Effect of Superdisintegrants on Theophylline Pellets Prepared by Extrusion–Spheronization Technique

Abstract

The present study was carried out to investigate the effect of superdisintegrants on the drug release characteristics of Theophylline pellets prepared by the extrusion–spheronization technique. Theophylline was selected as a model drug, while microcrystalline cellulose (MCC) was used as the primary pelletizing aid. Three superdisintegrants, namely sodium starch glycolate (Primojel), croscarmellose sodium (Ac-Di-Sol), and crospovidone (Polyplasdone XL10), were incorporated to evaluate their influence on pellet characteristics and dissolution behaviour. Pellets were prepared using suitable granulating liquids and binders, and their physical properties, including particle size distribution, shape, flow properties, friability, drug content, disintegration, and in-vitro dissolution, were evaluated. The prepared pellets exhibited good sphericity with circularity values ranging from 0.968 to 1.00, excellent flow characteristics, low friability (<0.1%), and drug content within acceptable limits (89.06–98.89%). All formulations disintegrated within 30 minutes, with croscarmellose sodium-containing pellets showing faster disintegration than sodium starch glycolate formulations. The incorporation of superdisintegrants significantly enhanced drug release compared to pellets containing only MCC. The dissolution behaviour was found to depend on the type and concentration of superdisintegrant used. Sodium starch glycolate exhibited the highest swelling capacity, croscarmellose sodium provided rapid water penetration and disintegration, while cros povidone showed comparatively lower swelling behaviour.