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- Title
The Safety of EXPAREL (Bupivacaine Liposome Injectable Suspension) Administered by Peripheral Nerve Block in Rabbits and Dogs.
- Authors
Richard, Brigitte M.; Newton, Paul; Ott, Laura R.; Haan, Dean; Brubaker, Abram N.; Cole, Phaedra I.; Ross, Paul E.; Rebelatto, Marlon C.; Nelson, Keith G.
- Abstract
A sustained-release DepoFoam injection formulation of bupivacaine (EXPAREL, 15mg/mL) is currently being investigated for postsurgical analgesia via peripheral nerve block (PNB). Single-dose toxicology studies of EXPAREL (9, 18, and 30mg/kg), bupivacaine solution (Bsol, 9mg/kg), and saline injected around the brachial plexus nerve bundle were performed in rabbits and dogs. The endpoints included clinical pathology, pharmacokinetics, and histopathology evaluation on Day 3 and Day 15 (2/sex/group/period). EXPAREL resulted in a nearly 4-fold lower Cmax versus Bsol at the same dose. EXPAREL was well tolerated at doses up to 30mg/kg. The only EXPAREL-related effect seen was minimal to mild granulomatous inflammation of adipose tissue around nerve roots (8 of 24 rabbits and 7 of 24 dogs) in the brachial plexus sites. The results indicate that EXPAREL was well tolerated in these models and did not produce nerve damage after PNB in rabbits and dogs.
- Subjects
NERVE block; INTRAVENOUS therapy; LIPOSOMES; INJECTIONS; ANALGESIA; LABORATORY rabbits; LABORATORY dogs
- Publication
Journal of Drug Delivery, 2012, p1
- ISSN
2090-3014
- Publication type
Article
- DOI
10.1155/2012/962101