	US 12,239,653 B2
	Combination decitabine and cedazuridine solid oral dosage forms
Aram Oganesian, Dublin, CA (US); Nipun Davar, Pleasanton, CA (US); and Jim Hwaicher Kou, San Jose, CA (US)
Assigned to Taiho Pharmaceutical Co., Ltd., Tokyo (JP)
Appl. No. 17/904,536
Filed by Taiho Pharmaceutical Co., Ltd., Tokyo (JP)
PCT Filed Feb. 24, 2021, PCT No. PCT/US2021/019310 § 371(c)(1), (2) Date Aug. 18, 2022, PCT Pub. No. WO2021/173598, PCT Pub. Date Sep. 2, 2021.
Claims priority of provisional application 62/981,304, filed on Feb. 25, 2020.
Prior Publication US 2023/0089147 A1, Mar. 23, 2023
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 31/706 (2006.01); A61K 9/00 (2006.01); A61K 9/20 (2006.01); A61K 9/48 (2006.01); A61K 31/20 (2006.01); A61K 31/7016 (2006.01); A61K 31/717 (2006.01)

CPC A61K 31/706 (2013.01) [A61K 9/0056 (2013.01); A61K 9/20 (2013.01); A61K 9/4891 (2013.01); A61K 31/20 (2013.01); A61K 31/7016 (2013.01); A61K 31/717 (2013.01)]

10 Claims

1. A method of treating a disorder that is treatable with decitabine in a subject in need thereof, comprising administering to the subject a solid oral dosage form consisting of 100 mg cedazuridine, 35 mg decitabine, lactose monohydrate, hydroxypropyl methyl cellulose, croscarmellose sodium, colloidal silicon dioxide, and magnesium stearate, and optionally a coating, wherein the solid oral dosage form upon daily administration to a human provides plasma levels of decitabine with a 5-day AUC for decitabine that is equivalent to the 5-day AUC for a daily intravenous dose of decitabine of 20 mg/m2 administered as a 1 h infusion, thereby treating the disorder.