Warren J W, Price J C
J Pharm Sci. 1977 Oct;66(10):1409-12. doi: 10.1002/jps.2600661015.
The effect of binder solution viscosity and drying temperature on the integranular migration of propoxyphene hydrochloride was studied. Wet granulations containing the drug were prepared using binder solutions with viscosities ranging from 1 to 1000 cps. Temperature studies were conducted using granulations prepared with a 3-cps binder solution and dried at 40, 50, 60, 70, and 80 degrees. Drug migration decreased with increased binder solution viscosity, and insignificant migration occurred in granulations prepared with binder solutions having apparent viscosities above 90 cps. No significant effect on intergranular drug migration was observed within the drying temperature range studied. Tablets compressed from a granulation in which drug migration was high showed a greater tablet-to-tablet drug content variation than a granulation with lower migration, even though each dried granulation was thoroughly mixed before tableting.
研究了黏合剂溶液黏度和干燥温度对盐酸丙氧芬整粒迁移的影响。使用黏度范围为1至1000厘泊的黏合剂溶液制备含药湿颗粒。使用由3厘泊黏合剂溶液制备并在40、50、60、70和80摄氏度下干燥的颗粒进行温度研究。药物迁移随黏合剂溶液黏度的增加而降低，在使用表观黏度高于90厘泊的黏合剂溶液制备的颗粒中发生的迁移不明显。在所研究的干燥温度范围内，未观察到对颗粒间药物迁移有显著影响。即使在压片前将每个干燥颗粒充分混合，由药物迁移率高的颗粒压制的片剂也比迁移率低的颗粒表现出更大的片间药物含量差异。
