Taste masked orodispersible tablet of atomoxetine hydrochloride

Abstract

In the present work, orodispersible tablets of atomoxetine HCl were designed by preparing tasteless complexes of atomoxetine HCl with weak cation ion exchange resins (Kyron T 134). The ion exchange complex were prepared by the batch process using activated Kyron T 134 with a drug: resin ratios 1:1, 1:2, 1:3 and 1:4 (% w/w). IR analysis, assay content and decomplexation studies confirmed complex formation. It was found that maximum complexation of drug with resin was noted between pH range 5-7, while activation of ion exchange resin affects the percent drug loading. Drug release from drug: resin complex in salivary pH was insufficient to impart bitter taste. A study on super-disintegrants along with directly compressible diluents is studied and its effect on disintegration time and enhance mouth feel. The prepared batches of tablets were evaluated for hardness, friability, drug content uniformity and in vitro dispersion time. Based on in vitro disintegration time (approximately 30 s), formulations were tested for in vitro drug release pattern in 0.1N HCl.