Effect of starch paste and sodium starch glycolate on compaction behavior of wet granulated paracetamol formulations studied using a fully instrumented rotary tablet press

Abstract

Purpose.
To study the effect of varying proportion of binder starch paste (SP) and disintegrant sodium starch glycolate (SSG) on compaction behavior of wet granulated paracetamol (PCM) formulations, using a fully instrumented rotary tablet press.
Methods.
Wet granulation formulations were prepared using PCM, SP as binder (2.5, 5, or 10 %w/w), SSG as disintegrant (0, 4, 8, or 12 %w/w), microcrystalline cellulose (MCC) and magnesium stearate (MS) (1.5 %w/w). Upper and lower punch force-displacement data during in-die compaction was captured using a fully instrumented rotary tablet press at 13.8 rpm at 4.8 ? 0.6, 8.2 ? 0.9, and 11.8 ? 1.8 kN force. Elastic recovery and tablet tensile strength was determined as a function of starch and SSG concentration and compaction force.
Results.
At a given compaction force, increasing proportion of SSG led to higher values of elastic energy (0.28 to 0.76 Nm with increase in SSG from 0 to 12 % at 5% starch and 11.8 kN compaction pressure). The negative effect of SSG on overall compressibility of granules was due to its high elastic recovery and reduction in interparticulate bonding. Comparison of elastic energy with increasing SP level, a decrease in elastic recovery was evident (0.60 to 0.50 to 0.31 Nm for 2.5, 5 and 10 % starch at 4% SSG and 11.8 kN force). At a given composition, an increase in compaction force led to an increase in elastic recovery (0.15 to 0.33 to 0.50 Nm at 4% SSG and 5% starch for force of 4.8, 8.2, and 11.8 kN, respectively). Tensile strength, with change in SSG and binder (SP) concentration, was indirectly proportional to elastic recovery during compaction.
Conclusions.
A negative and positive influence, respectively of SSG and SP was evident on elastic recovery and tensile strength of tablets.