Abstract
We compared the safety profiles of two types of nanoparticles intravenously administered to rats, prepared from PLA 50 and Me.PEG-PLA 50 by emulsification/solvent evaporation using cholate as tensioactive agent. With PLA 50/Cholate nanoparticles, no signs of toxicity were noted at 75 mg kg −1. At higher doses, 220 and 440 mg kg −1, marked toxicity (mortality and marked clinical signs) was observed with dose-related hematological changes (decrease of thrombocytes count, increase of Prothrombine Time and Activated Partial Thromboplastin Time) and biochemical changes (increase of aminotransferases activities). All changes were transient and disappeared on Day 9. With Me.PEG-PLA 50/Cholate nanoparticles, no lethality and no clinical changes were observed after intravenous administration of Me.PEG-PLA 50/Cholate even at high dose, up to 440 mg kg −1. The improved safety profile of Me.PEG-PLA 50/Cholate nanoparticles as compared to PLA 50/Cholate nanoparticles suggests that the steric repulsion owing to the high density of Me.PEG chains on the nanoparticles surface prevents the coagulation cascade and associated toxicity.
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