ABSTRACT
Tacrolimus, a cornerstone of immunosuppressive therapy in solid organ transplantation, has a narrow therapeutic range with considerable inter-individual and intra-individual pharmacokinetic variability. To date, there is no information on the pharmacokinetics of tacrolimus in Iranian liver transplant recipients. This study was designed to determine pharmacokinetic properties of orally administered tacrolimus in Iranian adult liver transplant recipients. Tacrolimus doses and steady state whole blood trough concentrations as well as patient demographic and clinical data were obtained retrospectively using the 30 included patients' medical records. Pharmacokinetic parameters were estimated by using a nonlinear mixed effect model program [Monolix version 3.1]. Absorption rate constant was fixed at two hours[-1]. Drug apparent clearance [CL/F], apparent volume of distribution [Vd/F], and elimination half life [t1/2 Beta] were calculated. The administered dose of tacrolimus to the patients ranged from 0.02 to 0.14 mg/Kg/day. Tacrolimus blood trough concentrations varied widely within the range of 1.8 to 30 ng/mL. The mean values of CL/F, Vd/F, and t1/2 Beta were found to be 9.3 +/- 0.96 L/h, 101 +/- 29 L, and 7.5 hours, respectively. The pharmacokinetics of tacrolimus was highly variable among our patients. CL/F, Vd/F, and t«? of tacrolimus in this study were comparable to reported values from Italian heart transplant patients but somewhat different from reported ones from other solid organ transplant populations
ABSTRACT
This study aimed to investigate and compare the bacterial safety of handmade and commercial ready-to-use enteral feeding formulas used in an Iranian teaching hospital. In this experimental study, a total number of 70 samples [21 handmade formulas sampled at two sampling times, i.e. the time of preparation and 18 h after preparation, and 28 commercial ready-to-use formulas] were studied. Total count of viable microorganisms, coliform count and Staphylococcus aureuscount for all samples were conducted. Out of 42 handmade samples, 16 samples [76%] had total viable counts greater than 103 CFU/g in the first sampling time and 17 samples [81%] had total viable counts greater than 103 CFU/g in the second sampling time. Also, 11 [52%] had coliform contamination in the first sampling time which reached 76% [16 samples] in the second sampling time. Regarding contamination with S. aureus, 5 samples [24%] were contaminated in the first-and 13 samples [62%] were contaminated in the second-sampling time. Out of 28 commercial formulas, 27 samples [96%] had total viable counts greater than 103 CFU/g. Also, 24 samples [86%] were contaminated with S. aureus and 27 samples [96%] were contaminated with coliforms. In order to compare these two formulas, the results of Mann-Whitney test showed that contamination of ready to use formulas in all three microbiological samples was significantly more than that for handmade samples. The results of the present study indicate that the microbial safety of enteral feeding solutions in this hospital is much lower than standard values, demonstrating that the development of protocols for clean techniques in the preparation, handling and storage of both commercial and handmade enteral feeds is necessary