MODE OF INCORPORATION OF SUPER DISINTERGRANTS AND THEIR EFFECTS ON THE PROPERTIES OF PARACETAMOL TABLETS
Keywords:
Crospovidone (CP), Croscarmellose sodium (CCS), Sodium starch glycolate (SSG), super disintegrant, extragranular, intragranular, wet granulation.Abstract
Introduction: Super disintegrants are substances that are used to aid the breakdown of tablets so
as to release their active medicament. In this research, crospovidone (CP), croscarmellose sodium
(CCS) and sodium starch glycolate (SSG) were incorporated intragranularly, extragranularly, both
intragranularly and extragranularly into paracetamol tablets so that their effects could be
investigated.
Aim: The aim is to compare the effect of three super disintegrants on the tableting properties of
paracetamol formulation by wet granulation.
Methods: Granules were prepared and they were characterized for particle size, angle of repose,
bulk and tapped densities, Carr’s index (CI), and Hausner’s ratio (HR). Tablets were compressed
from granules weighing 650mg with a single punch press using a 12mm flat faced punch and
compressed at 57.5 MPa. The compressed tablets were stored at 75% RH/25 0C for 24 hours to
allow for elastic recovery. Tablet properties such as weight variation, tablet thickness, crushing
strength (CS), and disintegration time (DT), and in vitro drug release were evaluated.
Results: The results obtained revealed a good flow (with angle of repose < 300) for all the batches
of granules, CI < 20%, and HR < 1.2 for all batches. All tablets had friability less than 1% which
implies they passed the friability test. Tablets with intragranular addition of the super disintegrants
had the highest crushing strength and longest disintegration time as compared to the other methods
of addition. Tablets with the extragranular addition of super disintegrants had the highest value for
Disintegration Efficiency Ratio (DER).
Conclusion: This shows that mode of incorporation of the disintegrant has an effect on the tablet
properties. The extragranular addition of super disintegrants is the preferred mode of addition from
the results obtained.