Philip Anil K, Philip Betty
School of Pharmacy, College of Pharmacy and Nursing, University of Nizwa, Birkat Al Mouz, Nizwa-616, Sultanate of Oman.
Curr Drug Deliv. 2010 Jul;7(3):230-7. doi: 10.2174/156720110791560964.
In the present study, a phase transited nondisintegrating polymeric capsular system in achieving delayed as well as improved osmotic flow for the model drug cefadroxil was developed. Asymmetric membrane capsule (AMC) was prepared by precipitation of asymmetric membrane (AM) on the fabricated glass mold pins via wet phase inversion process. Effect of different formulation variables were studied based on 23 factorial design, namely, level of osmogen, ethylcellulose, pore former, apart from studying the effect of varying osmotic pressure on drug release. Scanning electron microscopy showed an outer dense non-porous region and an inner lighter porous region for the prepared AMC. Statistical test (Dunnett multiple comparison test) was applied for in vitro drug release (n=6) at P < 0.05. The best formulation in the design closely corresponded to the extra design checkpoint formulation by a similarity factor (f2) of 98.91, and a difference factor (f1) of 2.17. The drug release was independent of agitation intensity but dependent on the osmotic pressure of the dissolution medium. The release kinetics followed Higuchi model, and mechanism of release was Fickian diffusion.
在本研究中，开发了一种相转变非崩解聚合物胶囊系统，用于实现模型药物头孢羟氨苄的延迟释放以及改善渗透流。通过湿相转化工艺，在制造的玻璃模具销上沉淀不对称膜（AM）来制备不对称膜胶囊（AMC）。基于23析因设计，研究了不同制剂变量的影响，即渗透剂水平、乙基纤维素、致孔剂，此外还研究了不同渗透压对药物释放的影响。扫描电子显微镜显示，制备的AMC有一个外部致密无孔区域和一个内部较浅的多孔区域。对体外药物释放（n = 6）应用统计检验（Dunnett多重比较检验），P < 0.05。设计中的最佳制剂与额外设计检查点制剂非常接近，相似因子（f2）为98.91，差异因子（f1）为2.17。药物释放与搅拌强度无关，但取决于溶出介质的渗透压。释放动力学遵循Higuchi模型，释放机制为菲克扩散。
