A long-term in vitro biocompatibility study of a biodegradable polyurethane and its degradation products

The biological safety of degradation products from degradable biomaterials is very important. In this study a new method is proposed to test the cytotoxicity of these degradation products with the aim to save time, laboratory animals, and research funds. A biodegradable polyurethane (PU) foam was subjected to this test method. The PU had soft segments of DL‐lactide/ϵ‐caprolactone and hard segments synthesized from butanediol and 1,4‐butanediiosocyanate. Copolymer foams without urethane segments, consisting of DL‐lactide/ϵ‐caprolactone, were tested as well. Accumulated degradation products were collected by degrading the foams in distilled water at 60°C up to 52 weeks. Cell‐culture medium was prepared from powder medium with this water. In different tests the cytotoxicity of this medium was established. The first signs of cytotoxicity were observed after 3–5 weeks of degradation. This accounts for both materials and reestablishes the good short‐term biocompatibility of these materials. The PU showed more toxicity toward the end stages of degradation in comparison with the copolymer. This is probably related to the accumulation of degradation products of the urethane segments. In the in vivo situation the degradation of the PU and the metabolism and excretion of degradation products may differ. Therefore, long‐term in vivo studies will have to establish whether these in vitro results are representative for the in vivo behavior of the degrading PU. © 2005 Wiley Periodicals, Inc. J Biomed Mater Res, 2006