DEVELOPMENT AND CHARACTERIZATION OF ORAL SWELLABLE RAPID RELEASE FILM WITH SUPERDISINTEGRANT-SURFACTANT Original Article NEHA IMTIAZ 1* , SUTAPA BISWAS MAJEE 2 , GOPA ROY BISWAS 3 1* School of Pharmaceutical Technology, Adamas University, Barasat-Barrackpore Road, P. O.-Jagannathpur, Kolkata 700126, West Bengal, 2 Department of Pharmacy, NSHM Knowledge Campus, Kolkata-Group of Institutions, 124, B L Saha Road, Kolkata 700053, West Bengal, 3 Department of Pharmaceutics, Guru Nanak Institute of Pharmaceutical Science and Technology, 147F, Nilgunj Road, Shahid Colony, Panihati, Kolkata 700110, West Bengal * Email: neha11imtiaz@gmail.com Received: 15 Sep 2020, Revised and Accepted: 17 Nov 2020 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. Keywords: HPMC E15 LV, PVA, Guar gum, Crosscarmellose sodium, Swelling index, Oral rapidly swellable disintegrating film © 2021 The Authors. Published by Innovare Academic Sciences Pvt Ltd. This is an open access article under the CC BY license (https://creativecommons.org/licenses/by/4.0/) DOI: https://dx.doi.org/10.22159/ijcpr.2021v13i1.40821. Journal homepage: https://innovareacademics.in/journals/index.php/ijcpr 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]. These films are taken without water due to their ability to disintegrate within a few seconds releasing medication in oral mucosa for absorption and thus can be used for dysphasic and schizophrenic patients. 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. Oral mucoadhesive films can be further classified as and swellable sustained-release films. Non- mucoadhesive oral films consist of orodispersible films. Swellable rapid release films are prepared by using swellable polymers like hydroxypropylmethylcellulose, sodium carboxymethylcellulose, polyethylene oxide, pectin, alginate, xanthan gum. Bhikshapathi et al. [4] reported that films prepared with hydroxypropyl methylcellulose (HPMC) and polyvinyl alcohol (PVA) were quite flexible with the desired peelability. Systems consisting of these polymers absorb a significant amount of water to form a gel. As dissolution medium or biological fluid penetrates the film matrix, swelling is initiated and drug molecules begin to move out of the film by diffusion. In order to facilitate the faster onset of swelling in the mouth, there is a need to accelerate saliva secretion. This can be achieved by incorporating saliva stimulating agents in the formulation. Generally, acids which are used in the preparation of food can be utilized as salivary stimulants, e. g, citric acid, malic acid, lactic acid, ascorbic acid and tartaric acid etc. Among these, citric acid is most preferred saliva stimulating agent in the formulation. Faster disintegration of the film can be attained by using superdisintegrants like sodium starch glycolate, cross carmellose sodium, cross povidone to promote the faster release of drug. Sarangi et al. [5] reported that films prepared with 20% w/w superdisintegrant demonstrated faster disintegration of the films. Gum is added in the oral film formulation, promotes adhesion to the mucosal surface and prevents swallowing of swollen film on administration. The prepared film therefore, is designed to swell rapidly, stick/adhere to the oral mucosa for rapid disintegration to occur to release the drug, which is absorbed by bypassing hepatic first-pass metabolism. In the present study oral swellable rapid release films of diclofenac sodium were prepared using HPMC E15 LV, PVA and guar gum. Other excipients like cross carmellose sodium, citric acid and Tween 80 were incorporated for their superdisintegrant, saliva stimulating and wetting effects, respectively. The ultimate goal of the study was to develop oral films with rapid swelling and disintegration properties to ensure fast release of drug and rapid onset of action when placed in oral mucosa. No other previous studies have developed swellable rapid release oral films by employing superdisintegrant, surfactant and saliva stimulating agent simultaneously in the formulation. MATERIALS AND METHODS Material Hydroxypropylmethylcellulose E15 LV was purchased from Loba Chemie Pvt. Ltd, polyvinyl alcohol from Merck and Co., guar gum from Akshar Exim Company Pvd. Ltd, dibutyl phthalate from International Journal of Current Pharmaceutical Research ISSN- 0975-7066 Vol 13, Issue 1, 2021