Impact of blend properties on die filling during tableting
Autor: | Jens Dhondt, Kenny Pandelaere, G. Di Pretoro, J.P. Remon, Chris Vervaet, T. De Beer, Valérie Vanhoorne, B. Van Snick, W. Grymonpré |
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Jazyk: | angličtina |
Rok vydání: | 2018 |
Předmět: |
PRESS
business.product_category Technology and Engineering Compressive Strength Friction CONTINUOUS DIRECT COMPRESSION Drug Compounding Pharmaceutical Science 02 engineering and technology 030226 pharmacology & pharmacy Permeability FORCED FEEDER Excipients 03 medical and health sciences Tableting Die filling 0302 clinical medicine Blend properties PLS model Paddle Technology Pharmaceutical PARACETAMOL Turret Composite material SPEED Porosity Models Statistical PLATFORM 021001 nanoscience & nanotechnology FORMULATION DESIGN Continuous manufacturing PRODUCTS Chemistry Models Chemical Pharmaceutical Preparations Compressibility Die (manufacturing) POWDER FLOW PROPERTIES 0210 nano-technology business Material properties Displacement (fluid) Databases Chemical Metoprolol Tablets WEIGHT VARIABILITY |
Zdroj: | INTERNATIONAL JOURNAL OF PHARMACEUTICS |
ISSN: | 0378-5173 1873-3476 |
Popis: | Based on characterization of a wide range of fillers and APIs, thirty divergent blends were composed and subsequently compressed on a rotary tablet press, varying paddle speed and turret speed. The tablet weight variability was determined of 20 grab samples consisting of each 20 tablets. Additionally, the bulk residence time, ejection force, pre-compression displacement, main compression force, die fill fraction and feed frame fill fraction were determined during each run. Multivariate data analysis was applied to investigate the relation between the process parameters, blend characteristics, product and process responses. Blends with metoprolol tartrate as API showed high ejection forces. This behavior could be linked to the high wall friction value of metoprolol tartrate. The main responses related to the die filling could be predicted via a PLS model based on blend characteristics. Tablet weight variability was highly correlated with the variability on pre-compression displacement and main compression force. A good predictive model for tablet weight variability was obtained taking the porosity, wall friction angle, flowability, density, compressibility and permeability into account. Additionally, turret speed and paddle speed were included in the calibration of the model. The applied approach can save resources (material, time) during early drug product development. |
Databáze: | OpenAIRE |
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