DEVELOPMENT AND CHARACTERIZATION OF ORAL SWELLABLE RAPID RELEASE FILM WITH SUPERDISINTEGRANT-SURFACTANT

Neha Imtiaz,Gopa Roy Biswas,Sutapa Biswas Majee

doi:10.22159/ijcpr.2021v13i1.40821

Neha Imtiaz, Gopa Roy Biswas + Show 1 more

Open Access

https://doi.org/10.22159/ijcpr.2021v13i1.40821

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Abstract

Objective: Oral disintegrating films consisting of hydrophilic polymer are designed to be quickly hydrated by saliva, adhere to the mucosa and disintegrate rapidly to release the drug. The aim of the present study was to prepare stable, flexible swellable rapid release oral films with hydroxypropyl methylcellulose E15 LV (HPMC) and polyvinyl alcohol (PVA) in different ratios. Guar gum was incorporated as the mucoadhesive agent. In order to achieve rapid disintegration of the film cross carmellose sodium (superdisintegrant) and surfactant like Tween 80 were added. The model drug used in the study was diclofenac sodium. Methods: Films were developed using HPMC E15 LV and PVA by solvent casting method and characterized for thickness, swelling index, disintegration time, folding endurance, drug content, and in vitro drug release pattern and kinetics. Results: The prepared swellable rapid release oral films were quite flexible and transparent with a smooth texture. The swelling index study confirmed that the films possessed the desired swelling property. Fastest disintegration was observed with the oral film containing HPMC: PVA in the ratio of 2:1, guar gum at 120 mg, 20% w/w crosscarmellose sodium and 4%w/w Tween 80. The swellable rapid release oral films were found to follow either Higuchi or Korsmeyer-Peppas model with drug release following either Fickian or non-Fickian diffusion. Maximum drug release of around 70% was observed from the above-mentioned film in 1hr in simulated salivary fluid. Conclusion: Therefore, swellable rapid release oral films with HPMC E15 LV: PVA, guar gum, croscarmellose sodium and Tween 80 demonstrated satisfactory swelling, rapid disintegration and improved drug release for oromucosal absorption.

Highlights

Attempts towards developing innovative drug delivery systems, ensuring efficacy, safety and patient acceptability led to the development of oral films [1]
Fastest disintegration was observed with the oral film containing hydroxypropyl methylcellulose E15 LV (HPMC): polyvinyl alcohol (PVA) in the ratio of 2:1, guar gum at 120 mg, 20% w/w crosscarmellose sodium and 4%w/w Tween 80
In order to improve the peelability and to achieve customized drug release from the developed oral swellable rapid release films, HPMC was used in combination with PVA, which is a disintegrating polymer capable of facilitating burst release

Summary

Introduction

Attempts towards developing innovative drug delivery systems, ensuring efficacy, safety and patient acceptability led to the development of oral films [1] Their improved systemic bioavailability results from bypassing first-pass effect and better permeability due to a well-supplied vascular and lymphatic drainage in the oral mucosa [2]. Oral films are found to be satisfactory in many situations like allergic conditions, cold and cough, sore throat, nausea, pain, mouth ulcers, CNS disorders and CVS disorders [3]. They can be broadly classified as mucoadhesive and non-mucoadhesive oral films.

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