Formulation evaluation and optimization of fast disintegrating tablets of ketorolac tromethamine
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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.
KeywordsFast disintegrating tablet Ketorolac tromethamine Phospholipon 80H Maltodextrin 32 Full factorial design
The authors are thankful to MSN Laboratories Ltd. Andhra Pradesh, India for providing gift sample of KT. They also wish to express their gratefulness to the ASBASJSM College of pharmacy for providing necessary facilities for the study.
Compliance with ethical standards
Conflict of interest
All authors declare that they have no conflict of interest.
Statement of human and animal rights
This article does not contain any studies with human and animal subjects performed by any author.
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