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The Development of Floating Multiple Unit Mini Tablets of Bosentan Using QbD: Characterisation and Pharmacokinetic Study

[ Vol. 11 , Issue. 2 ]

Author(s):

Santosh Kumar Panda*, Manoranjan Sahu, Kahnu Charan Panigrahi, Chinam Niranjan Patra and Goutam Kumar Jena   Pages 179 - 194 ( 16 )

Abstract:


Background: Multiple dosing is required for bosentan in order to achieve steady-state concentration. Hence formulating bosentan controlled release formulation could be an approach to solve this issue.

Objective: The objective is to develop floating multiple unit minitablets of bosentan using the Quality by design approach.

Methods: Failure mode effect analysis (FMEA) and Taguchi design are employed in order to screen highly critical factors. Box-Behnken design (BBD) was adopted for the process of optimization.

Results: The quantity of gelucire 39/01, HPMC K15 M, and sodium bicarbonate was found to be one of the significant factors using Taguchi design. The Box-Behnken design results in the optimised formulation showing floating lag time within 3 min, floating time of nearly 15 h, time to release 50% of drug of 3.6 h, time to release 90% of drug of 11h and better bioavailability compared to pure drug.

Conclusion: It can be concluded that floating multiple unit minitablet can be used as an encouraging approach for sustaining the drug release of bosentan.

Keywords:

Bosentan, risk assessment, taguchi design, box-behnken design, bio-analytical study, solid state characterization, bioavailability.

Affiliation:

School of Pharmaceutical Education and Research, Berhampur University, Odisha, School of Pharmaceutical Education and Research, Berhampur University, Odisha, Roland Institute of Pharmaceutical Sciences (Affiliated to Biju Patnaik University of Technology, Odisha, India), Berhampur, Roland Institute of Pharmaceutical Sciences (Affiliated to Biju Patnaik University of Technology, Odisha, India), Berhampur, Roland Institute of Pharmaceutical Sciences (Affiliated to Biju Patnaik University of Technology, Odisha, India), Berhampur

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