Global approach for the validation of an in-line Raman spectroscopic method to determine the API content in real-time during a hot-melt extrusion process

Netchacovitch, Lauranne; Thiry, Justine; Bleye, Charlotte De; Dumont, Elodie; Évrard, Brigitte; Hubert, Ph.; Ziémons, Eric

doi:10.1016/j.talanta.2017.04.060

Cited by 17 publications

(15 citation statements)

References 13 publications

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“…Two of three of these studies used the same model of the phantom (PhAT: Pharmaceutical Area Testing) with the same condition of excitation and diameter of point for quantification of the drugs, although with different types of equipment (79,80). These examples show that some accessories and devices can be applicable for different equipment configurations, including different manufacturers, as in a study performed by Netchacovitch and colleagues (33). In this study, a Kaiser Optical Systems probe coupled to a Perkin Elmer device was used.…”

Section: Raman Spectroscopy In Process Analytical Technologymentioning

confidence: 99%

“…Therefore, it uses a specific band intensity of the spectra (28). The multivariate analysis is a set of techniques that allows statistical analysis of data collected with more than one variable (29)(30)(31)(32) such as the wavelengths and spectral interactions (33).…”

Section: Raman Calibration Modelmentioning

confidence: 99%

“…Such an approach enables real-time understanding of these processes. Therefore, it has essential advantages as PAT tools, meeting regulatory requirements (33,46,53,77).…”

Section: Raman Spectroscopy In Process Analytical Technologymentioning

confidence: 99%

“…The calibration models should consider the concentration of the drugs in the powder mixture, the time of exposure of the sample to radiation, and the volume of the sample. This volume shall not overstep three times the unit dose range (33,36,46,84).…”

Section: Raman Spectroscopy In Process Analytical Technologymentioning

confidence: 99%

“…Like the previous study, a univariate and a multivariate model (including all wavelengths and their interactions) were developed for quantification of itraconazole in line, for monitoring the hot-melt extrusion process. The validation for the two calibration models occurred; however, the multivariate approach was more accurate due to including a more significant number of variables in the model (33). Such an approach may justify the use of multivariate models in 100% of the studies presented in Table 3.…”

Section: Raman Spectroscopy In Process Analytical Technologymentioning

confidence: 99%

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Raman Spectroscopy for Quantitative Analysis in the Pharmaceutical Industry

2020

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Raman spectroscopy is a very promising technique increasingly used in the pharmaceutical industry. Due to its development and improved instrumental versatility achieved over recent decades and through the application of chemometric methods, this technique has become highly precise and sensitive for the quantification of drug substances. Thus, it has become fundamental in identifying critical variables and their clinical relevance in the development of new drugs. In process monitoring, it has been used to highlight in-line real-time analysis, and it has been used more commonly since 2004 when the Food and Drug Administration (FDA) launched Process Analytical Technology (PAT), integrated with the concepts of Pharmaceutical Current Good Manufacturing Practices (CGMPs) for the 21st Century. The present review presents advances in the application of this tool in the development of pharmaceutical products and processes in the last six years.

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Section: Raman Spectroscopy In Process Analytical Technologymentioning

confidence: 99%

Section: Raman Calibration Modelmentioning

confidence: 99%

“…Such an approach enables real-time understanding of these processes. Therefore, it has essential advantages as PAT tools, meeting regulatory requirements (33,46,53,77).…”

Section: Raman Spectroscopy In Process Analytical Technologymentioning

confidence: 99%

Section: Raman Spectroscopy In Process Analytical Technologymentioning

confidence: 99%

Section: Raman Spectroscopy In Process Analytical Technologymentioning

confidence: 99%

See 3 more Smart Citations

Raman Spectroscopy for Quantitative Analysis in the Pharmaceutical Industry

2020

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Inline UV/Vis spectroscopy as PAT tool for hot-melt extrusion

Wesholowski

Prill

Berghaus

et al. 2018

Drug Deliv. and Transl. Res.

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Hot-melt extrusion on co-rotating twin screw extruders is a focused technology for the production of pharmaceuticals in the context of Quality by Design. Since it is a continuous process, the potential for minimizing product quality fluctuation is enhanced. A typical application of hot-melt extrusion is the production of solid dispersions, where an active pharmaceutical ingredient (API) is distributed within a polymer matrix carrier. For this dosage form, the product quality is related amongst others to the drug content. This can be monitored on- or inline as critical quality attribute by a process analytical technology (PAT) in order to meet the specific requirements of Quality by Design. In this study, an inline UV/Vis spectrometer from ColVisTec was implemented in an early development twin screw extruder and the performance tested in accordance to the ICH Q2 guideline. Therefore, two API (carbamazepine and theophylline) and one polymer matrix (copovidone) were considered with the main focus on the quantification of the drug load. The obtained results revealed the suitability of the implemented PAT tool to quantify the drug load in a typical range for pharmaceutical applications. The effort for data evaluation was minimal due to univariate data analysis, and in combination with a measurement frequency of 1 Hz, the system is sufficient for real-time data acquisition.

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