A Comparative Evaluation of Fast Dissolving Tablets of Acetaminophen Using Super-disintegrant Blends and Sublimation Method

Abstract

Fast disintegrating tablets (FDTs) are gaining prominence as drug delivery systems and emerging as one of the popular and widely accepted dosage forms, especially for the peadiatric and geriatric patients. This study aims to evaluate and compare the tablet properties of fast disintegrating tablets of acetaminophen prepared by super-disintegrant blends and sublimation methods. Two groups of tablets comprising various batches were prepared by wet granulation. Granules batches of one group of tablets (A-G) were prepared with different concentrations of sodium starch glycolate and croscarmellose sodium while the other group of tablets (H-N) were incorporated with varying concentrations of menthol into the batches. The granules were subjected to analysis and compressed into tablets. The post-compression parameters of the tablets such as weight uniformity, crushing strength, friability, wetting and disintegration times, as well as dissolution studies were evaluated. Drug-excipient compatibility studies using Fourier transform infrared (FTIR) analysis was also carried out. Granules were fair to good in flow with Carr’s indices ≤ 20.14 and angles of repose ranging from 21.34 to 35.00°. Tablets crushing strength values were between 3.44 to 8.26 kp while their friability values were < 1.52%. They showed wetting and disintegration times that were ≥ 0.18 and ≥ 0.25 min. Dissolution studies showed that four batches of tablets (two from each method used in formulation) achieved 100% drug release within 30 min. FTIR analysis shows no interactions between acetaminophen and excipients used in formulation. Tablets from both methods were comparable in their tablet properties but the disintegrant blend tablets exhibited superior crushing strengths, hence formed harder tablets, while the sublimation method tablets were superior in their wetting and disintegration times.

Keywords: acetaminophen, super-disintegrants, sublimation, tablet parameters