A Novel Acetaminophen Soft-Chew Formulation Produced via Hot-Melt Extrusion with In-line Near-Infrared Monitoring as a Process Analytical Technology Tool

2020 ◽  
Vol 21 (2) ◽  
Author(s):  
Pengchong Xu ◽  
Jiaxiang Zhang ◽  
Suresh Bandari ◽  
Michael A. Repka
Keyword(s):  
Near Infrared ◽  
Process Analytical Technology ◽  
Hot Melt Extrusion ◽  
Melt Extrusion ◽  
Infrared Monitoring ◽  
Technology Tool ◽  
Analytical Technology ◽  
Hot Melt

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

Pharmaceutics ◽  
2021 ◽  
Vol 13 (9) ◽  
pp. 1432
Author(s):  
Nimra Munir ◽  
Michael Nugent ◽  
Darren Whitaker ◽  
Marion McAfee
Keyword(s):  
Machine Learning ◽  
Near Infrared ◽  
Process Analytical Technology ◽  
Learning Algorithms ◽  
Hot Melt Extrusion ◽  
Machine Learning Algorithms ◽  
Melt Extrusion ◽  
Future Directions ◽  
And Control ◽  
Hot Melt

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 design’ (QbD) approach by the Food and Drug Administration (FDA), many research studies have focused on implementing process analytical technology (PAT), including near-infrared (NIR), Raman, and UV–Vis, coupled with various machine learning algorithms, to monitor and control the HME process in real time. This review gives a comprehensive overview of the application of machine learning algorithms for HME processes, with a focus on pharmaceutical HME applications. The main current challenges in the application of machine learning algorithms for pharmaceutical processes are discussed, with potential future directions for the industry.

Potential of Near-Infrared Chemical Imaging as Process Analytical Technology Tool for Continuous Freeze-Drying

2018 ◽  
Vol 90 (7) ◽  
pp. 4354-4362 ◽  
Author(s):  
Davinia Brouckaert ◽  
Laurens De Meyer ◽  
Brecht Vanbillemont ◽  
Pieter-Jan Van Bockstal ◽  
Joris Lammens ◽  
...  
Keyword(s):  
Freeze Drying ◽  
Near Infrared ◽  
Process Analytical Technology ◽  
Chemical Imaging ◽  
Technology Tool ◽  
Analytical Technology

scholarly journals A novel transflectance near infrared spectroscopy technique for monitoring hot melt extrusion

2015 ◽  
Vol 496 (1) ◽  
pp. 117-123 ◽  
Author(s):  
A.L. Kelly ◽  
S.A. Halsey ◽  
R.A. Bottom ◽  
S. Korde ◽  
T. Gough ◽  
...  
Keyword(s):  
Infrared Spectroscopy ◽  
Near Infrared Spectroscopy ◽  
Near Infrared ◽  
Hot Melt Extrusion ◽  
Spectroscopy Technique ◽  
Melt Extrusion ◽  
Hot Melt

scholarly journals HOT MELT EXTRUSION IN ENGINEERING OF DRUG COCRYSTALS: A REVIEW

2021 ◽  
pp. 10-19
Author(s):  
ARCHANA RAJADHYAX ◽  
UJWALA SHINDE ◽  
HARITA DESAI ◽  
SHRUSHTI MANE
Keyword(s):  
Crystal Engineering ◽  
Process Analytical Technology ◽  
Hot Melt Extrusion ◽  
Dosage Forms ◽  
Solvent Free ◽  
Water Soluble ◽  
Melt Extrusion ◽  
Pharmaceutical Dosage Forms ◽  
Free Process ◽  
Hot Melt

Crystal engineering technique has been widely explored in recent times to bring about changes in crystallinity which aids to achieve various goals such as solubility enhancement, stability and in vivo bioavailability without altering the chemical properties of the drug. Cocrystallisation is one of the crystal engineering approaches where the drug and an inert coformer are linked together by hydrogen bonding forming supramolecular homosynthon or heterosynthon using solvent-based or solvent-free techniques. Processing of active pharmaceutical ingredients with inert water-soluble coformers yields multicomponent crystalline cocrystals with high-performance characteristics and enhanced flow properties. Due to the emerging need of the industry for greener techniques, hot melt extrusion (HME), a continuous and solvent-free process is emerging as a field of interest in the mechanochemical synthesis of various pharmaceutical dosage forms such as solid dispersions, implants, ointments, and cocrystals. The current review emphasizes the role of HME as a cocrystallization technique for drugs to tailor-make their properties and ease of formulation. The distinct feature of HME is phase control during the process of cocrystallization. Furthermore, the selection of appropriate coformers with desirable water-solubility and stability features makes HME amenable to cocrystallization of versatile actives yielding suitable dosage forms. The application of process analytical technology further adds ease of monitoring during HME in cocrystallization approaches. Due to these salient features of HME, it can act as a prospective technique for cocrystallization of versatile drugs thus yielding dosage forms with desirable solubility and stability features.

Active content determination of pharmaceutical tablets using near infrared spectroscopy as Process Analytical Technology tool

Talanta ◽  
2015 ◽  
Vol 144 ◽  
pp. 1352-1359 ◽  
Author(s):  
Pierre-François Chavez ◽  
Pierre-Yves Sacré ◽  
Charlotte De Bleye ◽  
Lauranne Netchacovitch ◽  
Jérôme Mantanus ◽  
...  
Keyword(s):  
Infrared Spectroscopy ◽  
Near Infrared Spectroscopy ◽  
Near Infrared ◽  
Process Analytical Technology ◽  
Pharmaceutical Tablets ◽  
Content Determination ◽  
Technology Tool ◽  
Analytical Technology ◽  
Active Content

Understanding Hot Melt Extrusion via near Infrared Spectroscopy

NIR news ◽  
2014 ◽  
Vol 25 (7) ◽  
pp. 10-12 ◽  
Author(s):  
Brandye Smith-Goettler ◽  
Colleen M. Gendron ◽  
Robert F. Meyer
Keyword(s):  
Infrared Spectroscopy ◽  
Near Infrared Spectroscopy ◽  
Near Infrared ◽  
Hot Melt Extrusion ◽  
Melt Extrusion ◽  
Hot Melt
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