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
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