Rapidly Disintegrating Tablets Containing Taste Masked Clarithromycin

Abstract

The objective of this study was to mask the bitter taste of clarithromycin and to formulate rapidly disintegrating tablets (RDT) of the taste masked drug. Taste masking was achieved by melt granulation method using cetyl alcohol as meltable binder. Dissolution aid (KollidonCL) was added in the formulation to improve the dissolution rate of taste masked granules as the lipids are known to retard the dissolution. The formulation having drug-lipid-dissolution aid ratio of 1:1:0.15 showed significant taste masking, confirmed by drug release study in phosphate buffer pH 6.8 and taste evaluation. Taste evaluation of taste masked granules in human volunteers revealed considerable taste masking within 10s, whereas claritromycin was rated as very bitter with a score of +4 for 10s. The taste masked granules were formulated as rapid disintegrating tablets using disintegrant addition approach. Tablets were evaluated for various parameters such as hardness, friability, drug content, in-vitro and in-vivo disintegration time and dissolution rate. Tablets of batch F6 containing Kollidon CL as superdisintegrating agent showed faster disintegration. Dissolution profile of optimized RDT in phosphate buffer pH 6.8 showed reduction in dissolution rate initially but more than 85% drug was dissolved after 45 min. The release profile thus obtained proved that the tablet could provide effective taste masking characteristics without compromising with dissolution rate.