A Novel Microwave Sensor for Real-Time Online Monitoring of Roll Compacts of Pharmaceutical Powders Online—A Comparative Case Study with NIR

Gupta, Anshu; Austin, Joe Dan; Davis, Sierra A.; Harris, Michael T.; Reklaitis, Gintaras V.

doi:10.1002/jps.24409

Cited by 22 publications

(11 citation statements)

References 20 publications

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“…The low calibration error confirmed that the process monitoring using NIRS during the roller compaction process is suitable [ 176 ]. Gupta et al monitored ribbon density and drug content using NIRS and microwave sensors in the roller compaction process [ 227 ]. Khorasani et al performed process monitoring using NIR and NIR-CI in a continuous roller compression granulation process.…”

Section: Application Of Pat Framework For Control Strategy Of the Unit Operationsmentioning

confidence: 99%

Process Analytical Technology Tools for Monitoring Pharmaceutical Unit Operations: A Control Strategy for Continuous Process Verification

Kim

et al. 2021

Pharmaceutics

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Various frameworks and methods, such as quality by design (QbD), real time release test (RTRT), and continuous process verification (CPV), have been introduced to improve drug product quality in the pharmaceutical industry. The methods recognize that an appropriate combination of process controls and predefined material attributes and intermediate quality attributes (IQAs) during processing may provide greater assurance of product quality than end-product testing. The efficient analysis method to monitor the relationship between process and quality should be used. Process analytical technology (PAT) was introduced to analyze IQAs during the process of establishing regulatory specifications and facilitating continuous manufacturing improvement. Although PAT was introduced in the pharmaceutical industry in the early 21st century, new PAT tools have been introduced during the last 20 years. In this review, we present the recent pharmaceutical PAT tools and their application in pharmaceutical unit operations. Based on unit operations, the significant IQAs monitored by PAT are presented to establish a control strategy for CPV and real time release testing (RTRT). In addition, the equipment type used in unit operation, PAT tools, multivariate statistical tools, and mathematical preprocessing are introduced, along with relevant literature. This review suggests that various PAT tools are rapidly advancing, and various IQAs are efficiently and precisely monitored in the pharmaceutical industry. Therefore, PAT could be a fundamental tool for the present QbD and CPV to improve drug product quality.

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Section: Application Of Pat Framework For Control Strategy Of the Unit Operationsmentioning

confidence: 99%

Process Analytical Technology Tools for Monitoring Pharmaceutical Unit Operations: A Control Strategy for Continuous Process Verification

Kim

et al. 2021

Pharmaceutics

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“…The authors made a step forward in this study with the use of mixed composition blend by combining one smooth and one knurled roll and especially by introducing measurement of API concentration. The pretreatment of the MRT signal was also first presented in this study (54) and has proven to be important in microwave data analysis. Microwave and NIR data were analyzed using PLS regression and artificial neural networks (ANNs).…”

Section: Application Of Microwave Resonance Technology In Monitoring the Roller Compaction Processmentioning

confidence: 95%

“…Microwave resonance technology (MRT) is a novel approach for measuring material's physical and chemical (54) properties. It is based on the interaction between water molecules and the electromagnetic field.…”

Section: Application Of Microwave Resonance Technology In Monitoring the Roller Compaction Processmentioning

confidence: 99%

“…The results of both studies (54,60) indicate that MRT is a promising tool for measuring CQAs of roller-compacted formulations such as density, moisture content and API concentration of the ribbons and for providing useful data during the roller compaction process in real-time. Although microwave resonance was shown to be more accurate than NIR spectroscopy for determining moisture content and density in roller-compacted ribbons, and it also does not require the use of sophisticated chemometric methods, and the sensors can be cheaply designed and fabricated, it does not provide as accurate information on chemical composition of the sample as NIR spectroscopy if it is correctly calibrated.…”

Section: Application Of Microwave Resonance Technology In Monitoring the Roller Compaction Processmentioning

confidence: 99%

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Process analytical technology tools for process control of roller compaction in solid pharmaceuticals manufacturing

Vovko

Vrečer

2020

Acta Pharmaceutica

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This article presents an overview of using process analytical technology in monitoring the roller compaction process. In the past two decades, near-infrared spectroscopy, near-infrared spectroscopy coupled with chemical imaging, microwave resonance technology, thermal effusivity and various particle imaging techniques have been used for developing at-, off-, on- and in-line models for predicting critical quality attributes of ribbons and subsequent granules and tablets. The common goal of all these methods is improved process understanding and process control, and thus improved production of high-quality products. This article reviews the work of several researchers in this field, comparing and critically evaluating their achievements.

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“…For instance, Gupta et al 180 used a PLS calibration model to simultaneously predict relative density, moisture content, and tensile strength in real time. Gupta et al 181 used microwave online real-time monitoring density, API content and moisture content of ribbon based on ANN or PLS models. In this study, the performance of the different multivariate models was compared.…”

Section: Application Of Multivariate Modeling Techniques In Tablet Ma...mentioning

confidence: 99%

Pharmaceutical application of multivariate modelling techniques: a review on the manufacturing of tablets

et al. 2021

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A Novel Microwave Sensor for Real-Time Online Monitoring of Roll Compacts of Pharmaceutical Powders Online—A Comparative Case Study with NIR

Cited by 22 publications

References 20 publications

Process Analytical Technology Tools for Monitoring Pharmaceutical Unit Operations: A Control Strategy for Continuous Process Verification

Process Analytical Technology Tools for Monitoring Pharmaceutical Unit Operations: A Control Strategy for Continuous Process Verification

Process analytical technology tools for process control of roller compaction in solid pharmaceuticals manufacturing

Pharmaceutical application of multivariate modelling techniques: a review on the manufacturing of tablets

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