School of Pharmacy, Royal College of Surgeons in Ireland, 123, St Stephens Green, Dublin 2, Ireland.
Int J Pharm. 2012 Jul 1;430(1-2):18-25. doi: 10.1016/j.ijpharm.2012.03.021. Epub 2012 Mar 20.
A two factor, three level (3(2)) face centred, central composite design (CCD) was applied to investigate the main and interaction effects of tablet diameter and compression force (CF) on hardness, disintegration time (DT) and porosity of mannitol based orodispersible tablets (ODTs). Tablet diameters of 10, 13 and 15 mm, and CF of 10, 15 and 20 kN were studied. Results of multiple linear regression analysis show that both the tablet diameter and CF influence tablet characteristics. A negative value of regression coefficient for tablet diameter showed an inverse relationship with hardness and DT. A positive value of regression coefficient for CF indicated an increase in hardness and DT with increasing CF as a result of the decrease in tablet porosity. Interestingly, at the larger tablet diameter of 15 mm, while hardness increased and porosity decreased with an increase in CF, the DT was resistant to change. The optimised combination was a tablet of 15 mm diameter compressed at 15 kN showing a rapid DT of 37.7s and high hardness of 71.4N. Using these parameters, ODTs containing ibuprofen showed no significant change in DT (ANOVA; p>0.05) irrespective of the hydrophobicity of the ibuprofen.
采用两因素三水平（3(2)）面心、中心组合设计（CCD）研究了片剂直径和压缩力（CF）对基于甘露醇的口腔分散片（ODT）硬度、崩解时间（DT）和孔隙率的主要影响和相互作用。研究了片剂直径为 10、13 和 15mm 以及 CF 为 10、15 和 20kN 的情况。多元线性回归分析结果表明，片剂直径和 CF 均影响片剂特性。片剂直径的回归系数为负值表明其与硬度和 DT 呈反比关系。CF 的回归系数为正值表明，由于片剂孔隙率降低，CF 增加会导致硬度和 DT 增加。有趣的是，在较大的片剂直径为 15mm 时，尽管 CF 增加会导致硬度增加和孔隙率降低，但 DT 抵抗变化。优化组合是直径为 15mm 的片剂在 15kN 下压缩，显示出快速的 DT 为 37.7s 和硬度为 71.4N。使用这些参数，含有布洛芬的 ODT 的 DT 没有显著变化（ANOVA；p>0.05），无论布洛芬的疏水性如何。
