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Continuous quantitative monitoring of powder mixing dynamics by near-infrared spectroscopy
Contributor(s):: Koller, DM, Posch, A, Horl, G, Voura, C, Radl, S, Urbanetz, N, Fraser, SD, Tritthart, W, Reiter, F, Schlingmann, M, Khinast, JG
FT-NIR spectroscopy with a fiber optical reflection probe was applied as a process analytical technology tool for the continuous quantitative in-line monitoring of pharmaceutical powder mixing processes in a bladed mixer. Two powders, acetyl salicylic acid as an active pharmaceutical ingredient...
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Continuous twin screw granulation - An advanced alternative granulation technology for use in the pharmaceutical industry
Contributor(s):: Bandari, Suresh, Nyavanandi, Dinesh, Kallakunta, Venkata Raman, Janga, Kartik Yadav, Sarabu, Sandeep, Butreddy, Arun, Repka, Michael A.
Hot melt extrusion has been an exciting technology in the pharmaceutical field owing to its novel applicability. Twin-screw granulation presents a great potential and offers many advantages relative to conventional granulation processes. Different twin-screw granulation techniques, such as...
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Continuous Twin Screw Granulation: A Review of Recent Progress and Opportunities in Formulation and Equipment Design
Contributor(s):: Portier, Christoph, Vervaet, Chris, Vanhoorne, Valérie
Continuous twin screw wet granulation is one of the key continuous manufacturing technologies that have gained significant interest in the pharmaceutical industry as well as in academia over the last ten years. Given its considerable advantages compared to wet granulation techniques operated in...
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Continuous powder feeding for pharmaceutical solid dosage form manufacture: a short review
Contributor(s):: Blackshields, Caroline A., Crean, Abina M.
Offers an extremely well-informed look at the most promising future approaches to continuous manufacturing of innovative pharmaceutical products
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Continuous processing and the applications of online tools in pharmaceutical product manufacture: developments and examples
Contributor(s):: Ooi, Shing Minga, Sarkar, Srimantaa, Van Varenbergh, Grietb, Schoeters, Krisb, Heng, Paul Wan Sia
Continuous processing and production in pharmaceutical manufacturing has received increased attention in recent years mainly due to the industries’ pressing needs for more efficient, cost-effective processes and production, as well as regulatory facilitation. To achieve optimum product quality,...
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Continuous manufacturing of co-crystals: challenges and prospects
Contributor(s):: Chavan, Rahul, Thipparaboina, Rajesh, Yadav, Balvant, Shastri, Nalini
The last decade has witnessed extensive growth in the field of co-crystallization for mitigating the solubility and dissolutionrelated issues of poorly soluble drugs. This is largely because co-crystals can modify the physicochemical properties of drugs without any covalent modification in the...
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Continuous manufacturing of drug substance and small molecules: process and equipment view
Contributor(s):: Yazdanpanah, Nima
The continuous manufacturing of pharmaceutical compounds and fine chemicals is in high interest for the industry due to significant technical, quality, and economical advantages. This manufacturing method has its own challenges. Beside the more efficient, safer, and greener synthesis rout, a new...
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Continuous Manufacturing of High Quality Pharmaceutical Cocrystals Integrated with Process Analytical Tools for In-Line Process Control
Contributor(s):: Moradiya, Hiren G., Islam, Muhammad, Scoutaris, Nikolaos, Halsey, Sheelagh, Chowdhry, Babur Z., Douroumis, Dennis
A continuous manufacturing process for pharmaceutical indomethacin saccharine cocrystals was achieved by extrusion processing with high throughput. Down-stream milling and blending of the extrudates was followed by feeding the formulated cocrystals in a capsule-filling machine. By applying a...
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Continuous Manufacturing of Ketoprofen Delayed Release Pellets Using Melt Extrusion Technology: Application of QbD Design Space, Inline Near Infrared, and Inline Pellet Size Analysis
Contributor(s):: Vo, Anh, Kutz, Gerd, He, Herman, Narala, Sagar, Bandari, Suresh, Repka, Michael A.
