Metoclopramide Hydrochloride Loaded Oral Wafers for Postoperative Care of Children: In Vitro and In Vivo Evaluation

Abstract

The present study focused on the formulation of metoclopramide HCl (MET HCl) loaded oral wafers (OWs) as a fast dissolving dosage form without drinking water to produce a prompt improvement of emesis. OWs were prepared by casting technique using Hydroxypropyl Methylcellulose (HPMC) as a film forming agent and plasticizers like propylene glycol (PG), polyethylene glycol (PEG) 400 and polyethylene glycol 600. The prepared formulations were visually inspected and subjected to evaluation parameters such as thickness, weight variation, drug content, folding endurance, surface pH, tensile strength, mucoadhesiveness, percentage of moisture absorption, percentage of moisture loss and in vitro release study. G3 batch was selected for further investigations e.g. DSC, FTIR and in vivo evaluation. The bioavailability of MET HCl loaded OWs was assessed by measuring the plasma concentrations of MET HCl in different studied rabbit's groups' .All wafers were transparent, smooth, uniform and flexible. G3 batch (300 mg HPMC, 20% PEG 400) showed the highest tensile strength, percent elongation, mucoadhesiveness and faster drug release. The pharmacokinetic data of MET HCl loaded OWs preparation (G3 batch) showed a significant higher Cmax, AUC0-24 and lower Tmax (p<0.001) than oral plain MET HCl solution. It could be concluded that MET HCl loaded OWs is a promising fast-release preparation with enhanced rate and extent of drug absorption hence, higher therapeutic efficiency against vomiting and nausea in pediatrics, especially postoperatively can be expected.