Evaluation of the compression properties of co-processed paracetamol, gelatin and microcrystalline cellulose formulation prepared via melt-in agglomeration

High drug-loaded actives such as paracetamol allow little alteration in bulk size, relying more on processing techniques in formulating its dosages. The aim of this study is to evaluate tableting properties of co-processed paracetamol, gelatin and microcrystalline cellulose. Batches of co-processed paracetamol granules (A-E) were prepared by melt-in agglomeration process using paracetamol with varying amounts of gelatin (1.0, 2.0, 3.0 or 4.0 % w/w) or starch (3.0 % w/w) and microcrystalline cellulose. A control batch (F) of conventional granules was prepared by wet granulation method with starch mucilage (4.0 % w/w). The granules were subjected to micromeritic, compaction and differential scanning calorimetric analyses. The granules were compressed into tablets and their tablet properties evaluated. Granules of batches A-D had higher percent maximum volume reduction of 12.25 - 16.13 % compared to the percent maximum volume-reduction (9.52 and 11.81) of granules from batches E and F respectively. Differential scanning result indicates amorphous solidification of co-processed paracetamol. Tablets formulated from batches A-D showed improve tensile strength (3.63 - 8.26 Nm-2) and faster disintegration time (1.32- 1.12 min) compared to the tensile strengths (5.09 & 5.01 Nm-2) and disintegration times (2.54 & 4.43 min) of tablets from batches E and F respectively. There were no significant difference (p ≥ 0.05) in maximum amounts (> 70 %) of paracetamol released after 40 min. Unlike reported increase in disintegration times of paracetamol tablets processed with gelatin-slurry, melt-in agglomeration of paracetamol, gelatin and microcrystalline cellulose improved granules tabletability parameters, tablets disintegration time and dissolution properties.