Comparative evaluation of the powder properties and compression behaviour of a new cellulose-based direct compression excipient and Avicel PH-102.

摘要

This study compares the compression behaviour of a new cellulose-based tableting excipient, hereinafter referred to as UICEL-A/102, and Avicel PH-102, a commercial direct compression excipient commonly referred to as microcrystalline cellulose (MCC). UICEL-A/102 shows the cellulose II lattice, while Avicel PH-102 belongs to the cellulose I polymorphic form. The median particle diameters of UICEL-A/102 and Avicel PH-102 fractions used in the study were 107 and 97 microm, respectively. Compared with Avicel PH-102, UICEL-A/102 was more dense; the relative poured and tapped densities were: 0.277 and 0.327 (vs 0.195 and 0.248 for Avicel PH-102), respectively. The true density, rhotrue, of the two materials was comparable ( approximately 1.56 g cm(-3)). The slopes of the in-die and out-of-die Heckel curves for Avicel PH-102 were steeper than for UICEL-A/102. The relative density versus applied pressure plot was in good agreement with the modified Heckel equation. The out-of-die and in-die minimal pressure susceptibility (chipmin) values calculated were 3.36 x 10(-3) and 8.09 x 10(-3) MPa(-1) for UICEL-A/102 and 8.00 x 10(-3) and 16.12 x 10(-3) MPa(-1) for Avicel PH-102, respectively. The elastic recovery profiles showed UICEL-A/102 to be more elastic than Avicel PH-102. In conclusion, UICEL-A/102 and Avicel PH-102 differ in their compression behaviour under pressure. The different polymorphic forms could provide a possible explanation.