Influence of material properties and equipment configuration on loss-in-weight feeder performance for drug product continuous manufacture

Yadav, Indrajeetsinh K.; Holman, James; Meehan, E. J.; Tahir, Furqan; Khoo, Jiyi; Taylor, J. J.; Benedetti, Antonio; Aderinto, Opeyemi; Bajwa, Gurjit

doi:10.1016/j.powtec.2019.01.071

Cited by 21 publications

(7 citation statements)

References 20 publications

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“…Several studies have been published to study the effectiveness of LIW feeders in pharmaceutical manufacturing. [144,145] However, some studies suggest that there are better feeding options than LIW feeders at the low-dosage range, such as hot melt extrusion. [146] Furthermore, novel micro-feeders are also being developed in order to manufacture APIs in small doses.…”

Section: Conveyancementioning

confidence: 99%

“…LIW feeders directly measure the weight of the material in the feeder and allows for material to be transported at a controllable and precise mass flow rate. Several studies have been published to study the effectiveness of LIW feeders in pharmaceutical manufacturing [144,145] . However, some studies suggest that there are better feeding options than LIW feeders at the low‐dosage range, such as hot melt extrusion [146] .…”

Section: Unit Operationsmentioning

confidence: 99%

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Continuous Manufacturing of Active Pharmaceutical Ingredients: Current Trends and Perspectives

Hyer,

Gregory,

Kay

et al. 2024

Adv Synth Catal

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The pharmaceutical industry has traditionally employed batch processing as a means of synthesizing active pharmaceutical ingredients (APIs) on a commercial scale. Batch manufacturing enables API synthesis in large quantities in order to meet regulations. Yet, this strategy remains cumbersome, is labor‐intensive, and creates complex logistical networks. In recent decades, batch API processing has gradually eroded American economic competitiveness and has led to the off‐shoring of API manufacturing from the United States. Today it is estimated that +80% of APIs are manufactured overseas. Meanwhile, disruptions from the Coronavirus Disease (SARS‐CoV‐2) have exacerbated weaknesses in the global supply chain, culminating with widespread shortages of critical life‐saving drugs. These shortages have emphasized the importance of reshoring drug manufacturing to the U.S. and fostered a regulatory landscape that seeks advanced methods of API manufacturing in order to bolster America’s supply chain resiliency. Recently, increased attention has been directed towards continuous drug manufacturing to enable nonstop API production within modular stand‐alone flow systems. Continuous manufacturing (CM) facilitates modular automation, offers new avenues towards process intensification, and even enables in‐line analytical monitoring from raw materials to packaged products. This strategy offers better conversion, increased safety, reduced waste, and overall cost savings versus traditional batch‐style processing. The rise of advanced API manufacturing, coupled with the current regulatory landscape, offers a rare window of opportunity to convert traditional batch pharmaceutical processes into continuous, streamlined production systems to on‐shore API manufacturing and eliminate drug shortages. This review will outline the current state‐of‐the‐art in the CM of APIs and will highlight the translation of chemistry and unit operations from batch processes to modular CM systems.

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Section: Conveyancementioning

confidence: 99%

Section: Unit Operationsmentioning

confidence: 99%

Continuous Manufacturing of Active Pharmaceutical Ingredients: Current Trends and Perspectives

Hyer,

Gregory,

Kay

et al. 2024

Adv Synth Catal

View full text Add to dashboard Cite

show abstract

“… Chen and Ierapetritou (2020) ; Shier et al (2022) developed gray-box models based on Heckel's equation ( Heckel, 1961 ) based physical model proposed by ( Wang et al, 2017b ). The statistical models were developed to link the feeding performance with material properties, process parameters, and feeder configurations ( Jia et al, 2009 ; Pordesimo et al, 2009 ; Wang et al, 2017a ; Santos et al, 2018 ; Escotet-Espinoza et al, 2018 ; Wang et al, 2019 ; Bostijn et al, 2019 ; Stauffer et al, 2019 ; Yadav et al, 2019 ; Tahir et al, 2020 ; Bekaert et al, 2021 ).…”

Section: Introductionmentioning

confidence: 99%

Feed factor profile prediction model for two-component mixed powder in the twin-screw feeder

Kobayashi,

Kim,

Nagato

et al. 2024

International Journal of Pharmaceutics: X

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“…The powder is pushed forward by the flank of the screws in a relatively small open volume. This principle is prone to be influenced by material properties [4,5]. Cohesion and poor flowability-among others-can affect the feed rate and lead to variation in the content uniformity of the final dosage units [6].…”

Section: Introductionmentioning

confidence: 99%

Comparative Study of a Novel Micro-feeder and Loss-in-weight Feeders

2021

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Purpose Accurate and reliable feeding of small quantities of powder is crucial in many industries. It is particularly true in the case of pharmaceutical manufacturing. First, the exact dosage of highly potent active pharmaceutical ingredients (APIs) is essential. Second, due to the shift towards continuous manufacturing, processing agents must be supplied continuously. Last, with regard to personalized medicine products, small doses of API have to be processed with high flexibility. In all these applications, a few grams of powder or less per hour have to be fed, which makes processing very challenging. The common route of pre-blending causes additional effort in processing and quality control compared to direct continuous feeding, while material properties influence the performance of conventional feeders with conveying screw elements. Methods In this study, a novel micro-feeding system based on active volumetric displacement is investigated and compared to commercial LIW feeders of various scales. In the micro-feeder, the powder is filled into a cylindrical cartridge and pushed towards the process by a piston in a controlled manner. Tests are carried out with a free-flowing grade of lactose and croscarmellose sodium as an example of cohesive powder. Results At feed rates of a few grams per hour, for the investigated materials, the system has at least the same performance as conventional feeders at significantly higher feed rates. Especially at low feed rates, less fluctuations are obvious and accuracy and precision of the micro-feeder are at the same level as for the established feeding technology at rates ten times higher. Conclusion For the two types of investigated materials (free-flowing and cohesive), the micro-feeding system shows similar or better performance than conventional and commercially applied LIW feeders. The technology offers the potential for highly accurate, continuous feeding in the low-dose range.

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Influence of material properties and equipment configuration on loss-in-weight feeder performance for drug product continuous manufacture

Cited by 21 publications

References 20 publications

Continuous Manufacturing of Active Pharmaceutical Ingredients: Current Trends and Perspectives

Continuous Manufacturing of Active Pharmaceutical Ingredients: Current Trends and Perspectives

Feed factor profile prediction model for two-component mixed powder in the twin-screw feeder

Comparative Study of a Novel Micro-feeder and Loss-in-weight Feeders

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