It is proposed to investigate a biopolymeric repair material for avulsive maxillofacial injuries. Based on an independent, initial feasibility project, we now intend to formulate and characterize the components of this novel biopolymeric material in our proposed Phase I work. We will also conduct mechanical testing, including in vivo evaluations. Basic to this bone repair material is a composition containing the biopolymeric poly(propylene fumarate), which is an unsaturated cross-linkable polymer made from fumaric acid, one of the Krebs cycle acids, and polylene glycol, a commonly used diluent in parental drug formulations. This biopolymer, in powdered form, is used to incorporate an adsorbable filler, such as powdered hydroxyapatite or particulate bone. When the powdered biopolymer and adsorbable filler are hand-blended together, along with a suitable cross-linking agent, a useful bone repair """"""""putty"""""""" or grout results. This hand-workable bone grout solidifies in ~15 minutes at physiological temperatures with virtually no observable heat of reaction, and has physical properties suitable for the intended application. Further, controlled release antibiotics, growth factors, etc. may be incorporated into this formulation with the objective of being released in a predesigned manner (work of Phase II).
