US 12,295,953 B2
Oral gliptin compositions and method for preparation thereof
Ioannis Psarrakis, Lavrio (GR); and Konstantinos Lioumis, Lavrio (GR)
Assigned to PHARMA-DATA RESEARCH AND DEVELOPMENT SINGLE MEMBER S.A., Lavrio (GR)
Filed by PHARMA-DATA RESEARCH AND DEVELOPMENT SINGLE MEMBER S.A., Lavrio (GR)
Filed on Feb. 26, 2024, as Appl. No. 18/587,175.
Application 18/587,175 is a continuation of application No. 17/771,387, granted, now 11,944,621, previously published as PCT/EP2020/079945, filed on Oct. 23, 2020.
Claims priority of application No. 19205219 (EP), filed on Oct. 24, 2019.
Prior Publication US 2024/0285619 A1, Aug. 29, 2024
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 31/4985 (2006.01); A61K 9/00 (2006.01); A61K 9/08 (2006.01); A61K 47/10 (2017.01); A61K 47/12 (2006.01); A61K 47/14 (2017.01); A61K 47/18 (2017.01); A61K 47/20 (2006.01); A61K 47/26 (2006.01); A61K 47/36 (2006.01); A61K 47/38 (2006.01)
CPC A61K 31/4985 (2013.01) [A61K 9/0053 (2013.01); A61K 9/08 (2013.01); A61K 47/10 (2013.01); A61K 47/12 (2013.01); A61K 47/14 (2013.01); A61K 47/183 (2013.01); A61K 47/20 (2013.01); A61K 47/26 (2013.01); A61K 47/36 (2013.01); A61K 47/38 (2013.01)] 22 Claims
 
1. An aqueous liquid oral gliptin composition comprising:
about 2.5-about 3.5 w/v % of sitagliptin or a pharmaceutically acceptable salt or ester thereof;
a thickening agent, wherein the thickening agent is selected from the group consisting of hydroxyethylcellulose, hydroxypropylcellulose, sodium alginate, sodium carboxymethylcellulose, gellan gum, polyethylene oxide polymer, and any combination thereof, wherein the thickening agent is present in the aqueous liquid oral gliptin composition at about 0.1-about 2.0 w/v %;
an artificial non-sugar alcohol sweetening agent, wherein the artificial non-sugar alcohol sweetening agent is selected from the group consisting of sucralose, sodium saccharin, aspartame, acesulfame-K, cyclamate, and any combination thereof, wherein the artificial non- sugar alcohol sweetening agent is present in the aqueous liquid oral gliptin composition at 1-5 w/v %;
wherein the aqueous liquid oral gliptin composition has a sugar alcohol content of less than 20 w/v %;
an antioxidant;
a buffering agent; and
a preservative;
and wherein the pH of the aqueous liquid oral gliptin composition is from 3 to 8.