Misoprostol dispersible tablet
AssigneeAzanta Danmark A/S
InventorsSelvaraj Sekar, Elumalai Baskar, Arunachalam Malaiarasan, Venugopal Prabhakaran
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Abstract
The present invention relates to a solid pharmaceutical formulation comprising misoprostol or a pharmaceutically acceptable salt thereof. In particular, the invention relates to a dispersible tablet comprising misoprostol or a pharmaceutically acceptable salt thereof, providing alternative routes of administration. The tablet is particularly suited for cervical ripening, induction of labor, prevention and/or treatment of postpartum or post-abortion hemorrhage.
Claims21
A pharmaceutical tablet comprising misoprostol, or a pharmaceutically acceptable salt thereof, as the sole active ingredient;
- wherein the tablet has a content of 0.5-50 μg misoprostol, or an equivalent amount of a pharmaceutically acceptable salt thereof;
- and wherein the tablet further comprises:
- i) 5-20 wt % crospovidone,
- ii) 5-20 wt % of a cross-linked polymer of carboxymethyl cellulose or a crosslinked sodium carboxymethyl cellulose,
- iii) 5-20 wt % starch,
- iv) 30-85 wt % microcrystalline cellulose, and
- v) 0.1-2 wt % flow agent, subject to the proviso that the total of ingredients i) through v) and the misoprostol, or a pharmaceutically acceptable salt thereof, does not exceed 100 wt %, and wherein the tablet is suitable for sublingual or oral administration and is an immediate release tablet.
A pharmaceutical tablet comprising misoprostol, or a pharmaceutically acceptable salt thereof, as the sole active ingredient;
- wherein the tablet has a content of 0.5-50 μg misoprostol, or an equivalent amount of a pharmaceutically acceptable salt thereof;
- and wherein the tablet further comprises:
- i) 8-12 wt % crospovidone,
- ii) 8-12 wt % of a cross-linked polymer of carboxymethyl cellulose or a crosslinked sodium carboxymethyl cellulose,
- iii) 5-12 wt % starch,
- iv) 60-75 wt % microcrystalline cellulose, and
- v) 0.1-2 wt % flow agent, subject to the proviso that the total of ingredients i) through v) and the misoprostol, or a pharmaceutically acceptable salt thereof, does not exceed 100 wt %, and wherein the tablet is suitable for sublingual or oral administration and is an immediate release tablet.
Dependencies are inferred from the claim text.