Study on degradation and systemic toxicity of multiblock poly(aliphatic/aromatic-ester) copolymers

Implantable synthetic polymer materials differ in their mechanical properties and the rate of degradation depending on the particular application (temporoary or permanent prosthesis, drug delivery systems or others). The series of PED multiblock copolymers were synthesized. They are composed of poly(butylene terephthalate) (PBT) aromatic units (hard segments) and aliphatic sequences of dimer fatty acids (DFA) (soft segments). The composition of hard segments vary in the range from 26 to 70 wt. %. These polymers can be "tailor-made", and therefore, their properties can change along with the composition, from very soft and flexible materials to semi-rigid polymers. Their susceptibility to degradation is a function of hard/soft segment composition. Degradation test (buffer saline solution, pH = 7.4, temp. 37 DGC, time 5 weeks) as well as in vivo implantation test for 6 months confirm this statement. Polymers containing higher concentrations of soft segments are more susceptible to degradation than the materials with higher concentrations of hard, aromatic segments as demonstrated by GPC and ATR FT-IR. The chloroformic extracts from PED copolymers were analyzed by GC/MS to evaluate the chemical composition of potential extractables, especially from the polymers demonstrating higher susceptibility to degradation. Prepared saline extracts were subjected to the pyrogenicity tests on rabbits. The influence of the polymer composition on skin irritation was also evaluated by the intracutaneous injections of polymer extracts. Additionally, hemolysis test in contact with bulk polymers was performed. Evaluating the nature of local tissue response to PED extracts and the results of hemolysis test, we did not detect any indication of systemic toxicity over the compositional range of PED copolymers. These novel copolymers were shown to be biocompatible and are very promising materials for biomedical applications.