Particle diffusional layer thickness in a USP dissolution apparatus II: a combined function of particle size and paddle speed.

This work was to investigate the effects of particle size and paddle speed on the particle diffusional layer thickness h(app) in a USP dissolution apparatus II. After the determination of the powder dissolution rates of five size fractions of fenofibrate, including <20, 20-32, 32-45, 63-75, and 90-106 microm, the present work shows that the dependence of h(app) on particle size follows different functions in accordance with the paddle speed. At 50 rpm, the function of h(app) is best described by a linear plot of h{app} = 9.91sqrt d-23.31 (R(2) = 0.98) throughout the particle diameter, d, from 6.8 to 106 microm. In contrast, at 100 rpm a transitional particle radius, r, of 23.7 microm exists, under which linear relationship h(app) = 1.59r (R(2) = 0.98) occurs, but above which h(app) becomes a constant of 43.5 microm. Thus, h(app) changes not only with particle size, but also with the hydrodynamics under standard USP configurations, which has been overlooked in the past. Further, the effects of particle size and paddle speed on h(app) were combined using dimensionless analysis. Within certain fluid velocity/particle regime, linear correlation of h(app)/d with the square-root of Reynolds number (d\varpi/upsilon){1/2}, that is, h{app}/d = 1.5207 - 9.25 x 10{- 4} (d\varpi/n){1/2} (R(2) = 0.9875), was observed.