Formulation and physicochemical evaluation of diclofenac sodium chewable tablets

ABSTRACT

Taste masked diclofenac sodium, by three techniques, namely microencapsulation with ethylcellulose, ethylcellulose pan coating and 'inclusion complexation with beta-cyclodextrin followed by coating with an aqueous dispersion of ethylcellulose [Aquacoat], was formulated into chewable tablets. After several trials, three formulae, one for each type of the treated diclofenac sodium, were selected. The chosen three formulae were directly compressed into 10 mm diameter flat tablets containing 25 mg of diclofenac sodium and weighing about 600 mg. The produced tablets were evaluated with regard to their taste profile in addition to uniformity of dosage, friability, hardness and dissolution. The obtained results indicated that the three different batches of diclofenac sodium chewable tablets had good to excellent taste except for that based on diclofenac sodium-beta-cyclodextrin inclusion complex. The three batches complied with the pharmacopoeal [USP XXIV] requirements with regard to uniformity of dosage and friability and they showed reasonable hardness values. With regard to the in vitro release profile [in phosphate I buffer pH 7.4], two of the three chewable tablet batches showed fast release profiles, whereas the batch based on diclofenac sodium microcapsulcs showed a relatively slow release pattern