US 12,005,041 B2
Misoprostol dispersible tablet
Selvaraj Sekar, Tamilnadu (IN); Elumalai Baskar, Tamilnadu (IN); Arunachalam Malaiarasan, Tamilnadu (IN); and Venugopal Prabhakaran, Tamilnadu (IN)
Assigned to Azanta Danmark A/S, Valby (DK)
Filed by Azanta Danmark A/S, Valby (DK)
Filed on Jul. 11, 2022, as Appl. No. 17/861,711.
Application 17/861,711 is a continuation of application No. 16/870,556, filed on May 8, 2020, granted, now 11,406,615.
Application 16/870,556 is a continuation of application No. 15/324,395, granted, now 10,688,072, issued on Jun. 23, 2020, previously published as PCT/DK2015/050216, filed on Jul. 10, 2015.
Application 15/324,395 is a continuation of application No. 14/329,023, filed on Jul. 11, 2014, abandoned.
Claims priority of application No. 14176821 (EP), filed on Jul. 11, 2014.
Prior Publication US 2022/0347145 A1, Nov. 3, 2022
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 31/215 (2006.01); A61K 9/00 (2006.01); A61K 9/20 (2006.01); A61K 31/5575 (2006.01)
CPC A61K 31/215 (2013.01) [A61K 9/0034 (2013.01); A61K 9/0056 (2013.01); A61K 9/006 (2013.01); A61K 9/2027 (2013.01); A61K 9/2054 (2013.01); A61K 9/2059 (2013.01); A61K 31/5575 (2013.01); A61K 2121/00 (2013.01)] 21 Claims
 
1. 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.