US 11,925,613 B2
Eflornithine and sulindac, fixed dose combination formulation
Patrick Shannon, Pensacola, FL (US); Roberto Carlos Bravo González, Binningen (CH); and Jean Ducassou, Cestas (FR)
Assigned to Cancer Prevention Pharmaceuticals, Inc., Waconia, MN (US)
Filed by Cancer Prevention Pharmaceuticals, Inc., Tuscon, AZ (US)
Filed on Nov. 15, 2022, as Appl. No. 18/055,494.
Application 18/055,494 is a continuation of application No. 17/193,588, filed on Mar. 5, 2021, granted, now 11,529,326.
Application 17/193,588 is a continuation of application No. 15/771,484, granted, now 10,973,790, issued on Apr. 13, 2021, previously published as PCT/US2016/059689, filed on Oct. 31, 2016.
Claims priority of provisional application 62/358,698, filed on Jul. 6, 2016.
Claims priority of provisional application 62/248,810, filed on Oct. 30, 2015.
Claims priority of application No. 16306429 (EP), filed on Oct. 28, 2016; and application No. 16306430 (EP), filed on Oct. 28, 2016.
Prior Publication US 2023/0172887 A1, Jun. 8, 2023
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 31/198 (2006.01); A61K 9/20 (2006.01); A61K 9/28 (2006.01); A61K 31/192 (2006.01)
CPC A61K 31/198 (2013.01) [A61K 9/2009 (2013.01); A61K 9/2013 (2013.01); A61K 9/2054 (2013.01); A61K 9/2095 (2013.01); A61K 9/2813 (2013.01); A61K 9/2853 (2013.01); A61K 9/2866 (2013.01); A61K 31/192 (2013.01)] 19 Claims
OG exemplary drawing
 
1. A method of producing a single dosage unit tablet comprising (a) about 375 mg of eflornithine hydrochloride monohydrate, (b) about 75 mg of sulindac, and (c) about 1 to about 1.5 weight percent magnesium stearate comprising:
(a) pre-mixing the sulindac and a first excipient to form a first mixture;
(b) mixing the first mixture with a second mixture comprising eflornithine hydrochloride monohydrate and a second excipient to form a blend;
(c) screening the blend to form a granulated blend;
(d) adding magnesium stearate to the granulated blend to obtain a final blend; and
(e) applying a compression force to the final blend to form the tablet.