title: Pharmacokinetic study of sulbactomax.
abstract: We have evaluated pharmacokinetics of a fixed dose combination (FDC) of ceftriaxone and sulbactam (2:1) or sulbactomax in eight healthy volunteers. A 1.5 g dose of sulbactomax, 1 g dose of ceftriaxone and 0.5 g sulbactam were given intravenously in a balanced two-ways cross-over study. Serially collected plasma sample was analyzed for ceftriaxone and sulbactam by high performance liquid chromatography (HPLC). The mean peaks of ceftriaxone and sulbactam concentrations in plasma were 152.06+/-6.65 microg/ml and 21.32+/-1.80 microg/ml, respectively and plasma half-lives for ceftriaxone and sulbactam were 5.2+/-0.35 hr and 0.94+/-0.038 hr, respectively. The AUC0-24 for ceftriaxone and sulbactam was 760.16+/-27.68 microg.hr/ml and 20.74+/-2.34 microg.hr/ml, respectively, with elimination rate constant of 0.133+/-0.009 hr(-1) and 0.732+/-0.029 hr(-1), respectively. The kinetics of ceftriaxone and sulbactum did not change in combination as compared to the alone treatment. Also, concentration of the ceftriaxone after 24 hr is higher than the minimum inhibitory concentration (MIC) of the most of the gram positive and gram negative bacteria indicating that one dose in a day is sufficient to treat the disease caused by these organisms.
authors.affiliation: Office of Research Support,Venus Medicine Research Centre, Hill Top Industrial Estate, Bhatoli Kalan, Baddi, HP, India. ors@venusremedies.com
authors.forename: Anurag
authors.initials: A
authors.lastname: Payasi
authors.forename: Manu
authors.initials: M
authors.lastname: Chaudhary
authors.forename: Ankush
authors.initials: A
authors.lastname: Gupta
authors.forename: Vivek Kumar
authors.initials: VK
authors.lastname: Dwivedi
authors.forename: Anuj
authors.initials: A
authors.lastname: Bhatnagar
mesh_terms: D000328:Adult; D000900:Anti-Bacterial Agents / Q000097:blood / Q000493:pharmacokinetics*; D002443:Ceftriaxone / Q000097:blood / Q000493:pharmacokinetics*; D018592:Cross-Over Studies; D004338:Drug Combinations; D006801:Humans; D007275:Injections, Intravenous; D008297:Male; D008826:Microbial Sensitivity Tests; D013407:Sulbactam / Q000097:blood / Q000493:pharmacokinetics*
chemical_list: D000900:Anti-Bacterial Agents; D004338:Drug Combinations; D002443:Ceftriaxone; D013407:Sulbactam