Combination Decitabine And Cedazuridine Solid Oral Dosage Forms
Patent No. EP4069254 (titled "Combination Decitabine And Cedazuridine Solid Oral Dosage Forms") was filed by Otsuka Pharmaceutical on Feb 24, 2021. The application was issued on Sep 11, 2024.
Patent Summary
A solid oral dosage form comprises 100 mg of cedazuridine and 35 mg of decitabine, with excipients including lactose monohydrate, hydroxypropyl methyl cellulose, croscarmellose sodium, colloidal silicon dioxide, and magnesium stearate, and an optional coating. Daily administration to humans provides decitabine plasma levels with a 5-day area under the curve (AUC) equivalent to a daily 20 mg/m² intravenous dose administered as a 1-hour infusion. Optionally, the ratio of decitabine AUC on day 2 versus day 1 is approximately 1.5:1 to 2:1. The formulation is designed to inhibit cytidine deaminase-mediated degradation of decitabine, providing pharmacodynamic effects, such as DNA demethylation, equivalent to intravenous administration for treating disorders including myelodysplastic syndromes and other cancers.
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Date
Description
EP4069254
- Application Number
- EP21761883A
- Filing Date
- Feb 24, 2021
- Status
- Granted And Under Opposition
- Aug 8, 2024
- Publication Date
- Sep 11, 2024
- External Links
- Slate, Register , Google Patents