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Drug Delivery Letters

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ISSN (Print): 2210-3031
ISSN (Online): 2210-304X

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Research Article

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

Author(s): Santosh Kumar Panda*, Manoranjan Sahu, Kahnu Charan Panigrahi, Chinam Niranjan Patra and Goutam Kumar Jena

Volume 11, Issue 2, 2021

Published on: 26 February, 2021

Page: [179 - 194] Pages: 16

DOI: 10.2174/2210303111666210226142015

Price: $65

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.

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