Phenylephrine hydrochloride compositions and containers
AssigneeEndo Operations Limited
InventorsReema Ajitkumar Puri, Harshil H. Jain, Tushar Hingorani, Kumaresh Soppimath
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Abstract
A ready-to-administer antioxidant free phenylephrine compositions has improved stability and is optionally free of metal chelating agents. Contemplated compositions are preferably packaged into a flexible polymer bag and maintain degradation of the phenylephrine at remarkably low levels, even over extended storage periods.
Claims19
A ready-to-administer sterile antioxidant free phenylephrine composition, comprising:
- phenylephrine or salt thereof at a concentration of equal or less than 0.4 mg/ml;
- a buffer comprising acetic acid, wherein the acetic acid is present in an amount of about 0.3 mg/mL;
- and
- a metal ion chelator, wherein the metal ion chelator is present in an amount of equal or less than 10 mcg/mL;
- wherein no more than 0.5% degradation products are formed from degradation of the phenylephrine upon storage of the phenylephrine composition over a period of at least six months at 25° C., and
- wherein the composition has a pH of between 4.0 and 5.5.
A method of manufacturing a ready-to-administer sterile antioxidant free phenylephrine composition, comprising:
- formulating a buffered liquid including phenylephrine or salt thereof;
- wherein the buffered composition comprises an acetate buffer and has a pH of between 4.5 and 5.5, and optionally further comprises a metal ion chelator;
- wherein the phenylephrine or salt thereof is present in the buffered liquid at a concentration of equal or less than 0.4 mg/ml;
- and terminally sterilizing the liquid composition;
- wherein no more than 0.25% degradation products are formed from degradation of the phenylephrine upon storage of the phenylephrine composition over a period of at least six months at 25° C.
A ready-to-administer sterile antioxidant free phenylephrine composition, essentially consisting of:
- phenylephrine or salt thereof at a concentration of between about 0.04 mg/ml and about 0.4 mg/ml;
- a buffer comprising acetic acid, wherein the acetic acid is present in an amount of about 0.3 mg/mL;
- and
- a metal ion chelator, wherein the metal ion chelator is present in an amount of equal or less than 10 μg/mL;
- wherein no more than 0.5% degradation products are formed from degradation of the phenylephrine upon storage of the phenylephrine composition over a period of at least six months at 25° C., and
- wherein the composition has a pH of between 4.0 and 5.5.
Dependencies are inferred from the claim text.