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

Stranzinger, Sandra; Markl, Daniel; Khinast, Johannes; Paudel, Amrit

doi:10.1016/j.trac.2020.116147

Cited by 23 publications

(10 citation statements)

References 158 publications

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“…During the last decade, a growing interest in the use of NIR-CI in the field of pharmaceutical analysis has been observed (16). Further, noteworthy reviews on the merits of NIRS with special emphasis on pharmaceutics and dosage forms are the reviews by De Beer et al (17) and, more recent, the review by Stranzinger et al (18). NIRS has been successfully been used for raw material testing, process monitoring, and product quality control (19)(20)(21)(22)(23).…”

Section: Highlightsmentioning

confidence: 99%

Near-Infrared Hyperspectral Imaging as a Monitoring Tool for On-Demand Manufacturing of Inkjet-Printed Formulations

et al. 2021

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This study evaluates the potential use of near-infrared hyperspectral imaging (NIR-HSI) for quantitative determination of the drug amount in inkjet-printed dosage forms. We chose metformin hydrochloride as a model active pharmaceutical ingredient (API) and printed it onto gelatin films using a piezoelectric inkjet printing system. An industry-ready NIR-HSI sensor combined with a motorized movable linear stage was applied for spectral acquisition. Initial API-substrate screening revealed best printing results for gelatin films with TiO2 filling. For calibration of the NIR-HSI system, escalating drug doses were printed on the substrate. After spectral pre-treatments, including standard normal variate (SNV) and Savitzky-Golay filtering for noise reduction and enhancement of spectral features, principal component analysis (PCA) and partial least squares (PLS) regression were applied to create predictive models for the quantification of independent printed metformin hydrochloride samples. It could be shown that the concentration distribution maps provided by the developed HSI models were capable of clustering and predicting the drug dose in the formulations. HSI model prediction showed significant better correlation to the reference (HPLC) compared to on-board monitoring of dispensed volume of the printer. Overall, the results emphasize the capability of NIR-HSI as a fast and non-destructive method for the quantification and quality control of the deposited API in drug-printing applications. Graphical abstract

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Section: Highlightsmentioning

confidence: 99%

Near-Infrared Hyperspectral Imaging as a Monitoring Tool for On-Demand Manufacturing of Inkjet-Printed Formulations

et al. 2021

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“…The study of density is therefore broadly applicable and brings valuable insights into the characteristics and fundamental understanding of matters and processes. Conventionally, density measurements play an important role in quality control, for instance, to characterize fuels, 1–3 oils, 1,4 and pharmaceutical and cosmetic products, 5–7 or to determine alcohol or sugar concentration in beverages. 8,9 Nevertheless, density-based methods have been somehow regarded as “information poor” due to the limitations of conventional methods.…”

Section: Introductionmentioning

confidence: 99%

Advanced density-based methods for the characterization of materials, binding events, and kinetics

Doan-Nguyen

Crespy

2022

Chem. Soc. Rev.

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“…In food science [4], it may be applied for inspection [5] or evaluation [6]. In pharmaceutical manufacturing, diffuse optics may join other process analytical technologies, for example to analyze and characterize particles [7] or powders [8]. A few other examples include archaeological soil analysis [9], dendrology (study of wood) [10], and art authentication analysis [11].…”

Section: Introductionmentioning

confidence: 99%

Dual-Slope Diffuse Reflectance Instrument for Calibration-Free Broadband Spectroscopy

et al. 2021

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This work presents the design and validation of an instrument for dual-slope broadband diffuse reflectance spectroscopy. This instrument affords calibration-free, continuous-wave measurements of broadband absorbance of optically diffusive media, which may be translated into absolute absorption spectra by adding frequency-domain measurements of scattering at two wavelengths. An experiment on a strongly scattering liquid phantom (milk, water, dyes) confirms the instrument’s ability to correctly identify spectral features and measure absolute absorption. This is done by sequentially adding three dyes, each featuring a distinct spectral absorption, to the milk/water phantom. After each dye addition, the absorption spectrum is measured, and it is found to reproduce the spectral features of the added dye. Additionally, the absorption spectrum is compared to the absorption values measured with a commercial frequency-domain instrument at two wavelengths. The measured absorption of the milk/water phantom quantitatively agrees with the known water absorption spectrum (R2=0.98), and the measured absorption of the milk/water/dyes phantom quantitatively agrees with the absorption measured with the frequency-domain instrument in six of eight cases. Additionally, the measured absorption spectrum correctly recovers the concentration of one dye, black India ink, for which we could accurately determine the extinction spectrum (i.e., the specific absorption per unit concentration). The instrumental methods presented in this work can find applications in quantitative spectroscopy of optically diffusive media, and particularly in near-infrared spectroscopy of biological tissue.

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

Cited by 23 publications

References 158 publications

Near-Infrared Hyperspectral Imaging as a Monitoring Tool for On-Demand Manufacturing of Inkjet-Printed Formulations

Near-Infrared Hyperspectral Imaging as a Monitoring Tool for On-Demand Manufacturing of Inkjet-Printed Formulations

Advanced density-based methods for the characterization of materials, binding events, and kinetics

Dual-Slope Diffuse Reflectance Instrument for Calibration-Free Broadband Spectroscopy

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