Roles of granule size in over-granulation during high shear wet granulation.
Roles of granule size in over-granulation during high shear wet granulation.
复制标题
高剪切湿法制粒过程中颗粒尺寸在过度制粒中的作用。
DOI：
10.1002/jps.22118
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发表时间：
2010
影响因子：
3.8
通讯作者：
Changquan Calvin Sun
中科院分区：
文献类型：
--
作者：
Limin Shi;Yushi Feng;Changquan Calvin Sun
对高剪切湿法制粒（HSWG）过程中过度制粒问题的机理理解可以指导有效开发稳健的处方和生产工艺。使用微晶纤维素（MCC）作为模型化合物，我们表明，尺寸扩大是一个重要的机制，在HSWG过度造粒。较高的制粒水位导致较大的颗粒和较低的可压片性。随着含水量的增加，当含水量超过65%时，颗粒急剧增大。颗粒压片性随着粒度的增加而变差，当使用超过70%的水时变得过度制粒。对于一批研磨和过筛的过度制粒颗粒，过筛部分的可压片性随着粒度的增加而降低。最细级分（45-90微米）的可压片性几乎是最大级分（300-425微米）的四倍。这些结果表明，尺寸减小可以是解决过度造粒问题的有效策略。
A mechanistic understanding of the over-granulation problem during high shear wet granulation (HSWG) process can guide efficient development of robust formulation and manufacturing process. Using microcrystalline cellulose (MCC) as a model compound, we demonstrate that size enlargement is an important mechanism for over-granulation in HSWG. A higher granulation water level results in larger granules and lower tabletability. With increasing water, granules enlarge sharply when water level is higher than 65%. Granule tabletability deteriorates with increasing granule size and becomes over-granulated when more than 70% water is used. For a batch of over-granulated granule that is ground and sieved, tabletability of the sieved fractions decreases with increasing granule size. The tabletability of the finest fraction (45-90 microm) is nearly four times that of the largest fraction (300-425 microm). These results show that size reduction can be an effective strategy to address the problem of over-granulation.