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Design and evaluation of methotrexate buccal mucoadhesive patches

Author(s): Bhanja Satyabrata | P Ellaiah | Rohit Choudhury | KVR Murthy | Panigrahi Bibhutibhusan | Martha Sujit Kumar

Journal: International Journal of Pharmacy and Biomedical Sciences
ISSN 0976-5263

Volume: 01;
Issue: 02;
Start page: 31;
Date: 2010;
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Keywords: Methotrexate | mucoadhesive buccal patches | in-vitro drug release | ex-vivo drug release | Release kinetic studies

The goal of present investigation was to design and evaluate, mucoadhesive bilayered buccal devices comprising of a drug containing mucoadhesive layer and drug free backing membrane. Bilaminated patches composed of mixture of drug (methotrexate) and sodium alginate alone or in combination with sodium carboxy methyl cellulose, polyvinyl pyrollidine and carbopol 934 and backing membrane (ethyl cellulose). The patches were fabricated by solvent casting technique and evaluated for film weight uniformity, thickness, swelling index, surface pH, mucoadhesive strength, mucoadhesive time and folding endurance, in-vitro and ex-vivo drug release. A combination of sodium alginate with carbopol 934 and glycerol as plasticizer gave promising results. The optimum patches exhibits an in-vitro release of 82% through cellophane membrane and 70.78% in 8 h through buccal mucosa with satisfactory, mucoadhesive strength mucoadhesive time. The in vitro release kinetics through cellophane membrane fits well for Higuchi, while ex-vivo through buccal mucosa it followed zero-order kinetics. The ex-vivo data also fitted to Korsmeyer-Peppas equation which characterizes the release mechanism as non-Fickian, which means the drug release is independent of concentration gradients.
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