US 12,214,010 B2
Desmopressin oral compositions
Yu-Hsing Tu, West Windsor, NJ (US); Kalyan Kathala, Monroe, NJ (US); Romona Bhattacharya, Franklin Park, NJ (US); Yingjun Fan, Plainsboro, NJ (US); and Ashok Perumal, Monmouth Junction, NJ (US)
Assigned to Tulex Pharmaceuticals Inc., Cranbury, NJ (US)
Filed by Tulex Pharmaceuticals Inc., Cranbury, NJ (US)
Filed on Apr. 3, 2024, as Appl. No. 18/625,923.
Claims priority of provisional application 63/457,005, filed on Apr. 4, 2023.
Prior Publication US 2024/0335501 A1, Oct. 10, 2024
Int. Cl. A61K 38/10 (2006.01); A61K 9/00 (2006.01); A61K 38/095 (2019.01); A61K 47/10 (2017.01); A61K 47/12 (2006.01); A61K 47/14 (2017.01); A61K 47/18 (2017.01); C07K 7/16 (2006.01)
CPC A61K 38/095 (2019.01) [A61K 9/0053 (2013.01); A61K 47/10 (2013.01); A61K 47/12 (2013.01); A61K 47/14 (2013.01); A61K 47/183 (2013.01); C07K 7/16 (2013.01)] 22 Claims
 
1. A liquid pharmaceutical composition comprising
a) desmopressin acetate, wherein desmopressin acetate is present in an amount of from about 0.01 mg/mL to about 0.1 mg/mL;
b) a two-component, dual-functional, preservative-buffer system that comprises sodium benzoate and
benzoic acid, wherein the two-component, dual-functional, preservative-buffer system provides a pH of the liquid pharmaceutical composition that is about 5.0; and
c) water;
wherein the liquid pharmaceutical composition is an oral solution.