Showing papers by "Republic of Korea Army published in 2012"

Rapid detection of bacterial contamination of platelet-rich plasma-derived platelet concentrates using flow cytometry.

Abstract: Flow cytometry can be used to detect bacterial contamination of platelet products In this study, we investigated whether the incubation of a minimal volume of platelet-rich plasma (PRP)-derived platelet concentrates (PCs) with growth medium improved the analytical sensitivity of flow cytometry Five bacterial strains (Staphylococcus aureus, Staphylococcus epidermidis, Bacillus cereus, Klebsiella pneumoniae, and Escherichia coli) were used Platelets were inoculated with 10, 10(2), and 10(3) CFUs per mL; 05 mL, 10 mL, and 20 mL aliquots of spiked platelets were incubated with growth medium at 37°C for 24 hours During the incubation period, the numbers of events were analyzed every 4 hours by flow cytometry We could detect a low concentration (10 CFUs per mL) of bacteria in a small volume (minimum 05 mL) of PCs Irrespective of spiking concentrations and incubation volumes, the detection times of S aureus and S epidermidis were 24 hours or less, while those of B cereus, K pneumoniae, and E coli were 16 hours or less A higher spiking concentration made it possible to shorten the detection time The numbers of detected bacteria increased during the incubation However, the graphs corresponding to K pneumoniae and E coli showed peak levels and decreasing patterns during the incubation period The incubation of small volumes of PC with growth medium increased the analytical sensitivity of flow cytometry for bacterial detection Therefore, flow cytometry can serve as a useful method for sterility testing using PRP-derived PCs with only low levels of consequent platelet loss

Comparison of Pharmacokinetic Characteristics and the Safety between Amlodipine Maleate Tablet 5 mg and Amlodipine Besylate Tablet 5 mg

Abstract: 1 Department of Clinical Pharmacology and Therapeutics, Asan Medical Center, Seoul, Korea, University of Ulsan College of Medicine, School of Military Medicine, The First Republic of Korea Army, Department of Clinical Pharmacology and Therapeutics, Inje University Pusan Paik Hospital, Pusan, Korea, 5 Division of Clinical Pharmacology, Clinical Trials Center, Pusan National University Hospital, Division of Clinical Pharmacology, Clinical Trial Center, Samsung Medical Center, Technical research center, CKD research institute, Chong Kun Dang Pharmaceutical Co, Ltd Background: Amlodipine is a third-generation dihydropyridine calcium channel blocker for treating hypertension. Though marketed primarily as a besylate salt, there have been some efforts to find other comparable salts. Among them, maleate is the salt that has been considered favorable for many drugs. The aim of this study was to compare the pharmacokinetics, as well as safety and tolerability of amlodipine maleate with amlodipine besylate. Methods: This study was open, randomized, two-period crossover design investigated in twelve healthy male volunteers over a 144 h period after administrating two forms of amlodipine 5 mg, respectively. Each period was separated with 2 weeks. Plasma concentrations of amlodipine were determined by liquid chromatography-tandem mass spectrometry. Safety profiles were assessed by vital signs, physical examinations, electrocardiograms, laboratory testing and adverse events monitoring. Results: All subjects were completed this study. Geometric mean ratios (GMRs) of amlodipine maleate/amlodipine besylate of Cmax and AUClast for amlodipine were 0.92 (90 % confidence interval, 0.81 ∼ 1.05) and 1.05 (0.96 ∼ 1.16), respectively. No serious adverse events were reported, and no clinically relevant changes were observed in safety profiles during this trial. Conclusion: Pharmacokinetics, tolerability and the safety were comparable between amlodipine maleate and amlodipine besylate in healthy individuals.