Claims for Patent: 9,925,234

Summary for Patent: 9,925,234

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:	15/688,330
Patent Claims:	1. A method of increasing blood pressure in a human in need thereof, the method comprising: a) providing a unit dosage form for intravenous administration, wherein the unit dosage form comprises: i) from about 0.1 units/mL to about 1 unit/mL of vasopressin or a pharmaceutically-acceptable salt thereof; ii) from about 1 mM to about 10 mM acetate buffer; iii) no more than about 0-2% vasopressin degradation products; iv) about 5% dextrose; and v) water; and b) administering the unit dosage form to the human by intravenous administration, wherein the unit dosage form comprises from about 0.1 units/mL to about 1 unit/mL of vasopressin or the pharmaceutically-acceptable salt thereof; wherein: the unit dosage form has a pH of 3.6 to 3.9; 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 over about one day. 3. The method of claim 1, wherein the administration to the human is over 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 pharmaceutically-acceptable salt of vasopressin is present in the unit dosage form. 11. The method of claim 1, wherein the pharmaceutically-acceptable salt of vasopressin is not present in the unit dosage form. 12. The method of claim 1, wherein the unit dosage form further comprises chlorobutanol. 13. The method of claim 1, wherein the unit dosage form has a pH of 3.74-3.75. 14. 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. 15. 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.