DEVELOPMENT OPTIMIZATION AND EVALUATION OF EFFERVESCENT TABLETS OF CHLORPHENIRAMINE MALEATE USING BOX BEHNKEN DESIGN
Objective: The objective of present study was to develop effervescent tablets of Chlorpheniramine maleate (CPM) for the treatment of dysphasia.
Methods: Effervescent tablets were prepared by direct compression method and were optimized using box behnken design. Amount to sodium bicarbonate (X1), amount of tartaric acid (X2) and amount of fumaric acid (X3) were selected as independent variables, whereas disintegration time (Y1), amount of carbon dioxide (Y2) and drug release in 5 minutes (Y3) were selected as dependent variables. All the batches were also evaluated for general post compression evaluation of tablet such as-weight variation, thickness, friability and hardness. From the results of design batches, best batch was selected and evaluated for in vivo pharmacokinetic study in rabbit model.
Results: The disintegration time ranged from 103.33 Â± 0.24 sec to 157.00 Â± 0.75 sec while amount of carbon dioxide ranged from 0.26Â±0.014 g to 2.03Â±0.056 g in all the design batches. From the results of design batches, batch B4 was selected as optimized batch due to higher amount of released carbon dioxide and faster drug release as compared to other batches. Batch B4 was showing higher AUC and Cmax while lower tmax as compared to drug suspension while performing in vivo study of optimized batch in rabbit model.
Conclusion: The study concluded that the combination of sodium bicarbonate, tartaric acid and fumaric acid approach for development of effervescent tablet aids to achieve faster disintegration and faster drug release property for CPM.
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