Toward predicting tensile strength of pharmaceutical tablets by ultrasound measurement in continuous manufacturing.

Abstract:

:An ultrasound measurement system was employed as a non-destructive method to evaluate its reliability in predicting the tensile strength of tablets and investigate the benefits of incorporating it in a continuous line, manufacturing solid dosage forms. Tablets containing lactose, acetaminophen, and magnesium stearate were manufactured continuously and in batches. The effect of two processing parameters, compaction force and level of shear strain were examined. Young's modulus and tensile strength of tablets were obtained by ultrasound and diametrical mechanical testing, respectively. It was found that as the blend was exposed to increasing levels of shear strain, the speed of sound in the tablets decreased and the tablets became both softer and mechanically weaker. Moreover, the results indicate that two separate tablet material properties (e.g., relative density and Young's modulus) are necessary in order to predict tensile strength. A strategy for hardness prediction is proposed that uses the existing models for Young's modulus and tensile strength of porous materials. Ultrasound testing was found to be very sensitive in differentiating tablets with similar formulation but produced under different processing conditions (e.g., different level of shear strain), thus, providing a fast, and non-destructive method for hardness prediction that could be incorporated to a continuous manufacturing process.

journal_name

Int J Pharm

authors

Razavi SM,Callegari G,Drazer G,Cuitiño AM

doi

10.1016/j.ijpharm.2016.04.064

subject

Has Abstract

pub_date

2016-06-30 00:00:00

pages

83-9

issue

1-2

eissn

0378-5173

issn

1873-3476

pii

S0378-5173(16)30347-7

journal_volume

507

pub_type

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