Optimization of a high shear wet granulation process using focused beam reflectance measurement and particle vision microscope technologies

Arp, Zane; Smith, Ben; Dycus, Eric; O'grady, Des

doi:10.1002/jps.22556

Cited by 21 publications

(5 citation statements)

References 31 publications

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“…6 A focused beam reectance measurement (FBRM) probe can be used to obtain a detailed understanding of the particle size changes during the HSWG process and to determine the end-point properties of formulations. 7,8 Acoustic emission is another well-known approach for monitoring the HSWG process. It has been reported to be capable of monitoring changes in the physical properties of formulations during granulation.…”

Section: Introductionmentioning

confidence: 99%

Real-time monitoring of granule properties during high shear wet granulation by near-infrared spectroscopy with a chemometrics approach

et al. 2017

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We developed an in-line near-infrared spectroscopy (NIRS) monitoring method enabling a rapid and noninvasive analysis of granule properties during the high shear wet granulation (HSWG) process. Eleven batches were manufactured and used as the calibration dataset and an additional batch was manufactured and used as the validation dataset. The HSWG process was directly monitored using an acousto-optical tunable filter (AOTF)-NIR spectrometer and the NIR spectra related to the physical and chemical changes of the granules were acquired. The particle size, tapped density, bulk density, and powder flowability of the granules were qualitatively and quantitatively evaluated by a chemometrics approach. Principal component analysis (PCA) and partial least square regression (PLSR) were applied for the qualitative and quantitative modelling of the granule properties. The PCA score plots showed a clear relationship between the granule properties and the granulation progress and provided an effective means for the endpoint determination of the manufacturing process. The PLSR models constructed for the quantitative evaluation of the granule properties were demonstrated to be predictive with high accuracy. These findings allow HSWG to be monitored in-line and controlled effectively. A better understanding of the process by NIRS with chemometrics will contribute to developing high-quality drug products using the required quality-by-design approach.

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Section: Introductionmentioning

confidence: 99%

Real-time monitoring of granule properties during high shear wet granulation by near-infrared spectroscopy with a chemometrics approach

et al. 2017

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“…Focused beam reflectance measurement has been successfully employed in recent years to characterize the dynamics of granule size distribution in high shear wet granulators . FRBM was utilized as an in‐line probe during the granulation of brivanib alaninate at two different scales of manufacture.…”

Section: Resultsmentioning

confidence: 99%

“…These measurements have included the indirect process measures such as impeller power and torque; or direct granule attributes such as wet mass density. Direct measurements of attributes have utilized techniques such as focused beam reflectance measurement (FBRM) to measure granule chord length distribution (CLD) during granulation, which can be correlated to the particle size distribution (PSD) of granules. Traditionally, granule PSD has been the key parameter that is assessed through and across the unit operations .…”

Section: Introductionmentioning

confidence: 99%

Real-Time Assessment of Granule Densification in High Shear Wet Granulation and Application to Scale-up of a Placebo and a Brivanib Alaninate Formulation

Narang

Sheverev

Stepaniuk

et al. 2015

Journal of Pharmaceutical Sciences

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“…Several attempts have been made to control the properties of granules produced with HSWG. Measurements of the torque of a powder blender paddle using a power consumption meter [ 10 , 11 , 12 ], particle size of wet granules using the focused-beam-reflectance measurement [ 13 , 14 ], acoustic emission of granules using a microphone [ 15 , 16 , 17 ], and powder flow using a drag flow force sensor [ 18 , 19 ] can be used for various non-destructive and non-contact measurement methods for monitoring the granulation process.…”

Section: Introductionmentioning

confidence: 99%

Real-Time Monitoring of Critical Quality Attributes during High-Shear Wet Granulation Process by Near-Infrared Spectroscopy Effect of Water Addition and Stirring Speed on Pharmaceutical Properties of the Granules

Koyanagi¹,

Ueno²,

Sasaki

et al. 2022

Pharmaceuticals

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To produce high-quality pharmaceuticals, a real-time monitoring method for the high-shear wet granulation process (HSWG) was developed based on near-infrared spectroscopy (NIRS). Samples consisting of lactose, potato starch, and hydroxypropyl cellulose were prepared using HSWG with varying amounts of purified water (80, 90, and 100 mL) and impeller speed (200, 400, and 600 rpm), which produces granules of different characteristics. Twelve batches of samples were used for the calibration and nine batches were used for validation. After drying, the median particle size (D50), tapped density (TD), and Hauser ratio (HR) were measured. The best calibration models to predict moisture content (MC), D50, TD, and HR were determined based on pretreated NIR spectra using partial least squares regression analysis (PLSR). The temporal changes in the pharmaceutical properties under different amounts of water added and stirring speed were monitored in real time using NIRS/PLSR. Because the most important critical quality attribute (CQA) in the process was MC, granule characteristics such as D50, TD, and HR were analyzed with respect to MC. They might be used as robust and simple monitoring methods based on MC to evaluate the pharmaceutical properties of HSWG granules.

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Optimization of a high shear wet granulation process using focused beam reflectance measurement and particle vision microscope technologies

Cited by 21 publications

References 31 publications

Real-time monitoring of granule properties during high shear wet granulation by near-infrared spectroscopy with a chemometrics approach

Real-time monitoring of granule properties during high shear wet granulation by near-infrared spectroscopy with a chemometrics approach

Real-Time Assessment of Granule Densification in High Shear Wet Granulation and Application to Scale-up of a Placebo and a Brivanib Alaninate Formulation

Real-Time Monitoring of Critical Quality Attributes during High-Shear Wet Granulation Process by Near-Infrared Spectroscopy Effect of Water Addition and Stirring Speed on Pharmaceutical Properties of the Granules

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