Back to results
US 11,806,320 B2Granted
Isoproterenol compositions and methods
AssigneeEndo Ventures Limited
InventorsRonald Domalaon, Jinjiang Li, Tushar Hingorani, Kumaresh Soppimath
Life of this patent
Estimating the term…
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.
Claims18
A storage stable sterile ready-to-administer pharmaceutical composition, comprising:
- a buffered aqueous solution comprising isoproterenol at a concentration of between 1-10 mcg/mL;
- wherein the buffered aqueous solution has a pH range of between 3.0 and 4.5 and wherein the buffer is a tartrate buffer and has a concentration of equal to or less than 10 mM;
- wherein the solution further comprises ethylenediamine tetraacetic acid (EDTA) as a chelating agent at a concentration of about 5 mcg/mL and a tonicity agent;
- wherein the ready-to-administer 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.
2 more elements
A method of preparing a storage stable liquid sterile ready-to administer pharmaceutical composition, comprising:
- formulating a liquid parenteral composition for intravenous administration that contains in a buffered aqueous acidic solution isoproterenol, a chelating agent, and a tonicity agent;
- wherein the buffered aqueous acidic solution has a pH range of between 3.0 and 4.5, wherein the buffer is a tartrate buffer, and wherein the buffer has a concentration of equal to or less than 10 mM;
- wherein the isoproterenol is present in the composition at a concentration of between 1 and 10 mcg/mL;
- wherein the chelating agent is ethylenediamine tetraacetic acid (EDTA) and is present at a concentration of equal to or less than 10 mcg/mL;
- and
- sterilizing the liquid parenteral composition via thermal sterilization to obtain the storage stable liquid sterile ready-to-administer pharmaceutical composition,
- wherein the liquid sterile ready-to-administer pharmaceutical 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.
4 more elements
Dependencies are inferred from the claim text.