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Last Updated: October 22, 2019

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Claims for Patent: 9,937,223

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Summary for Patent: 9,937,223
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:15/606,442
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,937,223
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) acetate buffer; and iii) water, wherein the pharmaceutical composition has a pH from about 3.7 to about 3.8, wherein the pharmaceutical composition is provided in a container; b) puncturing a dispensing region of the container a first time and drawing from the container a portion of the pharmaceutical composition; c) intravenously administering the portion of 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; d) puncturing the dispensing region of the container a second time and drawing from the container a second portion of the pharmaceutical composition, wherein the second time that the dispensing region of the container is punctured occurs at least 48hours after the first time that the dispensing region of the container is punctured; e) intravenously administering the second portion of the pharmaceutical composition to the human, wherein the administration of the second portion of the pharmaceutical composition 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.

2. The method of claim 1, further comprising puncturing the dispensing region of the container a third time and drawing from the container a third portion of the pharmaceutical composition.

3. The method of claim 2, wherein the third puncture of the dispensing region of the container occurs after the second puncture of the dispensing region of the container occurs, and wherein the third puncture occurs within about 30 days of the first puncture of the dispensing region of the container.

4. The method of claim 3, further comprising administering the third portion of the pharmaceutical composition to the human, wherein the administration of the third portion occurs after the administration of the second portion, wherein the third administration occurs within about 30 days of the first time that the dispensing region of the container is punctured.

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 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, wherein the pharmaceutical composition further comprises chlorobutanol.

10. The method of claim 1, wherein a shelf-life of the pharmaceutical composition is from about 10 to about 20 months at 25 .degree. C.

11. The method of claim 1, further comprising diluting the portion of the pharmaceutical composition with a diluent prior to the intravenous administration of the portion of the pharmaceutical composition.

12. 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) acetate buffer; and iii) water, wherein the pharmaceutical composition has a pH from about 3.7 to about 3.8, wherein the pharmaceutical composition is provided in a container; b) puncturing a dispensing region of the container a first time and drawing from the container a portion of the pharmaceutical composition; c) intravenously administering the portion of 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; d) puncturing the dispensing region of the container a second time and drawing from the container a second portion of the pharmaceutical composition, wherein the second time that the dispensing region of the container is punctured occurs at least about 30 days after the first time that the dispensing region of the container is punctured; and e) intravenously administering the second portion of the pharmaceutical composition to the human, wherein the administration of the second portion of the pharmaceutical composition 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 container is stored at about room temperature from the first time that the dispensing region of the container is punctured to the second time that the dispensing region of the container is punctured, wherein the pharmaceutical composition comprises no more than about 2% total impurities at the second time that the dispensing region of the container is punctured.

13. The method of claim 12, wherein the total impurities comprise SEQ ID NO.: 2, and SEQ ID NO.:2 is present in the container in an amount of 0.1% to 0.5% at the second time that the dispensing region of the container is punctured.

14. The method of claim 12, wherein the total impurities comprise SEQ ID NO.:4, and SEQ ID NO.:4 is present in the container in an amount of 0.1% to 0.5% at the second time that the dispensing region of the container is punctured.

15. The method of claim 12, wherein the total impurities comprise SEQ ID NO.: 7, and SEQ ID NO.:7 is present in the container in an amount of 0.1% to 1% at the second time that the dispensing region of the container is punctured.

16. The method of claim 12, wherein room temperature is 22.degree. C. to 28.degree. C.

17. The method of claim 12, wherein room temperature is 25.degree. C.

18. The method of claim 12, further comprising diluting the portion of the pharmaceutical composition with a diluent prior to the intravenous administration of the portion of the pharmaceutical composition.

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