The effects of a blend of croscarmellose sodium and microcrystalline cellulose on the brittle fracture tendency of paracetamol tablets

Abstract

Background: Capping and lamination are major problems encountered in tablet production and they are indicators of the brittle fracture tendency of a tablet formulation.

Objective: The study aimed at determining the effect of a blend of two super-disintegrants on the brittle fracture tendency of paracetamol tablet.

Methods: Batches of paracetamol granules and tablets (B1-B5) were prepared by wet granulation using a blend of croscarmellose sodium and microcrystalline cellulose (MCC) at different ratios. The formulated granules’ pre- and post-compression parameters such as weight uniformity, dimensions, friability, crushing strength disintegration time, brittle fracture index (BFI) and dissolution studies were evaluated.

Results: Granules of the different batches of the formulations exhibited excellent flow properties. All of the formulated tablets met official compendial specifications for tablets except batch B4 tablets with tablet friability value of 1.35 %. The BFI of the paracetamol tablets with MCC alone (B5) had the lowest value (0.420), closely followed by the B3 tablets value (0.421) with 2 parts MCC and 1 part croscarmellose sodium. The highest BFI value of 0.582 was obtained from the B1 batch of tablets containing equal parts of the superdisintegrants.

Conclusion: The blend of superdisintegrants adversely affected the brittle fracture tendency of the paracetamol tablets by increasing the BFI of the tablets though to a lesser degree. The choice of two or more superdisintegrants in the formulation of fast disintegrating tablets should be undertaken with a careful study to avoid producing tablets that are prone to capping or lamination during tablet-die ejection.

Keywords: Superdisintegrants, Blend, Tablets properties, BFI