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A modified Kushner-Moore approach to characterising small-scale blender performance impact on tablet compaction
| Contributor(s):: Hikaru G. Jolliffe, Martin Prostredny, Carlota Mendez Torrecillas, Ecaterina Bordos, Collette Tierney, Ebenezer Ojo, Richard Elkes, Gavin Reynolds, Yunfei Li Song, Bernhard Meir, Sara Fathollahi, John Robertson
Continuous Direct Compaction (CDC) has emerged as a promising route towards producing solid dosage forms while reducing material, development time and energy consumption. Understanding the response of powder processing unit operations, especially blenders, is crucial. There is a substantial body...
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Model predictive in vitro dissolution testing in pharmaceutical continuous manufacturing: An equivalence study
| Contributor(s):: Atul Dubey, Su Qinglin, Paul Hermant, Federica Casati, Bhakti Halkude, Wei Wu, Anjana Ramnath, Stephen Born, Salvatore Mascia, Bayan Takizawa
A predictive mathematical model for tablet dissolution was developed and implemented in an end-to-end integrated continuous manufacturing pilot plant. The tablets were produced for immediate release with a proprietary extrusion-molding-coating (EMC) unit operation. Besides the mass balance of...
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Solid Dosage Form Analysis by near Infrared Spectroscopy: Comparison of Reflectance and Transmittance Measurements Including the Determination of Effective Sample Mass
| Contributor(s):: Iyer, M., Morris, H. R., Drennen, J. K.
Investigations into the near infrared analysis of intact tablets allow comparison of the reflectance and transmittance methodologies. The studies involved estimation of the effective sample mass and the effect of sample inhomogeneities. An empirical method for determining effective sample mass...
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Process analytical technology in continuous manufacturing of a commercial pharmaceutical product
| Contributor(s):: Vargas, Jenny, Nielsen, Sarah, Cárdenas, Vanessa, Gonzalez, Anthony, Aymat, Efrain, Almodovar, Elvin, Classe, Gustavo, Colón, Yleana, Sanchez, Eric, Romañach, Rodolfo
The implementation of process analytical technology and continuous manufacturing at an FDA approved commercial manufacturing site is described. In this direct compaction process the blends produced were monitored with a Near Infrared (NIR) spectroscopic calibration model developed with partial...
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Integrated hot-melt extrusion - injection molding continuous tablet manufacturing platform: Effects of critical process parameters and formulation attributes on product robustness and dimensional stability
| Contributor(s):: Desai, Parind M, Hogan, Rachael C., Brancazio, David, Puri, Vibha, Jensen, Keith D., Chun, Jung-Hoon, Myerson, Allan S., Trout, Bernhardt L.
This study provides a framework for robust tablet development using an integrated hot-melt extrusion-injection molding (IM) continuous manufacturing platform. Griseofulvin, maltodextrin, xylitol and lactose were employed as drug, carrier, plasticizer and reinforcing agent respectively. A...
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Flowsheet modeling of a continuous direct compression process
| Contributor(s):: Yoon, Seongkyu, Galbraith, Shaun, Cha, Bumjoon, Liu, Huolong
Continuous manufacturing for the production of pharmaceutical products is emerging as a key technology due to the advantages it has over traditional batch manufacturing methods. Process systems engineering is critical in rolling out this technology within the industry since it allows for more...
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Continuous powder feeding for pharmaceutical solid dosage form manufacture: a short review
| Contributor(s):: Blackshields, Caroline A., Crean, Abina M.
Offers an extremely well-informed look at the most promising future approaches to continuous manufacturing of innovative pharmaceutical products
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Continuous downstream processing of milled electrospun fibers to tablets monitored by near-infrared and Raman spectroscopy
| Contributor(s):: Szabo, E, Zahonyi, PGyurkes, M, Nagy, B, Galata, DL, Madarasz, L, Hirsch, E, Farkas, A, Andersen, SK, Vigh, T, Verreck, G, Csontos, I, Marosi, G, Nagy, ZK
Electrospinning is a technology for manufacture of nano- and micro-sized fibers, which can enhance the dissolution properties of poorly water-soluble drugs. Tableting of electrospun fibers have been demonstrated in several studies, however, continuous manufacturing of tablets have not been...
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Assessment of Robustness for a Near-Infrared Concentration Model for Real-Time Release Testing in a Continuous Manufacturing Process
| Contributor(s):: Colon, Yleana, Vargas, Jenny, Sánchez, Eric, Navarro, Gilfredo, Romañach, Rodolfo
This study describes the robustness test of a transmission near-infrared spectroscopic (NIRS) model for prediction of drug concentration in core tablets as part of real-time release testing (RTRt) efforts for a continuous manufacturing process. Seven calibration blend samples were prepared...