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

NEHA IMTIAZ; SUTAPA BISWAS MAJEE; GOPA ROY BISWAS

doi:10.22159/ijcpr.2021v13i1.40821

Authors

NEHA IMTIAZ School of Pharmaceutical Technology, Adamas University, Barasat-Barrackpore Road, P. O.-Jagannathpur, Kolkata 700126, West Bengal
SUTAPA BISWAS MAJEE Department of Pharmacy, NSHM Knowledge Campus, Kolkata-Group of Institutions, 124, B L Saha Road, Kolkata 700053, West Bengal
GOPA ROY BISWAS Department of Pharmaceutics, Guru Nanak Institute of Pharmaceutical Science and Technology, 147F, Nilgunj Road, Shahid Colony

DOI:

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

Keywords:

HPMC E15 LV, PVA, Guar gum, Crosscarmellose sodium, Swelling index, Oral rapidly swellable disintegrating film

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.

Downloads

Download data is not yet available.

References

1. Arun A, Amrish C, Vijay S, Kamla P. Fast dissolving oral films. An innovative drug delivery system and dosage form. Int J ChemTech Res 2010;2:576-83.
2. Irfan M, Rabel S, Bukhtar Q, Qadir MI, Jabeen F, Khan A. Orally disintegrating films: a modern expansion in drug delivery system. Saudi Pharm J 2016;9:537–46.
3. Malke M, Shidhaye, Kadam VJ. Formulation and evaluation of oxacarbazine fast-dissolving tablets. Indian J Pharm Sci 2007;69:211-4.
4. Jyothi S, DVRN Bhikshapathi. Development and optimization of fast dissolving oral film containing aripiprazole. Int J Pharm Sci Drug Res 2017;9:327-33.
5. Deepak KS, Suman KM, Sanjib KS, Ritesh KD, Rabi NR. Formulation and evaluation of fast dissolving oral films containing losartan potassium. Int J Res Pharm Chem 2017;7:470-81.
6. Obermeier T, Kohr K, Kramer KK. Oral quickly disintegrating film, which cannot be spit out for an antiemetic or antimigraine agent U. S. Patent 2008/0213343 A1; 2008.
7. Mcnaughton F. The use of ergotamine tartrate in migraine. Canad Med Assoc J 1935;33:664-5.
8. Barnhart SD. Thin-film oral dosage forms in the modified release. Drug Dev Technol 2007;1:34-5.
9. Wale A, Weller PJ. Handbook of pharmaceutical excipients; 1994;2:24, 27, 352, 448.
10. Arya A, Chandra A. Fast dissolving oral films: an innovative drug delivery system and dosage form. Int J Chemtech Res 2010;2:576-83.
11. Kumar RS, Annu, Kusuma L, Parudhvi R. Design, optimization and evaluation of cetirizine dihydrochloride fast dissolving films employing starch tartrate–a novel superdisintegrant. Int J Curr Pharm Res 2019;11:75-86.
12. Zankahana P, Rahil B, Samir S. Formulation optimization and evaluation of mouth dissolving film of ramosetron hydrochloride. Int J Curr Pharm 2020;12:99-106.
13. Indian Pharmacopoeia: Government of India, Ministry of Health and Family Welfare Department. 7th edition; 2014;1:559-621.
14. Dash S, Murthy PN, Nath L, Chowdhury P. Kinetic modeling on drug release from controlled drug delivery systems. Acta Poloniae Pharm Drug Res 2010;67:217-23.
15. Yogyata SP, Vishakha SH, Amruta NB. Polymers used for fast disintegrating oral films: a review. Int J Drug Sci Rev Res 2013;2129:169-78.
16. Teckoe J, Labriola A, Hansell J, Tom F. Stability study of PEG free, PVA based film coating system, AAPS; 2012. p. 1-4.
17. Sakellariou P, Rowe RC. Interactions in cellulose derivative films for oral drug delivery. Progress Polymer Sci 1995;20:889–942.
18. Banker GS. Film coating theory and practice. J Pharm Sci 1996;55:81–9.