Hutchings D, Kuzmak B, Sakr A
Department of Pharmaceutics and Drug Delivery Systems, College of Pharmacy, University of Cincinnati, Ohio 45267.
Pharm Res. 1994 Oct;11(10):1474-8. doi: 10.1023/a:1018960310144.
The influence of curing time and curing temperature for a commercially available ethylcellulose latex coating dispersion (Aquacoat) were evaluated using response surface methodology. Levels for the factor curing time ranged from 30 to 300 minutes while levels for curing temperature ranged from 45 degrees to 75 degrees C. Responses, A, kappa, and gamma, were derived from regression analysis of the dissolution profiles and correspond to the maximum amount of drug released over the 12 hour sampling period, the rate of release, and the inflection point of the dissolution profile, respectively. The nature of the response surface was dramatically influenced by the plasticizer incorporated into the coating formula. When dibutyl sebacate was employed as the plasticizer, faster release resulted (higher A and kappa values, lower gamma values) when samples were exposed to higher curing temperatures or were stored for longer periods of time. Paradoxically, when tributyl citrate was used as the plasticizer, slower release resulted when samples were exposed to more rigorous conditions. Overall, curing temperature had a more dramatic effect than curing time.
使用响应面法评估了市售乙基纤维素乳胶包衣分散体（Aquacoat）的固化时间和固化温度的影响。固化时间因素的水平范围为30至300分钟，而固化温度的水平范围为45摄氏度至75摄氏度。响应值A、κ和γ来自溶出曲线的回归分析，分别对应于12小时采样期内释放的最大药物量、释放速率和溶出曲线的拐点。响应面的性质受到包衣配方中所加入增塑剂的显著影响。当使用癸二酸二丁酯作为增塑剂时，样品暴露于较高的固化温度或储存较长时间会导致更快的释放（较高的A和κ值，较低的γ值）。矛盾的是，当使用柠檬酸三丁酯作为增塑剂时，样品暴露于更严格的条件下会导致释放较慢。总体而言，固化温度比固化时间的影响更显著。
