Development of a multivariate light-induced fluorescence (LIF) PAT tool for in-line quantitative analysis of pharmaceutical granules in a V-blender

Guay, Jean-Maxime; Lapointe-Garant, Pierre-Philippe; Gosselin, Ryan; Simard, Jean-Sébastien; Abatzoglou, Nicolas

doi:10.1016/j.ejpb.2013.12.013

Cited by 22 publications

(9 citation statements)

References 16 publications

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“…Durao et al [128] studied the concentrations of 5 different constituents in a 31 component multivitamin powder blend in real-time as the blend was fed to a tableting press. Guay et al [129] monitored blending of pharmaceutical components in a V-blender using a non-contact probe that was affixed to one of the lids of the V-blender. An acceleration sensor was used to trigger the acquisition of the LIF spectra when the mixture completely covered the probe window.…”

Section: Accepted Manuscriptmentioning

confidence: 99%

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Review of noninvasive methods to characterize granular mixing

Nadeem

Heindel

2018

Powder Technology

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Granular mixing is a common process observed in a variety of industries such as construction, chemical processing, food handling, and cosmetics and pharmaceutical manufacturing. Over the years several methods have been devised to characterize granular mixing and to provide information on the quality of the mixture as well as mixing end points. In this work, three different noninvasive measurement categories are reviewed, namely: velocimetric, spectroscopic, and tomographic techniques. Velocimetric techniques such as Particle Image Velocimetry (PIV) and Radioactive particle tracking (RPT) are able to provide the trajectories and velocities of individual particles during the mixing process. Spectroscopic techniques focus on the chemical composition of the sample and are well suited for applications where there is little difference in the physical properties of the constituents such as particle size and density. Tomographic techniques such as X-ray computed tomography (CT) and Magnetic Resonance Imaging (MRI) provide information such as the spatial distribution of the different constituents in the sample and are useful in determining dead zones and inhomogeneities. A few other techniques are also discussed, particularly passive acoustic methods which, though can neither provide spatial distribution nor individual particle trajectories, are still useful and can be employed to determine mixing end points. The objective of the work is to provide a comparative assessment of the various noninvasive techniques and discuss their ability to effectively characterize the mixing process. The reported techniques will be reviewed thoroughly based on their functionality, viability, and characterization capability. The advantages and disadvantages of the various techniques are summarized and a comparison of the utility of the techniques in various applications is discussed.

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Section: Accepted Manuscriptmentioning

confidence: 99%

“…Spectroscopic methods are uniquely suitable for pilot scale systems [120,129] and easily extendable to industrial scale systems [138,139]. As mentioned, spectroscopic systems require that…”

Section: Accepted Manuscriptmentioning

confidence: 99%

Review of noninvasive methods to characterize granular mixing

Nadeem

Heindel

2018

Powder Technology

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“…More than 60% of the top 200 selling drugs in 2000 had fluorescent structural properties (1). Fluorescence detection has increased sensitivity (2,3), lower detection limits (3), better signal-to-noise ratio (4), and decreased background noise (4) compared to ultraviolet (UV) and near-infrared (NIR) absorption spectroscopy methods. These advantages result from the Stokes shift between the excitation and emission maximum wavelength and the 90°signal collection angle which minimizes scattered light interference.…”

Section: Introductionmentioning

confidence: 99%

“…The % RH detection limit was 0.35% RH indicating that fluorophore response can be sensitive to very small changes in % RH. Guay et al (2) have recently reported the development of a multiple fluorophor full emission spectra (302-1149 nm) diode array LIF detector for inline quantitative analysis of pharmaceutical granulations. The effect of moisture, hydrostatic pressure, particle size, and dyes on the LIF signal was evaluated.…”

Section: Introductionmentioning

confidence: 99%

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Effect of Percent Relative Humidity, Moisture Content, and Compression Force on Light-Induced Fluorescence (LIF) Response as a Process Analytical Tool

Shah

Stagner

2015

AAPS PharmSciTech

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Abstract. The effect of percent relative humidity (16-84% RH), moisture content (4.2-6.5% w/w MC), and compression force (4.9-44.1 kN CF) on the light-induced fluorescence (LIF) response of 10% w/w active pharmaceutical ingredient (API) compacts is reported. The fluorescent response was evaluated using two separate central composite designs of experiments. The effect of % RH and CF on the LIF signal was highly significant with an adjusted R 2 =0.9436 and p<0.0001. Percent relative humidity (p=0.0022), CF (p<0.0001), and % RH 2 (p=0.0237) were statistically significant factors affecting the LIF response. The effects of MC and CF on LIF response were also statistically significant with a p value <0.0001 and adjusted R 2 value of 0.9874. The LIF response was highly impacted by MC (p<0.0001), CF (p<0.0001), and MC 2 (p=0022). At 10% w/w API, increased % RH, MC, and CF led to a nonlinear decrease in LIF response. The derived quadratic model equations explained more than 94% of the data. Awareness of these effects on LIF response is critical when implementing LIF as a process analytical tool.KEY WORDS: design of experiments (DOE); fluorescence quenching; light-induced fluorescence (LIF); moisture; process analytical technology (PAT).

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Blending and Characterization of Pharmaceutical Powders

Anderson

Velez

2018

AAPS Advances in the Pharmaceutical Sciences Series

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Development of a multivariate light-induced fluorescence (LIF) PAT tool for in-line quantitative analysis of pharmaceutical granules in a V-blender

Cited by 22 publications

References 16 publications

Review of noninvasive methods to characterize granular mixing

Review of noninvasive methods to characterize granular mixing

Effect of Percent Relative Humidity, Moisture Content, and Compression Force on Light-Induced Fluorescence (LIF) Response as a Process Analytical Tool

Blending and Characterization of Pharmaceutical Powders

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