Effect of Oxygen and Water on the Stability of Imipenem and Cilastatin Sodium for Injection
The study aimed to investigate the factors affecting the stability of imipenem and cilastatin sodium for injection (IMI/CIL) to improve the quality and stability in IMI/CIL preparation. In this study, the effects of headspace oxygen (HO), water content, particle shape, and particle size on the stabi...
| Main Authors: | , , , , , , , |
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| Format: | Article |
| Language: | English |
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Georg Thieme Verlag KG
2022-06-01
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| Series: | Pharmaceutical Fronts |
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| Online Access: | http://www.thieme-connect.de/DOI/DOI?10.1055/s-0042-1750043 |
| _version_ | 1823985205918040064 |
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| author | Meng Zhang Chun-Feng Liu Xiao-Yan Chen Li-Na Yang Chun-Mei Zhu Jian-Hao Teng Hao-Xiang Wu Fu-Li Zhang |
| author_facet | Meng Zhang Chun-Feng Liu Xiao-Yan Chen Li-Na Yang Chun-Mei Zhu Jian-Hao Teng Hao-Xiang Wu Fu-Li Zhang |
| author_sort | Meng Zhang |
| collection | DOAJ |
| description | The study aimed to investigate the factors affecting the stability of imipenem and cilastatin sodium for injection (IMI/CIL) to improve the quality and stability in IMI/CIL preparation. In this study, the effects of headspace oxygen (HO), water content, particle shape, and particle size on the stability of IMI/CIL were investigated. IMI/CIL was purged with air, premixed oxygen/nitrogen gas (5%/95%), or high-purity nitrogen (99.999%) at 20, 5, or 2% oxygen levels to prepare IMI/CIL with different HO levels. IMI/CIL was stored at 30, 45, and 75% relative humidity for 30 days to prepare IMI/CIL with different water contents. High-performance liquid chromatography method was used for analysis. The results showed that oxygen, water, particle shape, and particle size had significant effects on the stability of IMI/CIL, and free water content is a better predictor of the safety and stability of imipenem and cilastatin sodium than the total water content. The optimization scheme of the above parameters is proposed, which significantly improves the stability of IMI/CIL. This study led to a better understanding of the degradation mechanism of imipenem and cilastatin sodium, and could provide a reference for the selection and control of IMI/CIL process conditions. This study would contribute to the development of IMI/CIL with improved stability. |
| first_indexed | 2024-12-18T12:51:41Z |
| format | Article |
| id | doaj.art-38a8f10a6aa44049972138636f2572d7 |
| institution | Directory Open Access Journal |
| issn | 2628-5088 2628-5096 |
| language | English |
| last_indexed | 2024-12-18T12:51:41Z |
| publishDate | 2022-06-01 |
| publisher | Georg Thieme Verlag KG |
| record_format | Article |
| series | Pharmaceutical Fronts |
| spelling | doaj.art-38a8f10a6aa44049972138636f2572d72022-12-21T21:07:26ZengGeorg Thieme Verlag KGPharmaceutical Fronts2628-50882628-50962022-06-010402e78e8810.1055/s-0042-1750043Effect of Oxygen and Water on the Stability of Imipenem and Cilastatin Sodium for InjectionMeng Zhang0Chun-Feng Liu1Xiao-Yan Chen2Li-Na Yang3Chun-Mei Zhu4Jian-Hao Teng5Hao-Xiang Wu6Fu-Li Zhang7College of Chemistry and Chemical Engineering, Shanghai University of Engineering Science, Shanghai, People's Republic of ChinaPharmaceutical Process Optimization and Industrialization Engineering Research Center, Shanghai Institute of Pharmaceutical Industry, China State Institute of Pharmaceutical Industry, Shanghai, People's Republic of ChinaChina National Medicines Guorui Pharmaceutical Co., Ltd., Huainan, People's Republic of ChinaPharmaceutical Process Optimization and Industrialization Engineering Research Center, Shanghai Institute of Pharmaceutical Industry, China State Institute of Pharmaceutical Industry, Shanghai, People's Republic of ChinaPharmaceutical Process Optimization and Industrialization Engineering Research Center, Shanghai Institute of Pharmaceutical Industry, China State Institute of Pharmaceutical Industry, Shanghai, People's Republic of ChinaPharmaceutical Process Optimization and Industrialization Engineering Research Center, Shanghai Institute of Pharmaceutical Industry, China State Institute of Pharmaceutical Industry, Shanghai, People's Republic of ChinaPharmaceutical Process Optimization and Industrialization Engineering Research Center, Shanghai Institute of Pharmaceutical Industry, China State Institute of Pharmaceutical Industry, Shanghai, People's Republic of ChinaCollege of Chemistry and Chemical Engineering, Shanghai University of Engineering Science, Shanghai, People's Republic of ChinaThe study aimed to investigate the factors affecting the stability of imipenem and cilastatin sodium for injection (IMI/CIL) to improve the quality and stability in IMI/CIL preparation. In this study, the effects of headspace oxygen (HO), water content, particle shape, and particle size on the stability of IMI/CIL were investigated. IMI/CIL was purged with air, premixed oxygen/nitrogen gas (5%/95%), or high-purity nitrogen (99.999%) at 20, 5, or 2% oxygen levels to prepare IMI/CIL with different HO levels. IMI/CIL was stored at 30, 45, and 75% relative humidity for 30 days to prepare IMI/CIL with different water contents. High-performance liquid chromatography method was used for analysis. The results showed that oxygen, water, particle shape, and particle size had significant effects on the stability of IMI/CIL, and free water content is a better predictor of the safety and stability of imipenem and cilastatin sodium than the total water content. The optimization scheme of the above parameters is proposed, which significantly improves the stability of IMI/CIL. This study led to a better understanding of the degradation mechanism of imipenem and cilastatin sodium, and could provide a reference for the selection and control of IMI/CIL process conditions. This study would contribute to the development of IMI/CIL with improved stability.http://www.thieme-connect.de/DOI/DOI?10.1055/s-0042-1750043imipenemcilastatin sodiumstabilityoxidationfree water |
| spellingShingle | Meng Zhang Chun-Feng Liu Xiao-Yan Chen Li-Na Yang Chun-Mei Zhu Jian-Hao Teng Hao-Xiang Wu Fu-Li Zhang Effect of Oxygen and Water on the Stability of Imipenem and Cilastatin Sodium for Injection Pharmaceutical Fronts imipenem cilastatin sodium stability oxidation free water |
| title | Effect of Oxygen and Water on the Stability of Imipenem and Cilastatin Sodium for Injection |
| title_full | Effect of Oxygen and Water on the Stability of Imipenem and Cilastatin Sodium for Injection |
| title_fullStr | Effect of Oxygen and Water on the Stability of Imipenem and Cilastatin Sodium for Injection |
| title_full_unstemmed | Effect of Oxygen and Water on the Stability of Imipenem and Cilastatin Sodium for Injection |
| title_short | Effect of Oxygen and Water on the Stability of Imipenem and Cilastatin Sodium for Injection |
| title_sort | effect of oxygen and water on the stability of imipenem and cilastatin sodium for injection |
| topic | imipenem cilastatin sodium stability oxidation free water |
| url | http://www.thieme-connect.de/DOI/DOI?10.1055/s-0042-1750043 |
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