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Continuous Pharmaceutical Crystallization from Solution
09 Jun 2023 | Contributor(s):: Price, CJ
Brings together the essential know-how for anyone working in drug manufacturing, as well as chemical, food, and pharmaceutical scientists working on continuous processing
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Continuous processing and the applications of online tools in pharmaceutical product manufacture: developments and examples
09 Jun 2023 | 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
09 Jun 2023 | 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
09 Jun 2023 | 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 Process Development from Lab to Market, Role of Digital Tools
09 Jun 2023 | 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
09 Jun 2023 | 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 Manufacturing in Pharmaceutical Process Development and Manufacturing
09 Jun 2023 | 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 Crystallization Processes in Pharmaceutical Manufacturing: A Review
09 Jun 2023 | 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 flow asymmetric synthesis of chiral active pharmaceutical ingredients and their advanced intermediates
09 Jun 2023 | Contributor(s):: Otvos, SB, Kappe, CO
Catalytic enantioselective transformations provide well-established and direct access to stereogenic synthons that are broadly distributed among active pharmaceutical ingredients (APIs). These reactions have been demonstrated to benefit considerably from the merits of continuous processing and...
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Challenges, opportunities and recent advances in near infrared spectroscopy applications for monitoring blend uniformity in the continuous manufacturing of solid oral dosage forms
09 Jun 2023 | Contributor(s):: Velez, Natasha L., Drennen, James K., Anderson, Carl A.
Near infrared (NIR) spectroscopy has been widely recognized as a powerful PAT tool for monitoring blend uniformity in continuous manufacturing (CM) processes. However, the dynamic nature of the powder stream and the fast rate at which it moves, compared to batch processes, introduces challenges...
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Blend Segregation in Tablets Manufacturing and Its Effect on Drug Content Uniformity-A Review
09 Jun 2023 | Contributor(s):: Jakubowska, E, Ciepluch, N
Content uniformity (CU) of the active pharmaceutical ingredient is a critical quality attribute of tablets as a dosage form, ensuring reproducible drug potency. Failure to meet the accepted uniformity in the final product may be caused either by suboptimal mixing and insufficient initial blend...
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Challenges and Opportunities in Pharmaceutical Manufacturing Modeling and Optimization
09 Jun 2023 | Contributor(s):: Rogers, Amanda, Ierapetritou, Marianthi Eden, Mario R. Siirola, John D., Towler, Gavin P.
The pharmaceutical industry currently faces economic and regulatory challenges associated with process development. Process systems engineering (PSE) tools can play a role in developing robust and economically efficient manufacturing processes. However pharmaceutical companies have lagged behind...
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Assessment of Recent Process Analytical Technology (PAT) Trends: A Multiauthor Review
09 Jun 2023 | Contributor(s):: Simon, Levente L, Pataki, Hajnalka, Marosi, György, Meemken, Fabian, Hungerbühler, Konrad, Baiker, Alfons, Tummala, Srinivas, Glennon, Brian, Kuentz, Martin, Steele, Gerry, Kramer, Herman J. M, Rydzak, James W.
This multiauthor review article aims to bring readers up to date with some of the current trends in the field of process analytical technology (PAT) by summarizing each aspect of the subject (sensor development, PAT based process monitoring and control methods) and presenting applications both in...
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Applications of Flow Chemistry in the Pharmaceutical Industry-Highlights of the Recent Patent Literature
09 Jun 2023 | Contributor(s):: Hughes, DL
Flow chemistry is playing an increasingly important role in drug discovery, chemical process development, and manufacturing in the pharmaceutical and agrichemical industries. The current review covers patents and patent applications from 2017 to 1Q 2020 for which no accompanying journal articles...
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Applications of Supercritical Anti-Solvent Process in Preparation of Solid Multicomponent Systems
09 Jun 2023 | Contributor(s):: Liu, GJ, Li, JJ, Deng, SM
Solid multicomponent systems (SMS) are gaining an increasingly important role in the pharmaceutical industry, to improve the physicochemical properties of active pharmaceutical ingredients (APIs). In recent years, various processes have been employed for SMS manufacturing. Control of the particle...
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Approach to establishment of control strategy for oral solid dosage forms using continuous manufacturing
09 Jun 2023 | Contributor(s):: Ishimoto, Hayato, Kano, Manabu, Sugiyama, Hirokazu, Takeuchi, Hirofumi, Terada, Katsuhide, Aoyama, Atsushi, Shoda, Takuji, Demizu, Yosuke, Shimamura, Jinen, Yokoyama, Reiji, Miyamoto, Yuji, Hasegawa, Koji, Serizawa, Masaru, Unosawa, Kazuomi, Osaki, Kazuo, Asai, Naochika, Matsuda, Yoshihiro
As a result of the Research Article activities of the Japan Agency for Medical Research Article and Development (AMED), this document aims to show an approach to establishing control strategy for continuous manufacturing of oral solid dosage forms. The methods of drug development, technology...
