Ulipristal acetate tablets
AssigneeLaboratoire Hra-Pharma
InventorsErin Gainer, Helene Guillard, Denis Gicquel, Marianne Henrion, Celine Gnakamene
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Abstract
The invention relates to a pharmaceutical tablet for oral administration comprising ulipristal acetate together with the following excipients: at least one diluent in an amount of 50 to 98.5 wt %, at least one binding agent in an amount of 0 to 10 wt %, at least one disintegrating agent in an amount of 0.5 to 10 wt %, and at least one lubricant in an amount of 0 to 10 wt %.
Claims17
An oral pharmaceutical tablet comprising from 1 to 18 wt % ulipristal acetate, wherein ulipristal acetate is present in an amount ranging from 1 mg to 50 mg, 50 to 98.5 wt % of a diluent, 0.5 to 10 wt % of croscarmellose sodium, and 0.5 to 5 wt % of magnesium stearate, 0 to 10 wt % of a binding agent, wherein at least 80% of ulipristal acetate present in the tablet is dissolved within about 20 minutes when said tablet is subjected to an in vitro dissolution assay in a paddle apparatus at 37° C.±0.5° C., and in HCl 0.1N as dissolution medium.
Dependencies are inferred from the claim text.