Pacira Pharmaceuticals, Inc.

John J Grigsby, Jr

Jeffrey S Hall

Kathleen D A Los

Soroush M Ardekani

David J Turnbull

Louie Daniel Garcia

Stephanie M Kurz

Paige N Davis

Eran Levy

Damon A Leon

Alisha R Simonian

Embodiments of the present disclosure relates 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.

Manufacturing of bupivacaine multivesicular liposomes

Embodiments of the present application relate to compositions bupivacaine multivesicular liposomes (MVLs) prepared by a commercial manufacturing process with large particle diameter span.

Some embodiments of the present application are related to multivesicular liposome formulations comprising high concentration of bupivacaine for the purpose of preventing, treating or ameliorating pain, for example, post-surgical pain for an extended period of time. Processes of making and administering bupivacaine encapsulated multivesicular liposome formulations (BUP-MVLs) and their uses as medicaments are also provided.

Bupivacaine multivesicular liposome formulations and uses thereof

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.

Multivesicular liposome formulations of dexamethasone

Embodiments of the present disclosure relates to commercial manufacturing process of making bupivacaine multivesicular liposomes with improved yield and desired particle size distribution.

Embodiments of the present application relate to batches of bupivacaine multivesicular liposomes (MVLs) prepared by a commercial manufacturing process using independently operating dual tangential flow filtration modules.

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San Diego, CA, United States of America

John J Grigsby, Jr