BIO-AVAILABILITY AND BIO-EQUIVALENCE OF ENROFLOXACIN CONJUGATED NANO ZINC OXIDE IN BROILERS
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Date
2017-06
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SRI VENKATESWARA VETERINARY UNIVERSITY TIRUPATI – 517 502. (A.P) INDIA
Abstract
ABSTRACT:
Bioavailability and bioequivalence of enrofloxacin conjugated zinc oxide nano particles (ECZNP) in broilers was investigated in the present study. Forty adult broilers weighing approximately 2 kg were randomly divided into four groups consisting 10 birds in each group. Birds in group-I received ECZNP 10 mg.kg-1 by oral route, group-II received ECZNP 10 mg.kg-1 by intravenous route (IV), whereas group-III received standard enroflaxacin 10mg.kg-1 by oral route. Group-IV received standard enrofloxacin 10 mg.kg-1 by IV. Feed and water were withdrawn (12 hrs and 2 hrs respectively) before drug administration. Blood samples were obtained through both left and right jugular veins at predetermined time intervals i.e. for IV route at 0.83333 h, 0.166667 h, 0.25 h, 0.5 h, 0.75 h, 1 h, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h and 48 h and for oral route at 0 h, 0.25 h, 0.5 h, 0.75 h, 1 h, 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, 24 h, 36 h and 48 h time intervals after administration of drugs. Plasma was separated by centrifuging at 2500 RPM for 15 min and stored at -20º C until analysed for ECZNP and enrofloxacin by microbiological assay using Escherichia coli (MTCC 443). Based on time-plasma concentration profile the pharmacokinetic parameters were determined by non-compartmental methods. Detectable plasma concentrations of ECZNP and enrofloxacin after IV administration persisted up to 36 h whereas after oral administration, plasma concentrations of ECZNP and enrofloxacin were detected up to 48 h. Cmax (μg.mL-1) of ECZNP 0.73±0.03 μg.mL-1 was significantly (P<0.01) lower than enrofloxacin 1.48±0.02 after oral administration, where as in IV route initial concentration (C0) of ECZNP 3.86±0.41 was significantly (P<0.01) lower than enrofloxacin 6.45±0.25.
Important pharmacokinetic parameters obtained for ECZNP after its oral administration in group-I by non-compartmental analysis were: elimination rate constant (β) 0.06 h-1, elimination half-life (t1/2, β) 12.12±0.33 h, Cmax (μg.mL-1) 0.73±0.03, Tmax 4 h, area under time curve (AUC0-t μg.h.mL-1) 11.93±0.10, area under curve (AUCo-∞ μg.h.mL-1) 12.72±0.14, area under first moment curve (AUMCo-∞ μg.mL-1.h2) 208.39±3.59, volume of distribution (Vd L.kg-1) 4.12±0.08, total body clearance (ClB L.kg-1h-1) 0.24 and mean residence time (MRT) 16.38±0.15 h. In group-II the pharmacokinetic parameters of ECZNP for IV were: initial concentration of plasma (Co) 3.86±0.41 μg.mL1, Tmax 0.10±0.04 h, β 0.09±0.02 h-1, t1/2 β of 7.83±2.48 h, AUCo-t (μg.h.mL-1) 19.32±0.21, AUCo-∞ (μg.h.mL-1) 20.11±0.39, AUMCo-∞ (μg.mL-1.h2) 187.23±26.35, Vd (L.kg-1) 1.68±0.50, ClB (L.kg-1h-1) 0.15 and MRT 9.30±1.12 h. In group-III the pharmacokinetic parameters of enrofloxacin for oral were: Cmax (μg mL-1) 1.48±0.02 and Tmax 4.00±0.00 h, β 0.06±0.01 h-1, t½ β 11.85±1.42 h. AUCo-t (μg.h.mL-1) 24.05±0.91, AUCo-∞ (μg.h.mL-1) 25.59±1.40, AUMCo-∞ (μg.mL-1h2) 416.46±56.87, Vd (L.kg-1) 6.67±0.49, ClB (L.kg-1h-1) 0.39±0.02 and MRT (h) 16.22±1.36. In group-IV the pharmacokinetic parameters of enrofloxacin for intravenous (IV) were: Initial plasma concentration Co 6.45±0.25 μg.mL-1, Tmax 0.08 h, β 0.08±0.02 h-1, t½ β 9.11±2.20 h, AUCo-t (μg.h.mL-1) 32.92±0.97, AUCo-∞ (μg.h.mL-1) 34.40±1.18, AUMCo-∞ (μg.mL-1h2) 327.32±30.39, Vd (L.kg-1) 3.81±0.87, ClB (L.kg-1h-1) 0.29±0.01 and MRT 9.50±0.66 h.
It was found that the Tmax, t½ β, MRT, and β were comparable after both oral and IV administration of ECZNP and enrofloxacin, Cmax of ECZNP was significantly lower (P<0.01) than enrofloxacin for oral, where as in IV route, the initial concentration (Co) of ECZNP was significantly lower (P<0.01) than enrofloxacin, AUCo-t, AUC0-∞, AUMC0-∞, Vd, and ClB of ECZNP were significantly lower (P<0.01) than enrofloxacin for both IV and oral route. In this study the bioavailability (F %) of ECZNP was 63.364 ± 1.372% and was significantly (P<0.05) lower compared to oral counterpart 74.886 ± 5.992%. The results of presents study indicated that bioavailability of ECZNP was significantly lower than enrofloxacin, which can be explained by the fact that the actual concentration of enrofloxacin in ECZNP was 6 mg/10 mg (60%), while the reference standard enrofloxacin was 99% W/V. Hence ECZNP was not comparable to reference enrofloxacin, in future studies this problem can be overcome by taking equal concentrations of ECZNP in enrofloxacin.
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