Quality by Design (QbD)

Abstract This study presents a Quality by Design (QbD) strategy combined with Design of Experiments (DoE) to develop hybrid polymer–lipid hot-melt extruded (HME) formulations...

Control Strategy for Wurster Coating and Its Importance in Modern Drug Formulation Control Strategy for Wurster Coating plays a central...

Abstract Real-time release testing is defined in the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use...

Introduction to the Formulation and Design of Multiunit Particulate Systems Formulation and design of multiunit particulate systems focus on oral...

Abstract This work focused on N-nitroso-fluoxetine, a N-nitrosamine drug substance-related impurity (NDSRI) formed in fluoxetine-containing products via nitrosation pathways. N-nitroso-fluoxetine...

Abstract The prediction of tablet dissolution from in-process data remains a key challenge in pharmaceutical manufacturing, as in vitro dissolution...

Pharmaceutical tableting continues to be a vital step in manufacturing oral solid dosage forms. Even with progress in formulation science...

Abstract The commercial implementation of continuous granulation requires an intelligent control framework compliant with Quality by Design (QbD) principles. To...

Abstract The assurance of pharmaceutical product quality, safety, and efficacy has historically relied on rigorous analytical standards, pharmacopoeial specifications, and...

Abstract This study investigates the performance of different enteric coating systems by integrating dynamic vapor sorption (DVS), optical coherence tomography...