Industrial Pharmacy and its use of Drug Discovery Process Innovations

[摘要] Chemometric models and Quality by Design (QbD) are two sides of the same coin. While QbD models use experimentally designed settingsto optimize some quality attributes, these settings can also be used to predict the same attributes chemo metrically. The goal was tosynchronise the optimization of comparative dissolution results of carvedilol immediate release tablets with Chemometric prediction of theproduct's dissolution profile and content uniformity. As an industrial application, variables for optimization were chosen through riskassessment using archived product records at the pharmaceutical site. The sucrose, sodium starch glycolate, lactose monohydrate, and avicelPh 101 contents of the experimental tablets were varied in 20 different ways.

[学科分类] 药理学