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Claims for Patent: 9,375,478

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Claims for Patent: 9,375,478

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:14/717,882
Patent Claims: 1. A method of increasing blood pressure in a human in need thereof, the method comprising administering to the human a unit dosage form, wherein the unit dosage form consists essentially of: a) from about 0.01 mg/mL to about 0.07 mg/mL of vasopressin or a pharmaceutically-acceptable salt thereof; b) 10 mM acetate buffer; and c) water, wherein: the unit dosage form has a pH of 3.8; 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 unit dosage form further consists essentially of chlorobutanol.

3. The method of claim 1, wherein the human's mean arterial blood pressure is increased within 15 minutes of administration.

4. The method of claim 1, wherein the human's hypotension is associated with vasodilatory shock.

5. The method of claim 4, wherein the vasodilatory shock is post-cardiotomy shock.

6. The method of claim 5, 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.

7. The method of claim 4, wherein the vasodilatory shock is septic shock.

8. The method of claim 7, 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.

9. The method of claim 1, the method further comprising attaining a target blood pressure in the human and continuing the administration for a period of about 8 hours.

10. The method of claim 9, the method further comprising, after the period of about 8 hours, reducing the administration by about 0.005 units per minute.

11. The method of claim 1, the method further comprising reaching a target increase in blood pressure of the human, wherein if the target increase in blood pressure is not attained, the administration is increased by about 0.005 units per minute at 10-15 minute intervals until the target increase in blood pressure is attained.
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