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US 11,179,336 B1Granted
Manufacturing of bupivacaine multivesicular liposomes
AssigneePacira Pharmaceuticals, Inc.
InventorsJeffrey S. Hall, David J. Turnbull, John J. Grigsby, Jr., Soroush M. Ardekani, Paige N. Davis, Louie D. Garcia, Stephanie M. Kurz, Kathleen D. A. Los
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Abstract
Embodiments of the present application relate to commercial manufacturing processes for making bupivacaine multivesicular liposomes (MVLs) using independently operating dual tangential flow filtration modules.
Claims20
A composition of bupivacaine encapsulated multivesicular liposomes (MVLs), comprising:
- bupivacaine residing inside a plurality of internal aqueous chambers of the MVLs separated by lipid membranes, wherein the lipid membranes comprise 1, 2-dierucoylphosphatidylcholine (DEPC), 1, 2-dipalmitoyl-sn-glycero-3 phospho-rac-(1-glycerol) (DPPG), and at least one neutral lipid, the plurality of internal aqueous chambers of the MVLs also comprise lysine;
- and
- an aqueous medium in which the bupivacaine encapsulated MVLs are suspended;
- wherein the plurality of internal aqueous chambers of the MVLs has a pH of about 5.5;
- wherein the bupivacaine concentration in the composition is from about 11.3 mg/mL to about 17.0 mg/mL, wherein erucic acid concentration in the composition is about 23 μg/mL or less after the composition is stored at 25° C. for one month, and wherein the composition has a shelf life of up to 2 years when stored at 2-8° C.
2 more elements
Dependencies are inferred from the claim text.