Claims for Patent: 11,963,971

Summary for Patent: 11,963,971

Title:	Combination decitabine and cedazuridine solid oral dosage forms
Abstract:	Embodiments of the present invention provide solid oral dosage forms that upon daily administration to a subject provide plasma levels of decitabine with a 5-day AUC for decitabine that is equivalent to the 5-day AUC for a daily IV dose of decitabine of 20 mg/m2 administered as a one hour (1 h) infusion. Also provided according to embodiments of the present invention are solid oral dosage forms wherein upon daily administration to a subject provides a pharmacodynamic effect that is equivalent to the pharmacodynamic effect for a daily intravenous dose of decitabine of 20 mg/m2 administered as a one hour (1 h) infusion. Also provided are methods of treatment using a solid oral dosage form according to an embodiment of the invention.
Inventor(s):	Aram Oganesian, Nipun Davar, Jim Hwaicher Kou
Assignee:	Taiho Pharmaceutical Co Ltd
Application Number:	US18/309,440
Patent Claims:	1. 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. 2. The solid oral dosage form of claim 1, wherein upon daily administration to a human the ratio of AUC for decitabine on day 2 versus day 1 is about 1.5:1 to about 2:1. 3. The solid oral dosage form of claim 1, wherein the solid oral dosage form upon daily administration to a human provides a pharmacodynamic effect that is equivalent to the pharmacodynamic effect for a daily intravenous dose of decitabine of 20 mg/m2 administered as a 1 h infusion. 4. The solid oral dosage form of claim 3, wherein the pharmacodynamic effect is DNA demethylation. 5. The solid oral dosage form of claim 1, which is a tablet. 6. The solid oral dosage form of claim 1, which is a capsule. 7. The solid oral dosage form of claim 1, wherein the solid oral dosage form comprises the coating. 8. The solid oral dosage form of claim 7, wherein the coating is a color coating. 9. The solid oral dosage form of claim 8, wherein the coating is Opadry II 85F15458 Red.