Elucidation of the Molecular Mechanism of Wet Granulation for Pharmaceutical Standard Formulations in a High-Speed Shear Mixer Using Near-Infrared Spectroscopy
Abstract
:1. Introduction
2. Results and Discussion
2.1. Change in APC-Time Profiles of All the Formulations during HSWG Processes
2.2. Change in NIRS Spectra of Various Formulations during HSWG Processes
2.3. Prediction of the Wa and the APC Values by Partial Least-Squares Regression (PLSR) Calibration Models
2.4. Quantitative Relationships between Wa and NIRS Spectra of Wet Masses in the Formulation Consisting of LA and/or PS during HSWG Processes
2.5. Quantitative Relationships between APC and NIRS Spectra of Wet Masses of the Formulations Consisting of LA and/or PS during HSWG Processes
2.6. Molecular Level Granulation Mechanism during HSWG Processes of the Wet Mass Formulations Consisting of LA and/or PS Based on Changes in APC Values and NIRS
3. Materials and Methods
3.1. Materials
3.2. Methods
3.2.1. Granulation
3.2.2. Measurement of NIRS
3.2.3. Calibration Models to Predict the Pharmaceutical Properties in the Granular Formulated Powder Mixture
4. Conclusions
Author Contributions
Funding
Conflicts of Interest
References
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Matreials | F-1 | F-2 | F-3 | |||
---|---|---|---|---|---|---|
(g) | (%) | (g) | (%) | (g) | (%) | |
LA | 480 | 96 | 336 | 67.2 | 0 | 0 |
PS | 0 | 0 | 144 | 28.8 | 480 | 96 |
HPC-L | 20 | 4 | 20 | 4 | 20 | 4 |
Wa | 500 | 100 | 500 | 100 | 500 | 100 |
Wa | PC | CPV | SEV g/lot | Press Val | r Val | SEC g/lot | Press Cal | r Cal |
---|---|---|---|---|---|---|---|---|
F-1 | 2 | 98.2 | 7.10 | 3.03×103 | 0.999 | 7.14 | 2.90×103 | 0.999 |
F-2 | 2 | 91.7 | 3.37 | 6.79×102 | 1.000 | 2.22 | 2.82×102 | 1.000 |
F-3 | 2 | 96.5 | 2.09 | 32.62×102 | 1.00 | 1.84 | 1.92×102 | 1.000 |
APC | PC | CPV | SEV, W | Press Val | r Val | SEC, W | Press Cal | r Cal |
F-1 | 2 | 92.8 | 1.09 | 37.17×10 | 0.999 | 1.01 | 5.81×10 | 0.999 |
F-2 | 2 | 48.1 | 1.74 | 1.82×102 | 0.999 | 2.14 | 2.61×102 | 0.998 |
F-3 | 3 | 68.7 | 7.92 | 3.77×103 | 0.981 | 6.64 | 2.47×103 | 0.986 |
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Omata, R.; Hattori, Y.; Sasaki, T.; Sakamoto, T.; Otsuka, M. Elucidation of the Molecular Mechanism of Wet Granulation for Pharmaceutical Standard Formulations in a High-Speed Shear Mixer Using Near-Infrared Spectroscopy. Pharmaceuticals 2020, 13, 226. https://doi.org/10.3390/ph13090226
Omata R, Hattori Y, Sasaki T, Sakamoto T, Otsuka M. Elucidation of the Molecular Mechanism of Wet Granulation for Pharmaceutical Standard Formulations in a High-Speed Shear Mixer Using Near-Infrared Spectroscopy. Pharmaceuticals. 2020; 13(9):226. https://doi.org/10.3390/ph13090226
Chicago/Turabian StyleOmata, Ryo, Yusuke Hattori, Tetsuo Sasaki, Tomoaki Sakamoto, and Makoto Otsuka. 2020. "Elucidation of the Molecular Mechanism of Wet Granulation for Pharmaceutical Standard Formulations in a High-Speed Shear Mixer Using Near-Infrared Spectroscopy" Pharmaceuticals 13, no. 9: 226. https://doi.org/10.3390/ph13090226