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公开(公告)号:WO2022159564A1
公开(公告)日:2022-07-28
申请号:PCT/US2022/013104
申请日:2022-01-20
Applicant: PACIRA PHARMACEUTICALS, INC.
Inventor: HALL, Jeffrey, S. , TURNBULL, David, J. , GRIGSBY, John, J., Jr. , ARDEKANI, Soroush, M. , DAVIS, Paige, N. , GARCIA, Louie, D. , KURZ, Stephanie, M. , LOS, Kathleen, D., A.
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
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公开(公告)号:WO2023064446A1
公开(公告)日:2023-04-20
申请号:PCT/US2022/046535
申请日:2022-10-13
Applicant: PACIRA PHARMACEUTICALS, INC.
Inventor: DAVIS, Paige, N. , ARDEKANI, Soroush, M. , KURZ, Stephanie, M. , GARCIA, Louie, D. , LOS, Kathleen, D.A. , GRIGSBY, John, J., Jr. , LEON, Damon A. , LEVY, Eran , SIMONIAN, Alisha R.
Abstract: Some embodiments of the present application are related to multivesicular liposome (MVL) formulations encapsulating dexamethasone or an ester or an ester salt thereof, for example, dexamethasone sodium phosphate (DSP) that may provide about 3-28 days extended release of dexamethasone. Processes of making and administering dexamethasone encapsulated multivesicular liposome formulations and their uses for treating pain or inflammation are also provided.
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