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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)
Schlindwein W   +5 more
europepmc   +6 more sources

Sustained release dosage form of noscapine HCl using hot melt extrusion (HME) technique: formulation and pharmacokinetics. [PDF]

open access: yesDrug Deliv Transl Res, 2021
Sustained release formulation of noscapine (Nos) HCl could be useful in maintaining plasma Nos HCl level for prolonged period of time, which is important for chemo-sensitization. However, weakly basic drugs like Nos HCl have pH-dependent solubility.
Bagde A   +4 more
europepmc   +4 more sources

Investigation of Thermal and Viscoelastic Properties of Polymers Relevant to Hot Melt Extrusion, IV: Affinisol™ HPMC HME Polymers [PDF]

open access: yesAAPS PharmSciTech, 2015
Most cellulosic polymers cannot be used as carriers for preparing solid dispersion of drugs by hot melt extrusion (HME) due to their high melt viscosity and thermal degradation at high processing temperatures. Three HME-grade hydroxypropyl methylcelluloses, namely Affinisol™ HPMC HME 15 cP, Affinisol™ HPMC HME 100 cP, and Affinisol™ HPMC HME 4 M, have ...
Abu Serajuddin   +2 more
exaly   +7 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
Marion McAfee   +2 more
exaly   +3 more sources

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

open access: yesPharmaceuticals (Basel)
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.
Pantazos I   +4 more
europepmc   +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).
Gallas M   +3 more
europepmc   +2 more sources

Quality by Design Approach for Hot-Melt Extrusion Coupled Fused Deposition Modeling (HME-FDM) 3D Printing: A Systematic Review. [PDF]

open access: yesPharmaceutics
Background: Fused deposition modeling (FDM) is one of the most well-known and often published methods for 3D-printed drug delivery systems. In early scientific reports, the active pharmaceutical ingredients were added by soaking, but later, a new milestone was established, after researchers started to manufacture their own filaments by hot-melt ...
Arany P   +5 more
europepmc   +2 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).
Jongsuep Baek
exaly   +3 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.
Ilieva S   +3 more
europepmc   +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.
Daalmann M   +4 more
europepmc   +2 more sources

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