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In-Line UV-Vis Spectroscopy as a Fast-Working Process Analytical Technology (PAT) During Early Phase Product Development Using Hot Melt Extrusion (HME) [PDF]

open access: yesPharmaceutics, 2018
This paper displays the potential of an in-line PAT system for early phase product development during pharmaceutical continuous manufacturing following a Quality by Design (QbD) framework. Hot melt extrusion (HME) is used as continuous manufacturing process and UV–Vis spectroscopy as an in-line monitoring system. A sequential design of experiments (DoE)
Walkiria Schlindwein
exaly   +6 more sources

Machine Learning for Process Monitoring and Control of Hot-Melt Extrusion: Current State of the Art and Future Directions

open access: yesPharmaceutics, 2021
In the last few decades, hot-melt extrusion (HME) has emerged as a rapidly growing technology in the pharmaceutical industry, due to its various advantages over other fabrication routes for drug delivery systems. After the introduction of the ‘quality by
Nimra Munir   +3 more
doaj   +3 more sources

The Effect of Hot-Melt Extrusion of Mulberry Leaf on the Number of Active Compounds and Antioxidant Activity

open access: yesPlants, 2022
The aim of this study is to compare the functions of the physiologically active compounds of three types of mulberry leaf by cultivar, and to confirm the changes using hot-melt extrusion (HME−ML).
Hyun-Bok Kim, Suji Ryu, Jong-Suep Baek
doaj   +3 more sources

Sustainable Design and DoE-Based Optimization of Polymeric Systems for FDM 3D-Printed Indomethacin Amorphous Solid Dispersions [PDF]

open access: yesPharmaceuticals
Background/Objectives: Amorphous solid dispersions (ASDs) produced via hot-melt extrusion (HME) and fused deposition modeling (FDM) 3D printing represent a promising strategy for improving the performance of poorly water-soluble drugs.
Ioannis Pantazos   +4 more
doaj   +2 more sources

Vertical Hot-Melt Extrusion: The Next Challenge in Innovation [PDF]

open access: yesPharmaceutics
Background/Objectives: Hot-melt extrusion (HME) has become a key technology in pharmaceutical formulation, particularly for enhancing the solubility of poorly soluble Active Pharmaceutical Ingredients (APIs).
Maël Gallas   +3 more
doaj   +2 more sources

Rheology-Informed Working Thresholds for HME/FDM Processability in a PVA–Sorbitol–Paracetamol Model System [PDF]

open access: yesPharmaceutics
Background/Objectives: Oscillatory rheology is widely used in hot-melt extrusion (HME) and fused deposition modeling (FDM), but its translation into compact formulation-screening criteria remains limited.
Sofiya Ilieva   +3 more
doaj   +2 more sources

Characterization of Different Copovidone Grades as Carrier Materials in Hot Melt Extrusion of Amorphous Solid Dispersions [PDF]

open access: yesPharmaceutics
Background/Objectives: Copovidone (polyvinylpyrrolidone-vinyl acetate copolymer, PVP/VA) is a widely used pharmaceutical excipient with various applications in drug formulation.
Marvin Daalmann   +4 more
doaj   +2 more sources

A Hot-Melt Extrusion Risk Assessment Classification System for Amorphous Solid Dispersion Formulation Development

open access: yesPharmaceutics, 2022
Several literature publications have described the potential application of active pharmaceutical ingredient (API)–polymer phase diagrams to identify appropriate temperature ranges for processing amorphous solid dispersion (ASD) formulations via the hot ...
Samuel O. Kyeremateng   +8 more
doaj   +3 more sources

Evaluation of Process Parameters in the Development of Ternary Ketoprofen Amorphous Solid Dispersions via Hot Melt Extrusion [PDF]

open access: yesPharmaceutics
Background/Objectives: Poor aqueous solubility of active pharmaceutical ingredients (APIs) remains a critical barrier to effective oral formulation. This study investigated the production of ketoprofen amorphous solid dispersions (ASDs) via hot melt ...
Ana Stjepanović   +6 more
doaj   +2 more sources

Process Development for the Continuous Manufacturing of Carbamazepine-Nicotinamide Co-Crystals Utilizing Hot-Melt Extrusion Technology [PDF]

open access: yesPharmaceutics
Objectives: Hot-melt extrusion (HME) offers a solvent-free, scalable approach for manufacturing pharmaceutical co-crystals (CCs), aligning with the industry’s shift to continuous manufacturing (CM).
Lianghao Huang   +6 more
doaj   +2 more sources

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