Claims for Patent: 9,981,006

Summary for Patent: 9,981,006

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:	15/688,305
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,981,006
Patent Claims:	1. A method of increasing blood pressure in a human in need thereof, the method comprising: providing a pharmaceutical composition that comprises, in a unit dosage form i) from about 0.1 .mu.g/mL to about 2 .mu.g/mL of vasopressin or a pharmaceutically-acceptable salt thereof; ii) dextrose; iii) from about 1 mM to about 10 mM acetate buffer; and iv) SEQ ID NO.: 2, wherein the unit dosage form has a pH of 3.6 to 3.9; storing the unit dosage form for at least about 24 hours at a concentration from about 0.1 .mu.g/ml to about 2 .mu.g/mI vasopressin or a pharmaceutically-acceptable salt thereof; and after the storing, intravenously administering the unit dosage form 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 vasopressin or the pharmaceutically-acceptable salt thereof and SEQ ID NO.:2 are present in the unit dosage form at a ratio of about 1000: about 1 to about 30: about 1, wherein the unit dosage form that is administered to the human comprises from about 0.1.mu.g/mL to about 2 .mu.g/mL of vasopressin or the pharmaceutically-acceptable salt thereof; and the human is hypotensive. 2. The method of claim 1, wherein the unit dosage form further comprises a pH adjusting agent. 3. The method of claim 1, wherein the unit dosage form further comprises hydrochloric acid. 4. The method of claim 1, wherein the unit dosage further comprises sodium hydroxide. 5. The method of claim 1, wherein the dextrose is present at 5%. 6. The method of claim 1, wherein the vasopressin or the pharmaceutically-acceptable salt thereof and SEQ ID NO.: 2 are present in the unit dosage form at a ratio of about 950: about 1. 7. The method of claim 1, wherein the vasopressin or the pharmaceutically-acceptable salt thereof and SEQ ID NO.: 2 are present in the unit dosage form at a ratio of about 70: about 1. 8. The method of claim 1, wherein the vasopressin or the pharmaceutically-acceptable salt thereof and SEQ ID NO.: 2 are present in the unit dosage form at a ratio of about 35: about 1. 9. The method of claim 1, wherein the administration to the human is over about one day. 10. The method of claim 1, wherein the administration to the human is over about one week. 11. The method of claim 1, wherein the human's mean arterial blood pressure is increased within 15 minutes of administration. 12. The method of claim 1, wherein the human's hypotension is associated with vasodilatory shock. 13. The method of claim 12, wherein the vasodilatory shock is post-cardiotomy shock. 14. The method of claim 13, wherein the administration provides to the human from about 0.03 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. 15. The method of claim 12, wherein the vasodilatory shock is septic shock. 16. The method of claim 15, 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. 17. The method of claim 1, wherein the unit dosage form has a pH of 3.74-3.75. 18. The method of claim 1, wherein the unit dosage form comprises about 1 mM acetate buffer, and wherein the unit dosage form has a pH of 3.7 to 3.9. 19. The method of claim 1, wherein the unit dosage form comprises about 10 mM acetate buffer, and wherein the unit dosage form has a pH of 3.6 to 3.7.