Near‐infrared spectroscopy and imaging for the monitoring of powder blend homogeneity

El‐Hagrasy, Arwa S.; Morris, Hannah R.; D’Amico, Frank; Lodder, Robert A.; Drennen, James K.

doi:10.1002/jps.1082

Cited by 176 publications

(89 citation statements)

References 16 publications

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“…Real-time monitoring has been used in pharmaceutical unit operations such as drying, 3,4 blending, [5][6][7][8][9] and fluid bed coating, but no studies of in-line sensor measurements of film coating in a pan coater have been reported. (Recent studies from Sweden 10,11 monitored the coating of beads in a fluid bed coater.)…”

Section: Introductionmentioning

confidence: 99%

Quantitative analysis of film coating in a pan coater based on in-line sensor measurements

et al. 2005

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A method was developed that enables in-line analysis of film coating thickness on tablets during a pan coating operation. Real-time measurements were made using a diffusereflectance near-infrared (NIR) probe positioned inside the pan during the coating operation. Real-time spectra of replicate batches were used for modeling film growth. Univariate analysis provided a simple method for in-line monitoring of the coating process using NIR data. An empirical geometric 2-vector volumetric growth model was developed, which accounts for differential growth on the face and band regions of biconvex tablets. The thickness of the film coat was determined by monitoring the decrease of absorption bands characteristic of a component of the tablet core and monitoring the increase of bands characteristic of a component in the coating material. There was good correlation between values estimated from the NIR data and the measured tablet volumetric growth. In-line measurements allow the coating process to be stopped when a predetermined tablet coating thickness is achieved.

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Section: Introductionmentioning

confidence: 99%

Quantitative analysis of film coating in a pan coater based on in-line sensor measurements

et al. 2005

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“…35 The statistical tools such as Principal Component Regression (PCR), Partial Least Squares (PLS) & Multi-term Linear Regression (MLR) are widely used for developing a quantitative NIR calibration model for evaluating blend uniformity results.…”

Section: Advanced Analytical Methods (Process Analytical Technology)mentioning

confidence: 99%

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2016

IJPSR

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ABSTRACT:The Process validation involves a series of activities over the lifecycle of the product and process. The FDA guidance described three stages of process validation which includes Process Design, Process Qualification, and Continued Process Verification (CPV). The CPV stage is a never ending approach that continues throughout the entire commercial lifecycle of the product. CPV is dependent on compliance with GMP principles and ensures that manufacturing process remains in a state of control. Establishment of Critical process parameters (CPP) and assessment of Critical quality attributes (CQA) of a product ensures robust manufacturing process and thereby improves productivity and desired quality. The product stability program, change control process & annual product review process serves as key drivers for monitoring process stability. Process analytical technology (PAT) applications such as near infra red spectroscopy, raman spectroscopy & multivariate statistical process control can be viewed as enablers for CPV. The primary goal of PAT is to reduce process variabilities that may impact CQA's of a product. Continued Process verification is an effective quality risk management tool for detecting trends and implementing preventive measures prior to CQA failures. Conducting a gap analysis helps to detect discrepancies related to manufacturing process, quality control systems of a pharmaceutical industry and becomes mandatory to achieve regulatory compliance. Ensuring data integrity is an essential component of industry's responsibility to ensure safety, efficacy and quality of drugs and is a direct measure to protect the public health.

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“…Near infrared chemical imaging (NIR-CI) has also been used in the field of pharmaceutical technology [18][19][20][21]. More recently, NIR-CI has been used by Lopes et al to detect and classify counterfeit antiviral drugs [22] and to determine their chemical composition [23].…”

Section: Since Its Approval By the American Food And Drug Agency (Fdamentioning

confidence: 99%

Detection of counterfeit Viagra® by Raman microspectroscopy imaging and multivariate analysis

Sacré

Deconinck

Saerens

et al. 2011

Journal of Pharmaceutical and Biomedical Analysis

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During the past years, pharmaceutical counterfeiting was mainly a problem of developing countries with weak enforcement and inspection programs. However, Europe and North America are more and more confronted with the counterfeiting problem. During this study, 26 counterfeits and imitations of Viagra ® tablets and 8 genuine tablets of Viagra ® were analysed by Raman microspectroscopy imaging.After unfolding the data, three maps are combined per sample and a first PCA is realised on these data. Then, the first principal components of each sample are assembled. The exploratory and classification analysis are performed on that matrix.PCA was applied as exploratory analysis tool on different spectral ranges to detect counterfeit medicines based on the full spectra (200-1800 cm After the exploratory analysis, three different classification algorithms were applied on the full spectra dataset: linear discriminant analysis, k-nearest neighbour and soft independent modelling of class analogy.PCA analysis of the 830-880cm -1 spectral region discriminated genuine samples while the multivariate analysis of the spectral region between 1200-1290 cm -1 returns no satisfactory results.A good discrimination of genuine samples was obtained with multivariate analysis of the full spectra region (200-1800 cm -1). Application of the k-NN and SIMCA algorithm returned 100% correct classification during both internal and external validation.

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Near‐infrared spectroscopy and imaging for the monitoring of powder blend homogeneity

Cited by 176 publications

References 16 publications

Quantitative analysis of film coating in a pan coater based on in-line sensor measurements

Quantitative analysis of film coating in a pan coater based on in-line sensor measurements

Untitled

Detection of counterfeit Viagra® by Raman microspectroscopy imaging and multivariate analysis

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