Chapter 11 - Application of Quality by Design Approach for Hot-Melt Extrusion Process Optimization
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Development, optimization and in-vivo evaluation of cyanocobalamin loaded orodispersible films using hot-melt extrusion technology: A quality by design (QbD) approach
2021, Journal of Drug Delivery Science and TechnologyCitation Excerpt :CPPs are parameters of the manufacturing process that should be monitored or controlled to ensure the desired quality of the product. Feed rate, processing temperature, screw speed, torque, residence time, and shear force were examined as critical process parameters (CPPs) in HME [17]. Quality risk assessment studies were applied to classify potential high-risk formulation variables that have a major influence on the CQAs.
A comprehensive overview of extended release oral dosage forms manufactured through hot melt extrusion and its combination with 3D printing
2021, International Journal of PharmaceuticsCitation Excerpt :Therefore, process analytical technologies as well as the statistical tools are important QbD tools. Process analytical technologies like Raman, UV/vis and NIR spectroscopy can provide a continuous in-line evaluation of critical parameters affecting product quality (Suryawanshi et al., 2019). Factors affecting the quality of sustained-release paracetamol tablet were evaluated using DoE and PAT as tools for QbD.
Quality-by-design in hot melt extrusion based amorphous solid dispersions: An industrial perspective on product development
2021, European Journal of Pharmaceutical SciencesCitation Excerpt :The primary goal of risk assessment methodology is to identify, analyze, and evaluate the potential risk associated with each CMA and CPP, and their influence on the product CQAs. The Ishikawa diagram is a graphical tool to highlight all possible variables and the potential risk of CMAs and CPPs on the CQAs of a drug product (Suryawanshi et al., 2019). Based on the published literature, process knowledge, and initial experimental data, the FMEA can be used to evaluate the modes, causes, and effects of each potential failure and their severity (S), occurrence (O), and detectability (D); such parameters are usually expressed on a scale of 1–10.
Hot-melt extrusion: A versatile technology
2020, Remington: The Science and Practice of PharmacyOral disintegration films: applications and production methods
2023, Journal of Food Science and Technology