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US 12,551,454 B2Granted
Isoproterenol compositions and methods
AssigneePh Health Limited
InventorsRonald Domalaon, Jinjiang Li, Tushar Hingorani, Kumaresh Soppimath
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Abstract
Storage stable aqueous ready-to-administer formulations comprising isoproterenol are presented with desirable stability characteristics. In preferred aspects, formulations are terminally sterilized and packaged in a suitable format, such as a polymeric bag with metalized overwrap and include a non-contact oxygen scavenger.
Claims8
A storage stable sterile ready-to-administer pharmaceutical composition comprising:
- isoproterenol at a concentration between 1 and 10 mcg/mL;
- a buffer at a concentration equal to or less than 10 mM, wherein the buffer comprises tartaric acid;
- a chelating agent at a concentration of about 5 mcg/mL;
- a tonicity agent;
- and
- water,
- wherein the composition has a pH between 3.0 and 4.5;
- wherein the composition contains, after storage over at least three weeks at 60° C. in a container having a headspace that has not been flushed with an inert gas, equal to or less than 2.0% of total impurities formed from degradation of the isoproterenol, and
- wherein the composition is formulated for intravenous administration and is antioxidant free.
6 more elements
Dependencies are inferred from the claim text.