EFFECT OF THE MODE OF SUPER DISINTEGRANT INCORPORATION ON DISSOLUTION IN WET GRANULATED TABLETS

被引:46
作者
GORDON, MS
RUDRARAJU, VS
DANI, K
CHOWHAN, ZT
机构
[1] Institute of Pharmaceutical Sciences, Syntex Inc., Palo Alto, California, 94304
关键词
D O I
10.1002/jps.2600820222
中图分类号
R914 [药物化学];
学科分类号
100701 ;
摘要
The effect of the mode of super disintegrant incorporation in wet granulated tablets was investigated with three super disintegrants: sodium starch glycolate, crospovidone, and croscarmellose sodium. The disintegrants were incorporated extragranularly or intragranularly or distributed equally between the two phases. Lactose, naproxen, or dibasic calcium phosphate was used as the principal tablet component to provide various degrees of solubility to the formulations. The formulations were dried to three different levels of moisture content. The results indicated that, for the formulations studied, extragranular incorporation resulted in faster dissolution than did equal distribution intragranularly and extragranularly, which in turn was superior to intragranular incorporation. Granulation moisture content was found to have a formulation-specific impact on tablet dissolution, with each main tablet component behaving in a different fashion. When all other factors were kept constant, there was a tendency for croscarmellose sodium to produce faster tablet dissolution than sodium starch glycolate or crospovidone. The super disintegrants tended to promote laster dissolution in a neutral pH medium than in an acidic medium.
引用
收藏
页码:220 / 226
页数:7
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