Nondestructive measurements of the compact strength and the particle-size distribution after milling of roller compacted powders by near-infrared spectroscopy

Gupta, Abhay; Peck, Garnet E.; Miller, Ronald W.; Morris, Kenneth R.

doi:10.1002/jps.20003

Cited by 76 publications

(48 citation statements)

References 12 publications

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“…The interest in understanding the effect of operating parameters and material properties has also lead to research efforts for real-time monitoring of ribbon density, where nearinfrared spectroscopy (NIRS) has been the principal analytical technique used (12)(13)(14)(15). Real-time monitoring with subsequent control of roller compaction parameters is being followed to minimize the effects of density variation and control the properties of manufactured tablets.…”

Section: Introductionmentioning

confidence: 99%

Evaluation of Three Approaches for Real-Time Monitoring of Roller Compaction with Near-Infrared Spectroscopy

et al. 2012

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Abstract. Three different approaches have been evaluated for monitoring ribbon density through realtime near-infrared spectroscopy measurements. The roll compactor was operated to produce microcrystalline cellulose (MCC) ribbons of varying densities. The first approach used the slope of the spectra which showed a variation through the ribbon that could be attributed to density. A second qualitative approach was also developed with a principal component analysis (PCA) model with spectra taken in-line during the production of ribbons in an ideal roll pressure range. The PCA (i.e., real-time) density scans show that the model was able to qualitatively capture the density responses resulting from variation in process parameters. The third approach involved multivariate partial least squares (PLS) calibration models developed at wavelength regions of 1,120-1,310 and 1,305-2,205 nm. Also, various PLS models were developed using three reference methods: caliper, pycnometer, and in-line laser. The third approach shows a quantitative difference between the model-predicted and the measured densities. Models developed at high-wavelength region showed highest accuracy compared with models at low-wavelength region. All the PLS models showed a high accuracy along the spectra collected throughout the production of the ribbons. The three methods showed applicability to process control monitoring by describing the changes in density during in-line sampling.

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Section: Introductionmentioning

confidence: 99%

Evaluation of Three Approaches for Real-Time Monitoring of Roller Compaction with Near-Infrared Spectroscopy

et al. 2012

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“…The calibration models built from static sampling mode showed inferior performance in terms of figures of merits, especially the validation results, irrespective of the spectral preprocessing technique for all types of NIR probes. This is quite interesting as most of the previous studies based on static spectral acquisition reported improved performances of the models due to their smooth surface of the flakes (16,18,22,27,28). In this study, the performances of the models were poorer when the models were built using static spectral data.…”

Section: Effect Of Sampling Mode On Nir Spectral Feature and Calibratmentioning

confidence: 63%

“…Gupta et al reported that content uniformity, density, and tensile strength (TS) of the flakes could be predicted in-line with appropriate design of experiments and calibration model (16,18).…”

Section: Introductionmentioning

confidence: 99%

Application of Near-Infrared Spectroscopy in Real-Time Monitoring of Product Attributes of Ribbed Roller Compacted Flakes

Samanta

Karande

et al. 2012

AAPS PharmSciTech

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Abstract. This study assessed the utility of near-infrared (NIR) spectroscopy for the real-time monitoring of content uniformity and critical quality attributes (tensile strength, Young's modulus, and relative density) of ribbed roller compacted flakes made by axially corrugated or ribbed rolls. A custom-built setup was used to capture off-line NIR spectra from the flakes containing micronized chlorpheniramine maleate, microcrystalline cellulose, lactose, and magnesium stearate. The partial least square regression method was employed to build calibration models from these off-line NIR spectra using experimental design and validated using test set validation. During calibration model development, various factors, such as spectral acquisition mode, probe positioning, spectral preprocessing method, and beam size, were investigated to improve the prediction ability of the models. The statistical results obtained for calibration models and their validation revealed that dynamic spectral acquisition and proper probe positioning were very crucial to minimize the incorporation of variability in NIR spectra resulting from the flake's undulation. Calibration and validation statistics also suggested the importance of selecting appropriate spectral preprocessing method and beam size. In this study, best calibration models resulted from standard normal variate followed by first derivative preprocessed dynamic spectra captured using beam sizẽ 1.2 mm. Best calibration models constructed from off-line NIR spectra were used in real-time analysis of flake attributes. Finally, adequacy of best calibration models was established from real-time prediction results. Overall, with the proposed setup, it was possible to monitor the roller compaction process in real time for various properties associated with the ribbed flakes in a rapid, efficient, and nondestructive manner.

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“…The CQAs of rollercompacted granules are the granule characteristics (e.g., moisture content, relative density, tensile strength, and particle-size distribution) and the content uniformity. To monitor these CQAs, there were three studies [23][24][25], in which NIR spectra from the mid-point of the ribbons as they exited the rolls were collected in-line.…”

Section: Roller Compactionmentioning

confidence: 99%

“…Then, a model for the prediction of the mechanical strength of the ribbons, based on the slope of the best-fit line through the spectra was constructed (calculated by regression analysis). The model could also be used to predict the particle-size distribution of the compacts after milling [23].…”

Section: Roller Compactionmentioning

confidence: 99%

Process Analytical Technology for continuous manufacturing of solid-dosage forms

Fonteyne

Vercruysse

Leersnyder

et al. 2015

TrAC Trends in Analytical Chemistry

144

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Currently, pharmaceutical production is making the switch from batch processing towards continuous processing. The quality of intermediate and end products produced by batch processes is assured by off-line testing. It is obvious that off-line tests in analytical laboratories cancel out the advantages of continuous processing, so the critical quality attributes of continuously produced pharmaceuticals need to be monitored in real time. In 2004, the US Food and Drug Administration launched the process analytical technology (PAT) concept to stimulate the pharmaceutical industry to change from off-line to real-time quality testing. This review explores the implementation of PAT tools within continuous pharmaceutical processes (i.e., blending, spray drying, roller compaction, twin-screw granulation and compression), focusing on both opportunities and challenges.

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Nondestructive measurements of the compact strength and the particle-size distribution after milling of roller compacted powders by near-infrared spectroscopy

Cited by 76 publications

References 12 publications

Evaluation of Three Approaches for Real-Time Monitoring of Roller Compaction with Near-Infrared Spectroscopy

Evaluation of Three Approaches for Real-Time Monitoring of Roller Compaction with Near-Infrared Spectroscopy

Application of Near-Infrared Spectroscopy in Real-Time Monitoring of Product Attributes of Ribbed Roller Compacted Flakes

Process Analytical Technology for continuous manufacturing of solid-dosage forms

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