Development and evaluation of omeprazole pellets fabricated by sieving-spheronization and extrusion - spheronization process

ABSTRACT

Pelletized dosage forms can be prepared by different methods which, in general, are time consuming and labor intensive. The current study was carried out to investigate the feasibility of preparing the spherical pellets of omeprazole by sieving-spheronization. An optimized formulation was also prepared by extrusion-spheronization process to compare the physical parameters between these two methods. The omeprazole pellets were consisted of microcrystalline cellulose, polyvinylpyrrolidone K 30, sodium lauryl sulphate and polyethylene glycol 6000. The omeprazole delay release system was developed by coating the prepared pellets with aqueous dispersion of Kollicoat 30 DP. The moisture content, spheronization speed and residence time found to influence the final properties of omeprazole pellets prepared by extrusion-spheronization and sieving-spheronization. The Mann-Whitney test revealed that both methods produced closely similar characteristics of the pellets in terms of, friability [p=0.553], flowability [p=0.677], hardness [p=0.103] and density [bulk, p=0.514, tapped, p=0.149] except particle size distribution [p=0.004]. The percent drug release from the coated formulation prepared by sieving-spheronization and extrusion spheronization was observed to be 84.12 +/- 1.10% and 82.67 +/- 0.96%, respectively. Dissolution profiles of both formulations were similar as indicated by values of f1 and f2, 1.52 and 89.38, respectively. The coated formulation prepared by sieving-spheronization and commercial reference product, Zimore[registered] also showed similar dissolution profiles [f1=1.22, f2=91.52]. The pellets could be prepared using sieving-spheronization. The process is simple, easy, less time- and labor-consuming and economical as compared to extrusion-spheronization process.