Industrial application of QbD and NIR chemometric models in quality improvement of immediate release tablets.

ABSTRACT: Quality by Design (QbD) and chemometric models are different sides of the same coin. While QbD models utilize experimentally designed settings for optimization of some quality attributes, these settings can also be utilized for chemometric prediction of the same attributes. We aimed to synchronize optimization of comparative dissolution results of carvedilol immediate release tablets with chemometric prediction of dissolution profile and content uniformity of the product. As an industrial application, selection of variables for optimization was done by performing risk assessment utilizing the archived product records at the pharmaceutical site. Experimental tablets were produced with 20 different settings with the variables being contents of sucrose, sodium starch glycolate, lactose monohy

SUBMITTER: Ramadan A 

PROVIDER: S-EPMC8233525 | biostudies-literature | 2021 Jun

REPOSITORIES: biostudies-literature