Functionality of GalenIQ 721 as excipient for direct compression tablets.

ABSTRACT

The purpose of the work is the comparative evaluation of GalenIQ 721, against known excipients such as Pharmatose M200 and Alfacel type 102. The evaluated parameters included compactibility curves, tablet ejection pressure, disintegration time and flowability of individual powders and mixtures of the excipients and amoxicillin. The surrogate and explicit compactibility of Alfacel 102 (492 N; 7.9 N) is superior, followed by GalenIQ 721 (310 N; 0.93 N) and Pharmatose M200 (203 N; -2.8 N). The lubricity of Alfacel 102 is superior (ejection pressure - Pe=0.590 MPa), followed by GalenIQ 721 (Pe=6.45 MPa) and Pharmatose M200 (Pe=6.51 MPa). Disintegrability of tablets was better by GalenIQ (0.33 s/N), followed by Alfacel 102 (2.48 s/N) and Pharmatose M200 (4.47 s/N).GalenIQ 721 displays a powder fluidity of (14.4 g/s), followed by Alfacel 102 (7.88 g/s) and Pharmatose M200 (0.99 g/s). The tableting functionality of GalenIQ 721 is better than that of Pharmatose M200 but inferior of that of Alfacel 102. Although the GalenIQ 721 characteristics, predominantly brittle, are expected to be more stable to changes in formula composition and process conditions than those of Alfacel 102, plastic behavior.