Method for manufacturing a monophasic pharmaceutical product...

A - Human Necessities – 61 – K

Patent

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A61K 31/565 (2006.01)

Patent

CA 2624380

The invention relates to a method for manufacturing a monophasic pharmaceutical product for oral therapy of dysfunctional uterine bleeding, where an oral monophasic combination of dienogest and ethinylestradiol in low dosage is used together with one or more pharmaceutically acceptable excipients/carriers, with which moderate proliferation of the endometrium with complete transformation and brief and slight withdrawal bleeding in the hormone-free period is achieved through the hormone levels remaining at a constant low level.

L'invention concerne un procédé pour produire une préparation pharmaceutique à phase unique destinée à être administrée par voie orale pour traiter un saignement utérin dysfonctionnel. Selon l'invention, une association à phase unique de dienogest et d'éthinylestradiol en faible dosage, destinée à être administrée par voie orale, est utilisée avec un ou plusieurs adjuvants/excipients pharmaceutiquement acceptables. Cette préparation pharmaceutique induit une prolifération modérée de l'endomètre, qui est accompagnée d'une transformation complète, et d'une hémorragie de privation faible et de courte durée pendant la période sans hormone, par maintien d'un niveau hormonal faible.

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