TASTE-MASKING AND DISSOLUTION ENHANCEMENT OF DICLOFENAC SODIUM ORODISPERSIBLE TABLETS USING SPRAY-DRYING TECHNIQUE
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Abstract
Diclofenac sodium is a potent non-steroidal anti-inflammatory drug with bitter taste and slightly water soluble properties. The aim of this study is to develop diclofenac sodium orodispersible tablet formulation which is taste-masked and enhanced dissolution rate by spray-drying method. Polyvinylpyrrolidone K30 (PVP K30) was used as a polymeric carrier in the drug/polymer ratios of 1:1, 1:2, and 1:4. The obtained particles were then characterized. The particles were spherical shape with wide range of size distribution. Diclofenac sodium was completely entrapped in the polymer cause masking of the drug taste. The solid stage of diclofenac sodium was changed from crystalline to amorphous state. The obtain particles which the drug/polymer ratios of 1:1 and 1:2 were further prepared as orodispersible tablets by direct compression method. Superdisintegrants consisted of cross-linked polyvinylpyrrolidone, sodium starch glycolate and cross-linked sodium carboxylmethylcellulose were used in various ratios. The formulation consists of 3% (w/w) cross-linked polyvinylpyrrolidone and 6% (w/w) cross-linked sodium carboxylmethylcellulose showed the most rapid disintegration time of 65 seconds and the dissolution rate was also enhanced. Diclofenac sodium from the formulation completely dissolved in 150 minutes while the formulation consists of untreated drug took more than 360 minutes to completely dissolve.
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