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Design and Characterization of Double Layered Mucoadhesive System Containing Bisphosphonate Derivative

DOI: 10.1155/2013/604690

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Abstract:

The objective of this study is to evaluate the effect of formulation variables on different evaluation properties such as cumulative percentage release and swelling index in development of two layered buccal mucoadhesive system consisting of a highly water soluble drug risedronate sodium. The mucoadhesive systems were developed with varied concentrations of the polymers (1-2%) using plasticizer/permeation enhancer (25–50% w/w of polymer). Two layered films comprised of risedronate sodium with chitosan (85% deacetylated) and hydroxypropylmethyl cellulose (HPMC 4KM) interpolymer complex of different ratios were prepared by solvent casting method. An impermeable backing membrane of ethyl cellulose was incorporated into the films. The study shows the effect of multipolymeric films on the release of a bisphosphonates derivative. The optimized formulations showed films with uniform drug content ( ), thickness ( ?mm to ?mm), mucoadhesivity ( ?g), and controlled drug release profile up to a period of 10 hours. The films were also studied for swelling index, moisture uptake, viscosity, folding endurance, water vapor transmission rate, and mucoadhesive time. 1. Introduction The selection of suitable polymers for manufacturing a drug delivery system is a major and important factor when formulation of controlled release buccal delivery systems for enhancing mucoadhesivity and obtaining controlled release profile is considered. A drug delivery system using a single polymer may not give the desired drug release profile when compared to blending polymers to get suitable and desired results with mucoadhesive drug delivery systems [1]. Buccal mucosa is an attractive route for the delivery of drugs through systemic route, because of its relatively good permeability with a rich blood supply. A drug can be easily applied and localized to the application site and can be removed from the site whenever necessary. Buccal films are highly flexible and easily tolerated by the patients. It also ensures accurate dosing of the drug. During the last decade, bioadhesive polymers received considerable attention as platforms for buccal controlled drug delivery due to their ability to localize the dosage form in specific regions to enhance bioavailability [2]. Due to their small size and thickness, they have improved patient compliance, compared to tablets. Since mucoadhesion implies attachment to the buccal mucosa, films can be formulated to exhibit a systemic or local action. Films releasing drug towards the buccal mucosa exhibit the advantage of avoiding the first pass effect by

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