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Landscape and opportunities for active pharmaceutical ingredient manufacturing in developing African economies
09 Jun 2023 | Contributor(s):: Riley, DL, Strydom, IChikwamba, R, Panayides, JL
Africa is one of the world's fastest growing economies, with South Africa having the fifth highest worldwide pharmaceutical expenditure per capita. In recent years, several companies have considered regional pharmaceutical production but have failed to make the investment, in stark contrast to...
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Integrated continuous manufacturing in pharmaceutical industry: current eolutionary steps toward revolutionary future
09 Jun 2023 | Contributor(s):: Nada A Helal, Ola Elnoweam, Heba Abdullah Eassa, Ahmed M Amer, Mohamed Ashraf Eltokhy, Mohamed A Helal, Heba A Fayyaz, Mohamed Ismail Nonou
Continuous manufacturing (CM) has the potential to provide pharmaceutical products with better quality, improved yield and with reduced cost and time. Moreover, ease of scale-up, small manufacturing footprint and on-line/in-line monitoring and control of the process are other merits for CM....
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Integrated Flow Processing - Challenges in Continuous Multistep Synthesis
09 Jun 2023 | Contributor(s):: Pieber, B, Gilmore, K, Seeberger, PH
The way organic multistep synthesis is performed is changing due to the adoption of flow chemical techniques, which has enabled the development of improved methods to make complex molecules. The modular nature of the technique provides not only access to target molecules via linear flow...
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Industry perspective on process analytical technology tools and applications in API development
09 Jun 2023 | Contributor(s):: Chanda, Arani, Daly, Adrian M., Foley, David A., Lapack, Mark A., Mukherjee, Samrat, Orr, John D., Reid, George L., Thompson, Duncan R., Ward, Howard W.
The IQ Consortium reports on the current state of process analytical technology (PAT) for active pharmaceutical ingredient (API) development in branded pharmaceutical companies. The article uses an API process workflow (process steps from raw material identification through to finished API) to...
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Improving chemical synthesis using flow reactors
09 Jun 2023 | Contributor(s):: Wiles, C, Watts, P
Owing to the competitive nature of the pharmaceutical industry, Research Articleers involved in lead compound generation are under continued pressure to identify and develop promising programmes of Research Article in order to secure intellectual property. The potential of a compound for...
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Hot-Melt Extrusion: from Theory to Application in Pharmaceutical Formulation
09 Jun 2023 | Contributor(s):: Patil, H, Tiwari, RV, Repka, MA
Hot-melt extrusion (HME) is a promising technology for the production of new chemical entities in the developmental pipeline and for improving products already on the market. In drug discovery and development, industry estimates that more than 50% of active pharmaceutical ingredients currently...
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From circular synthesis to material manufacturing: advances, challenges, and future steps for using flow chemistry in novel application area
09 Jun 2023 | Contributor(s):: Sivo, A, Galaverna, RDGomes, GR, Pastre, JC, Vile, G
Continuous-flow technologies are becoming increasingly relevant in the chemistry field. The vast arrays of reactor design, in terms of structural geometry, mixing, and residence time, the modularity of these systems, adaptable for every application, and the easy downstream integrations are at the...
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Global Regulatory Landscape
09 Jun 2023 | Contributor(s):: Matsuda, Y
Continuous manufacturing (CM) of pharmaceuticals is a rapidly growing approach in the production of active pharmaceutical ingredients and finished products. The European Medicines Agency, the US Food and Drug Administration, and the Pharmaceuticals and Medical Devices Agency have independently...
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Granulation development in batch-to-batch and continuous processes from a quality by design perspective
09 Jun 2023 | Contributor(s):: Ko, Seung Jin, Lee, Ju-Hyun, Kang, Chin-Yang, Park, Jun-Bom
The process of quality by design (QbD) is of great importance in drug development. This review describes the design of experiments (DoE) method, which is an important component of QbD. DoE is predominantly divided into a screening phase and an optimization phase. The screening phase uses...
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Flow Chemistry, Continuous Processing, and Continuous Manufacturing: A Pharmaceutical Perspective
09 Jun 2023 | Contributor(s):: May, SA
Flow chemistry has become a vibrant area for Research Article over the past decade. This perspective is intended to capture insights on how these advances have and will continue to impact the development and commercialization of active pharmaceutical ingredients. A series of chemistry examples...
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Flow Chemistry: Recent Developments in the Synthesis of Pharmaceutical Products
09 Jun 2023 | Contributor(s):: Porta, R, Benaglia, M, Puglisi, A
Recently, application of the flow technologies for the preparation of fine chemicals, such as natural products or Active Pharmaceutical Ingredients (APIs), has become very popular, especially in academia. Although pharma industry still relies on multipurpose batch or semibatch reactors, it is...
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Feed frame: The last processing step before the tablet compaction in pharmaceutical manufacturing
09 Jun 2023 | Contributor(s):: Sierra-Vega, Nobel, Romañach, Rodolfo J., Méndez, Rafael
The feed frame is a force-feeding device used in the die filling process. The die filling process is crucial within pharmaceutical manufacturing to guarantee the critical quality attributes of the tablets. In recent years, interest in this unit has increased because it can affect the properties...