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Advanced methodologies for cocrystal synthesis
09 Jun 2023 | Contributor(s):: Douroumis, D, Ross, SA, Nokhodchi, A
Pharmaceutical cocrystals are multicomponent systems composed of two or more molecules and held together by H-bonding. Currently, cocrystals provide exciting opportunities in the pharmaceutical industry for the development and manufacturing of new medicines by improving poor physical properties...
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Advanced Pharmaceutical Manufacturing: A Functional Definition
09 Jun 2023 | Contributor(s):: Romañach, Rodolfo J., Stelzer, Torsten, Sanchez, Eric, Muzzio, Fernando
The term “Advanced Pharmaceutical Manufacturing” (APM) has become an ubiquitous buzzword with deep potential policy implications. There is a real danger that APM will be seen as a general panacea for solving economic woes and drug shortages, devoiding it from specific meaning, and depriving the...
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Advances in Twin-Screw Granulation
09 Jun 2023 | Contributor(s):: Vanhoorne, Valerie, Kumar, Ashish
Twin-screw granulation (TSG) is an emerging process technology that allows both wet and dry granulation of powders with a wide range of properties. This technology is of particular interest to the pharmaceutical industry, which is currently aiming to shift from batch to continuous mode...
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Aerobic oxidations in flow: opportunities for the fine chemicals and pharmaceuticals industries
09 Jun 2023 | Contributor(s):: Gavriilidis, A, Constantinou, AHellgardt, K, Hii, KK, Hutchings, GJ, Brett, GL, Kuhn, S, Marsden, SP
Molecular oxygen is without doubt the greenest oxidant for redox reactions, yet aerobic oxidation is one of the most challenging to perform with good chemoselectivity, particularly on an industrial scale. This collaborative review (between teams of chemists and chemical engineers) describes the...
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Advanced Manufacturing and Process Analytical Technology - for Competitiveness and Resilience in Pharmaceutical Manufacturing
09 Jun 2023 | Contributor(s):: Alvarado-Hernández, Bárbara, Fontalvo-Lascano, María A., Valetín-Román, Nashaly, Méndez- Román, Rafael, Méndez Piñero, Mayra, De Hoyos Ruperto, Moraima., Romañach, Rodolfo
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A review of emerging technologies enabling improved solid oral dosage form manufacturing and processing
09 Jun 2023 | Contributor(s):: Sohail Arshad, Muhammad, Zafar, Saman, Yousef, Bushra, Alyassin, Yasmine, Ali, Radeyah, AlAsiri, Ali, Chang, Ming-Wei, Ahmad, Zeeshan, Ali Elkordy, Amal, Faheem, Ahmed, Pitt, Kendal
Tablets are the most widely utilized solid oral dosage forms because of the advantages of self-administration, stability, ease of handling, transportation, and good patient compliance. Over time, extensive advances have been made in tableting technology. This review aims to provide an insight...
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A review of PAT strategies in secondary solid oral dosage manufacturing of small molecules
09 Jun 2023 | Contributor(s):: Laske, Stephan, Paudel, Amrit, Scheibelhofer, Otto, Sacher, Stephan, Hoermann, Theresa, Khinast, Johannes, Kelly, Adrian, Rantannen, Jukka, Korhonen, Ossi, Stauffer, Fanny, De Leersnyder, Fien, De Beer, Thomas, Mantanus, Jerome, Chavez, Pierre-Francois, Thoorens, Benjamin, Ghiotti, Patrizia, Schubert, Martin, Tajarobi, Pirjo, Haeffler, Gunnar, Lakio, Satu, Fransson, Magnus, Sparen, Anders, Abrahmsen-Alami, Susanna, Folestad, Staffan, Funke, Adrian, Backx, Ivo, Kavsek, Barbara, Kjell, Francois, Michaelis, Marc, Page, Trevor, Palmer, John, Schaepman, Alexander, Sekulic, Sonja, Hammond, Steve, Braun, Birgit, Colegrove, Brenda
Pharmaceutical solid oral dosage product manufacturing is a well-established, yet revolutionizing area. To this end, process analytical technology (PAT) involves interdisciplinary and multivariate (chemical, physical, microbiological and mathematical) methods for material (e.g. materials,...
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A Review of Process Analytical Technology (PAT) in the U.S. Pharmaceutical Industry
09 Jun 2023 | Contributor(s):: Munson, James, Stanfield, C. Freeman, Gujral, Bir
Process Analytical Technologies (PAT) are used to provide timely analysis of critical quality parameters with the end goal of improving final product quality as well as reducing manufacturing costs, thereby significantly benefiting the Pharmaceutical Industry. PAT involves mostly on-line or...
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A review of twin screw wet granulation mechanisms in relation to granule attributes
09 Jun 2023 | Contributor(s):: Zhang, Yi, Liu, Tongzhou, Kashani-Rahimi, Shahab, Zhang, Feng
Due to the trend of continuous pharmaceutical manufacturing, twin screw wet granulation (TSWG), a continuous process, has gained increased Research Article interest as a potential substitution of traditional batch granulation processes. Despite the complex nature of TSWG, its mechanisms have been...