Claims for Patent: 9,925,233

Summary for Patent: 9,925,233

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:	15/612,649
Patent Claims:	1. A method of increasing blood pressure in a human in need thereof, the method comprising: a) storing at 5.degree. C. for at least about one month a pharmaceutical composition for intravenous administration comprising, 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; and iii) from about 1 mM to about 10 mM acetate buffer, wherein the unit dosage form has a pH of 3.6 to 3.9, wherein the pharmaceutical composition exhibits no more than about 1% degradation of vasopressin or the pharmaceutically-acceptable salt thereof after the storage at 5.degree. C. for about one month; and b) administering to the human the pharmaceutical composition, wherein the pharmaceutical composition comprises from about 0.1 .mu.g/mL to about 2 .mu.g/mL of vasopressin or the pharmaceutically acceptable salt thereof; 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; and the human is hypotensive. 2. The method of claim 1, wherein the administration to the human is for about one day. 3. The method of claim 1, wherein the administration to the human is for about one week. 4. The method of claim 1, wherein the human's mean arterial blood pressure is increased within 15 minutes of administration. 5. The method of claim 1, wherein the human's hypotension is associated with vasodilatory shock. 6. The method of claim 5, wherein the vasodilatory shock is post-cardiotomy shock. 7. The method of claim 6, 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. 8. The method of claim 5, 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, wherein the pharmaceutical composition exhibits no more than about 2% degradation of vasopressin or the pharmaceutically-acceptable salt thereof after storage of the pharmaceutical composition at 5.degree. C. for about two months. 11. A method of increasing blood pressure in a human in need thereof, the method comprising: a) storing at 25.degree. C. for at least about one month a pharmaceutical composition for intravenous administration comprising, 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; and iii) from about 1 mM to about 10 mM acetate buffer, wherein the unit dosage form has a pH of 3.6 to 3.9, wherein the pharmaceutical composition exhibits no more than about 2% degradation of vasopressin or the pharmaceutically-acceptable salt thereof after the storage at 25.degree. C. for about one month; and b) administering to the human the pharmaceutical composition, wherein the pharmaceutical composition comprises from about 0.1 .mu.g/mL to about 2 .mu.g/mL of vasopressin or the pharmaceutically acceptable salt thereof; 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; and the human is hypotensive. 12. The method of claim 11, wherein the human's mean arterial blood pressure is increased within 15 minutes of administration. 13. The method of claim 11, wherein the human's hypotension is associated with vasodilatory shock. 14. The method of claim 13, wherein the vasodilatory shock is post-cardiotomy shock. 15. The method of claim 14, 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. 16. The method of claim 13, wherein the vasodilatory shock is septic shock. 17. The method of claim 16, 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. 18. The method of claim 11, wherein the pharmaceutical composition exhibits no more than about 5% degradation after storage of the pharmaceutical composition at 25.degree. C. for about two months. 19. The method of claim 1, wherein the unit dosage form has a pH of 3.74-3.75. 20. 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. 21. 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. 22. The method of claim 11, wherein the unit dosage form has a pH of 3.74-3.75. 23. The method of claim 11, 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. 24. The method of claim 11, 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.