Preclinical Toxicity Evaluation of Paclitaxel Biopolymer Formulation

A preclinical toxicology study of paclitaxel biopolymer formulation (PBF) (paclitaxelloaded poly(3-hydroxybutyrate) (PHB) microparticles) was done in order to assess its safety and to forecast side and toxic effects in a clinical study on patients. The toxicity, allergenic and pyrogenic properties were studied. The acute toxicity study showed that PBF is much less toxic in equivalent PTX-content doses than PTX in conventional formulation when administered intraperitoneally to mice and rats. However the chronic toxicity study showed that at intraperitoneal administration PBF has a distinct cumulative properties and toxic effects that prevent PBF from clinical testing in current composition. Thus, the PBF as prolong needs to be corrected its parameters for further drug formulation development.