Ulipristal Acetate Tablets

摘要

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 %.

主权项

1. An oral pharmaceutical tablet comprising ulipristal acetate in an amount ranging from 1 mg to 50 mg, a diluent, a disintegrating agent, and a lubricant, 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 at pH=1.