Claims for Patent: 12,186,362

Summary for Patent: 12,186,362

Title:	Vasopressin formulations for use in treatment of hypotension
Abstract:	Provided herein are peptide formulations comprising polymers as stabilizing agents. The peptide formulations can be more stable for prolonged periods of time at temperatures higher than room temperature when formulated with the polymers. The polymers used in the present invention can decrease the degradation of the constituent peptides of the peptide formulations.
Inventor(s):	Matthew Kenney, Vinayagam Kannan, Sunil Vandse, Suketu Sanghvi
Assignee:	Endo Operations Ltd
Application Number:	US17/472,393
Patent Claims:	1. A pharmaceutical formulation, comprising: a) about 0.1 units/mL to about 1 unit/mL of vasopressin or a pharmaceutically-acceptable salt thereof; b) an acetate buffer; c) dextrose or sodium chloride or combinations thereof; and d) water; wherein the formulation has a pH of about 3.5 to about 4; wherein the formulation is stable at a room temperature of between about 20° ° C. to about 25° C. for up to about 8 months; and wherein the formulation comprises no more than about 17% total impurities. 2. The pharmaceutical formulation of claim 1, comprising a total volume of about 10 mL to about 500 mL. 3. The pharmaceutical formulation of claim 1, wherein the acetate buffer is chosen from acetic acid, sodium acetate, sodium acetate trihydrate, or combinations thereof. 4. The pharmaceutical formulation of claim 1, wherein the formulation further comprises a stabilizer. 5. The pharmaceutical formulation of claim 1, wherein the formulation further comprises a pH adjusting agent. 6. The pharmaceutical formulation of claim 1, wherein the formulation comprises no more than about 6% of Gly9-AVP impurity. 7. The pharmaceutical formulation of claim 1, wherein the formulation comprises no more than about 6% of Glu4-AVP impurity. 8. The pharmaceutical formulation of claim 1, wherein the formulation is stored in a drip-bag or a bottle. 9. The pharmaceutical formulation of claim 1, wherein the about 0.1 units/mL to about 1 unit/mL of vasopressin or a pharmaceutically-acceptable salt thereof comprises between about 0.1 μg/mL to about 2 μg/mL of vasopressin or a pharmaceutically-acceptable salt thereof. 10. A pharmaceutical formulation, comprising in a unit dosage form: a) about 0.1 units/mL to about 1 unit/mL of vasopressin or a pharmaceutically-acceptable salt thereof; b) an acetate buffer; and c) dextrose or sodium chloride or combinations thereof; wherein the unit dosage form has a pH of about 3.5 to about 4; wherein the unit dosage form exhibits no more than about 10% degradation of the vasopressin or the pharmaceutically-acceptable salt thereof after storage of the formulation at a temperature of about 20° C. to about 25º C for up to 8 months. 11. The pharmaceutical formulation of claim 10, wherein the about 0.1 units/mL to about 1 unit/mL of vasopressin or a pharmaceutically-acceptable salt thereof comprises between about 0.1 μg/mL to about 2 μg/mL of vasopressin or a pharmaceutically-acceptable salt thereof. 12. The pharmaceutical formulation of claim 10, wherein the unit dosage form has a pH of about 3.7 to about 4.0. 13. The pharmaceutical formulation of claim 10, wherein the formulation is stored at a temperature of about 25° C. 14. The pharmaceutical formulation of claim 10, wherein the formulation comprises about 0.2 units/mL, 0.4 units/mL, 0.6 units/mL, or 1 unit/mL of vasopressin or a pharmaceutically acceptable salt thereof. 15. The pharmaceutical formulation of claim 10, wherein the total volume of the formulation is about 10 mL to about 500 mL. 16. The pharmaceutical formulation of claim 10, wherein the formulation comprises less than about 6.0% Gly9-AVP impurity. 17. The pharmaceutical formulation of claim 10, wherein the acetate buffer is chosen from acetic acid, sodium acetate, sodium acetate trihydrate, or combinations thereof. 18. The pharmaceutical formulation of claim 10, wherein the formulation is stored in a bottle or an intravenous bag.