	US 11,938,109 B2
	Methods for the preparation of a levothyroxine solution
Yannis Psarrakis, Lavrion-Attica (GR); and Konstantinos Lioumis, Lavrion-Attica (GR)
Assigned to EMP LEVO US B.V., Maastricht (NL)
Filed by EMP Levo US B.V., Maastricht (NL)
Filed on Jul. 23, 2021, as Appl. No. 17/383,786.
Application 17/383,786 is a continuation of application No. 16/315,549, granted, now 11,096,915, previously published as PCT/EP2017/066823, filed on Jul. 5, 2017.
Claims priority of provisional application 62/358,270, filed on Jul. 5, 2016.
Claims priority of application No. 2017110 (NL), filed on Jul. 5, 2016.
Prior Publication US 2021/0353577 A1, Nov. 18, 2021
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 31/198 (2006.01); A61K 9/00 (2006.01); A61K 47/02 (2006.01); A61K 47/10 (2017.01); A61K 47/12 (2006.01); A61K 47/14 (2017.01); A61K 47/26 (2006.01)

CPC A61K 31/198 (2013.01) [A61K 9/0053 (2013.01); A61K 47/02 (2013.01); A61K 47/10 (2013.01); A61K 47/12 (2013.01); A61K 47/14 (2013.01); A61K 47/26 (2013.01)]

24 Claims

1. An oral levothyroxine solution having a pH between 3.5-4.9; and having an improved stability for at least 6 months at 40° C., comprising: i) levothyroxine or a salt thereof, ii) 20-80 w/w % of a water-miscible organic solvent or a sugar alcohol or a combination thereof, iii) a preservative, and iv) water, and wherein, after storage for 6 months at 40° C., the levothyroxine content in the oral levothyroxine solution is more than 94%.