	US 11,786,512 B2
	Stable pharmaceutical compositions of dihydroergotamine mesylate
Harish Govindaraja Setty Chinnari, Hyderabad (IN); Somashekhar Battini, Hyderabad (IN); and Jagdish Lotan Lohar, Pune (IN)
Assigned to SLAYBACK PHARMA LLC, Princeton, NJ (US)
Filed by Slayback Pharma LLC, Princeton, NJ (US)
Filed on Sep. 22, 2020, as Appl. No. 17/28,863.
Claims priority of application No. 201941038367 (IN), filed on Sep. 23, 2019.
Prior Publication US 2021/0085657 A1, Mar. 25, 2021
Int. Cl. A61K 9/00 (2006.01); A61K 47/02 (2006.01); A61K 47/20 (2006.01); A61K 47/10 (2017.01); A61K 31/4985 (2006.01); A61K 31/437 (2006.01)

CPC A61K 31/437 (2013.01) [A61K 9/0019 (2013.01); A61K 31/4985 (2013.01); A61K 47/02 (2013.01); A61K 47/10 (2013.01); A61K 47/20 (2013.01)]

11 Claims

1. A method of treating migraine in a patient in need thereof, the method comprising providing a stable pharmaceutical composition comprising 1.0 mg/mL of dihydroergotamine mesylate;

wherein the pH of the composition ranges from 5.0 to 6.0;

wherein a level of 2′-epi-9,10-dihydro ergotamine is no greater than 2.0% w/w when stored at 25° C./60% relative humidity for 12 months as measured by HPLC, and

wherein said pharmaceutical composition is an injectable composition.