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US 10,478,406 B2Granted
High-pH solid-state epinephrine formulation
AssigneeHARC Therapeutics AG
InventorRobert Chisholm
Life of this patent
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Abstract
Epinephrine formulated in aqueous solvent at a basic pH of about 8.5 remains in solid state. My data show that epinephrine formulated at a pH of about 8.5 is surprisingly resistant to oxidation. I here teach how to formulate solid-state epinephrine in basic solution, and how to use solid-state epinephrine to make pharmaceutical dosage forms.
Claims1
A process for manufacturing a solid-state epinephrine pharmaceutical dosage form, the process comprising:
- mixing epinephrine in an aqueous solvent and at least one basic-pH excipient to produce a mixture having a pH of about 8.5, whereby the epinephrine remains in solid state,
- wherein the mixture comprises an antioxidant and a chelating agent,
- wherein the process comprises the step of removing the aqueous solvent to produce a dry dosage form, and
- wherein the dry dosage form is a tablet.
1 more element
Dependencies are inferred from the claim text.