ABSTRACT

Aim and objective: The present investigation aimed to formulate controlled-release bosentan floating tablets by hot melt granulation technique. Method: Different quantities of xanthan gum and ethyl cellulose were used in the melt granulation process to prepare the floating tablets. Results and discussion: The formulations were subjected to pre-compression parameters like angle of repose, bulk density, tapped density, Hausner’s ratio, Carr’s index, and post- compression parameters like hardness, floating lag time, floating time, and dissolution. The Pharmacopoeia limits were achieved for all formulations. Drug release from tablets was tested in vitro for 24 hours in 0.1 N HCl (pH 1.2). F6 was discovered to be the best formulation out of all the formulations, exhibiting 93.55% in-vitro drug release over 24 hours with a lag time of 9 seconds. By increasing the concentrations of polymers the drug release was prolonged. Drug-excipient compatibility studies have shown that there was no interaction between drug and excipients. Accelerated stability studies revealed a high degree of consistency with the original formulation, indicating the stability of the formulations. By using Sprague Dawley rats, in-vivo studies were carried out and pharmacokinetic parameters were determined. Conclusion: From the results, conclude that the prepared bosentan floating tablets were able to prolong drug release, increased bioavailability, and have maximum therapeutic efficacy. Keywords: Gastro-retentive drug delivery system, Bosentan, carnauba wax, xanthan gum, floating tablets, pH, In vitro
Publication date: 01/09/2024

https://ijbpas.com/pdf/2024/September/MS_IJBPAS_2024_8335.pdf

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https://doi.org/10.31032/IJBPAS/2024/13.9.8335