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Dupont Pharma
FT-NIR models for predicting film quality parameters in titanium dioxide-free tablet coatings
Abstract
This study leverages Fourier Transform Near-Infrared (FT-NIR) spectroscopy to monitor the coating process of pharmaceutical tablets using PVA-based TiO2-free films, with talc and iron oxides as opacifiers. By employing a combination of multivariate analytical techniques to evaluate the…
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Unveiling Swelling and Erosion Dynamics: Early Development Screening of Mirabegron Extended Release…
Abstract
Although the development of extended release (ER) matrices has been extensively investigated, understanding the most appropriate mechanism of drug release to achieve the desired release remains a cost- and time-consuming challenge in the early stages of formulation development. This study…
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Simultaneous prediction of the API concentration and mass gain of film coated tablets using…
Abstract
This study investigates the simultaneous prediction of active pharmaceutical ingredient (API) concentration and mass gain in film-coated tablets using Partial Least Squares (PLS) regression combined with three data fusion (DF) techniques: Low-Level (LLDF), Mid-Level (MLDF), and…
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Dissolution of copovidone-based amorphous solid dispersions: Influence of atomic layer coating,…
Abstract
Atomic layer coating (ALC) is an emerging, solvent-free technique to coat amorphous solid dispersion (ASD) particles with a nanolayer ceramic coating that has been shown to improve powder characteristics and limit drug crystallization. Herein, we evaluate the impact of aluminum oxide…
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Investigating the Effects of Formulation Variables on the Disintegration of Spray Dried Amorphous…
Abstract
Amorphous solid dispersion (ASD) tablets based on hydrophilic polymer carriers may encounter disintegration challenges. In this work, the effect of different formulation composition variables on the ASD tablet disintegration performance was systematically studied. GDC-0334: copovidone…
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Fluid bed granulation – Process optimization
Abstract
Fluidized bed granulation is a single unit operation that integrates several process transformations including powder transfer and fluidization, atomization of binder solution and wetting of the fluidized powder, growth and consolidation of granules, drying, and discharge of the granular…
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Stability of Dexamethasone during Hot-Melt Extrusion of Filaments based on Eudragit® RS, Ethyl…
Hot-melt extrusion (HME) potentially coupled with 3D printing is a promising technique for the manufacturing of dosage forms such as drug-eluting implants which might even be individually adapted to patient-specific anatomy. However, these manufacturing methods involve the risk of thermal…
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Development of novel portable NIR spectroscopy process analytical technology (PAT) tool for…
The aim of this research was to develop a process analytical technology (PAT) tool for monitoring the transformation process of the active ingredient ibuprofen into the fast-dissolving salt ibuprofen sodium during the wet granulation process. Two near-infrared (NIR) spectrophotometers, namely…
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Assessing Abuse-Deterrent formulations utilizing Ion-Exchange resin complexation processed via…
Opioid misuse is a public health crisis in the United States. In response, the FDA has approved drug products with abuse-deterrent features to reduce the risk of prescription opioid abuse. Abuse-deterrent formulations (ADFs) typically employ physical or chemical barriers or incorporate…
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Using AI/ML to predict blending performance and process sensitivity for Continuous Direct…
Utilising three artificial intelligence (AI)/machine learning (ML) tools, this study explores the prediction of fill level in inclined linear blenders at steady state by mapping a wide range of bulk powder characteristics to processing parameters. Predicting fill levels enables the calculation of…
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