	US 11,865,180 B2
	Levothyroxine formulations for oral use
Kocherlakota Chandrashekhar, Secunderabad (IN); and Banda Nagaraju, Hyderabad (IN)
Assigned to LEIUTIS PHARMACEUTICALS LLP, Telangana (IN)
Filed by LEIUTIS PHARMACEUTICALS LLP, Hyderabad (IN)
Filed on Apr. 28, 2022, as Appl. No. 17/661,116.
Application 17/661,116 is a continuation of application No. 15/773,619, granted, now 11,364,196, previously published as PCT/IB2016/056615, filed on Nov. 3, 2016.
Claims priority of application No. 5957/CHE/2015 (IN), filed on Nov. 4, 2015.
Prior Publication US 2022/0249362 A1, Aug. 11, 2022
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 47/40 (2006.01); A61K 31/198 (2006.01); A61K 47/18 (2017.01); A61K 47/26 (2006.01); A61K 9/00 (2006.01); A61K 47/10 (2017.01)

CPC A61K 47/40 (2013.01) [A61K 9/006 (2013.01); A61K 31/198 (2013.01); A61K 47/10 (2013.01); A61K 47/183 (2013.01); A61K 47/26 (2013.01)]

4 Claims

1. A spray formulation of Levothyroxine comprising:

(i) levothyroxine sodium in a concentration of 0.0025-5% by weight of the total formulation;

(ii) buffering agents or pH adjusting agents selected from arginine, alanine, and lysine in a concentration of 0.0015-0.5% by weight of the total formulation;

(iii) one or more solvents, wherein the solvents are selected from one or more of propylene glycol, glycerol, polyethylene glycol (PEG), and water;

(iv) sulfobutylether cyclodextrin (SBECD), and

wherein the formulation has less than 2% of total impurities when stored at 40° C., 75% RH for 3 months.