Claims for Patent: 9,687,526

Summary for Patent: 9,687,526

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):	Kenney; Matthew (New Haven, MI), Kannan; Vinayagam (Rochester, MI), Vandse; Sunil (Basking Ridge, NJ), Sanghvi; Suketu (Kendall Park, NJ)
Assignee:	PAR PHARMACEUTICAL, INC. (Chestnut Ridge, NY)
Application Number:	15/289,640
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,687,526
Patent Claims:	1. A method of increasing blood pressure in a human in need thereof, the method comprising: a) providing a pharmaceutical composition for intravenous administration comprising: i) from about 0.01 mg/mL to about 0.07 mg/mL of vasopressin or a pharmaceutically-acceptable salt thereof; ii) acetic acid; and iii) water, wherein the pharmaceutical composition has a pH of 3.8; b) storing the pharmaceutical composition at 2-8.degree. C. for at least 4 weeks; and c) intravenously administering the pharmaceutical composition to the human, wherein the administration provides to the human from about 0.01 units of vasopressin or the pharmaceutically-acceptable salt thereof per minute to about 0.1 units of vasopressin or the pharmaceutically-acceptable salt thereof per minute, wherein the human is hypotensive, wherein the pharmaceutical composition exhibits less than about 5% degradation after storage at 2-8.degree. C. for about four weeks. 2. The method of claim 1, wherein the pharmaceutical composition further comprises SEQ ID NO: 2 in an amount of about 0.01% after storage for about 4 weeks at 2-8.degree. C. 3. The method of claim 1, wherein the pharmaceutical composition further comprises SEQ ID NO: 3 in an amount of about 0.01% after storage for about 4 weeks at 2-8.degree. C. 4. The method of claim 1, wherein the pharmaceutical composition further comprises SEQ ID NO: 4 in an amount of about 0.01% after storage for about 4 weeks at 2-8.degree. C. 5. The method of claim 1, wherein the human's mean arterial blood pressure is increased within 15 minutes of administration. 6. The method of claim 5, wherein the human's hypotension is associated with vasodilatory shock. 7. The method of claim 6, wherein the vasodilatory shock is post-cardiotomy shock. 8. The method of claim 6, wherein the vasodilatory shock is septic shock. 9. The method of claim 8, wherein the administration provides to the human from about 0.01 units of vasopressin or the pharmaceutically-acceptable salt thereof per minute to about 0.07 units of vasopressin or the pharmaceutically-acceptable salt thereof per minute. 10. The method of claim 1, further comprising attaining a target blood pressure in the human and continuing the administration for a period of about 8 hours. 11. The method of claim 10, further comprising, after the period of about 8 hours, reducing the administration by about 0.005 units per minute. 12. The method of claim 1, wherein the pharmaceutical composition is stored at about 5.degree. C. 13. The method of claim 1, wherein the pharmaceutical composition exhibits less than 1% degradation after storage at 2-8.degree. C. for about four weeks. 14. The method of claim 1, wherein the pharmaceutical composition is not lyophilized. 15. The method of claim 1, wherein the pharmaceutical composition form is not frozen. 16. The method of claim 1, wherein the pharmaceutical composition is diluted in a diluent prior to administration to the subject. 17. The method of claim 16, wherein the pharmaceutical composition is diluted to a concentration of from about 0.21 .mu.g/mL to about 2.1 .mu.g/mL of vasopressin or the pharmaceutically acceptable salt thereof. 18. The method of claim 16, wherein the diluent is 0.9% saline. 19. The method of claim 16, wherein the diluent is 5% dextrose in water. 20. The method of claim 1, wherein the pharmaceutical composition further comprises chlorobutanol.