ABSORBABLE BIOPOLYMERS DERIVED FROM DIMER FATTY-ACIDS

A new class of aliphatic copolyanhydrides was synthesized from nonlinear hydrophobic dimers (FAD) of erucic acid and sebacic acid which possessed the desired physico-chemical and mechanical properties for use as a carrier for drugs. The polymers were synthesized by melt condensation to yield film-forming polymers with molecular weights of 250,000. The copolymer composition was determined by H-1-NMR and gravimetric methods. In vitro degradation studies showed that these polymers degrade following a first-order kinetics with a rapid degradation in the first 10 days leaving a residue which is mostly the FAD comonomer. The drug release from the polymer also followed a first-order kinetics which correlates with the degradation process of the polymer. Drugs like carboplatin, methotrexate, tetracycline, and gentamicin were released in vitro for over 2 weeks and in some cases over 6 weeks. In vivo biocompatibility tests in rats and rabbits in the brain, muscle, and subcutaneously, demonstrated their toxicological inertness and biodegradability. The 1 : 1 copolymer of FAD : SA was selected as a carrier for various applications including a gentamicin-releasing implant which is now undergoing human clinical trials for the treatment of osteomyelitis.