Ultra Long Dental Analgesia and Anesthesia

Grant support is given for the production of flurbiprofen- and bupivacaine-impregnated collagenfoam for clinical testing of efficacy in reducing post-extraction pain to be performed at the NationalInstitute of Dental Research (MDR). The applicant company owns the patented Lecithin-CoatedMicrocrystaI (MC) Technology which enables water-insoluble drugs to be injected into tissue forsustained release delivery. We have conducted clinical studies which show that insertion ofnon-steroidal anti-inflammatory (NSAID) drugs into the tooth socket reduces post-extraction pain for upto 6 hours. Pharma-Logic has conducted formulation studies which show that NIC-flurbiprofen (anNSAID) and MC-bupivacaine (a ocal anesthetic) can be incorporated into Gelfoam(R) (a sterile, solid,compressible, cross-linked collagen foam used in surgery). The MDR and Pharma-Logic are entering intoa CRADA for the purpose testing whether insertion of MC-fluriprofen and MC-bupivacaine impregnatedGelfoam(R) into the tooth socket will relieve post-extraction pain for 36 hrs. Specific activities under thisproposal include (I) finalization of the preparation (quality control and shelf-life), (2) GMP manufactureof a clinical batch, (3) submission to the MDR, (4) further in vitro testing for the purposes of optimizationand QA, and (5) experimentation with MC-antibiotics in Gelfoam(R) as a follow-on product.