Brooke D
J Pharm Sci. 1975 Aug;64(8):1409-12. doi: 10.1002/jps.2600640836.
Dissolution profiles are calculated for sieve cuts of varying width based on a derived equation, which assumes diffusion rate-limited dissolution under sink conditions from spherical particles. It is shown that even the narrowest of sieve cuts may vary from cube root law expectations by as much as 3 percent, depending on the distribution of particles across the cut. Much smaller deviations from the cube root law occur when the weight distribution of diameters is constant across a sieve cut. It is concluded that when experimental data are treated on the assumption that sieve cuts act like monosized powders, errors generally will be acceptable except in cases of critical tests of dissolution rate theory. In those cases, more information about the powder distribution should be given.
基于一个推导公式,针对不同宽度的筛析颗粒计算溶出曲线,该公式假定在漏槽条件下球形颗粒的溶出受扩散速率限制。结果表明,即使是最窄的筛析颗粒,根据颗粒在筛析中的分布情况,其与立方根定律预期值的差异可能高达3%。当筛析中直径的重量分布恒定时,与立方根定律的偏差会小得多。结论是,当在筛析颗粒如同单粒径粉末的假设下处理实验数据时,一般来说误差是可以接受的,除非在溶出速率理论的关键测试中。在那些情况下,应该给出更多关于粉末分布的信息。