Development of bilayered mucoadhesive patches for buccal delivery of felodipine: in vitro and ex vivo characterization

Order of Publishing in Issue: 
5
Volume :4
Issue :2
April, 2010 - June, 2010
Page No: 
673-683
Authors: 
Chinna Reddy Palem, Ramesh Gannu, Vamshi Vishnu Yamsani, Shravan Kumar Yamsani and Madhusudan Rao Yamsani*
Address: 
Centre for Biopharmaceutics and Pharmacokinetics, University College of Pharmaceutical Sciences, Kakatiya University, Warangal-506009, Andhra Pradesh, India.
Email-ID: 
ymrao123@yahoo.com

Abstract : Bilayered buccoadhesive patch for systemic administration of felodipine was developed using hydroxy propyl methyl cellulose as primary layer and Eudragit RLPO as secondary layer. In vitro drug permeation studies through porcine buccal membrane and buccal absorption studies in human volunteers were performed. Six formulations were developed by solvent casting technique and evaluated for in vitro drug release, moisture absorption, mechanical properties, surface pH, in vitro bioadhesion and in vitro permeation offelodipine through porcine buccal membrane from bilayered buccal patch. Formulation BB4 showed a drug release of 94.6 % with zero order releaseprofile and permeated 41.6 % of drug with a flux of 0.113 mg h–1cm–2 through porcine buccal membrane. Formulation BB4 showed 3.42 N and1.63 mJ peak detachment force and work of adhesion respectively. The physicochemical interactions between felodipine and polymer wasinvestigated by Fourier transform infrared (FTIR) Spectroscopy. According to FTIR the drug did not show any evidence of an interaction with thepolymer. A stability study of optimized patch BB4 was done in natural human saliva; it was found that both drug and buccal patches were stable inhuman saliva. The results indicate that suitable bilayered buccoadhesive patches with desired permeability could be prepared.

Keywords: 
Buccal patches, felodipine, bioadhesion, mechanical properties, buccal delivery
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