Delayed-release dosage forms are mainly manufactured as batch processes and include coated tablets, pellets, or particles with gastric resistant polymers. Authors propose a novel approach using the hot-melt extrusion technique to prepare delayed release dosage forms via a continuous manufacturing...
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Continuous manufacturing of tablets with PROMIS-line. Introduction and case studies from continuous feeding, blending and tableting
Contributor(s):: Simonaho, Simo-Pekka, Ketolainena, Jarkko, Ervasti, Tuomas, Toiviaine, Maunu, Korhonen, Ossi
Drug manufacturing technology is in the midst ofmodernization and continuousmanufacturing of drug products is especially the focus of great interest. The adoption of new manufacturing approaches requires extensive cooperation between industry, regulatory bodies, academics and equipment...
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Continuous Manufacturing Process Development from Lab to Market, Role of Digital Tools
Contributor(s):: Yazdanpanah, Nima
The continuous manufacturing of pharmaceutical compounds and fine chemicals is in high interest for the industry due to significant technical, quality, and economical advantages. Beside the more efficient, safer, and greener synthesis route, a new process design paradigm and equipment selection...
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Continuous flow technology vs. the batch-by-batch approach to produce pharmaceutical compounds
Contributor(s):: Cole, KP, Johnson, MD
Introduction: For the manufacture of small molecule drugs, many pharmaceutical innovator companies have recently invested in continuous processing, which can offer significant technical and economic advantages over traditional batch methodology. This Expert Review will describe the reasons for...
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Continuous Heterogeneous Crystallization on Excipient Surfaces
Contributor(s):: Yazdanpanah, Nimaa, Testa, Christopher J., Perala, Siva R. K., Jensen, Keith D., Braatz, Richard D., Myerson, Allan S., Trout, Bernhardt L.
A novel continuous heterogeneous crystallization process is, developed in which the active pharmaceutical ingredient (API) is crystallized directly on the surface of an excipient within the crystallizer. The produet is subsequently dried and formed into tablets without the need for complex...
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Continuous Manufacturing in Pharmaceutical Process Development and Manufacturing
Contributor(s):: Burcham, Christopher L., Florence, Alastair J., Johnson, Martin D.
The pharmaceutical industry has found new applications for the use of continuous processing for the manufacture of new therapies currently in development. The transformation has been encouraged by regulatory bodies as well as driven by cost reduction, decreased development cycles, access to new...
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Continuous Manufacturing of a Polymer Stabilized Emulsion Monitored with Process Analytical Technology
Contributor(s):: Qwist, PK, Sander, CBostijn, N, Jessen, V, Rantanen, J, de;Beer, T
Moving from batch to continuous manufacturing (CM) requires implementation of process analytical technology (PAT), as it is crucial to monitor and control these processes. CM of semi-solids has been demonstrated but implementation of a broader range of PAT tools with in- or on-line process...
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Continuous manufacturing – the Green Chemistry promise?
Contributor(s):: Klavs F. Jensen
Continuous manufacturing and Green Chemistry, are two promising approaches to synthesis with underutilized potential that are gaining traction by the wider pharmaceutical community. We review Green Chemistry advances resulting when transitioning to continuous manufacturing with focus on Green...
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Continuous Crystallization Processes in Pharmaceutical Manufacturing: A Review
Contributor(s):: Orehek, J, Teslic, D, Likozar, B
This scientific paper presents an overview of continuous solution crystallization in the pharmaceutical industry. Since the specific knowledge spectrum of precipitation is very broad, topics covering the following were analyzed and assessed in detail: a comparison between batch and continuous...
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Continuous direct compression: Development of an empirical predictive model and challenges regarding PAT implementation
Contributor(s):: Bekaert, B., Van Snick, B., Pandelaere, K., Dhondt, J., Di Pretoro, G., De Beer, T., Vervaet, C., Vanhoorne, V.
In this study, an empirical predictive model was developed based on the quantitative relationships between blend properties, critical quality attributes (CQA) and critical process parameters (CPP) related to blending and tableting. The blend uniformity and API concentration in the tablets were...
