| abstract |
Embodiments relate to commercial manufacturing processes for making bupivacaine multivesicular liposomes (MVLs) using independently operating dual tangential flow filtration modules, wherein the MVL lipid membranes comprise 1,2-dierucoyl phosphatidylcholine (DEPC), 1,2-dipalmitoyl-sn-glycero-3-phospho-rac-(l-glycerol) (DPPG), and at least one neutral lipid typically cholesterol and tricaprylin, and preferably comprise pH modifying agents including lysine which limit hydrolysis of the DEPC to erucic acid such that the erucic acid concentration in the composition is about 23 pg/mL or less following storage at 25°C for one month. manufacturing of bupivacaine multivesicular liposomes |