Summary of - Maraviroc oral disintegration tablet: analytical design of experiments (DoE) for assessment and comparison of invitro dissolution profiles

Document Type

Article

Abstract

Study Background: Bioavailability of a newly developed solid oral dose depends on its release profile affecting its absorption.

Research goal and Objective: To compare dissolution profiles of a newly developed maraviroc oral disintegration tablet and the marketed product Axentri® tablet aided with a QbD based RP-HPLC method for sample analysis.

Methodological approach :

  1. An orally disintegrating tablet of maraviroc was formulated using a direct compression technique with sodium starch glycolate as super disintegrants and talc and magnesium stearate as glidants.
  2. Dissolution study was carried out in 0.1N HCl to predict bioequivalence and the samples were analyzed using the RP-HPLC method developed using AQbD approach.

Results and Discoveries :

  1. Optimized formulation (F2) exhibited 90% drug release in 5 minutes and a disintegration time of 22 seconds with dissolution profiles similar to the marketed reference meeting the FDA requirements.
  2. The developed method was validated as per ICH guidelines Q2(R1).

Conclusion: Maraviroc oral disintegrating tablets were prepared and superior statement consistency was established. A QbD based analytical method development approach was used for analysis of dissolution study samples using RP-HPLC.

Publication Date

May 2022

Recommended Citation

Ramesh A, Jagadish PC, Jhawar V, Das P, Patil P, Mutalik S. Maraviroc oral disintegration tablet: analytical design of experiments (DoE) for assessment and comparison of in vitro dissolution profiles. Current Pharmaceutical Analysis. 2022 May 1;18(4):427-36.

DOI/Link : https://doi.org/10.2174/1573412917666210823091007

Publication Date

2022

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