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Continuous downstream processing of milled electrospun fibers to tablets monitored by near-infrared and Raman spectroscopy
Contributor(s):: Szabo, E, Zahonyi, PGyurkes, M, Nagy, B, Galata, DL, Madarasz, L, Hirsch, E, Farkas, A, Andersen, SK, Vigh, T, Verreck, G, Csontos, I, Marosi, G, Nagy, ZK
Electrospinning is a technology for manufacture of nano- and micro-sized fibers, which can enhance the dissolution properties of poorly water-soluble drugs. Tableting of electrospun fibers have been demonstrated in several studies, however, continuous manufacturing of tablets have not been...
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Continuous end-to-end production of solid drug dosage forms: Coupling flow synthesis and formulation by electrospinning
Contributor(s):: Balogh, Attila, Domokos, András, Farkas, Balázs, Farkas, Attila, Rapi, Zsolt, Kiss, Domokos, Nyiri, Zoltán, Eke, Zsuzsanna, Szarka, Györgyi, Örkényi, Róbert, Mátravölgyi, Béla, Faigl, Ferenc
Based on the concept of continuous manufacturing an end-to-end benchtop device was developed unprecedented for the production of solid drug dosage forms by connecting flow synthesis and formulation via electrospinning (ES). Together with the optimized two-step continuous-flow synthesis of...
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Concentration monitoring with near infrared chemical imaging in a tableting press
Contributor(s):: Dalvi, Himmat, Fauteux-Lefebvre, Clémence, Guay, Jean-Maxime, Abatzoglou, Nicolas, Gosselin, Ryan
Monitoring powder potency and homogeneity is important in achieving real-time release testing in a continuous tablet manufacturing operation. If quality related issues are encountered, monitoring powder potency inside a feed frame offers a last opportunity to intervene in the process before...
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Continuous blending monitored and feedback controlled by machine vision-based PAT tool
Contributor(s):: Lászlo Galata, Dorián, Mészaros, Lilla, Ficzere Máté, Vass, Panna, Nagy, Brigitta, Szabó, Edina, Domokos, András, Farkas, Attila, Csontos, István, Marosi, György, Nagy, Zsombor Kristóf
In a continuous powder blending process machine vision is utilized as a Process Analytical Technology (PAT) tool. While near-infrared (NIR) and Raman spectroscopy are reliable methods in this field, measurements become challenging when concentrations below 2 w/w% are quantified. However, an...
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Characterizing drug product continuous manufacturing residence time distributions of major/minor excipient step changes using near infrared spectroscopy and process parameters
Contributor(s):: Shi, Zhenqi, Manley, Leo
The material residence time distribution in a continuous manufacturing process can be utilized to develop, design and justify the process control strategy. This paper successfully demonstrates using both major and minor formulation component step changes to determine the system response using...
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Combination of PAT and mechanistic modeling tools in a fully continuous powder to granule line: Rapid and deep process understanding
Contributor(s):: Domokos, András, Pusztai, Éva, Madarász, Lajos, Nagy, Brigitta, Gyürkés, Martin, Farkas, Attila (24372641300), Fülöp, Gergő, Casian, Tibor, Szilágyi, Botond., Nagy, Zsombor Kristóf
Comprehensive understanding of an integrated continuous pharmaceutical technology was achieved in this study by a combining design of experiments and mechanistic modeling-based simulations. The powder to granule line consisted of twin-screw wet granulation, vibrational fluid-bed drying and...
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Comparison Between Pure Component Modeling Approaches for Monitoring Pharmaceutical Powder Blends with Near‑Infrared Spectroscopy in Continuous Manufacturing Schemes
Contributor(s):: Rish, Adam J., Henson, Samuel R., Alam, Md. Anik, Liu, Yang, Drennen, James K., Anderson, Carl A.
Near-infrared (NIR) spectroscopy has become an important process analytical technology (PAT) for monitoring and implementing control in continuous manufacturing (CM) schemes. However, NIR requires complex multivariate models to properly extract the relevant information and the traditional model...