Vasopressin formulations for use in treatment of hypotension

CAFC
  • US 9,744,239 B2
  • Filed: 05/20/2015
  • Issued: 08/29/2017
  • Est. Priority Date: 01/30/2015
  • Status: Active Grant
First Claim
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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.

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