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

Claim 13:
14. A process of preparing an orodispersible 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; 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, the process comprising:
(i) providing estetrol particles having a volume median diameter between 2 μm to 50 μm and containing at least 90 wt. % of estetrol monohydrate;
(ii) mixing 1 part by weight of the estetrol particles with 2-1,000 parts by weight of one or more pharmaceutically acceptable excipients to obtain a dry blend; and
(iii) compressing the dry blend into a solid dosage unit.