Abstract
Particular interest now centers on the preparation of sterile unit-dose preparations. When preparations are purified from microorganisms using classic sterilization techniques, serious degradations may occur, especially in temperature sensitive drugs and drug active components. Sultamicillin is the tosylate salt of the double ester of sulbactam plus ampicillin. Sultamicillin (SULT) tosylate has previously been shown to be clinically and bacteriologically effective in a variety of infections. The use of high-energy radiation, such as gamma rays, for the sterilization of pharmaceuticals offers considerable interest because of the clear advantages this process has compared with other methods of sterilization. However, radiosensitivity of irradiated pharmaceuticals is important in this respect. Thus, radiosensitivity of SULT and its potential use as a dosimetric material were investigated by electron spin resonance (ESR) spectroscopy in the present work. Samples of SULT powder were irradiated at doses of 3, 6, 10 and 15 kGy and ESR spectra were recorded at room and at different temperatures. Variations of different spectroscopic parameters with irradiation dose, temperature and storage time were evaluated using data derived from experimental ESR spectra which exhibited five different resonance peaks. Stabilities of the radiolytic intermediates at high temperatures were also investigated through annealing studies performed at 340, 345 and 350 K. Rapid decreases in resonance peak heights above 325 K were considered a manifestation of the unstable character of the radiolytical intermediates at high temperature, although they decayed relatively slowly at room temperature. Seven different mathematical functions have been tried to fit the experimental dose–response data, and a power function of the applied dose was found to describe best the dose–response data.
Published Version
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