Characterization of NIR interfaces for the feeding and in-line monitoring of a continuous granulation process

Román-Ospino, Andrés D.; Tamrakar, Ashutosh; Igne, Benoît; Dimaso, Elyse Towns; Airiau, Christian; Clancy, Donald J.; Pereira, Glinka; Muzzio, Fernando J.; Singh, Ravendra; Ramachandran, Rohit

doi:10.1016/j.ijpharm.2019.118848

Cited by 14 publications

(6 citation statements)

References 25 publications

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“…Based on the MVA model, the API concentration was found to be significantly related to the change in powder density. Therefore, the API concentration was determined by monitoring the powder density [34]. This showed that the PAT-based modeling method is a useful tool to increase insight into the process and process scale-up.…”

Section: Pat-based Modeling Methodsmentioning

confidence: 99%

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Model-Based Scale-up Methodologies for Pharmaceutical Granulation

et al. 2020

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In the pharmaceutical industry, it is a major challenge to maintain consistent quality of drug products when the batch scale of a process is changed from a laboratory scale to a pilot or commercial scale. Generally, a pharmaceutical manufacturing process involves various unit operations, such as blending, granulation, milling, tableting and coating and the process parameters of a unit operation have significant effects on the quality of the drug product. Depending on the change in batch scale, various process parameters should be strategically controlled to ensure consistent quality attributes of a drug product. In particular, the granulation may be significantly influenced by scale variation as a result of changes in various process parameters and equipment geometry. In this study, model-based scale-up methodologies for pharmaceutical granulation are presented, along with data from various related reports. The first is an engineering-based modeling method that uses dimensionless numbers based on process similarity. The second is a process analytical technology-based modeling method that maintains the desired quality attributes through flexible adjustment of process parameters by monitoring the quality attributes of process products in real time. The third is a physics-based modeling method that involves a process simulation that understands and predicts drug quality through calculation of the behavior of the process using physics related to the process. The applications of these three scale-up methods are summarized according to granulation mechanisms, such as wet granulation and dry granulation. This review shows that these model-based scale-up methodologies provide a systematic process strategy that can ensure the quality of drug products in the pharmaceutical industry.

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Section: Pat-based Modeling Methodsmentioning

confidence: 99%

“…Figure 1. Summary of the approach to control the pharmaceutical manufacturing process using the process analytical technology tool [34]. The figure was modified, with permission from Elsevier.…”

Section: Pat-based Modeling Methodsmentioning

confidence: 99%

Model-Based Scale-up Methodologies for Pharmaceutical Granulation

et al. 2020

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“…Roman-Ospino et al [76] evaluated three NIR probe interfaces for TSG based on the prediction performance of a multivariate analysis. A calibration model consistent with the change in API concentration was obtained from the data obtained through the second interface.…”

Section: Pat Implementation In Pharmaceutical Granulation Techniquesmentioning

confidence: 99%

Granulation process analysis technologies and potential applications in traditional Chinese medicine

Cui

Hou

Feng

et al. 2022

Acupuncture and Herbal Medicine

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Pharmaceutical production is changing from batch production to continuous production, during which granulation is one of the most important unit operations. The quality of mass-produced products is traditionally guaranteed by conducting off-line testing, which cannot meet the demand of continuous production for real-time monitoring of critical process parameters and critical quality attributes (CQAs) of the pharmaceutical granulation technology. Since the U.S. Food and Drug Administration proposed process analytical technology (PAT) in 2004, many PAT tools have been developed to monitor the granulation process and provide information regarding the granulation operation conditions and endpoint determination. In this article, we review the recent research and application of two PAT modes in the granulation process, namely, single CQA and multi-CQA PAT, with the aim to provide references for comprehensively improving the technological level of the pharmaceutical granulation process. Furthermore, the potential applications in traditional Chinese Medicine are discussed.

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“…In the realm of food and pharmaceuticals, NIR spectroscopy has reached a point to where it is readily available in both screening technologies and in process monitoring applications [136,137]. As a screening technology, NIR can be used in a laboratory setting and at "point-of-use" as a portable technology [138].…”

Section: Nir In Food and Pharmaceutical Raw Materialsmentioning

confidence: 99%

QCM Sensor Arrays, Electroanalytical Techniques and NIR Spectroscopy Coupled to Multivariate Analysis for Quality Assessment of Food Products, Raw Materials, Ingredients and Foodborne Pathogen Detection: Challenges and Breakthroughs

Bwambok

Siraj

Macchi

et al. 2020

Sensors

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Quality checks, assessments, and the assurance of food products, raw materials, and food ingredients is critically important to ensure the safeguard of foods of high quality for safety and public health. Nevertheless, quality checks, assessments, and the assurance of food products along distribution and supply chains is impacted by various challenges. For instance, the development of portable, sensitive, low-cost, and robust instrumentation that is capable of real-time, accurate, and sensitive analysis, quality checks, assessments, and the assurance of food products in the field and/or in the production line in a food manufacturing industry is a major technological and analytical challenge. Other significant challenges include analytical method development, method validation strategies, and the non-availability of reference materials and/or standards for emerging food contaminants. The simplicity, portability, non-invasive, non-destructive properties, and low-cost of NIR spectrometers, make them appealing and desirable instruments of choice for rapid quality checks, assessments and assurances of food products, raw materials, and ingredients. This review article surveys literature and examines current challenges and breakthroughs in quality checks and the assessment of a variety of food products, raw materials, and ingredients. Specifically, recent technological innovations and notable advances in quartz crystal microbalances (QCM), electroanalytical techniques, and near infrared (NIR) spectroscopic instrument development in the quality assessment of selected food products, and the analysis of food raw materials and ingredients for foodborne pathogen detection between January 2019 and July 2020 are highlighted. In addition, chemometric approaches and multivariate analyses of spectral data for NIR instrumental calibration and sample analyses for quality assessments and assurances of selected food products and electrochemical methods for foodborne pathogen detection are discussed. Moreover, this review provides insight into the future trajectory of innovative technological developments in QCM, electroanalytical techniques, NIR spectroscopy, and multivariate analyses relating to general applications for the quality assessment of food products.

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Characterization of NIR interfaces for the feeding and in-line monitoring of a continuous granulation process

Cited by 14 publications

References 25 publications

Model-Based Scale-up Methodologies for Pharmaceutical Granulation

Model-Based Scale-up Methodologies for Pharmaceutical Granulation

Granulation process analysis technologies and potential applications in traditional Chinese medicine

QCM Sensor Arrays, Electroanalytical Techniques and NIR Spectroscopy Coupled to Multivariate Analysis for Quality Assessment of Food Products, Raw Materials, Ingredients and Foodborne Pathogen Detection: Challenges and Breakthroughs

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