Design and evaluation of fast dissolving oro-dispersible films of metoclopramide hydrochloride using 32 multifactorial designs

Abstract

Objective: The objective of the present work was to develop and optimize fast dissolving orodispersible films containing metoclopramide hydrochloride using 32 multifactorial designs.

Methods: The films were prepared by solvent casting method using hydroxypropyl methyl cellulose E5 (HPMC E5) and sodium starch glycolate (SSG) as two independent variables in three levels in concentration 2.5, 3, 3.5% w/wand 1, 1.5, and 2 % respectively. The percent of in vitro drug release (Y1) and the disintegration time (Y2) were chosen and studied as dependent responses. The prepared films were also evaluated for their weight uniformity, thickness, surface pH, drug content, in vitro disintegration time, in vitro drug release, film stability and mechanical properties as folding endurance.

Results: All the films were transparent. The films weight (mg) was ranging from 63±0.78 to 86±0.82 while the film thickness (mm) and the folding endurance range from 0.22±0.53, 50±0.58 to 0.32±0.35 and 90±0.84 respectively. The drug content (mg %) was studied, and it ranges from 98.24±1.08 to 99.07±1.02. It was found that the relative standard deviation (% RSD) met the criteria of USP specification for drug content (>6%). In vitro disintegration time was tested; all films satisfied the requirement of disintegration time for fast dissolving dosage form (<1 min), it ranged from 2.24±1.75 to 3.18±1.87 sec. The stability studies revealed no significant differences before and after storage for the all formulations.

Conclusion: An optimized metoclopramide HCl film was achieved that could be a benefit to a patient suffering from emesis, in which hydroxypropyl methylcellulose (E5) was used as a film forming polymer in its high level (3.5%) in addition to sodium starch glycolate in its high level (2%).