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US 12,186,362 B2Granted
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.
Claims18
A pharmaceutical formulation, comprising:
- a) about 0.1 units/mL to about 1 unit/mL of vasopressin or a pharmaceutically-acceptable salt thereof;
- b) an acetate buffer;
- c) dextrose or sodium chloride or combinations thereof;
- and
- d) water;
- wherein the formulation has a pH of about 3.5 to about 4;
- wherein the formulation is stable at a room temperature of between about 20° ° C. to about 25° C. for up to about 8 months;
- and
- wherein the formulation comprises no more than about 17% total impurities.
6 more elements
A pharmaceutical formulation, comprising in a unit dosage form:
- a) about 0.1 units/mL to about 1 unit/mL of vasopressin or a pharmaceutically-acceptable salt thereof;
- b) an acetate buffer;
- and
- c) dextrose or sodium chloride or combinations thereof;
- wherein the unit dosage form has a pH of about 3.5 to about 4;
- wherein the unit dosage form exhibits no more than about 10% degradation of the vasopressin or the pharmaceutically-acceptable salt thereof after storage of the formulation at a temperature of about 20° C. to about 25º C for up to 8 months.
3 more elements
Dependencies are inferred from the claim text.