Title:Maraviroc Oral Disintegration Tablet: Analytical Design of Experiments
(DoE) for Assessment and Comparison of In vitro Dissolution Profiles
Volume: 18
Issue: 4
Author(s): Akula Ramesh, Jagadish Purale Channabasavaish*, Vinay Jhawar , Proneel Das , Prajakta Patil and Srinivas Mutalik
Affiliation:
- Department of Pharmaceutical Chemistry, Manipal College of Pharmaceutical
Sciences, Manipal Academy of Higher Education, Manipal, Karnataka, India
Keywords:
Analytical QbD, direct compression, dissolution comparison, maraviroc, orally disintegrating tablet, similarity factor.
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.
