With increased use of degradable polymers in implantable medical devices, the characterization of degradation products is of particular interest from both a risk assessment and regulatory perspective. Such analysis may include the interrogation of both the terminal degradation products of a material as well as the intermediate degradation products (i.e. those release prior to complete dissolution or breakdown of the material).
Cambridge Polymer Group can assist you with structuring studies in order to characterize what your biodegradable polymer is breaking down into, as well as the concentration of these eluted products as a function of the material lifetime. Such studies typically require careful consideration of the material chemistry and end-use biological environment for the purpose of selecting the in vitro degradation conditions. Sample preparation methodology in advance of analytical testing is critical to eliminate interferences while preserving the degradation products at a sufficient concentration for identification and quantitation.
Studies may be conducted to evaluate whether a material undergoes different degradation mechanisms in vitro vs in vivo (i.e. are the degradation pathways or kinetics influenced by enzymatic degradation). Also possible are collaborations that explore in vivo degradation products in conjunction with, for example, a simulated tissue or small animal study.
Characterization of polymer degradation products typically leverages GC-MS and LC-MS chromatographic analysis for the trace identification of the degradation products from a complex matrix. Other techniques that may be employed to study the effect of degradation on the polymeric device include SEM-EDS, NMR, GPC, ATR-FTIR, or TGA-FTIR.
Contact Cambridge Polymer Group for assistance with: