US 11,986,555 B2
Chewable pharmaceutical product for delivery of colesevelam hydrochloride
Tommy L. Chau, Ashburn, VA (US)
Assigned to COSETTE PHARMACEUTICALS, INC., Bridgewater, NJ (US)
Filed by Cosette Pharmaceuticals, Inc., Bridgewater, NJ (US)
Filed on Feb. 23, 2022, as Appl. No. 17/678,178.
Application 17/678,178 is a division of application No. 15/215,804, filed on Jul. 21, 2016, granted, now 11,291,628.
Prior Publication US 2022/0175669 A1, Jun. 9, 2022
Int. Cl. A61K 9/00 (2006.01); A61K 9/14 (2006.01); A61K 31/785 (2006.01); A61P 3/06 (2006.01)
CPC A61K 9/0056 (2013.01) [A61K 9/145 (2013.01); A61K 31/785 (2013.01); A61P 3/06 (2018.01)] 4 Claims
 
1. A method of making a chewable pharmaceutical product for delivery of colesevelam hydrochloride comprising:
(ix) heating an amount of one or more maltitol syrups to a temperature of in the range of 120-160° F.;
(x) melting a lubricant;
(xi) blending dry ingredients in a mixer, the dry ingredients comprising: at least colesevelam hydrochloride and a bulking agent;
(xii) adding the one or more maltitol syrups, the lubricant, a humectant, and an emulsifier to the dry ingredients in the mixer;
(xiii) optionally adding one or more of a flavoring, coloring, and an antioxidant to the mixture;
(xiv) mixing all of the ingredients until substantially uniform to form an active-ingredient-containing matrix;
(xv) extruding the active-ingredient-containing matrix and then cutting to form the chewable pharmaceutical product,
wherein the amount of the one or more maltitol syrups in the chewable pharmaceutical product is in the range of 60-70% by weight;
(xvi) packaging the chewable pharmaceutical product,
wherein the one or more maltitol syrups comprise two maltitol syrups: a first maltitol syrup having a higher solids content than a second maltitol syrup, which are present in a weight ratio (first maltitol syrup:second maltitol syrup) of from 2:1 to 4:1, which in combination, have an effective solids content in the range of 81.5-83.3%.