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Full Length
Research Paper
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Drug-drug interaction between ciprofloxacin and diclofenac
ophthalmic drops at ocular level
Abbas Khan1, Zafar Iqbal1*, Muhammad
Imran Khan1, Jamshaid Ali Khan1,
Muhammad Khalid Javed1 and Zia Ahmad2
1Department
of Pharmacy, University of Peshawar, Peshawar-25120,
Pakistan.
2Eye
Department, Mardan Medical Complex, Khyber PakhtunKhwa,
Pakistan.
*Corresponding
author. E-mail:
zafar_iqbal@upesh.edu.pk or
zafardr61@yahoo.com.
Tel: +92-91-9216750. Fax: +92-91-9218131.
Accepted 1 December, 2011. |
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Abstract |
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In present times, there has been interest in
multi-drug combinations for treatment of ocular
infections, which are more commonly antibiotics
and analgesics. Ciprofloxacin and diclofenac
sodium were used concomitantly and
pharmacokinetic drug-drug interactions between
them were studied. To investigate disposition
kinetics of ciprofloxacin eye drops (0.3%) alone
and with co-administration of diclofenac sodium
eye drops (0.1%) for pharmacokinetic drug-drug
interaction(s). A randomized clinical trial was
conducted in 84 human volunteers and the aqueous
humor samples were collected from the eyes at
various time intervals and concentration of
ciprofloxacin in aqueous humor was determined
using a validated reversed-phase high
performance liquid-chromatography/ultraviolet
detection method. The results were subjected to
statistical analysis to determine whether a
statistically significant difference was
observed between the two groups. The mean age of
the patients in this study ranged from 40 to 83
years, and gender distribution was 46.0% female
and 54.0% males. The maximum concentration of
ciprofloxacin in aqueous humor observed was 0.47
± 0.057 µg/ml at 0.83 h. While the
maximum concentration with concurrent
administration of ciprofloxacin with diclofenac
sodium was 0.44 ± 0.00577 µg/ml at 0.25 h. Time
to reach maximum concentration was decreased to
0.3 h. t1/2abs and tα1/2
were not significantly affected by
co-administration of the ciprofloxacin eye drops
with the diclofenac sodium eye drops (P = 0.73),
however, t1/2β was
significantly affected (P = 0.036).
Similarly, apparent volume of distribution,
volume of central compartment, steady-state
distribution volume, AUC0-t and MRT
were also significantly reduced due to
concurrent administration of the diclofenac
sodium eye drops with the ciprofloxacin eye
drops (P = 0.021, 0.0.017, 0.05, 0.01 and 0.04).
On the other hand, the ocular Clt was
significantly elevated (P = 0.04),
while absorption rate constant (P =
0.58) was non significantly decreased due to
concurrent administration of the diclofenac
sodium eye drops, while Cmax was not
significantly affected. Diclofenac sodium
affects the pharmacokinetics of ciprofloxacin
when co-administered with ciprofloxacin eye
drops.
Key words:
Ciprofloxacin ophthalmic drops, pharmacokinetics drug-drug
interaction, aqueous humor.
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