Verification of the mixing processes of the active pharmaceutical ingredient, excipient and lubricant in a pharmaceutical formulation using a resonant acoustic mixing technology

Tanaka, Ryoma; Takahashi, Naoyuki; Nakamura, Y.; Hattori, Yusuke; Ashizawa, Kazuhide; Otsuka, Makoto

doi:10.1039/c6ra16209f

Cited by 34 publications

(27 citation statements)

References 16 publications

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“…By controlling the vibration through acceleration and frequency in the RAM, GNP particles were uniformly embedded (or coated) on the LDPE pellet surfaces (Figure 1(d)). Furthermore, aggregated GNP particles above several tens of micrometers were effectively pulverized by strong collisions between particles in the RAM mixing step [25]. The surface morphologies of GNP- Through melt-mixing process in the internal mixer, GNPcoated LDPE pellets were mechanically mixed at 160°C for 30 minutes; finally, LDPE/GNP insulating nanocomposite was fabricated.…”

Section: Resultsmentioning

confidence: 99%

Polyethylene/Graphene Nanoplatelet Nanocomposite-Based Insulating Materials for Effective Reduction of Space Charge Accumulation in High-Voltage Direct-Current Cables

Park

Kim

Jung³

et al. 2019

Journal of Nanomaterials

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We have demonstrated a straightforward hydrophobic surface modification of graphene nanoplatelets (GNPs) through a defect-healing process to fabricate well-dispersed insulating low-density polyethylene (LDPE)/GNP nanocomposites and have confirmed their effective suppression of space charge accumulation. Without any organic modifiers, GNPs containing oxygen-based functional groups at the edges were successfully reduced at optimal high-temperature defect-healing condition and modified to have hydrophobic surface properties similar to those of the LDPE matrix. The degree of dispersion and the reproducibility of the mechanically melt-mixed LDPE/GNP nanocomposites were immediately analyzed by thickness-normalized optical absorption measurement. In the LDPE matrix, below the percolation threshold concentration, well-dispersed GNP fillers effectively acted as trapping sites under high electric fields, resulting in the successful suppression of packet-like space charge accumulation (field enhancement factor=1.04 @ 0.1 wt% LDPE/GNP nanocomposite).

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Section: Resultsmentioning

confidence: 99%

Polyethylene/Graphene Nanoplatelet Nanocomposite-Based Insulating Materials for Effective Reduction of Space Charge Accumulation in High-Voltage Direct-Current Cables

Park

Kim

Jung³

et al. 2019

Journal of Nanomaterials

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“…As shown in Table 1, 30 pharmaceutical formulations were weighed and placed in individual 50 mL glass sample containers. These samples were mixed completely by RAM at 100g (1.0g = 9.8 m/s 2 ) for 300 s. 25,30 In addition, the samples in Run 1 -4 for mixing process monitoring were prepared on the basis of the formulations in Table 2, and the mixing processes were monitored using the NIR method.…”

Section: Methodsmentioning

confidence: 99%

“…For calibration model building, samples of the 30 types of calibration model stated previously were examined, and which were assumed to be completely mixed by RAM (vibration force was 100g; blending time 300 s). 25,30 A total of 540 NIR spectra were obtained six times during vibration at each vibration force setting (40, 60, or 80g). The software used for spectral analysis was Pirouette 4.5 (Infometrix, Bothell, WA).…”

Section: 29mentioning

confidence: 99%

“…1). 30 In brief, RAM can produce an ideal mixing state with low drug contents over a very short period of time in comparison with ordinary methods using a modified V-shape blender. Therefore, RAM has been applied to a broad field of mixing applications.…”

Section: Introductionmentioning

confidence: 99%

“…Therefore, RAM has been applied to a broad field of mixing applications. [28][29][30] RAM can be applied to blending processes with low drug content formulations in pharmaceutical manufacturing processes. However, the risk management of quality in actual production has not yet been established for the RAM method.…”

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

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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Numerical study on the hydrodynamics of highly viscous liquid under vertical acoustic vibration

Yu,

Jia,

Zhan

et al. 2024

AIChE Journal

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This study investigated the hydrodynamics of highly viscous liquid under vertical acoustic vibration, and examined the effects of vibration parameters and filling ratio on the strain rate, stretching index, and convective intensity of high‐viscosity liquid. A numerical simulation model of gas–liquid flows was developed using computational fluid dynamics method and validated through experiment. Under acoustic vibration, the high‐viscosity liquid predominantly experienced extensional and shearing flows. Significant deformation of the high‐viscosity liquid was observed near the interface between gas and liquid. Increasing the amplitude or frequency of acoustic vibration, selecting a combination of low‐frequency and high amplitude under equal acceleration conditions, as well as appropriately reducing the filling ratio can enhance the stretching and shearing effects on the liquid, and improve the strength of convection. The findings also established a predictive relationship between amplitude and frequency, enabling the determination of optimal mixing conditions.

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Verification of the mixing processes of the active pharmaceutical ingredient, excipient and lubricant in a pharmaceutical formulation using a resonant acoustic mixing technology

Abstract: Mixing processes are important for making high-quality pharmaceutical formulations and are related to dissolution and chemical stability in pharmaceutical manufacturing.

Cited by 34 publications

References 16 publications

Polyethylene/Graphene Nanoplatelet Nanocomposite-Based Insulating Materials for Effective Reduction of Space Charge Accumulation in High-Voltage Direct-Current Cables

Polyethylene/Graphene Nanoplatelet Nanocomposite-Based Insulating Materials for Effective Reduction of Space Charge Accumulation in High-Voltage Direct-Current Cables

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

Numerical study on the hydrodynamics of highly viscous liquid under vertical acoustic vibration

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