Acta Periodica Technologica 2019 Issue 50, Pages: 304-310
https://doi.org/10.2298/APT1950304S
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The effect of magnesium stearate and sodium starch glycolate on powder flowability
Švonja-Parezanović Gordana (University of Novi Sad, Faculty of Medicine, Department of Pharmacy, Novi Sad, Serbia)
Lalić-Popović Mladena (University of Novi Sad, Faculty of Medicine, Department of Pharmacy, Novi Sad, Serbia)
Goločorbin-Kon Svetlana (University of Novi Sad, Faculty of Medicine, Department of Pharmacy, Novi Sad, Serbia)
Todorović Nemanja (University of Novi Sad, Faculty of Medicine, Department of Pharmacy, Novi Sad, Serbia)
Pavlović Nebojša (University of Novi Sad, Faculty of Medicine, Department of Pharmacy, Novi Sad, Serbia)
Jovičić-Bata Jelena (University of Novi Sad, Faculty of Medicine, Department of Pharmacy, Novi Sad, Serbia)
The powder flow plays an important role in the manufacture of dosage form
such as direct compression tablets. The objective of this research was to
investigate the individual and interaction effects of magnesium stearate
(MgSt) (Merck Ltd., Germany) as lubricant and sodium starch glycolate (SSG)
(Primojel®) as superdesintegrator on powder flowability. Powder formulations
were prepared by mixing different concentration of MgSt (0.25% and 5%) and
SSG (0.5% and 4%) with microcrystalline cellulose (MCC) (Vivapur®101) or
spray-dried lactose (LAC) (Super Tab 21AN) as diluents. Eight powder
formulations were prepared using as filler LAC and MCC, as
superdesintegrator SSG and as lubricant MgSt in ratios as follows: P1 (LAC :
0.5% SSG : 0.25% MgSt); P2 (LAC : 4% SSG : 5% MgSt); P3 (LAC : 0.5% SSG : 5%
MgSt); P4 (LAC : 4% SSG : 5% MgSt); P5 (MCC : 0.5% SSG : 0.25% MgSt); P6
(MCC : 4% SSG : 5% MgSt); P7 (MCC : 0.5% SSG : 5% MgSt); P8 (MCC : 4% SSG :
0.25% MgSt). The powder formulations were evaluated using indirect methods
of flowability evaluation according to 9th European Pharmacopoeia:
measurement of tapped and bulk density (Ph.Eur.9, 2.9.34) and angle of
repose (Ph.Eur. 2.9.36). Also, compressibility index, Hausner’s ratio were
calculated. A full factorial design with three factors at two levels and
response surface methodology were applied to evaluate the influence of
various concentrations of MgSt and SSG on powder flowability. The results
indicate that flow properties improved with decrease of SSG content and with
increase of MgSt content. Magnesium stearate in powder formulations with
microcrystalline cellulose has a greater influence on the improvement of the
flow properties than powder formulations with spray-dried lactose.
Keywords: magnesium stearate, sodium starch glycolate, powder, flowability, factorial design