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Feedback in Flow for Accelerated Reaction Development
09 Jun 2023 | Contributor(s):: Reizman, BJ, Jensen, KF
The pharmaceutical industry is investing in continuous flow and high-throughput experimentation as tools for rapid process development accelerated scale-up. Coupled with automation, these technologies offer the potential for comprehensive reaction characterization and optimization, but with the...
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Fit-for-Purpose Miniature NIR Spectroscopy for Solid Dosage Continuous Manufacturing
09 Jun 2023 | Contributor(s):: Karry, Krizia, Singh, Ravendra, Muzzio, Fernando
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Evolution of flow-oriented design strategies in the continuous preparation of pharmaceuticals
09 Jun 2023 | Contributor(s):: Fulop, Z, Szemesi, PBana, P, Eles, J, Greiner, I
The dynamic progress in the multi-step continuous-flow synthesis of active pharmaceutical ingredients is part of the current industrial revolution. The recently implemented examples are the forerunners of safer and more sustainable pharmaceutical manufacturing. These systems utilize...
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Direct compaction: An update of materials, trouble-shooting, and application
09 Jun 2023 | Contributor(s):: Li, Z, Zhao, LJLin, X, Shen, L, Feng, Y
Direct compaction (DC) is the preferred choice for tablet manufacturing; however, only less than 20% of active pharmaceutical ingredients could be compacted via DC as its high requirement for functional properties of materials. Materials with improper functionalities could lead to serious...
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Design of an Integrated Continuous Manufacturing System
09 Jun 2023 | Contributor(s):: Oka, Sarang S, Escotet-Espinoza, M Sebastian Singh, Ravendra Scicolone, James V Hausner, Douglas B Ierapetritou, Marianthi, Muzzio, Fernando J
This chapter presents a systematic, 12-step approach for designing, implementing, integrating, optimizing, and validating a continuous manufacturing system. Wherever appropriate, it also discusses the regulatory relevance of the technology integration effort. When considering the development of a...
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Coupling hot melt extrusion and fused deposition modeling: Critical properties for successful performance
09 Jun 2023 | Contributor(s):: Bandari, Suresh, Nyavanandi, Dinesha, Dumpa, Nagireddy, Repka, Michael A.
Interest in 3D printing for pharmaceutical applications has increased in recent years. Compared to other 3D printing techniques, hot melt extrusion (HME)-based fused deposition modeling (FDM) 3D printing has been the most extensively investigated for patient-focused dosage. HME technology can be...
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Contribution of hot-melt extrusion technology to advance drug delivery in the 21st century
09 Jun 2023 | Contributor(s):: Tiwari, RV, Patil, H, Repka, MA
Introduction: Hot-melt extrusion (HME) technology is applied successfully in the plastic, rubber and food industry. HME has also emerged as an important technology for drug delivery applications in pharmaceutical Research Article and manufacturing because of its process automation and low-cost...
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Control of Batch and Continuous Crystallization Processes using Reinforcement Learning
09 Jun 2023 | Contributor(s):: Benyahia, Brahim, Anandan, Paul Danny Rielly, Chris Türkay, Metin, Gani, Rafiqul
In crystallization processes, the control of particle size distribution, shape and purity are crucial to achieve the targeted critical quality attributes of the final drug product and meet the pharmaceutical regulatory requirements. This work presents novel optimal trajectory tracking control...
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Continuous, one-step synthesis of pharmaceutical cocrystals via hot melt extrusion from neat to matrix-assisted processing - State of the art
09 Jun 2023 | Contributor(s):: Gajda, Maciej, Nartowski, Karol P., Pluta, Janusz, Karolewicz, Bożena
Use of hot melt extrusion (HME) as continuous manufacturing process in the cocrystal synthesis is of increasing interest from both industrial and academic perspective and it is seen as a newly developing branch of mechanochemistry with possible broad application in single step synthesis and...
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Continuous-Flow Technology—A Tool for the Safe Manufacturing of Active Pharmaceutical Ingredients
09 Jun 2023 | Contributor(s):: Gutmann, B, Cantillo, D, Kappe, CO
In the past few years, continuous-flow reactors with channel dimensions in the micro- or millimeter region have found widespread application in organic synthesis. The characteristic properties of these reactors are their exceptionally fast heat and mass transfer. In microstructured devices of...
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Continuous twin screw granulation - An advanced alternative granulation technology for use in the pharmaceutical industry
09 Jun 2023 | 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
09 Jun 2023 | 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 manufacturing: the future in pharmaceutical solid dosage form manufacturing
09 Jun 2023 | Contributor(s):: Desai, Parind Mahendrakumar, Van Vaerenbergh, Griet, Holman, Jim, Liew, Celine Valeria, Heng, Paul Wan Sia
As rising costs outpace new drug development, the pharmaceutical industry has come under intense pressure to improve the efficiency of its manufacturing processes. Continuous process manufacturing provides a proven solution. Among its many benefits are: minimized waste, energy consumption, and...