Étude des corrélations entre un simulateur de compression et une presse à comprimer industrielle

Abstract : Scaling up is a critical step in the pharmaceutical tablet industry. At the laboratory scale, compaction simulators allow the reproduction of rotary tablet press behaviours in order to manufacture predictive prototypes. This predictivity is decisive for complex release profile tablets. The work was an assessment of the correlations between the STYL'One Evolution simulator and an industrial Hata 55LSU-3L press taking a Geomatrix™ technology tablet as a comparison basis. These tablets have been produced successively on the simulator and on the Hata press. Two types of data have been compared: physicochemical characteristics of the tablets (mass, thickness, hardness, friability, dissolution) and process parameters (filling height, compression pressure, compression thickness). Results showed an important similarity between both characteristics and parameters populations. Tablet hardness was significantly lower on the simulator than on the industrial press. This is due to over-mixing leading to over-lubrication occurring in the simulator feeding shoe. Concerning the predictivity of the dissolution profile for the complex tablet, the interest of the simulator has been demonstrated. As such, all of these conclusions support the investment required for a compaction simulator purchase.
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Master Thesis
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Submitted on : Monday, July 1, 2019 - 12:16:02 PM
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Lucile Kowalski. Étude des corrélations entre un simulateur de compression et une presse à comprimer industrielle. Sciences pharmaceutiques. 2019. ⟨dumas-02169547⟩

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