Grant support is requested for the production of flurbiprofen- and bupivacaine-impregnated collagen foam for clinical testing of efficacy in reducing post-extraction pain to be performed at the National Institute of Dental Research (MDR). The Pharma-Logic, Inc. (the applicant company) owns the patented Lecithin-Coated MicrocrystaI (MC) Technology which enables water-insoluble drugs to be injected into tissue for sustained release delivery. Dr. Raymond Dionne of the MDR has conducted clinical studies which show that insertion of non-steroidal anti-inflammatory (NSAID) drugs into the tooth socket reduces post-extraction pain for up to 6 hours. Pharma-Logic has conducted formulation studies which show that NIC-flurbiprofen (an NSAID) and MC-bupivacaine (a local 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 into a CRADA for the purpose testing whether insertion of MC-fluriprofen and MC-bupivacaine impregnated Gelfoam(R) into the tooth socket will relieve post-extraction pain for 36 hrs. Specific activities under this proposal include (I) finalization of the preparation (quality control and shelf- life), (2) GMP manufacture of a clinical batch, (3) submission to the MDR, (4) further in vitro testing for the purposes of optimization and QA, and (5) experimentation with MC-antibiotics in Gelfoam(R) as a follow-on product.
