safety evaluation of exparel (depofoam bupivacaine) administered by repeated subcutaneous injection in rabbits and dogs: species comparison

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ID: 224195
2011
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Abstract
EXPAREL (bupivacaine extended-release liposome injection), DepoFoam bupivacaine, is in development for prolonged postsurgical analgesia. Repeat-dose toxicity studies were conducted in rabbits and dogs to compare the potential local and systemic toxicities of EXPAREL and bupivacaine HCl (Bsol), and the reversibility of any effects. Dogs tolerated much larger doses than rabbits. EXPAREL-related minimal-to-moderate granulomatous inflammation was noted at the injection sites. In recovery animals, the granulomatous inflammation was observed less frequently and was characterized by an increased number of multinucleated giant cells. These effects were considered a normal response to liposomes and nonadverse. Rabbits are more sensitive than dogs. In rabbits, convulsions were noted with EXPAREL and more frequently with Bsol; a NOAEL was not identified. In dogs, EXPAREL was well tolerated (NOAEL > 30 mg/kg/dose). The cumulative exposure of EXPAREL in these studies is well in excess of the proposed maximum single-dose exposure that is intended in humans.
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Authors ;Brigitte M. Richard;Douglas E. Rickert;Paul E. Newton;Laura R. Ott;Dean Haan;Abram N. Brubaker;Phaedra I. Cole;Paul E. Ross;Marlon C. Rebelatto;Keith G. Nelson
Journal linux dev center, downloaded from http://www linuxdevcenter com/lpt/a/1636
Year 2011
DOI
10.1155/2011/467429
URL
http://dx.doi.org/10.1155/2011/467429
Keywords
Pharmacy and materia medica

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