Soh Josephine L P, Wang Feng, Boersen Nathan, Pinal Rodolfo, Peck Garnet E, Carvajal M Teresa, Cheney James, Valthorsson Hedinn, Pazdan Jim
Department of Industrial and Physical Pharmacy, School of Pharmacy and Pharmaceutical Sciences, Purdue University, West Lafayette, IN 47907, USA.
Drug Dev Ind Pharm. 2008 Oct;34(10):1022-35. doi: 10.1080/03639040801925990.
This article aimed to model the effects of raw material properties and roller compactor operating parameters (OPs) on the properties of roller compacted ribbons and granules with the aid of principal component analysis (PCA) and partial least squares (PLS) projection. A database of raw material properties was established through extensive physical and mechanical characterization of several microcrystalline cellulose (MCC) and lactose grades and their blends. A design of experiment (DoE) was used for ribbon production. PLS models constructed with only OP-modeled roller compaction (RC) responded poorly. Inclusion of raw material properties markedly improved the goodness of fit (R(2) = .897) and model predictability (Q(2) = 0.72).
本文旨在借助主成分分析（PCA）和偏最小二乘法（PLS）投影，模拟原材料特性和辊压机制备参数（OPs）对辊压带状物和颗粒性质的影响。通过对几种微晶纤维素（MCC）和乳糖等级及其混合物进行广泛的物理和机械表征，建立了原材料特性数据库。采用实验设计（DoE）进行带状物生产。仅用OPs模拟辊压（RC）构建的PLS模型响应不佳。纳入原材料特性显著提高了拟合优度（R(2) = 0.897）和模型预测能力（Q(2) = 0.72）。
