Introduction: Nitrofurantoin (NFT) is abroad spectrum bactericidal antibiotic. The bioavailability of NFT is affected by many factors. Samafurantin® tablets containing 50 mg NFT were manufactured by Samarra drug industry. Urinary excretion studies were employed since; the urinary tract is the main site of NFT action and excretion. Objective: The objective of the study was to investigate the effect of Uricol® and food on secondary pharmacokinetic parameters of Samafurantin® tablets with different doses by applying urinary data. Methods: Twelve healthy male volunteers participated in this study. Urine samples were collected from each volunteer after overnight fasting at a specified time intervals which considered as a blank sample for measuring urine pH of urine. After that, volunteers were randomly divided into two groups (G1 and G2) each of six. Group 1 was administered 100 mg of NFT (Two tablets of 50 mg Samafurantin®) while, G2 was administered 200 mg of NFT (Four tablets of 50 mg Samafurantin®) as a single oral dose. Both groups administered the dose on an empty stomach (fasting), along with one Uricol® of 5 g sachet on fasting, and on full stomach after eating a standard breakfast after 1-week washout period between each experiment and another. For each experiment, urine samples were collected from each volunteer from 0.25 to 7 h post dosing. In addition, the volume of each void urine sample was measured. Results: Both groups (G1 and G2) showed only slight differences in the pH of urine after administration of Samafurantin® as compared with that of the blank. While, the pH of urine for both groups was higher after administration of Samafurantin® tablets along with Uricol® 5 g. In both groups, each of Uricol® and food exhibited no significant differences (P < 0.05) in secondary pharmacokinetic parameters of NFT; the rate constant of elimination (Kel) and absorption (Ka) and consequently their half-life (t0.5 el and t0.5 abs) as long as the drug followed first-order kinetics. While significant differences (P < 0.05) were observed for maximum excretion rate (ExRmax), cumulative amount excreted in urine (CAe) and CAe as percentage of the dose. This could be attributed to the pH-change of urine by Uricol® which alkalinized the urinary and kidney tract or delaying gastric emptying by food. Same observations were attained when comparing G1 with G2 after administration of NFT on fasting. Conclusions: Administration of Samafurantin® tablets at higher doses, along with Uricol® or with food increases secondary pharmacokinetic parameters related to the rate and extent of absorption and elimination without significant changes in their corresponding rate constants and half-lives. © 2018 Drug Invention Today.
A direct, sensitive and efficient spectrophotometric method for the determination of nitrofurantoin
drug (NIT) in pure as well as in dosage form (capsules) was described. The suggested method was
based on reduction NIT drug using Zn/HCl and then coupling with 3-methyl-2-benzothiazolinone
hydrazone hydrochloride (MBTH) in the presence of ammonium ceric sulfate. Spectrophotometric
measurement was established by recording the absorbance of the green colored product at 610 nm.
Using the optimized reaction conditions, beer’s law was obeyed in the range of 0.5-30 μg/mL, with
good correlation coefficient of 0.9998 and limits of detection and quantitation of 0.163 and 0.544
μg/mL, respectively. The accuracy and
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