A multiple-unit tablet formulation for multi-layer drug-coated granules

Abstract

Formulation studies were conducted to ascertain the feasibility of designing a multiple-unit tablet dosage form containing multi-layer drug-coated granules prepared in a fluidized bed process. Compression of the coated granules into tablets resulted in different release characteristics that were dependent on the type and content of the excipients used and the compression pressure. An excipient mixture consisting of 34.5% w/w microcrystalline cellulose, 2.0% w/w crospovidone and 1.0% w/w colloidal silicon dioxide was found to be suitable for the tabletting of the coated granules at a moderate compression pressure. The resultant tablets, which contained as high as 62.5% w/w of the coated granules, had a fast disintegrating time (4 to 6 min), reasonable hardness (126 to 135 N) and low friability (≤1.0%), satisfying the prerequisites for a multiple-unit tablet formulation. The tablets also exhibited in vitro drug release profiles that simulated closely, up to 80% total release, those of the constituent uncompressed granules.