Raman spectroscopy as a PAT for pharmaceutical blending: Advantages and disadvantages

Riolo, Daniela; Piazza, Alessandro; Cottini, C.; Serafini, Margherita; Lutero, Emilio; Cuoghi, Erika; Gasparini, Lorena; Botturi, Debora; Marino, Iari Gabriel; Aliatis, Irene; Bersani, Danilo; Lottici, Pier Paolo

doi:10.1016/j.jpba.2017.11.030

Cited by 35 publications

(16 citation statements)

References 19 publications

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“…This technique is being extensively explored in the field of pharmaceutics and food industry for quality control‐related applications in the manufacturing of medicinal tablets and instant food mixes 28‐30 . This technique has been evaluated as a process analytical tool to determine the end point of the mixing for pharmaceutical blends 31 . Riolo et al 31 compared the Raman spectroscopic data with the data obtained by conventional high‐performance liquid chromatography (HPLC) method based on the standard deviation analysis and found that the Raman data are more substantial than HPLC ones.…”

Section: Introductionmentioning

confidence: 99%

Raman imaging for measuring homogeneity of dry binary blend: Combining microscopy with spectroscopy for technologists

Gupta

Pathak

Chaudhary

et al. 2020

Analytical Science Advances

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Expanding the capabilities of Raman scattering as an analytical tool for engineering applications can optimize the technological output immensely. Understanding the homogeneity of any blended mix is one such significant parameter in the family of composite building construction materials that needs an appropriate tool for its measurement. Raman spectromicroscopy has been established here for the purpose of studying the chemical homogeneity at the microscopic scale of a dry binary blend used in the building constructions as an example. In this study, two waste stone powdered materials, obtained from western Indian stone fields, have been characterized in their respective unmixed forms using Raman spectroscopy up to an extent so that the same can be developed as a microscopic tool to clearly “see” the chemical homogeneity of a mixture. A step‐by‐step study has been carried out by first, simply making a physically separated and identifiable boundary of the two materials followed by obtaining a Raman line image. The Raman line map could clearly identify the boundary, which otherwise was not possible to appreciate visibly. The same recipe has been extended to study the homogeneity of a binary mixture (blended in 1:1 ratio), using a Raman area map. The novelty of the work lies in the advancement in the analytical tool's family to see the chemical homogeneity of building construction materials at the microscopic level. Chemical imaging using Raman spectroscopy has been demonstrated as a simple tool to understand the homogeneity of the dry binary blend, which was not possible by other simple techniques. Using Raman area mapping proves to be a quick, valuable, and effective tool for measuring the homogeneity of the blended mixes at the microscopic scale and important for application in building construction materials.

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Section: Introductionmentioning

confidence: 99%

Raman imaging for measuring homogeneity of dry binary blend: Combining microscopy with spectroscopy for technologists

Gupta

Pathak

Chaudhary

et al. 2020

Analytical Science Advances

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“…Riolo and colleagues (78) highlighted the importance of Raman spectroscopy monitoring in the early part of a production process. The acquisition of initial data is fundamental for statistical treatment and identification of variabilities, aiming to determine the outcome of powder mixtures and ensure the manufacture of safe and effective medicines.…”

Section: Raman Spectroscopy In Process Analytical Technologymentioning

confidence: 99%

“…Additionally, other two studies of 13 (Table 3) presented real time monitoring of the powder mixing process. The drug substance quantification occurred during the process, which allowed for evaluating the mixing profiles, as well as identifying the outcome of these, ensuring their uniformity (78)(79)(80).…”

Section: Raman Spectroscopy In Process Analytical Technologymentioning

confidence: 99%

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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“…Process analytical technology (PAT) has been successfully implemented to track the coating process, both in-line and on-line modes, with high precision. Near-infrared [6][7][8], conventional computer scanners [9], terahertz pulsed imaging [10], and Raman spectroscopy [11][12][13][14][15][16][17] have been successfully used to quantify the coating thickness. However, these techniques are typically capable of measuring an average value of the coated tablet and often do not show the coating distribution on the individual tablet.…”

Section: Introductionmentioning

confidence: 99%

Image-Based Artificial Intelligence Methods for Product Control of Tablet Coating Quality

Hirschberg,

Edinger,

Holmfred

et al. 2020

Pharmaceutics

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Mimicking the human decision-making process is challenging. Especially, many process control situations during the manufacturing of pharmaceuticals are based on visual observations and related experience-based actions. The aim of the present work was to investigate the use of image analysis to classify the quality of coated tablets. Tablets with an increasing amount of coating solution were imaged by fast scanning using a conventional office scanner. A segmentation routine was implemented to the images, allowing the extraction of numeric image-based information from individual tablets. The image preprocessing was performed prior to utilization of four different classification techniques for the individual tablet images. The support vector machine (SVM) technique performed superior compared to a convolutional neural network (CNN) in relation to computational time, and this approach was also slightly better at classifying the tablets correctly. The fastest multivariate method was partial least squares (PLS) regression, but this method was hampered by the inferior classification accuracy of the tablets. Finally, it was possible to create a numerical threshold classification model with an accuracy comparable to the SVM approach, so it is evident that there exist multiple valid options for classifying coated tablets.

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Raman spectroscopy as a PAT for pharmaceutical blending: Advantages and disadvantages

Cited by 35 publications

References 19 publications

Raman imaging for measuring homogeneity of dry binary blend: Combining microscopy with spectroscopy for technologists

Raman imaging for measuring homogeneity of dry binary blend: Combining microscopy with spectroscopy for technologists

Raman Spectroscopy for Quantitative Analysis in the Pharmaceutical Industry

Image-Based Artificial Intelligence Methods for Product Control of Tablet Coating Quality

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