EFFECTS OF ENVIRONMENTAL EXPOSURE ON THE PHARMACOKINETICS OF CIPROFLOXACIN TABLET IN HEALTHY HUMAN VOLUNTEERS
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ABSTRACT
Ciprofloxacin is a flouroquinololone antibiotic that is commonly prescribed empirically in Nigeria due to its broad spectrum of activity. However, the drug product is illegally handled by drug hawkers that allow the drug to be exposed to some environmental forces which may affect the drug quality and its pharmacokinetic profiles. This study is aimed at assessing pharmacokinetic profiles of exposed samples of ciprofloxacin marketed by hawkers in the three senatorial areas of Gombe State. Sample A represents non-exposed and control while samples B, C and D represent exposure to different environmental conditions in Gombe state for three months. The in vitro quality control of the drug sample was carried out using 2002 and 2009 B.P standards. The parameters determined were identification, assay, disintegration, dissolution and friability test. The method used was adopted and validated by U.V spectrophotometry and a wavelength (λmax) of 271 nm was measured which served as our working wavelength. The validation parameters used were: Precision (within day and between days), percentage extraction recovery and linearity. The linearity of the calibration curve was determined. In the pharmacokinetics studies, six apparently healthy volunteers were enrolled and were administered with 500 mg of ciprofloxacin each with non-exposed and the exposed samples of the ciprofloxacin and saliva samples were collected before and after administration with wash out period of one week intervals between studies. Pharmacokinetic parameters generated were: Cmax, Tmax, AUC0-∞, lag time, t1/2α, t1/2β, Kα, Kβ, Vd, Cl and were compared at P ≤ 0.05 between the sample A and samples B, C, and D respectively. The results indicated that all the samples showed positive to identification test. Friability and disintegration values were within the acceptable limits ( ≤ 1% and ≤ 30 min respectively). The dissolution and assay parameters of the exposed sample D were 66% and 82.9% which were less than the accepted limits of ≥ 70% and vii 95-105% respectively indicating low quality compared to others. The within day and between day precision were 1.1 and 1.5 % RSD respectively and both were within the acceptable limit of ≤ 2%. The percentage extraction recovery was 98.8% which was within the acceptable range of 95-105%. The calibration curve that was constructed was found to be linear within 1-6 μg/ml with a correlation coefficient of 0.998. When sample A was compared with each of sample B, C, and D, there was no significant difference except between sample A and D which showed a significant (p ≤ 0.05) change in elimination half life (t1/2β), 3.03 h for A and 1.63 h for D; and elimination rate constant (Kβ), 0.28 h -1 for A, and 0.638 h -1 for D. Elimination half life and elimination rate constant are parameters that determine how drugs are removed from the body. Shorter half life shown for sample D means the exposed drug will be easily removed from the body. This may give a sub-therapeutic drug level and loss of antibacterial activity. It can be concluded that the environmental conditions of the senatorial area where ciprofloxacin tablet sample D was exposed affected its assay, dissolution, elimination half life and elimination rate constant profiles thereby affecting its quality and pharmacokinetics.
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