A systematic investigation of external lubrication of mini-tablets on a rotary tablet press with focus on the tensile strength

EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS(2024)

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摘要
External lubrication is an alternative to internal lubrication and its related detrimental effects on properties of tablets like tensile strength (TS). However, to date there are hardly any systematic investigations on external lubrication of mini -tablets on rotary tablet presses. Aim of this study was the systematic investigation of the impact of parameters tableting pressure, tableting speed, dosing rate and air pressure on the TS of mini -tablets. Both studies, the Central Composite Design (CCD) with SMCC 90 and the subsequently executed D -optimal design with SMCC 50, exhibited that tableting pressure had the highest positive effect on TS. Tableting speed and dosing rate in the CCD presumably did not seem to influence the TS, air pressure represented a positive coefficient. An additional temporal factor seemed to impact the results, deduced from the negative effect of the experimental order on TS in the CCD and from the negative correlation along the execution order in the residual plots. Additional long runs support findings of a non-linear decrease of TS over time. An interplay between dosing rate level and performance of the dust extraction collector is assumed, making more magnesium stearate available in the tablet press and potentially causing gradual contamination of the powder over time.
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关键词
Mini -tablets,Tableting,Rotary tablet press,External lubrication,Internal lubrication,Statistical design
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