Formulation evaluation and optimization of fast disintegrating tablets of ketorolac tromethamine

다국어 초록 (Multilingual Abstract)

In this study, we aimed to design fast disintegrating tablets (FDT) of ketorolac tromethamine (KT) to reduce gastric side effects of KT by physically associating it with phospholipon 80H (PL) by wet granulation. First preliminary batches were formulated to determine the effect of PL on tablet characteristics and to select best superdisintegrant among sodium starch glycolate and crospovidone. The effect of PL and maltodextrin (MD) concentrations on hardness, disintegration time and % drug release at 4 min was studied for the optimization of FDT. Optimization of FDT was done by employing 32 full factorial design using Design expert 10.1 software. The optimized batch of FDT showed disintegration time and percent release value of 37.33 ± 1.47 s and 42.74 ± 1.53% respectively. It was also found that 91.87% of drug was released within 10 min. Thus, by an appropriate combination of excipients, it was possible to formulate FDT capable of undergoing fast disintegration and having optimum hardness using simple and conventional techniques.

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