Partial Least Squares Regression-Based Robust Forward Control of the Tableting Process
In this study, we established a robust feed-forward control model for the tableting process by partial least squares regression using the near-infrared (NIR) spectra and physical attributes of the granules to be compressed. The NIR spectra of granules are rich in information about chemical attribute...
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| Published in: | Pharmaceutics Vol. 12; no. 1; p. 85 |
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| Main Authors: | , , |
| Format: | Journal Article |
| Language: | English |
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| ISSN: | 1999-4923, 1999-4923 |
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| Abstract | In this study, we established a robust feed-forward control model for the tableting process by partial least squares regression using the near-infrared (NIR) spectra and physical attributes of the granules to be compressed. The NIR spectra of granules are rich in information about chemical attributes, such as the compositions of any ingredients and moisture content. Polymorphism and pseudo-polymorphism can also be quantitatively evaluated by NIR spectra. We used the particle size distribution, flowability, and loose and tapped density as the physical attributes of the granules. The tableting process was controlled by the lower punch fill depth and the minimum distance between the upper and lower punches at compression, which were specifically related to the tablet weight and thickness, respectively. The feed-forward control of the process would be expected to provide some advantages for automated and semi-automated continuous pharmaceutical manufacturing. As a result, our model, using a combination of NIR spectra and the physical attributes of granules to control the distance between punches, resulted in respectable agreement between the predicted process parameters and actual settings to produce tablets of the desired thickness. |
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| AbstractList | In this study, we established a robust feed-forward control model for the tableting process by partial least squares regression using the near-infrared (NIR) spectra and physical attributes of the granules to be compressed. The NIR spectra of granules are rich in information about chemical attributes, such as the compositions of any ingredients and moisture content. Polymorphism and pseudo-polymorphism can also be quantitatively evaluated by NIR spectra. We used the particle size distribution, flowability, and loose and tapped density as the physical attributes of the granules. The tableting process was controlled by the lower punch fill depth and the minimum distance between the upper and lower punches at compression, which were specifically related to the tablet weight and thickness, respectively. The feed-forward control of the process would be expected to provide some advantages for automated and semi-automated continuous pharmaceutical manufacturing. As a result, our model, using a combination of NIR spectra and the physical attributes of granules to control the distance between punches, resulted in respectable agreement between the predicted process parameters and actual settings to produce tablets of the desired thickness. In this study, we established a robust feed-forward control model for the tableting process by partial least squares regression using the near-infrared (NIR) spectra and physical attributes of the granules to be compressed. The NIR spectra of granules are rich in information about chemical attributes, such as the compositions of any ingredients and moisture content. Polymorphism and pseudo-polymorphism can also be quantitatively evaluated by NIR spectra. We used the particle size distribution, flowability, and loose and tapped density as the physical attributes of the granules. The tableting process was controlled by the lower punch fill depth and the minimum distance between the upper and lower punches at compression, which were specifically related to the tablet weight and thickness, respectively. The feed-forward control of the process would be expected to provide some advantages for automated and semi-automated continuous pharmaceutical manufacturing. As a result, our model, using a combination of NIR spectra and the physical attributes of granules to control the distance between punches, resulted in respectable agreement between the predicted process parameters and actual settings to produce tablets of the desired thickness.In this study, we established a robust feed-forward control model for the tableting process by partial least squares regression using the near-infrared (NIR) spectra and physical attributes of the granules to be compressed. The NIR spectra of granules are rich in information about chemical attributes, such as the compositions of any ingredients and moisture content. Polymorphism and pseudo-polymorphism can also be quantitatively evaluated by NIR spectra. We used the particle size distribution, flowability, and loose and tapped density as the physical attributes of the granules. The tableting process was controlled by the lower punch fill depth and the minimum distance between the upper and lower punches at compression, which were specifically related to the tablet weight and thickness, respectively. The feed-forward control of the process would be expected to provide some advantages for automated and semi-automated continuous pharmaceutical manufacturing. As a result, our model, using a combination of NIR spectra and the physical attributes of granules to control the distance between punches, resulted in respectable agreement between the predicted process parameters and actual settings to produce tablets of the desired thickness. |
| Author | Hattori, Yusuke Otsuka, Makoto Naganuma, Miki |
| AuthorAffiliation | Research Institute of Pharmaceutical Sciences, Faculty of Pharmacy, Musashino University, 1-20 Shin-machi, Nishi-Tokyo city, Tokyo 202-8585, Japan; s1443033@stu.musashino-u.ac.jp (M.N.); motsuka@musashino-u.ac.jp (M.O.) |
| AuthorAffiliation_xml | – name: Research Institute of Pharmaceutical Sciences, Faculty of Pharmacy, Musashino University, 1-20 Shin-machi, Nishi-Tokyo city, Tokyo 202-8585, Japan; s1443033@stu.musashino-u.ac.jp (M.N.); motsuka@musashino-u.ac.jp (M.O.) |
| Author_xml | – sequence: 1 givenname: Yusuke surname: Hattori fullname: Hattori, Yusuke – sequence: 2 givenname: Miki surname: Naganuma fullname: Naganuma, Miki – sequence: 3 givenname: Makoto surname: Otsuka fullname: Otsuka, Makoto |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/31968698$$D View this record in MEDLINE/PubMed |
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| CitedBy_id | crossref_primary_10_1016_j_ijpharm_2023_123610 crossref_primary_10_3389_fcimb_2024_1500440 crossref_primary_10_3390_pharmaceutics12100910 crossref_primary_10_1039_D0RA08030F crossref_primary_10_1016_j_microc_2021_106497 |
| Cites_doi | 10.1002/jps.20430 10.1016/S0378-5173(99)00315-4 10.3109/10837450.2015.1102278 10.1039/C3RA45375H 10.1208/s12249-011-9642-x 10.1021/mp300390m 10.1016/j.ijpharm.2008.10.010 10.1016/j.ijpharm.2017.04.004 10.1002/jps.10323 10.1016/j.ijpharm.2015.09.029 10.1111/j.2042-7158.2011.01297.x 10.1016/j.ijpharm.2017.04.054 10.1016/S0939-6411(03)00004-3 10.1002/jps.20362 10.1021/acs.analchem.7b01907 10.1208/pt040219 10.1039/a700782e 10.1208/s12249-011-9669-z 10.1002/cem.1349 10.1016/0378-5173(93)90022-8 10.2116/analsci.33.65 10.1023/A:1011038526805 10.1016/j.powtec.2018.03.027 10.1039/C7RA05252A 10.3390/pr3020339 10.1016/j.ijpharm.2010.12.012 10.1007/s12247-010-9079-x 10.1002/jps.23148 10.1016/j.ijpharm.2003.11.022 10.1007/s12247-017-9276-y 10.1255/jnirs.1037 |
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| Keywords | high-shear wet granulation near-infrared spectroscopy partial least squares regression robust control feed-forward control tableting process data analysis |
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| SubjectTerms | Accuracy Automation Cellulose feed-forward control high-shear wet granulation Manufacturing Moisture content near-infrared spectroscopy partial least squares regression Particle size Pharmaceuticals Polymorphism Process controls process data analysis Product quality robust control Spectrum analysis tableting |
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| Title | Partial Least Squares Regression-Based Robust Forward Control of the Tableting Process |
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