Patent ID: 11957694
Assignee: ESTETRA SRL
Field: Pharmaceuticals (Chemistry)
Classification: CPC A | IPC A

Claim 0:
1. A solid pharmaceutical dosage unit having a weight between 30 and 1,000 mg, the dosage unit comprising:
(a) 0.1-25 wt. % of estetrol particles containing at least 90 wt. % of estetrol monohydrate, wherein the estetrol particles have a volume median diameter of from 5 μm to 15 μm; and
(b) 75-99.9 wt. % of one or more pharmaceutically acceptable excipients;
wherein the solid dosage unit contains from 10 mg to 20 mg of the estetrol monohydrate and releases at least 70% of the estetrol monohydrate within 5 minutes when subject to dissolution testing by placing one unit in 900 mL of an aqueous dissolution medium comprising KH2PO4 and NaOH at pH 6.8 and a temperature of 37±0.5° C., in a vessel of a paddle apparatus at a stirring speed of 50 rpm.