A QUALITY BY DESIGN (QBD) APPROACH OF ASSESSING THE EFFECT OF SUPER DISINTEGRANT PROPERTY OF KHAYA SENEGALENSIS GUM ALONE AND IN COMBINATION WITH STANDARD SUPER DISINTEGRANTS IN METRONIDAZOLE TABLET PREPARED BY DIRECT COMPRESSION

Abstract

Purpose: The aim of this study is to use quality by design approach to assess the effect of a natural polymer, Khaya
senegalensis gum (KSG) alone and in combination with Crospovidone (CPV) and Sodium starch Glycolate (SSG) as
super disintegrants in metronidazole tablets formulated via direct compression.
Principal methodology: Design of Experiments (DoE) was employed to derive the formulation matrix for the three
components KSG, SSG & CPV as well as the ratio for the optimized formulation, coded equations and contour lines
of observed effects on the responses including disintegration time (DT), Crushing strength (CS) & Friability (FR).
The powders were mixed in the ratio generated and directly compressed using a pair of 12 mm punches on a single
punch tableting machine at a compression pressure of 8 MT to produce 650 mg unit of tablets.
Key findings: The resulting effect of the responses revealed that, KSG and SSG both conferred strength to the tablets
and produced the least friable tablets at high, moderate and low levels. On the other hand, tablets containing CPV
produced the softest and most friable tablets. However, DT was rapid for all runs ranging between 7.5 to 11.6 seconds
with KSG runs taking the longest time. The optimized formulation contained KSG (2.856%) & SSG (5.144%) only
as given by the desirability function.
Conclusion: The effect of the mixture components was an effective reduction in DT, FR and acceptable CS only
where KSG levels were present from 1.33 to 8%w/w while the optimized formulation was seen to be valid for its close
similarities with the predicted values. This shows that Khaya senegalensis gum can be used as a super disintegrant in
conventional metronidazole tablets manufactured by direct compression most especially where fast disintegration and
tablet robustness is required.