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Non-destructive detection of disintegrant levels in compressed oral solid dosage forms
23 Jul 2024 | Contributor(s):: Sultan, Tipu, Rozin, Enamul Hasan, Dave, Vivek S., Cetinkaya, Cetin
Quality issues related to compressed oral solid dosage (OSD) forms, such as tablets, arise during the design, development, and production stages, despite established processes and robust production tools. One of the primary quality concerns is the disintegration properties and drug release...
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Machine learning framework for extracting micro-viscoelastic and micro-structural properties of compressed oral solid dosage forms
23 Jul 2024 | Contributor(s):: Sultan, Tipu, Rozin, Enamul Hasan, Paul, Shubhajit, Tseng, Yin-Chao, Cetinkaya, Cetin
A compressed pharmaceutical oral solid dosage (OSD) form is a strongly micro-viscoelastic material composite arranged as a network of agglomerated particles due to its constituent powders and their bonding and fractural mechanical properties. An OSD product's Critical Quality Attributes, such as...
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Machine learning modeling for ultrasonic quality attribute assessment of pharmaceutical tablets for continuous manufacturing and real-time release testing
23 Jul 2024 | Contributor(s):: Sultan, Tipu, Rozin, Enamul Hasan, Paul, Shubhajit, Tseng, Yin-Chao, Dave, Vivek S., Cetinkaya, Cetin
In in-process quality monitoring for Continuous Manufacturing (CM) and Critical Quality Attributes (CQA) assessment for Real-time Release (RTR) testing, ultrasonic characterization is a critical technology for its direct, non-invasive, rapid, and cost-effective nature. In quality evaluation with...
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Orodispersible films: Product transfer from lab-scale to continuous manufacturing
23 Jul 2024 | Contributor(s):: Thabet, Yasmin, Breitkreutz, Joerg
Orodispersible films have been described as new beneficial dosage forms for special patient populations. Due to various production settings, different requirements on film formulations are required for non- continuous and continuous manufacturing. In this study, a continuous coating machine was...
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Optimization of Critical Quality Attributes in Tablet Film Coating and Design Space Determination Using Pilot-Scale Experimental Data
23 Jul 2024 | Contributor(s):: Liu, Huolong, Meyer, Robert, Flamm, Matthew, Wareham, Laura, Metzger, Matthew, Tantuccio, Anthony, Yoon, Seongkyu
In this study, the novel high-speed tablet film coating process in the continuous manufacturing was investigated. The influence of key process variables (inlet air flow rate, inlet air temperature, and suspension spray rate) were investigated using a Box-Behnken experimental design method....
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Effect of shape on the physical properties of pharmaceutical tablets
23 Jul 2024 | Contributor(s):: Sultan, Tipu, Cetinkaya, Cetin
Despite a well-established process understanding, quality issues for compressed oral solid dosage forms are frequently encountered during various drug product development and production stages. In the current work, a non-destructive contact ultrasonic experimental rig integrated with a...
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Micro-viscoelastic characterization of compressed oral solid dosage forms with ultrasonic wave dispersion analysis
23 Jul 2024 | Contributor(s):: Sultan, Tipu, Paul, Shubhajit, Rozin, Enamul Hasan, Tseng, Yin-Chao, Bazzocchi, Michael C. F., Cetinkaya, Cetin
Due to their constituent powders, the materials of advanced compressed oral solid dosage (OSD) forms are micro-composites and strongly visco-elastic at macro- and micro-length scales. The disintegration, drug release, and mechanical strength of OSD forms depend on its micro-texture (such as...
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Formulation development of a continuously manufactured orodispersible film containing warfarin sodium for individualized dosing
23 Jul 2024 | Contributor(s):: Niese, Svenja, Quodbach, Julian
Continuously manufactured orodispersible films (ODFs) offer a promising approach for individualized therapy with an easy to administer solid dosage form. The aim of this study was to develop a long ODF containing warfarin sodium to enable safe and more flexible dosing. Formulation development was...