PAKISTAN SOCIETY OF PHARMACOGNOSY & NATURAL THERAPY
PAKISTAN SOCIETY OF PHYTOPHARMACOLOGY & THERAPEUTICS
PAKISTAN SOCIETY OF PHARMACOGNOSY & NATURAL THERAPY*** PAKISTAN SOCIETY OF PHYTOPHARMACOLOGY & THERAPEUTICS
 
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ASSESSMENT OF BIOEQUIV ALENCE AND PHARMACOKINETICS OF CIPROFLOXACIN IN HEAL THY MALE SUBJECTS


Muhammad Khalid Khan* and Muhammad Farid Khan Faculty of
Pharmacy, Comal University, Dera Ismail Khan, NWFP, Pakistan

 

ABSTRACT: Pharmacokinetics and bioequivalence studies of two ciprofloxacin brands (Ciprofloxacin & Ciproxin) were conducted in 14 healthy male volunteers after oral administration. Each brand (test and reference) consisted of 500 mg of Ciprofloxacin. The drug was analyzed in plasma samples with a microbiological assay using Streptococcusfaecalis as test organism. The elimination half-life of 3.92 :!: 0.45 and 3.72 :!: 0.29 h was calculated for both brands. The peak plasma concentrations of (3.95 :!: 0.33 ug/mL) and (3.89 :!: 0.22 /lg/mL) was attained in about I hour for both Test and Reference Ciprofloxacin respectively. The mean :t SE values for total area under the curve (AUC 0-00) were 22.11 :!:1.94, and 19.33 :!: 0.75 h.mglI for both test and reference tablets respectively. The mean:!: SE values of clearance were 29.02 :!: 1.70 and 31.63 :!: 1.39 l/h for both formulations respectively. The mean:!: SE volume of distribution was 147.95 :!: 17.25 and 165.56 :!: 9.44 L respectively for both test and reference tablets of Ciprofloxacin. This study indicated that all pharmacokinetic and bioequivalence parameters for both ciprofloxacin formulations are statistically non-significant, hence both formulations are bioequivalent.

KEYWORDS: Pharmacokinetics, Bioequivalence, Microbiological assay Ciprofloxacin & Ciproxin