Stable liquid remifentanil formulations
AssigneeMylan Inc.
InventorsDaniel Swaim ROBINS, Leena Selvaraj, Rajaram Vaidyanathan
Life of this patent
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Abstract
A stable, non-aqueous, liquid pharmaceutical composition contains remifentanil dissolved in a non-aqueous solvent. The formulation is provided with a pH ranging from about 2.0 to about 3.5 and can be used as an injectable. A method for preparing the formulation is also provided.
Claims38
An injectable liquid pharmaceutical composition comprising remifentanil dissolved in a non-aqueous solvent containing at least one hydrophilic organic component, wherein the composition is water-miscible, has a pH ranging from about 2.0 to about 3.5 and at least one of:
- i) a room temperature shelf life stability of at least about one year and ii) a refrigerated shelf life stability at about 5° C. of at least about two years.
A method for preparing an injectable liquid composition of at least one of:
- i) a room temperature shelf life stability of at least about one year and ii) a refrigerated shelf life stability at about 5° C. of at least about two years, comprising mixing remifentanil with a non-aqueous solvent containing at least one hydrophilic organic component, and adjusting the pH of the resulting mixture to a pH ranging from about 2.0 to about 3.5.
An injectable liquid pharmaceutical composition comprising remifentanil hydrochloride dissolved in a non-aqueous solvent containing propylene glycol and polyethylene glycol, wherein the composition has a pH ranging from about 2.0 to about 3.5 and at least one of:
- i) a room temperature shelf life stability of at least about one year and ii) a refrigerated shelf life stability at about 5° C. of at least about two years.
An injectable liquid pharmaceutical composition comprising remifentanil dissolved in a non-aqueous solvent containing at least one hydrophilic organic component, wherein the composition is water-miscible, has a pH ranging from about 2.0 to about 3.5 and a shelf life stability at about 40° C. of at least about six months.
An injectable liquid pharmaceutical composition comprising remifentanil dissolved in a liquid wherein the composition is characterized by least one of:
- i) a shelf life stability at about 40° C. of at least about six months,
- ii) a room temperature shelf life stability of at least about one year and,
- iii) a refrigerated shelf life stability at about 5° C. of at least about two years.
A stable liquid pharmaceutical composition comprising remifentanil in a non-aqueous solvent, in an amount ranging from about 0.25 mg/mL to about 1 mg/mL.
Dependencies are inferred from the claim text.