PREPARATION OF SUSTAINED RELEASE DICLOFENAC SODIUM TABLETS USING CHITOSAN AND POLYVINYLPYRROLIDONE K90 AS COMBINED BINDING AGENTS
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Abstract
Sustained release diclofenac sodium (DS) granules were prepared by granulation of DS powder and a poorly water-soluble diluent, dibasic calcium phosphate (DCP), with the binding solution of a swellable polymer, chitosan (CS), in various concentrations. Dissolution profiles of the prepared granules were studied. The granules containing DS, DCP and CS in the ratios of 10:10:0.1 and 10:5:0.1 were chosen to compress into tablets using various contents of a disintegrant, croscarmellose sodium (Ac-Di-Sol®). Their dissolution profiles were studied and very slow tablet dissolution rates were observed. Polyvinylpyrrolidone K90 (PVP) and CS were used as the combined binder system to granulate the 10:5 DS:DCP mixture in order to modify the dissolution rates of the DS tablets. The 10:5 DS:DCP granules prepared by using various ratios of CS to PVP, as combined binders, were compressed into tablets using Ac-Di-Sol® in the concentrations of 1% and 2% as disintegrant. The effects of PVP and Ac-Di-Sol® contents on dissolution of the prepared DS tablets were investigated. It was found that the usage of the combined binders, CS and PVP, provided faster tablet dissolution than did the usage of CS alone as binder. The dissolution enhancing effect of Ac-Di-Sol® on tablet dissolution was more prominent in the DS tablets containing low content of PVP but was less significant in the tablets consisted of PVP in high content. Optimum contents of PVP and Ac-Di-Sol®, employed in the tablet formulation, were recognized as the important factor in developing the sustained release DS tablet having the most possible required dissolution profile.
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