NIR-Guided Coating Optimization of Omega-3 Fatty Acid Mini Soft Capsules with Pitavastatin and Ezetimibe
Background: This study aimed to optimize the coating process of Omega-3 fatty acid (OM3-FA) mini soft capsules containing the active pharmaceutical ingredients (APIs) pitavastatin and ezetimibe using near-infrared (NIR) spectroscopy for in-process monitoring. Cardiovascular disease treatments benefi...
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2024-10-01
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| Online Access: | https://www.mdpi.com/1999-4923/16/11/1374 |
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| author | Hye-Ri Han Ji Hoon Choi Je Hwa Yoo Jin-Hyuk Jeong Sang-Beom Na Ji-Hyun Kang Dong-Wook Kim Chun-Woong Park |
| author_facet | Hye-Ri Han Ji Hoon Choi Je Hwa Yoo Jin-Hyuk Jeong Sang-Beom Na Ji-Hyun Kang Dong-Wook Kim Chun-Woong Park |
| author_sort | Hye-Ri Han |
| collection | DOAJ |
| description | Background: This study aimed to optimize the coating process of Omega-3 fatty acid (OM3-FA) mini soft capsules containing the active pharmaceutical ingredients (APIs) pitavastatin and ezetimibe using near-infrared (NIR) spectroscopy for in-process monitoring. Cardiovascular disease treatments benefit from combining OM3-FA with lipid-lowering agents, but formulating such combinations in mini soft capsules presents challenges in maintaining stability and mechanical integrity. Methods: The coating process was developed using a pan coater and real-time NIR monitoring to ensure uniformity and quality. NIR spectroscopy enabled precise control of coating thickness, ensuring consistent drug distribution across the capsule surface. Results: The optimized process minimized OM3-FA oxidation and preserved the mechanical integrity of the capsules, as confirmed by texture analysis and in-vitro dissolution testing. This integration of NIR spectroscopy as a process analytical technology (PAT) significantly improved coating quality control, resulting in a stable and effective combination therapy for pitavastatin and ezetimibe in a mini soft capsule form. Conclusion: This approach offers an efficient solution for enhancing patient adherence in cardiovascular disease management. The application of NIR spectroscopy for real-time monitoring highlights its broader significance in pharmaceutical manufacturing, where it can serve as a versatile tool for ensuring product quality and optimizing production efficiency in diverse formulation processes. By incorporating NIR-based PAT, manufacturers can not only achieve product-specific improvements but also establish a foundation for continuous manufacturing and automated quality assurance systems, ultimately contributing to a more streamlined and robust production environment. |
| format | Article |
| id | doaj-art-69c6138884b843daa231b1f3784331df |
| institution | DOAJ |
| issn | 1999-4923 |
| language | English |
| publishDate | 2024-10-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Pharmaceutics |
| spelling | doaj-art-69c6138884b843daa231b1f3784331df2025-08-20T02:48:02ZengMDPI AGPharmaceutics1999-49232024-10-011611137410.3390/pharmaceutics16111374NIR-Guided Coating Optimization of Omega-3 Fatty Acid Mini Soft Capsules with Pitavastatin and EzetimibeHye-Ri Han0Ji Hoon Choi1Je Hwa Yoo2Jin-Hyuk Jeong3Sang-Beom Na4Ji-Hyun Kang5Dong-Wook Kim6Chun-Woong Park7Department of Pharmacy, Chungbuk National University, Cheongju 28160, Republic of KoreaDepartment of Pharmacy, Chungbuk National University, Cheongju 28160, Republic of KoreaDepartment of Pharmacy, Chungbuk National University, Cheongju 28160, Republic of KoreaDepartment of Pharmacy, Chungbuk National University, Cheongju 28160, Republic of KoreaDepartment of Pharmacy, Chungbuk National University, Cheongju 28160, Republic of KoreaInstitute of New Drug Development, and Respiratory Drug Development Research Institute, School of Pharmacy, Jeonbuk National University, Jeonju 54896, Republic of KoreaCollege of Pharmacy, Wonkwang University, Iksan 54538, Republic of KoreaDepartment of Pharmacy, Chungbuk National University, Cheongju 28160, Republic of KoreaBackground: This study aimed to optimize the coating process of Omega-3 fatty acid (OM3-FA) mini soft capsules containing the active pharmaceutical ingredients (APIs) pitavastatin and ezetimibe using near-infrared (NIR) spectroscopy for in-process monitoring. Cardiovascular disease treatments benefit from combining OM3-FA with lipid-lowering agents, but formulating such combinations in mini soft capsules presents challenges in maintaining stability and mechanical integrity. Methods: The coating process was developed using a pan coater and real-time NIR monitoring to ensure uniformity and quality. NIR spectroscopy enabled precise control of coating thickness, ensuring consistent drug distribution across the capsule surface. Results: The optimized process minimized OM3-FA oxidation and preserved the mechanical integrity of the capsules, as confirmed by texture analysis and in-vitro dissolution testing. This integration of NIR spectroscopy as a process analytical technology (PAT) significantly improved coating quality control, resulting in a stable and effective combination therapy for pitavastatin and ezetimibe in a mini soft capsule form. Conclusion: This approach offers an efficient solution for enhancing patient adherence in cardiovascular disease management. The application of NIR spectroscopy for real-time monitoring highlights its broader significance in pharmaceutical manufacturing, where it can serve as a versatile tool for ensuring product quality and optimizing production efficiency in diverse formulation processes. By incorporating NIR-based PAT, manufacturers can not only achieve product-specific improvements but also establish a foundation for continuous manufacturing and automated quality assurance systems, ultimately contributing to a more streamlined and robust production environment.https://www.mdpi.com/1999-4923/16/11/1374coatingnear-infrared spectroscopyprocess analytical technologyOmega-3 fatty acids |
| spellingShingle | Hye-Ri Han Ji Hoon Choi Je Hwa Yoo Jin-Hyuk Jeong Sang-Beom Na Ji-Hyun Kang Dong-Wook Kim Chun-Woong Park NIR-Guided Coating Optimization of Omega-3 Fatty Acid Mini Soft Capsules with Pitavastatin and Ezetimibe Pharmaceutics coating near-infrared spectroscopy process analytical technology Omega-3 fatty acids |
| title | NIR-Guided Coating Optimization of Omega-3 Fatty Acid Mini Soft Capsules with Pitavastatin and Ezetimibe |
| title_full | NIR-Guided Coating Optimization of Omega-3 Fatty Acid Mini Soft Capsules with Pitavastatin and Ezetimibe |
| title_fullStr | NIR-Guided Coating Optimization of Omega-3 Fatty Acid Mini Soft Capsules with Pitavastatin and Ezetimibe |
| title_full_unstemmed | NIR-Guided Coating Optimization of Omega-3 Fatty Acid Mini Soft Capsules with Pitavastatin and Ezetimibe |
| title_short | NIR-Guided Coating Optimization of Omega-3 Fatty Acid Mini Soft Capsules with Pitavastatin and Ezetimibe |
| title_sort | nir guided coating optimization of omega 3 fatty acid mini soft capsules with pitavastatin and ezetimibe |
| topic | coating near-infrared spectroscopy process analytical technology Omega-3 fatty acids |
| url | https://www.mdpi.com/1999-4923/16/11/1374 |
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