Claims for Patent: 12,533,351

Summary for Patent: 12,533,351

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:	US18/305,527
Patent Claims:	1. 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 an auto-injector or a prefilled syringe, the solution does not require reconstitution or dilution prior to subcutaneous administration, and when said parenteral unit dosage form is stored in a pouch at 25° C. and 60% relative humidity for three months, an increase in total amount of impurities as compared to an initial amount of impurities is less than 2.6% by weight. 2. The parenteral unit dosage form according to claim 1, wherein the pH of the aqueous solution is in the range of 4.2 to 4.8. 3. The parenteral unit dosage form according to claim 1, wherein the aqueous solution is free of preservative or complexing agent. 4. The parenteral unit dosage form according to claim 1, wherein the pharmaceutical acceptable salt of dihydroergotamine is dihydroergotamine mesylate and it is present at a concentration ranging from 0.5 to 1.5 mg/ml. 5. The parenteral unit dosage form according to claim 1, wherein, when said parenteral unit dosage form is stored in a pouch at 40° C. and 75% relative humidity for three months, an increase in total amount of impurities as compared to an initial amount of impurities is less than 1.7% by weight. 6. The parenteral unit dosage form according to claim 1, wherein, when said parenteral unit dosage form is stored in a pouch at 25° C. and 60% relative humidity for three months, the dosage form contains impurity of Formula I in an amount less than 0.25% by weight 7. The parenteral unit dosage form according to claim 1, wherein, when the parenteral unit dosage form is stored in a pouch at 40° C. and 75% relative humidity for three months, the dosage form contains impurity of Formula I in an amount less than 0.7% by weight. 8. The parenteral unit dosage form according to claim 1, wherein, when the parenteral unit dosage form is stored in a pouch at 25° C. and 60% relative humidity for three months, the dosage form contains impurity of Formula II in an amount less than 1.4% weight 9. The parenteral unit dosage form according to claim 1, further comprising one or more co-solvents. 10. The parenteral unit dosage form of claim 1, wherein the dosage form is packaged in an atmosphere containing less than 1% oxygen. 11. The parenteral unit dosage form of claim 1, wherein the dosage form is packaged with an oxygen scavenger. 12. The parenteral unit dosage form of claim 1, wherein the dosage form is packaged in a pouch.