Radiation sterilization of formoterol.
OBJECTIVE
Radiation sterilization is becoming increasingly popular for the sterilization of many pharmaceutical products. We have investigated the gamma radiation induced effects on formoterol fumarate by HPLC and ESR spectroscopy.


CONCLUSIONS
Numerical simulation of the evolution of the ESR signal versus dose was performed using linear regression, quadratic fit and power function. The shape of the dosimetric curve is linear in the range 5-30 kGy. Owing to the weak number of free radicals generated during the irradiation, the accuracy of measurements is low. For a dose of 25 kGy, discriminating irradiated from unirradiated samples is possible if the storage period is less than 250 days. The comparison between chromatographic profiles of irradiated and unirradiated samples showed minor differences.


CONCLUSIONS
From our preliminary results, radiosterilization of formoterol fumarate may be technically feasible. Estimation of the irradiation dose by ESR may be possible but, due to the weak number of free radicals generated during the irradiation, the accuracy of measurements appeared low.
Basly
J P
JP
Laboratoire de Chimie Analytique et Bromatologie, UFR de Pharmacie, Université de Limoges, France. Basly@alpha1.unilim.fr
Longy
I
I
Bernard
M
M
D002851:Chromatography, High Pressure Liquid; D004578:Electron Spin Resonance Spectroscopy; D004983:Ethanolamines / Q000528:radiation effects*; D000068759:Formoterol Fumarate; D005609:Free Radicals; D005720:Gamma Rays; D011829:Radiation Dosage; D015203:Reproducibility of Results; D013242:Sterilization / Q000379:methods*
D004983:Ethanolamines; D005609:Free Radicals; D000068759:Formoterol Fumarate