Wu C, McGinity J W
College of Pharmacy, University of Texas at Austin 78712, USA.
Int J Pharm. 1999 Jan 15;177(1):15-27. doi: 10.1016/s0378-5173(98)00312-3.
The objective of this study was to investigate the influence of methylparaben, ibuprofen, chlorpheniramine maleate and theophylline on the thermal and mechanical properties of polymeric films of Eudragit RS 30 D. The effects of methylparaben and ibuprofen in the film coating on the rate of drug release from Eudragit RS 30 D coated beads were also studied. The physical and mechanical properties of the cast films and coated beads were investigated using thermal analysis, tensile testing, X-ray diffraction analysis and dissolution testing. The results demonstrated that the glass transition temperature of the Eudragit RS 30 D decreased with increasing levels of methylparaben, ibuprofen and chlorpheniramine maleate in the film. Theophylline exerted no influence on the thermal properties of the polymer. The higher levels of the ibuprofen and methylparaben incorporated into the film resulted in a decrease in the tensile strength of the film. The decrease in Young's modulus of Eudragit RS 30 D coated beads was attributed to an increase in the flexibility of the polymeric films when the level of methylparaben or ibuprofen in the polymeric dispersion was increased. The dissolution data demonstrated that the rate of release of the ibuprofen from coated beads was decreased by increasing the amount of ibuprofen and methylparaben in the polymeric film coating.
本研究的目的是考察对羟基苯甲酸甲酯、布洛芬、马来酸氯苯那敏和茶碱对Eudragit RS 30 D聚合物薄膜的热性能和机械性能的影响。还研究了薄膜包衣中对羟基苯甲酸甲酯和布洛芬对Eudragit RS 30 D包衣微丸药物释放速率的影响。采用热分析、拉伸试验、X射线衍射分析和溶出试验研究了流延膜和包衣微丸的物理和机械性能。结果表明,随着薄膜中对羟基苯甲酸甲酯、布洛芬和马来酸氯苯那敏含量的增加,Eudragit RS 30 D的玻璃化转变温度降低。茶碱对聚合物的热性能没有影响。薄膜中布洛芬和对羟基苯甲酸甲酯含量的增加导致薄膜拉伸强度降低。当聚合物分散体中对羟基苯甲酸甲酯或布洛芬的含量增加时,Eudragit RS 30 D包衣微丸的杨氏模量降低归因于聚合物薄膜柔韧性的增加。溶出数据表明,通过增加聚合物薄膜包衣中布洛芬和对羟基苯甲酸甲酯的量,可降低包衣微丸中布洛芬的释放速率。