Ultrasonic real-time in-die monitoring of the tablet compaction process—A proof of concept study

Stephens, James D.; Kowalczyk, Brian R.; Hancock, Bruno C.; Kaul, Gautam; Cetinkaya, Çetin

doi:10.1016/j.ijpharm.2012.09.014

Cited by 13 publications

(5 citation statements)

References 21 publications

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“…They found that SOS is sensitive to the mixing time of magnesium stearate and the dwell time of the compaction cycle (Leskinen et al, 2013). The in-die real-time tablet monitoring system has also been used by Stephens et al (2013) to evaluate the tablet mechanical integrity and the presence of defects, and its applicability as a control system was validated. Although the in-die measurement provides valuable information, the mechanical strength of a tablet is different if measured outof-die.…”

Section: Introductionmentioning

confidence: 99%

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

Razavi

Callegari

Drazer

et al. 2016

International Journal of Pharmaceutics

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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.

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Section: Introductionmentioning

confidence: 99%

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

Razavi

Callegari

Drazer

et al. 2016

International Journal of Pharmaceutics

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show abstract

“…The ultrasonic method is also widely applied in the field of pharmaceutical research. Since ultrasonics use a mechanical wave, the speed of sound is sensitive to mechanical properties, and thus, it has been used to determine the porosity and elastic modulus of tablets and coating thickness [58,[68][69][70][71][72][73][74][75][76]. As an example, Figure 5 shows the wireless transmission of ultrasonic waveforms for monitoring drug tablet properties and defects as reported by Stephens et al [70].…”

Section: Application Examplesmentioning

confidence: 99%

Review of sensing technologies for measuring powder density variations during pharmaceutical solid dosage form manufacturing

Stranzinger

Markl

Khinast

et al. 2021

TrAC Trends in Analytical Chemistry

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“…Contact ultrasound testing was employed by Akseli et al in the characterization of the physicalmechanical attributes of coated tablets (Akseli et al, 2009). The study involved the use of a delay-line transducer containing active element in a series of contact pulse/echo ultrasonic waves Recently, Stephens investigated contact ultrasonic testing for real-time monitoring of physical-mechanical behavior of tablets during compression (Stephens et al, 2013b). The study included a transducer for the generation of ultrasonic waves, directly connected to the upper punch of the tablet compression machine.…”

Section: Contact and Wireless Ultrasonic Testingmentioning

confidence: 99%

“…The delivery of drugs from a tablet is greatly influenced by its composition and physical-mechanical properties such as geometric dimensions, density, breaking force etc. (Stephens et al, 2013b).…”

Section: Introductionmentioning

confidence: 99%

Emerging technologies for the non-invasive characterization of physical-mechanical properties of tablets

Dave

Shahin

Youngren-Ortiz³

et al. 2017

International Journal of Pharmaceutics

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The density, porosity, breaking force, viscoelastic properties, and the presence or absence of any structural defects or irregularities are important physical-mechanical quality attributes of popular solid dosage forms like tablets. The irregularities associated with these attributes may influence the drug product functionality. Thus, an accurate and efficient characterization of these properties is critical for successful development and manufacturing of a robust tablets. These properties are mainly analyzed and monitored with traditional pharmacopeial and non-pharmacopeial methods. Such methods are associated with several challenges such as lack of spatial resolution, efficiency, or sample-sparing attributes. Recent advances in technology, design, instrumentation, and software have led to the emergence of newer techniques for non-invasive characterization of physical-mechanical properties of tablets. These techniques include near infrared spectroscopy, Raman spectroscopy, X-ray microtomography, nuclear magnetic resonance (NMR) imaging, terahertz pulsed imaging, laser-induced breakdown spectroscopy, and various acoustic- and thermal-based techniques. Such state-of-the-art techniques are currently applied at various stages of development and manufacturing of tablets at industrial scale. Each technique has specific advantages or challenges with respect to operational efficiency and cost, compared to traditional analytical methods. Currently, most of these techniques are used as secondary analytical tools to support the traditional methods in characterizing or monitoring tablet quality attributes. Therefore, further development in the instrumentation and software, and studies on the applications are necessary for their adoption in routine analysis and monitoring of tablet physical-mechanical properties.

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Ultrasonic real-time in-die monitoring of the tablet compaction process—A proof of concept study

Cited by 13 publications

References 21 publications

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

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

Review of sensing technologies for measuring powder density variations during pharmaceutical solid dosage form manufacturing

Emerging technologies for the non-invasive characterization of physical-mechanical properties of tablets

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