RESUMO
Ionising radiation used for sterilization can have an effect on the physicochemical properties of pharmaceutically relevant excipient systems, affecting therefore the stability of the formulation. The effect of gamma irradiation on the phase behaviour (cloud point--CP) and critical micelle concentration (CMC) of aqueous solutions of Triton X-100, used as a model nonionic surfactant, is investigated in this paper. Micellar solutions were irradiated with gamma-rays in a dose range between 0 and 70 kGy, including the sterilization range of pharmaceutical preparations. The decreased observed in CP and CMC values of micellar solutions at all absorbed doses was explained in terms of changes in molecular mass distribution of ethoxylated surfactant and the formation of cross-linked species. These results were complemented by mass spectrometry, UV-vis and NMR spectroscopy. Although the findings indicate degradation of polyethoxylated chains by water radical attacks, there was no spectroscopic evidence of radiation damage to aromatic ring or hydrocarbon tail of surfactant. Models based on Flory-Huggins theory were employed to estimate CP from changes in mass distribution and to obtain cross-linking fractions. Surface tension measurements of non-irradiated and irradiated solutions were used for estimating the effectiveness and efficiency of surfactant in the formulation.
