EP3826614A1 — A parenteral unit dosage form of dihydroergotamine

USPTO Abstract

The present invention relates to a parenteral unit dosage form comprising an aqueous solution having dihydroergotamine or pharmaceutically acceptable salt thereof as a sole active ingredient, one or more pH adjusting agents, wherein the pH of the aqueous solution is in the range of 4.1 to 4.8, wherein the solution is contained in the reservoir of a syringe having a plunger stopper at one end and a needle shield or a tip cap at other end, wherein the plunger stopper, needle shield or tip cap is made up of rubber or elastomeric material, wherein the solution remains in contact with the rubber or elastomeric material during the shelf life of the parenteral dosage form, further wherein said aqueous solution contains substantially lower amount of impurity of a compound of Formula I and impurity of a compound of Formula II Formula I Formula II as compared to aqueous solution having a pH of 4.0 or less, when the parenteral unit dosage form is stored at 25° C and 60 % relative humidity for at least three months.