Injectable phenylephrine compositions
AssigneeHikma Pharmaceuticals USA Inc.
InventorMatija Simac
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Abstract
Described herein is a product including a ready-to-administer injectable formulation, the formulation including phenylephrine or a pharmaceutically acceptable salt thereof, a tonicity agent and a pH adjusting agent, wherein the pH adjusting agent is tartaric acid; and wherein the formulation of this oxygen sensitive substance is stable for prolonged period of times even when manufactured without protection from oxygen and when packed and stored in a flexible plastic container without modification of atmosphere by oxygen removal from the bag or the overwrap.
Claims14
A product comprising a ready-to-administer injectable formulation, the formulation comprising phenylephrine or a pharmaceutically acceptable salt thereof, an osmolality adjusting agent, and a pH adjusting agent that is tartaric acid in an amount less than 0.05 mg/ml, wherein the formulation is contained in a flexible plastic container.
A product comprising a ready-to-administer injectable formulation, the formulation comprising phenylephrine or a pharmaceutically acceptable salt thereof, an osmolality adjusting agent and a pH adjusting agent that is tartaric acid in an amount less than 0.05 mg/ml;
- wherein the formulation is contained in a flexible plastic container;
- wherein oxygen has not been removed from the product;
- and wherein the level of total impurities is less than 0.40% after 3 months at 40 degrees Celsius as determined by HPLC.
Dependencies are inferred from the claim text.