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US 2017/0360878 A1Published application
Vasopressin formulations for use in treatment of hypotension
AssigneePar Pharmaceutical, Inc.
InventorsMatthew Kenney, Vinayagam Kannan, Sunil Vandse, Suketu Sanghvi
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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.
Claims16
1-15. (canceled)
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 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 no greater than 4.1;
- the unit dosage form further comprises impurities that are present in an amount of 0.9%-1.7%, wherein the impurities have from about 85% to about 100% sequence homology to SEQ ID NO.:
- 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.
4 more elements
Dependencies are inferred from the claim text.