Bupivacaine liquid formulations

A pharmaceutical product comprising a stable, ready-to-administer formulation comprising an initial concentration of bupivacaine hydrochloride, a tonicity agent, and water packaged in a flexible plastic container wherein the innermost layer of the container comprises polypropylene, wherein the formulation has an initial pH of from 4.3 to 4.5, and wherein the pH drift of the formulation is less than 0.4 pH units following thermal sterilization of the pharmaceutical product, and wherein following storage of the container for at least about 6 months at room temperature, the formulation (1) has a pH drift of less than about 0.2 pH units, (2) contains from about 97% to about 103% of the initial concentration of bupivacaine, and (3) contains not more than about 0.1% total impurities as determined by a peak area percent method by high-performance liquid chromatography (HPLC).

(canceled)

24-29. (canceled)

A pharmaceutical product comprising a stable, ready-to-administer formulation comprising an initial concentration of bupivacaine hydrochloride, a tonicity agent, and water packaged in a flexible plastic container wherein the innermost layer of the container comprises polypropylene, wherein the formulation has an initial pH of from 4.3 to 4.5, and wherein the pH drift of the formulation is less than 0.4 pH units following thermal sterilization of the pharmaceutical product, wherein the formulation is substantially free of a buffer and does not contain epinephrine or a pharmaceutically acceptable salt thereof, and wherein following storage of the container for at least about 6 months at room temperature, the formulation 1) has a pH drift of less than about 0.2 pH units, (2) contains from about 97% to about 103% of the initial concentration of bupivacaine, and (3) contains not more than about 0.1% total impurities as determined by a peak area percent method by high-performance liquid chromatography (HPLC).

31-32. (canceled)

The pharmaceutical product of claim 31, wherein the innermost layer of the container further comprises a butadiene-styrene copolymer.

A pharmaceutical product comprising a stable, ready-to-administer formulation comprising an initial concentration of 0.625 mg/mL or 1.25 mg/mL bupivacaine hydrochloride, sodium chloride, and water packaged in a flexible plastic container wherein the innermost layer of the container comprises polypropylene and a butadiene-styrene copolymer, wherein the formulation has an initial pH of from 4.3 to 4.5, and wherein the pH drift of the formulation is less than 0.4 pH units following thermal sterilization of the pharmaceutical product, and wherein following storage of the container for at least about 6 months at room temperature, the formulation (1) has a pH drift of less than about 0.2 pH units, (2) contains from about 97% to about 103% of the initial concentration of bupivacaine, and (3) contains not more than about 0.10% total impurities as determined by a peak area percent method by high-performance liquid chromatography (HPLC).