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US 2024/0197621 A1Published application
Buffered Lidocaine Injectable Formulations and Methods for Making Same
OwnerKirankumar R. Chaudhari, Ahmad A. Abu Sharar +1inventors
InventorsKirankumar R. Chaudhari, Ahmad A. Abu Sharar, Ragheb M. AbuRmaileh
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Abstract
A stable liquid formulation for parenteral administration that includes lidocaine or a pharmaceutically acceptable salt thereof. The formulation includes a low concentration of a sodium bicarbonate buffer, sodium chloride, and an optional pH adjuster in an aqueous solution that has a pH of about 6.5 to about 7.2. The liquid formulation is a stable formulation that is supplied as a ready-to-use or product in a container or vial with a carbon dioxide rich headspace.
Claims23
An injectable liquid formulation in a container, the formulation comprising:
- a. lidocaine or a pharmaceutically acceptable salt thereof present at a concentration of about 5 to about 20 mg/mL as the sole pharmaceutically active agent;
- b. sodium bicarbonate buffer present at a concentration of about 4 to about 17 mg/mL;
- and
- c. a carrier,
- wherein the injectable liquid formulation has a pH of about 6.5 to about 7.4 and the container comprises a gas headspace, the gas headspace comprises greater than 20% carbon dioxide.
2 more elements
Dependencies are inferred from the claim text.