On-Line Monitoring of Powder Blend Homogeneity by Near-Infrared Spectroscopy

Sekulic, Sonja; Ward, Howard W.; Brannegan, Daniel R.; Stanley, Elizabeth D.; Evans, Christine L.; Sciavolino, Steven T.; Hailey, Perry A.; Aldridge, Paul K.

doi:10.1021/ac950964m

Cited by 232 publications

(123 citation statements)

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“…[12][13][14] Noninvasive measurements for these processes can now be performed through the use of fiber optics. Several literature examples of process analytical chemistry and process monitoring using NIR spectroscopy to obtain both qualitative [15][16][17] and quantitative 8,[18][19][20] analytical information have been reported. Process applications are well known in the areas of both solids 8,[15][16][17]19,20 and liquids.…”

Section: Introductionmentioning

confidence: 99%

“…Several literature examples of process analytical chemistry and process monitoring using NIR spectroscopy to obtain both qualitative [15][16][17] and quantitative 8,[18][19][20] analytical information have been reported. Process applications are well known in the areas of both solids 8,[15][16][17]19,20 and liquids. 18 Kirsch and Drennen 19 conducted quantitative an NIR analysis of tablet film coating by measuring tablets removed from the process (at-line).…”

Section: Introductionmentioning

confidence: 99%

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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%

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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“…Monitoring powder blending process by using NIR spectroscopy has been investigated, [15][16][17] because it is highly desired to detect the homogeneity of mixed powder. The outline of the blending test setup is shown in Fig.…”

Section: B Blending Monitoring Testmentioning

confidence: 99%

A polychromator-type near-infrared spectrometer with a high-sensitivity and high-resolution photodiode array detector for pharmaceutical process monitoring on the millisecond time scale

Murayama

Genkawa

Ishikawa

et al. 2013

Review of Scientific Instruments

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In the fine chemicals industry, particularly in the pharmaceutical industry, advanced sensing technologies have recently begun being incorporated into the process line in order to improve safety and quality in accordance with process analytical technology. For estimating the quality of powders without preparation during drug formulation, near-infrared (NIR) spectroscopy has been considered the most promising sensing approach. In this study, we have developed a compact polychromator-type NIR spectrometer equipped with a photodiode (PD) array detector. This detector is consisting of 640 InGaAs-PD elements with 20-μm pitch. Some high-specification spectrometers, which use InGaAs-PD with 512 elements, have a wavelength resolution of about 1.56 nm when covering 900-1700 nm range. On the other hand, the newly developed detector, having the PD with one of the world's highest density, enables wavelength resolution of below 1.25 nm. Moreover, thanks to the combination with a highly integrated charge amplifier array circuit, measurement speed of the detector is higher by two orders than that of existing PD array detectors. The developed spectrometer is small (120 mm × 220 mm × 200 mm) and light (6 kg), and it contains various key devices including the high-density and high-sensitivity PD array detector, NIR technology, and spectroscopy technology for a spectroscopic analyzer that has the required detection mechanism and high sensitivity for powder measurement, as well as a high-speed measuring function for blenders. Moreover, we have evaluated the characteristics of the developed NIR spectrometer, and the measurement of powder samples confirmed that it has high functionality.

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“…In particular, NIR has attracted attention in a very wide range of fields in combination with chemometric technology. 8 NIR spectroscopy is used in pharmaceutical analysis to extract information on the chemical and physical factors of ingredient content, [9][10][11][12][13] moisture, [14][15][16] crystalline polymorphism, [17][18][19] particle size, 15,20,21 and density. 21 The energy level of NIR light is between visible light and infrared light (IR).…”

Section: Introductionmentioning

confidence: 99%

In-line and Real-time Monitoring of Resonant Acoustic Mixing by Near-infrared Spectroscopy Combined with Chemometric Technology for Process Analytical Technology Applications in Pharmaceutical Powder Blending Systems

et al. 2017

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Resonant acoustic® mixing (RAM) technology is a system that performs high-speed mixing by vibration through the control of acceleration and frequency. In recent years, real-time process monitoring and prediction has become of increasing interest, and process analytical technology (PAT) systems will be increasingly introduced into actual manufacturing processes. This study examined the application of PAT with the combination of RAM, near-infrared spectroscopy, and chemometric technology as a set of PAT tools for introduction into actual pharmaceutical powder blending processes. Content uniformity was based on a robust partial least squares regression (PLSR) model constructed to manage the RAM configuration parameters and the changing concentration of the components. As a result, real-time monitoring may be possible and could be successfully demonstrated for in-line real-time prediction of active pharmaceutical ingredients and other additives using chemometric technology. This system is expected to be applicable to the RAM method for the risk management of quality.

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On-Line Monitoring of Powder Blend Homogeneity by Near-Infrared Spectroscopy

Cited by 232 publications

References 3 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

A polychromator-type near-infrared spectrometer with a high-sensitivity and high-resolution photodiode array detector for pharmaceutical process monitoring on the millisecond time scale

In-line and Real-time Monitoring of Resonant Acoustic Mixing by Near-infrared Spectroscopy Combined with Chemometric Technology for Process Analytical Technology Applications in Pharmaceutical Powder Blending Systems

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