Radiosterilization dosimetry of vitamins: an ESR study.
OBJECTIVE
As an alternative to heat and gas exposure sterilization, ionizing radiation is gaining interest as a sterilization process for medicinal products. Detection and dosimetry of pharmaceutical radiosterilization is a growing concern for numerous government regulatory agencies world-wide.


METHODS
Equations to describe the ESR curves versus the dose and storage time were developed using mathematical procedures. For this investigation six vitamins (riboflavin, biotin, thiamine mononitrate, thiamine hydrochloride, folic acid and pyridoxine) were chosen as models.


RESULTS
The yield of free radicals is in the range 1.7 10(18)-7.3 10(19) radicals mol(-1) (G values from 0.0003 to 0.025 mol J(-1)). Apart from qualitative detection, ESR spectrometry can be used for dose estimation; when an exponential function is applied to the variation of peak-to-peak amplitude on dose, the function correlates well with the data. Tests were carried out to investigate whether storage has an effect on the concentration of free radicals. In order to estimate the time limit of detection, decay curves were modelled using a bi-exponential function. From this, the time limit from the irradiation (25 kGy) for identification of irradiated vitamins by ESR was evaluated. In the commercial drug market, radicals should be detected for up to 2 years after irradiation; this probably will be the case for the vitamins studied, with the exception of folic acid and pyridoxine.


CONCLUSIONS
The detection method based on ESR dosimetry seems promising. ESR dosimetry requires only small samples, and minimal time and effort for sample preparation; the measurement is non-destructive.
Basly
J P
JP
UPRES EA 1085 Biomolécules et cibles cellulaires tumorales, UFR de Pharmacie, Limoges, France. basly@unilim.fr
Basly
I
I
Bernard
M
M
D004307:Dose-Response Relationship, Radiation; D004578:Electron Spin Resonance Spectroscopy; D005609:Free Radicals / Q000032:analysis; D005720:Gamma Rays; D015394:Molecular Structure; D004364:Pharmaceutical Preparations / Q000528:radiation effects; D011874:Radiometry; D012680:Sensitivity and Specificity; D013242:Sterilization / Q000379:methods*; D013997:Time Factors; D014815:Vitamins / Q000528:radiation effects*
D005609:Free Radicals; D004364:Pharmaceutical Preparations; D014815:Vitamins