a Department of Pharmaceutics, B.K. Mody Government Pharmacy College , Rajkot , Gujarat , India.
Drug Dev Ind Pharm. 2019 May;45(5):767-774. doi: 10.1080/03639045.2019.1569675. Epub 2019 Feb 5.
The aim of the present investigation was to improve the compressibility and flow property of cefuroxime axetil by co-processing it with mannitol and chitosan chlorhydrate using spray drying method. 3 full factorial design, having inlet air temperature and mannitol: chitosan chlorhydrate ratio as independent variables was used for the optimization. Statistical analysis of obtained results revealed that both independent variables had significant effect on response variables (p value < .05). Evaluation of dependent variables suggested, excellent to good flow properties (angle of repose, Carr's index, and Hausner's ratio) for all prepared batches. Desirability function was used for the selection of the optimized batch which was evaluated for Kawakita's equation, Heckel's plot to assess compression behavior of co-processed product under applied pressure. Result of this analysis revealed that the optimized batch product had better compressibility than physical mixture. The tablets prepared by directly compressing spray-dried product, exhibited excellent tensile strength acceptable friability (<1%) and similar release profile when compared with marketed formulation (Similarity factor 89.24 and dissimilarity factor 1.79). So the results of the present investigation concluded that cefuroxime axetil was successfully co-processed with above mentioned excipients by using spray drying method to make it directly compressible.
本研究的目的是通过喷雾干燥法将头孢呋辛酯与甘露醇和壳聚糖盐酸盐共处理,以提高其可压缩性和流动性。采用 3 因素完全实验设计,以进风温度和甘露醇:壳聚糖盐酸盐的比例为自变量进行优化。对获得的结果进行统计学分析表明,两个自变量对响应变量均有显著影响(p 值<0.05)。对各批制剂的评价表明,其流动性能均为优良至良好(休止角、卡尔指数和豪斯纳比)。采用可接受性函数选择优化批次,并用 Kawakita 方程和 Heckel 图对施加压力下共处理产品的压缩行为进行评价。分析结果表明,优化批产品的可压缩性优于物理混合物。直接压片喷雾干燥产品制备的片剂,其拉伸强度良好(可接受的脆碎度<1%),释放曲线与市售制剂相似(相似因子 89.24,差异因子 1.79)。因此,本研究的结果表明,头孢呋辛酯可成功地与上述赋形剂通过喷雾干燥法共处理,使其可直接压片。