Abstract

The challenge in orally disintegrating tablets (ODTs) production encompasses the compromise between instantaneous disintegration and sufficient physico-mechanical properties, therefore the aim of this study was to evaluate the influence of selected disintegrants on the characteristics of ODTs manufactured using novel ready-to-use excipients (Ludiflash^® or Parteck^®) by direct compression method. Effect of selected disintegrants (croscarmellose sodium, microcrystalline cellulose and four types of crospovidone) on hardness, friability, wetting time, in vitro and in vivo disintegration time, roughness and stability parameters has been studied. The prepared tablets were also evaluated for surface morphology and pore structure. 3% w/w addition of all examined disintegrants enabled obtaining tablets showing physico-mechanical properties that are suitable for ODTs, but disintegration times < 30 s were observed only in formulations with crospovidones. The surface of Ludiflash^® and Parteck^®ODTs was relatively homogenous dispersion with pores, cracks and fissures. Formulations with Ludiflash^® showed both less porous textures with low specific surface area (BET values up to 0.77 m²/g) and shorter wetting and disintegration times. The optimized formulation containing superfine crospovidone and Ludiflash^® (L2) or Parteck^® (P2) was found to be stable, had a pleasant mouth feel and disintegrated in the oral cavity within only 10 and 26 s, respectively.

Key words: Orodispersible tablet, Ludiflash^®, Parteck^®, direct compression, disintegrant.