Gordon M S, Chatterjee B, Chowhan Z T
Institute of Pharmaceutical Sciences, Syntex Inc., Palo Alto, CA 94304.
J Pharm Sci. 1990 Jan;79(1):43-7. doi: 10.1002/jps.2600790111.
A computer-optimized experimental design was used to study the effect of incorporating a "super disintegrant", croscarmellose sodium, intragranularly, extragranularly, or distributed equally between the two phases of a tablet in which a poorly soluble drug constituted at least 92.5% of the formulation. The results were analyzed by means of a general quadratic response surface model and suggest that tablets with the same total concentration of super disintegrant dissolve at a faster rate when the super disintegrant is included intragranularly. Tablet friability was not affected by the method of super disintegrant incorporation.
采用计算机优化实验设计,研究在一种片剂中,将“超级崩解剂”交联羧甲基纤维素钠加入颗粒内、颗粒外或在片剂的两个相之间平均分布时的效果,该片剂中难溶性药物占制剂的比例至少为92.5%。通过通用二次响应面模型对结果进行分析,结果表明,当超级崩解剂加入颗粒内时,具有相同总浓度超级崩解剂的片剂溶解速度更快。片剂的脆碎度不受超级崩解剂加入方法的影响。