Vasopressin liquid formulations
AssigneeHikma Pharmaceuticals USA Inc.
InventorsGyongyi Szakalas-Gratzl, Ping Ma, James Murtagh
Life of this patent
Estimating the term…
Abstract
A liquid pharmaceutical composition for intravenous administration that includes vasopressin or a pharmaceutically acceptable salt thereof. The formulation further includes a lactate buffer or lactic acid, optionally in combination with a pH adjuster. The pharmaceutical composition can have a pH of from about 3.0 to about 4.1 and demonstrates improved stability for long term storage, particularly at room temperature.
Claims39
A liquid pharmaceutical composition for intravenous administration comprising:
- i) vasopressin or a pharmaceutically acceptable salt thereof;
- ii) a buffer comprising lactic acid, a lactate salt, or a combination thereof;
- iii) water;
- and
- iv) optionally, a pH adjuster;
- wherein the pharmaceutical composition has a pH of from about 3.0 to about 4.1;
- and wherein, as measured by HPLC, the pharmaceutical composition retains 90% or more of the initial concentration of vasopressin or pharmaceutically acceptable salt thereof after storage for at least 18 months when stored at about 25° C. and about 60% relative humidity.
A pharmaceutical composition for intravenous administration consisting of:
- i) between 0.02 mg/mL and 0.05 mg/mL vasopressin or a pharmaceutically acceptable salt thereof;
- ii) a buffer consisting of lactic acid, a lactate salt, or a combination thereof;
- iii) water;
- and
- iv) optionally, a pH adjuster,
- wherein the pharmaceutical composition has a pH of from about 3.0 to about 3.7;
- and wherein, as measured by HPLC, the pharmaceutical composition retains 90% or more of the initial concentration of vasopressin or pharmaceutically acceptable salt thereof after storage for at least 18 months when stored at about 25° C. and about 60% relative humidity.
A pharmaceutical composition for intravenous administration consisting of:
- i) between 0.15 mg/mL and 0.25 mg/mL vasopressin or a pharmaceutically acceptable salt thereof;
- ii) a buffer consisting of lactic acid, a lactate salt, or a combination thereof;
- iii) water;
- and
- iv) optionally, a pH adjuster,
- wherein the pharmaceutical composition has a pH of from about 3.0 to about 3.5;
- and wherein, as measured by HPLC, the pharmaceutical composition retains about 90% or more of the initial concentration of vasopressin or pharmaceutically acceptable salt thereof after storage for about 18 months when stored at about 25° C. and about 60% relative humidity.
A method of increasing blood pressure in a patient in need thereof, the method comprising:
- a) providing a pharmaceutical composition comprising:
- i) vasopressin or a pharmaceutically acceptable salt thereof;
- ii) a buffer comprising lactic acid, a lactate salt, or a combination thereof;
- iii) water, and
- iv) optionally, a pH adjuster,
- wherein the pharmaceutical composition has a pH of from 3.0 to 4.1;
- and
- wherein, as measured by HPLC, the pharmaceutical composition retains 90% or more of the initial concentration of vasopressin or pharmaceutically acceptable salt thereof after storage at about 25° C. and 60% relative humidity for about 18 months;
- and
- b) intravenously administering the pharmaceutical composition to the patient.
Dependencies are inferred from the claim text.