Title:Design, Development and In vitro/Ex vivo Evaluation of Mucoadhesive Buccal Film of Benzydamine Hydrochloride for the Effective Treatment of Aphthous Stomatitis
VOLUME: 12 ISSUE: 4
Author(s):Deepak Sharma*, Amit Sharma and Rajeev Garg
Affiliation:I.K. Gujral Punjab Technical University, Jalandhar, Punjab 144603, Department of Pharmacology, Rayat Bahra Institute of Pharmacy, Hoshiarpur, Punjab 146104, Department of Pharmaceutics, Amar Shaheed Baba Ajit Singh Jujhar Singh Memorial (ASBASJSM) College of Pharmacy, Bela, Ropar, Punjab 140111
Keywords:Aphthous stomatitis, benzydamine hydrochloride, mucoadhesive buccal film, ex vivo drug permeation, in vitro drug
release, sustained delivery, HPMC, ex vivo mucoadhesive time.
Abstract:Background: During the recent two decades, the development of mucoadhesive drug delivery
system has been gained tremendous importance to cure many recurrent diseases of the oral cavity.
The drug delivery through the buccal route is quite challenging due to limited absorption area, movements
of the target region and regular flow of saliva lead to the sub-therapeutic drug level in the buccal
region.
Objective: The aim is to develop unidirectional release mucoadhesive buccal film for the mucosal
delivery of Benzydamine Hydrochloride (WO2016126217Al, EP0812193B1) and evaluate the effects
of a different grade of HPMC polymer (US5980942A) with the presumption to prolong the residence
time and therapeutic effectiveness at the target site.
Methods: Mucoadhesive buccal films were prepared by solvent casting evaporation method by employing
different grades of HPMC as mucoadhesive and rate controlling polymer. Total twenty-four
formulations were developed using ethyl cellulose as a backing layer. The prepared films were subjected
to various physicochemical parameters.
Results: The physicochemical parameters were found to be varied according to the type and concentration
of polymer used. On the basis of in vitro drug release, desired ex-vivo mucoadhesive time, mucoadhesive
force the formulations F4, F9, F14 and F19 were subjected to ex vivo drug permeation study.
The F14 film containing 1% w/v of HPMC K50M was considered optimized final formulation due to
higher ex vivo drug permeation. Drug-excipient compatibility was confirmed by FTIR and DSC. XRD
of final formulation revealed the amorphous nature of drug. SEM indicated the perfect binding between
backing and adhesive layer.
Conclusion: The developed mucoadhesive buccal film having adequate physicochemical properties
was capable to provide prolonged residence time and sustained delivery as compared to existing conventional
therapies.
