Fast-track to A Solid Dispersion Formulation Using Multi-way Analysis of Complex Interactions

Key information related to quality by design (QbD) applications in analytical methods development

“…Wu et al [68] proposed the Generalized Multiplicative ANOVA (GEMANOVA) model as an alternative to ANOVA (analysis of variance) for improving the interpretation and understanding of complex data sets obtained from monitoring the physical stability of a solid dispersion with X-ray powder diffraction (XRPD). The results obtained by the GEMANOVA model were easier to interpret and understand than those obtained from the ANOVA model, and a DS was established according to the QbD.…”

Determination of tacrolimus crystalline fraction in the commercial immediate release amorphous solid dispersion products by a standardized X-ray powder diffraction method with chemometrics

“…T g is a temperature range over which 20 the amorphous drug properties change from solid-like (glass) to 21 liquid-like (supercooled liquid). T g is often used as a benchmark to 22 assess amorphous system stability and storage condition because 23 chemical and physical stability of the amorphous system is affected 24 if stored above its T g (Wu et al, 2013;Yoshioka and Aso, 2007). In 25 general, an amorphous solid dispersion (ASD) formulation (which 26 contains only an amorphous drug and amorphous/crystalline 27 excipient(s) or only amorphous/crystalline excipient(s) and crys-28 talline drug or both drug and excipient(s) are in amorphous forms) is 29 considered stable if stored at 50 K or greater below the T g of the 30 formulation (Hancock et al,1995;Newman et al, 2012).…”