Department of Pharmaceutics, SRM College of Pharmacy, SRM Institute of Science & Technology, India.
Biomed Res Int. 2018 Sep 25;2018:7834159. doi: 10.1155/2018/7834159. eCollection 2018.
To build and inquire a statistically significant mathematical model for manufacturing methotrexate loaded chitosan nanoparticles (CsNP) of desired particle size. The study was also performed to evaluate the effect of formulation variables in the explored design space.
Ionotropic gelation technique was followed for chitosan nanocarriers by changing formulation variables suggested as per Design Expert software. Altering the levels of Chitosan, tripolyphosphate, methotrexate by 2 factorial design served the purpose. The CsNP were characterized for nanocarrier formation, particle size, and statistical analysis. Then mathematical model was statistically analyzed for fabricating desired formulation having particle size less than 200nm.
FT-IR, XRD reports confirmed the structural change in chitosan which lead to the formation of CsNP. For particle size, linear model was found to be best fit to explain effect of variables. Besides, high R (0.9958) defends the constancy of constructed model. Chitosan exhibited higher t-value in Pareto chart and a p-value <0.0001. Based on maximum desirability, optimization was performed and amount of variables for preparing CsNP of 180nm was predicted. The experiment was carried out with software suggested combination and particle size was found to be 176±4nm.
Low p-value endorsed the greater dominance of chitosan on particle size. Good model adequacy and small percentage error between predicted and experimented value established the reliability of constructed model for robust preparation of CsNP.
建立并研究一个具有统计学意义的数学模型，用于制备具有所需粒径的甲氨蝶呤负载壳聚糖纳米粒子（CsNP）。本研究还评估了制剂变量在探索设计空间中的影响。
采用离子凝胶化技术，通过改变设计专家软件建议的制剂变量来制备壳聚糖纳米载体。通过 2 因子设计改变壳聚糖、三聚磷酸钠、甲氨蝶呤的水平来达到目的。对 CsNP 进行纳米载体形成、粒径和统计分析。然后对数学模型进行统计分析，以制备粒径小于 200nm 的理想制剂。
FT-IR、XRD 报告证实了壳聚糖结构的变化，导致了 CsNP 的形成。对于粒径，线性模型被发现是最适合解释变量影响的模型。此外，高 R（0.9958）证明了所构建模型的稳定性。壳聚糖在 Pareto 图中表现出较高的 t 值和 p 值<0.0001。基于最大理想度进行了优化，并预测了制备粒径为 180nm 的 CsNP 的变量用量。实验采用软件建议的组合进行，发现粒径为 176±4nm。
低 p 值证明了壳聚糖对粒径的更大主导性。良好的模型充分性和预测值与实验值之间的小百分比误差确立了所构建模型用于稳健制备 CsNP 的可靠性。
