Maraviroc Oral Disintegration Tablet: Analytical Design of Experiments (DoE) for Assessment and Comparison of Initro Dissolution Profiles

Ramesh, Akula and Jagadish, PC and Jhawar, Vinay and Das, Proneel and Patil, Prajakta and Mutalik, Srinivas (2022) Maraviroc Oral Disintegration Tablet: Analytical Design of Experiments (DoE) for Assessment and Comparison of Initro Dissolution Profiles. Current Pharmaceutical Analysis, 18 (4). pp. 427-436. ISSN 1573-4129

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Abstract

Background :The bioavailability of a drug in a solid oral dose depends on its release from the drug product and its balance in dissolution. Compared with a reference drug, the newly developed formulation needs to establish bioequivalence by comparing the dissolution profile.Objectives: To compare dissolution profiles of a newly developed maraviroc oral disintegration tablet and the reference Axentri® tablet. The current research was designed to establish and validate an integral analytical consistency by Quality by Design (QbD) approach to quantify maraviroc from dissolution samples using the RP-HPLC method.Methods: Maraviroc was formulated into an orally disintegrating tablet using a direct compression technique at different concentrations of sodium starch glycolate as super disintegrants and talc and magnesium stearate as glidants. The dissolution test in 0.1N HCl was performed according to standard procedures to predict bioequivalence. The results of dissolution tests were analyzed using the QbD Box Behnken Design multivariate RP-HPLC method.Results: The optimized formulation (F2) was selected as it showed 90% drug release in 5 min and a disintegration time of 22 sec with dissolution profiles to the marketed reference to meet the FDA requirements of f2 similarity factor statistics.The integrated analytical QbD method was statistically analyzed by ANOVA, counter-plot, and 3D response surface plots,which demonstrated that the model is statistically significant. The developed method was validated as per ICH guidelines Q2 (R1).Conclusion: In conclusion, maraviroc oral disintegrating tablets have been well prepared, and superior statement consistency is established by the implementation of the QbD analytical method for orally disintegrating tablet excellence and adoption

Item Type: Article
Uncontrolled Keywords: Analytical QbD; Direct compression; Dissolution comparison; Maraviroc; Orally disintegrating tablet; Similarity factor
Subjects: Pharmacy > MCOPS Manipal > Pharmaceutical Chemistry
Pharmacy > MCOPS Manipal > Pharmaceutical Quality Assurance
Pharmacy > MCOPS Manipal > Pharmaceutics
Depositing User: KMC Library
Date Deposited: 18 Jul 2022 04:05
Last Modified: 18 Jul 2022 04:05
URI: http://eprints.manipal.edu/id/eprint/158942

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