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US 2026/0283954 A1Published application
Manufacturing of bupivacaine multivesicular liposomes
AssigneePacira Pharmaceuticals, Inc.
InventorsEran Levy, Jeffrey S. Hall, John J. Grigsby, JR.
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Abstract
Embodiments of the present disclosure relate to a new and improved large scale commercial manufacturing process of making bupivacaine multivesicular liposomes (MVLs). Batches of bupivacaine MVLs prepared by the new process have high yields, improved stabilities, and desired particle size distributions.
Claims25
A batch comprising a composition of bupivacaine encapsulated multivesicular liposomes (MVLs), the composition comprising:
- bupivacaine residing inside a plurality of internal aqueous chambers of 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) or a salt thereof, cholesterol, and tricaprylin;
- and
- an aqueous medium in which the bupivacaine encapsulated MVLs are suspended, wherein the aqueous medium also comprises unencapsulated bupivacaine;
- the total bupivacaine concentration in the composition is from 12 mg/mL to 17 mg/mL;
- wherein the batch has a volume of about 100 liters to about 300 liters;
- the bupivacaine encapsulated MVLs of the batch have a d90 volume-weighted particle diameter of about 48 μm when measured at least one time within first month of storage at 2° C. to 8° C.;
- and
- the bupivacaine MVL product yield of a batch is as high as about 85% but no less than about 82%.
5 more elements
Dependencies are inferred from the claim text.