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Continuous manufacturing
Sampling and diversion strategy for twin-screw granulation lines using batch statistical process…
Continuous manufacturing is now considered as a well-established technique by pharmaceutical companies. However, the limited number of filed applications reflects the complexity to translate a science that has been described in many publications to an actual drug product. Process stability…
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The Effect of Binder Types on the Breakage and Drying Behavior of Granules in a Semi-Continuous…
Current study investigated the effect of different binder types on the granule drying process and the granule breakage behavior in a semi-continuous fluid bed dryer integrated in the C25 ConsiGma-system. The studied binders (i.e. hydroxypropyl pea starch, hydroxypropyl methylcellulose E15,…
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In-depth analysis of the long-term processability of materials during continuous feeding
This study determined the feasibility of long-term continuous powder feeding and its effect on the overall process performance. Additionally, quantitative relationships were established between material properties, process settings and screw feeding responses during gravimetric feeding. Twelve…
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Real-Time Monitoring of Powder Mass Flowrates for Plant-Wide Control of a Continuous Direct…
While measurement and monitoring of powder/particulate mass flow rate are not essential to the execution of traditional batch pharmaceutical tablet manufacturing, in continuous operation, it is an important additional critical process parameter. It has a key role both in establishing that the…
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The effect of screw configuration and formulation variables on liquid requirements and granule…
The effect of two screw configurations with varying stagger angle was evaluated on the liquid amount required to produce good quality granules for a highly (mannitol-based) and a poorly (DCP-based) soluble formulation containing different binders. It is generally known that the use of a higher…
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Batch versus continuous blending of binary and ternary pharmaceutical powder mixtures
The material properties of excipients and active pharmaceutical ingredients (API's) are important parameters that affect blend uniformity of pharmaceutical powder formulations. With the current shift from batch to continuous manufacturing in the pharmaceutical industry, blending of excipients and…
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Determination and understanding of lead-lag between in-line NIR tablet press feed frame and off-line…
The influence of different tableting process parameters on lead-lag was studied by collecting in-line near-infrared (NIR) spectra in the filling chamber of the tablet press feed frame and off-line NIR tablet data. Lead-lag is defined as the difference in time and API concentration between the…
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Using Residence time distribution in pharmaceutical solid dose manufacturing – a critical review
While continuous manufacturing (CM) of pharmaceutical solid-based drug products has been shown to be advantageous for improving the product quality and process efficiency in alignment with FDA’s support of the quality-by-design paradigm (Lee, 2015, Ierapetritou et al., 2016, Plumb, 2005, Schaber,…
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Development and characterization of Novel topical oil/PEG creams of voriconazole for the treatment…
Voriconazole (VRC), a second generation triazole derivative emerged as a promising candidate for the treatment of fungal infections. Voriconazole is commercially available as oral and intravenous formulations, however administration through these routes is associated with several side effects like…
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Digital Twin of Low Dosage Continuous Powder Blending – Artificial Neural Networks and…
In this paper we present a thorough description of the digital twin development for a continuous pharmaceutical powder blending process in accordance with the Process Analytical Technologies (PAT) and Quality by Design (QbD) guidelines. A low-dosage system of caffeine active pharmaceutical…
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