Claims for Patent: 9,744,239

Summary for Patent: 9,744,239

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)
Assignee:	PAR PHARMACEUTICAL, INC. (Chestnut Ridge, NY)
Application Number:	14/717,877
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,744,239
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 consisting of, in a unit dosage form: i) from about 0.01 mg/mL to about 0.07 mg/mL of vasopressin or a pharmaceutically-acceptable salt thereof; ii) optionally chlorobutanol; iii) acetic acid, acetate, or a combination thereof; iv) 0-2% vasopressin degradation products; and v) water; b) diluting the unit dosage form in a diluent to provide a concentration from about 0.1 units/mL to about 1 unit/mL of vasopressin or the pharmaceutically-acceptable salt thereof; and c) administering the diluted unit dosage form to the human by intravenous administration; wherein: the unit dosage form has a pH of 3.5 to 4.1; 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 vasopressin degradation products include SEQ ID NO.: 2, wherein SEQ ID NO.: 2 is present in the unit dosage form in an amount of about 0.01%. 3. The method of claim 1, wherein the vasopressin degradation products include SEQ ID NO.: 3, wherein SEQ ID NO.: 3 is present in the unit dosage form in an amount of about 0.01%. 4. The method of claim 1, wherein the vasopressin degradation products include SEQ ID NO.: 4, wherein SEQ ID NO.: 4 is present in the unit dosage form in an amount of about 0.01%. 5. The method of claim 1, wherein the human's mean arterial blood pressure is increased within 15 minutes of administration. 6. The method of claim 1, wherein the human's hypotension is associated with vasodilatory shock. 7. The method of claim 6, wherein the vasodilatory shock is post-cardiotomy shock. 8. The method of claim 7, 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. 9. The method of claim 6, wherein the vasodilatory shock is septic shock. 10. The method of claim 9, 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. 11. 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. 12. The method of claim 11, the method further comprising, after the period of about 8 hours, reducing the administration by about 0.005 units per minute. 13. 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. 14. The method of claim 1, the method further comprising discarding a vial containing the unit dosage form at least 48 hours after a first puncture of the vial. 15. A method of increasing blood pressure in a human in need thereof, the method comprising: a) providing a pharmaceutical composition for intravenous administration consisting of, in a unit dosage form: i) from about 0.01 mg/mL to about 0.07 mg/mL of vasopressin or a pharmaceutically-acceptable salt thereof; ii) optionally chlorobutanol; iii) acetic acid, acetate, or a combination thereof; iv) 0-2% vasopressin degradation products; and v) water; b) diluting the unit dosage form in 0.9% saline or 5% dextrose in water to provide a concentration from about 0.1 units/mL to about 1 unit/mL of vasopressin or the pharmaceutically-acceptable salt thereof; and c) administering the diluted unit dosage form to the human by intravenous administration; wherein: the unit dosage form has a pH of 3.5 to 4.1; 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. 16. The method of claim 1, wherein the diluent is 0.9% saline. 17. The method of claim 1, wherein the diluent is 5% dextrose in water. 18. The method of claim 1, wherein the unit dosage form is not lyophilized. 19. The method of claim 1, wherein the unit dosage form is not frozen.