More potent and less toxic formulations of epinephrine and methods of medical use
OwnerJugal K. Tanejainventor
Life of this patent
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Abstract
The present invention provides pharmaceutical formulations of levorotatory-epinephrine, l-epinephrine, more potent and less toxic than existing pharmaceutical formulations of epinephrine, along with methods of producing and using these pharmaceutical formulations of l-epinephrine.
Claims7
A liquid pharmaceutical formulation of preservative-free and sulfite-free, 1 mg per mL l-epinephrine sterile solution for uses including injection;
- said liquid pharmaceutical formulation having a pH between 2.8 and 3.3;
- said liquid pharmaceutical formulation compounded in an aqueous solution as 1.0 to 1.06 mg/mL l-epinephrine, and further including a tonicity agent;
- said liquid pharmaceutical formulation having no more than 6.5% total impurities at release, including no more than 6% d-epinephrine and no more than 0.5% adrenalone, and no more than 12.5% total impurities over a shelf-life of at least 12 months, including no more than 12% d-epinephrine and no more than 0.5% adrenalone;
- said liquid pharmaceutical formulation stored in a container with an inert gas prior to use.
A liquid pharmaceutical formulation of preservative-free and sulfite-free, 1 mg per mL l-epinephrine sterile solution for uses including injection;
- said liquid pharmaceutical formulation having a pH between 2.8 and 3.3;
- said liquid pharmaceutical formulation compounded as 1.0 to 1.06 mg/mL l-epinephrine, along with 8.6 mg/mL sodium chloride as the tonicity agent, 7.26 mg/mL of 1 Normal hydrochloric acid as the dissolution agent, 987.11 mg/mL water for injection as a solvent, and with additional hydrochloric acid to adjust pH;
- said liquid pharmaceutical formulation having less than 6.5% total impurities at release, including less than 6% d-epinephrine and less than 0.5% adrenalone, and less than 12.5% total impurities over a shelf-life of at least 12 months, including less than 12% d-epinephrine and less than 0.5% adrenalone.
An injectable liquid pharmaceutical formulation of l-epinephrine sterile solution;
- said liquid pharmaceutical formulation having a pH between 2.8 and 3.3;
- said injectable liquid pharmaceutical formulation compounded in an aqueous solution as 1.0 to 1.06 mg/mL l-epinephrine, and further including a tonicity agent;
- said liquid pharmaceutical formulation including no more than about 6% d-epinephrine and no more than about 0.5% adrenalone at release, and no more than about 12% d-epinephrine and no more than about 0.5% adrenalone over a shelf-life of at least 12 months.
Dependencies are inferred from the claim text.