Marshall P V, Pope D G, Carstensen J T
Sandoz Research Institute, East Hanover, NJ 07936.
J Pharm Sci. 1991 Sep;80(9):899-903. doi: 10.1002/jps.2600800920.
To allow assessment of the long-term stability of tablet disintegrants, two mechanisms for their functionality (i.e., water uptake and swelling force generation) were monitored. Three disintegrants, alginic acid, sodium starch glycolate, and crospovidone, were used to establish the methodology. The water uptake and swelling force methodologies developed were reproducible, thus allowing for the evaluation of the effect of time, temperature, and humidity on these properties of disintegrants. The data obtained suggest that the process of water uptake and swelling force generation was essentially a two-step process. Initially, water entered the pore space in the powder bed; there was a definitive lag time before a swelling force was generated. In the stability evaluation of alginic acid and sodium starch glycolate, samples were stored for 1-year. Above 30 degrees C and 75% relative humidity, the swelling force performance of alginic acid was markedly affected. Changes seen with sodium starch glycolate were much less marked.
为了评估片剂崩解剂的长期稳定性，监测了其两种功能机制（即吸水和产生溶胀力）。使用三种崩解剂——海藻酸、淀粉乙醇酸钠和交联聚维酮来建立该方法。所开发的吸水和溶胀力方法具有可重复性，从而能够评估时间、温度和湿度对崩解剂这些性质的影响。获得的数据表明，吸水和产生溶胀力的过程本质上是一个两步过程。最初，水进入粉末床的孔隙空间；在产生溶胀力之前有一个明确的滞后时间。在海藻酸和淀粉乙醇酸钠的稳定性评估中，样品储存了1年。在30摄氏度以上和75%相对湿度条件下，海藻酸的溶胀力性能受到显著影响。淀粉乙醇酸钠的变化则不太明显。
