Process analytical technology (PAT) approach to the formulation of thermosensitive protein-loaded pellets: Multi-point monitoring of temperature in a high-shear pelletization

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• 作者：Katalin Kristó ; ^a ; Orsolya Ková ; cs^a ; Andrá ; s Kelemen^b ; Ferenc Lajkó ; ^c ; Gá ; bor Klivé ; nyi^c ; Bé ; la Jancsik^c ; Klá ; ra Pintye-Hó ; di^a ; Gé ; za Regdon jr.^a ; ^{geza.regdon@pharm.u-szeged.hu}
• 关键词：High-shear pelletization ; Elevated temperature measurement ; Protein ; Pepsin ; Enzyme activity ; Process analytical technology (PAT)
• 刊名：European Journal of Pharmaceutical Sciences
• 出版年：2016
• 出版时间：1 December 2016
• 年：2016
• 卷：95
• 期：Complete
• 页码：62-71
• 全文大小：1531 K
• 卷排序：95

文摘

In the literature there are some publications about the effect of impeller and chopper speeds on product parameters. However, there is no information about the effect of temperature. Therefore our main aim was the investigation of elevated temperature and temperature distribution during pelletization in a high shear granulator according to process analytical technology. During our experimental work, pellets containing pepsin were formulated with a high-shear granulator. A specially designed chamber (Opulus Ltd.) was used for pelletization. This chamber contained four PyroButton-TH® sensors built in the wall and three PyroDiff® sensors 1, 2 and 3 cm from the wall. The sensors were located in three different heights. The impeller and chopper speeds were set on the basis of 32factorial design. The temperature was measured continuously in 7 different points during pelletization and the results were compared with the temperature values measured by the thermal sensor of the high-shear granulator. The optimization parameters were enzyme activity, average size, breaking hardness, surface free energy and aspect ratio. One of the novelties was the application of the specially designed chamber (Opulus Ltd.) for monitoring the temperature continuously in 7 different points during high-shear granulation. The other novelty of this study was the evaluation of the effect of temperature on the properties of pellets containing protein during high-shear pelletization.