Optimization of Povidone K-30 and Sodium Starch Glycolate on Levofloxacin Tablet by Factorial Design

Abstract

The aim of this study was to determine the effect of binder and disintegrant excipients toward tablet properties of levofloxacin as the latter tends to suffer brittle fracture upon compression. The excipients used were povidone K-30 as the binder and sodium starch glycolate (SSG) as the disintegrant which the tablets were formulated according to factorial design 22 with two factors and two levels on each factor. Four formulas were prepared by wet granulation method using 2 and 4% of each povidone K-30 and sodium starch glycolate in various compositions. Tablet properties were evaluated for its hardness, friability, and disintegration time as well as dissolution profile. The data obtained was statistically analyzed using Minitab® 17 software to optimize the formulation and resulted in different impacts caused by each excipient. Povidone K-30 exhibited an increment in hardness, friability, disintegration time but a decrease indissolution profile of levofloxacin tablet. SSG decreased hardnessand disintegration time, but increased friability and dissolution profile of levofloxacin tablet. Overlaid contour plot showed that the optimal formula regarding tablet properties of friability, disintegration time, and dissolution profile is in composition of 2.01% povidone K-30 and 2.01% sodium starch glycolate. Keywords: levofloxacin tablet, povidone K-30, sodium starch glycolate, factorial design.

Formulation and Physical Characterization of Black Soybean (Glycine Max L.) Variety of Detam II Tablets with Dry Granulation Method

“…The good tablet hardness requirements are between 4-8 kP. The requirement for tablet fragility is friability <1% (Setyawan D., et al, 2020). All F1-F5 formulas gave results that did not meet the requirements due to several factors.…”

“…The excipient that is suitable as a binder for the dry granulation method of this study is PVP K30. The requirement for uncoated tablet disintegration is <15 minutes (Setyawan, D., et al, 2020). All F1-F5 formulas meet the crush time requirement.…”

“…One tablet is placed in the middle perpendicular to the instrument, then the tool is pressed and the tablet hardness value is seen. Generally, tablet hardness ranges from 4 -8 kP (Rabbani, F., et al, 2017, Setyawan D., et al, 2020.…”