ABSOLUTE AND RELATIVE BIOAVAILABILITY STUDY FOR THE NEWLY DEVELOPED NASAL NANOEMULSION IN SITU GEL OF ONDANSETRON HCl IN COMPARISON TO CONVENTIONALLY PREPARED IN SITU GEL AND INTRAVENOUS DOSAGES FORMS

Nidhal K. Maraie; Yasser Q. Almajidi; Ahmed Alshadher

doi:10.22159/ijap.2018v10i5.27396

Authors

Nidhal K. Maraie Department of Pharmaceutics, College of Pharmacy, Mustansiriyah University, Baghdad, Iraq
Yasser Q. Almajidi Department of Pharmaceutics, College of Pharmacy, Mustansiriyah University, Baghdad, Iraq
Ahmed Alshadher The National Center for Drugs Control and Research, Baghdad, Iraq

DOI:

https://doi.org/10.22159/ijap.2018v10i5.27396

Keywords:

Bioavailability study, In situ gel, Nanoemulsion, NIG, Ondansetron HCl

Abstract

Objective: The aim of the work was to study the absolute and relative bioavailability (using rabbits) of ondansetron HCl (ONH)from our newly prepared intranasal mucoadhesive nanoemulsion in situ gel (NIG) in comparison to intranasal mucoadhesive in situ gel (IG) prepared by the conventional method and intravenous injection.

Methods: Six male rabbits weighing 2.5-3 kg were used in this study, where the dose of ondansetron HCl (ONH) was calculated based on the body surface area (BSA) which is equivalent to 140Î¼l (containing 10 mg/ml) of NIG and IG and 700Î¼l of intravenous Zofran^Â®injection (containing 2 mg/ml) were given to the rabbits, separated with one week washout period. Serial blood samples were withdrawn and analyzed for simultaneous determination of the drug using HPLC (Knaure; 150 Ã—4.6 mm; 5 Î¼m particle size; 25 cm length) supported by guard column C18-4 mm diameter.

Results: The pharmacokinetics parameters for NIG; Cmax, Tmax, AUC0-t, AUC0-âˆžwere found to be greater than conventional in situ gel (IG). In vivo pharmacokinetic studies in rabbits showed a significant increase in C_max and AUC _0-Î±(P<0.001) with shorter T_maxusing NIG compared to IG containing the same NIG excipients, while the absolute bioavailability for NIG and IG (was 80.541 and 51.068 respectively).

Conclusion: The present studies ratify the bioavailability enhancement potential of NE used to prepare NIG for the drug and significantly high absolute bioavailability to be used as a successful alternative route to the IV injection and improve patient compliance.

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