Author(s): Guddu Kumar, Sunil Kumar Shah, C.K.Tyagi
The objective of the present study was to formulate, optimize and evaluate clarithromycin immediate release film coated tablet. In this work, selection of excipient Preformulation studies, tablets were formulated by wet granulation method, Pre-compression parameters, Post compression parameters and formulated trial batch was taken for optimization by full factorial design and Optimized batches on the basis of dissolution and stability studies, Optimized batches were coded as OF1, OF2, OF3, OF4, OF5, OF6, OF7, OF8 and OF9. The in vitro dissolution study was performed for all the optimized formulations. Similarity is found in the results of all the optimized formulations and innovator product. Among the entire optimized batches, formulation OF7 has been selected for calculating similarity factor, since it shows better results (i.e., faster disintegration time and rapid drug release) than other optimized batches. Similarity factor was calculated by comparing the in-vitro drug release profile for batch OF7 with the innovator product. The dissimilarity factor f1 value of 5.147 and similarity factor f2 value of 59.658 indicates that the two products were similar in in-vitro drug release. .From this study, it was concluded that optimized clarithromycin tablet (OF7) containing croscarmellose sodium (3.029%) and pregelatinized starch (6.029%) could be manufactured with reproducible characteristics from batch to batch. The finding of the present study has initiated the company to go in for scale up trial. Based on the reproducible results produced from batch to batch the company will decide to launch the product in the future.