of apremilast
William Brett Caldwell, Thousand Oaks, CA (US); Nathan Bennette, 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 Mar. 21, 2024, as Appl. No. 18/612,430.
Application 18/612,430 is a continuation of application No. 18/196,718, filed on May 12, 2023, granted, now 11,969,409.
Application 18/196,718 is a continuation of application No. 17/899,769, filed on Aug. 31, 2022, granted, now 11,752,129, issued on Sep. 12, 2023.
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 2024/0299350 A1, Sep. 12, 2024
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)]

30 Claims

1. A method of treating a patient suffering from a disease or disorder ameliorated by inhibiting PDE4 comprising administering to a patient an oral dosage form comprising:

a. a core tablet comprising (i) a drug layer comprising a water soluble polymer and a solid dispersion of amorphous apremilast and hypromellose acetate succinate (HPMCAS) in a weight ratio of 45:55 to 55:45, and (ii) a swellable layer comprising one or more swellable polymers;

b. a coating layer disposed on the core tablet; and

c. at least one drug release orifice on the dosage form surface,

wherein the dosage form is administered once-a-day.