scholarly journals Use of Terahertz-Raman Spectroscopy to Determine Solubility of the Crystalline Active Pharmaceutical Ingredient in Polymeric Matrices during Hot Melt Extrusion

2019 ◽  
Vol 16 (10) ◽  
pp. 4361-4371 ◽  
Author(s):  
Ecaterina Bordos ◽  
Muhammad T. Islam ◽  
Alastair J. Florence ◽  
Gavin W. Halbert ◽  
John Robertson
2007 ◽  
Vol 103 (2-3) ◽  
pp. 419-426 ◽  
Author(s):  
John G. Lyons ◽  
Harshad Holehonnur ◽  
Declan M. Devine ◽  
James E. Kennedy ◽  
Luke M. Geever ◽  
...  

Author(s):  
Maryam Karimi-Jafari ◽  
Rodrigo Soto ◽  
Ahmad B. Albadarin esources ◽  
Denise Croker ◽  
Gavin Walker

Pharmaceutics ◽  
2020 ◽  
Vol 12 (2) ◽  
pp. 116 ◽  
Author(s):  
Lærke Arnfast ◽  
Jeroen van Renterghem ◽  
Johanna Aho ◽  
Johan Bøtker ◽  
Dhara Raijada ◽  
...  

The specific aim in this study was to understand the effect of critical process parameters on the solid form composition of model drug compounds during hot melt extrusion using in-line Raman spectroscopy combined with Multivariate Curve Resolution-Alternating Least Squares (MCR-ALS) modeling for semi-quantitative kinetic profiling. It was observed that the hydrate and anhydrate solid forms of two model drugs in the melts of nitrofurantoin (NF):polyethylene oxide (PEO) and piroxicam (PRX):PEO could be resolved from a MCR-ALS model without an external calibration dataset. Based on this model, the influence of two critical process parameters (shear and temperature) on the solid form composition could be evaluated in a real-time mode and the kinetics of complex transformation pathways could be explored. Additionally, the dehydration pathways of NF monohydrate and PRX monohydrate in molten PEO could be derived. It can be concluded that dehydration of both hydrates in PEO occurs via competing mechanisms—a solution-mediated transformation pathway and a solid–solid transformation, and that the balance between these mechanisms is determined by the combined effect of both temperature and shear. Another important observation was that the water released from these hydrate compounds has a detectable effect on the rheological characteristics of this mixture.


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