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Radiation sterilization of formoterol
J P Basly1, I Longy, M Bernard
1Laboratoire de Chimie Analytique et Bromatologie, UFR de Pharmacie, Université de Limoges, France. Basly@alpha1.unilim.fr
Pharmaceutical Research
|June 1, 1997
Summary
Gamma radiation sterilization of formoterol fumarate is feasible, but accuracy is limited. While differences are detectable shortly after irradiation, electron spin resonance (ESR) measurements show low accuracy due to few free radicals.
Area of Science:
- Pharmaceutical Science
- Radiation Chemistry
Background:
- Radiation sterilization is a growing method for pharmaceutical products.
- Understanding radiation effects on active pharmaceutical ingredients (APIs) is crucial.
Purpose of the Study:
- To investigate the effects of gamma radiation on formoterol fumarate.
- To assess the feasibility of radiosterilization for this compound.
Main Methods:
- High-Performance Liquid Chromatography (HPLC) was used to analyze chemical changes.
- Electron Spin Resonance (ESR) spectroscopy was employed to detect free radicals.
Main Results:
- ESR signal intensity showed a linear relationship with dose in the 5-30 kGy range.
- Minor differences were observed in chromatographic profiles between irradiated and unirradiated samples.
- Low accuracy in ESR measurements was noted due to limited free radical generation.
Conclusions:
- Radiosterilization of formoterol fumarate appears technically feasible.
- ESR can potentially estimate irradiation dose, but accuracy is currently limited.
- Irradiated samples are distinguishable from unirradiated ones within 250 days post-irradiation at 25 kGy.