Claims for Patent: 11,819,501

Summary for Patent: 11,819,501

Title:	Parenteral unit dosage form of dihydroergotamine
Abstract:	A parenteral unit dosage form comprising an aqueous solution of dihydroergotamine or pharmaceutically acceptable salt thereof as a sole active ingredient, one or more pH adjusting agents, and optionally one or more co-solvents, wherein the pH of the aqueous solution is such that it contains substantially lower amount of impurity of Formula I and impurity of 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.
Inventor(s):	Alpesh Goyani, Deepak Singodia, Bhaskar Pallerla, Sudeep Kumar Agrawal, Subhas Balaram Bhowmick, Rajamannar Thennati
Assignee:	Sun Pharmaceutical Industries Ltd
Application Number:	US17/712,274
Patent Claims:	1. A method for effecting acute treatment of migraine or cluster headache episodes, comprising administering dihydroergotamine or a pharmaceutically acceptable salt thereof to a subject in need thereof, wherein said administering comprises injecting said dihydroergotamine or pharmaceutically acceptable salt thereof from an auto-injector or prefilled syringe of a parenteral unit dosage form comprising an aqueous solution of dihydroergotamine or a pharmaceutically acceptable salt thereof as a sole active ingredient, and one or more pH adjusting agents, wherein: the pH of the aqueous solution is in the range of 4.1 to 4.9, the solution is contained in the auto-injector or the prefilled syringe, and the solution does not require reconstitution or dilution prior to administration. 2. The method according to claim 1, wherein said injecting is by subcutaneous injection. 3. The method according to claim 1, wherein said injecting is by intramuscular injection. 4. The method according to claim 1, wherein the pH of the aqueous solution is in the range of 4.2 to 4.8. 5. The method according to claim 1, wherein the aqueous solution is free of one or both of preservative agents and complexing agents. 6. The method according to claim 1, wherein the pharmaceutically acceptable salt of dihydroergotamine is dihydroergotamine mesylate and it is present at a concentration of from 0.5 mg/ml to 1.5 mg/ml. 7. The method according to claim 1, wherein the aqueous solution further comprises one or more co-solvents. 8. The method according to claim 1, wherein the aqueous solution comprises dihydroergotamine or a pharmaceutically acceptable salt thereof at a concentration of from 0.75 to 1.5 mg/ml, ethanol, glycerine, methane sulfonic acid, sodium hydroxide, and water. 9. The method according to claim 1, wherein the aqueous solution comprises dihydroergotamine mesylate at a concentration of 1 mg/ml, ethanol, glycerine, methane sulfonic acid, sodium hydroxide, and water.