Factors Contributing to Drug Release From Enteric-Coated Omeprazole Capsules: An In Vitro and In Vivo Pharmacokinetic Study and IVIVC Evaluation in Beagle Dogs
This study was performed to explore factors influencing the release of the proton pump inhibitor omeprazole from enteric-coated capsules in vitro and absorption in vivo in beagle dogs. Enteric-coated pellets with different enteric coating materials and coating levels were designed and prepared. All...
| Main Authors: | , , , , |
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| Format: | Article |
| Language: | English |
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SAGE Publishing
2020-03-01
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| Series: | Dose-Response |
| Online Access: | https://doi.org/10.1177/1559325820908980 |
| _version_ | 1818188239358394368 |
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| author | Cheng Cui Jiabei Sun Xueqing Wang Zhenxi Yu Yaqin Shi |
| author_facet | Cheng Cui Jiabei Sun Xueqing Wang Zhenxi Yu Yaqin Shi |
| author_sort | Cheng Cui |
| collection | DOAJ |
| description | This study was performed to explore factors influencing the release of the proton pump inhibitor omeprazole from enteric-coated capsules in vitro and absorption in vivo in beagle dogs. Enteric-coated pellets with different enteric coating materials and coating levels were designed and prepared. All self-prepared formulations were characterized in vitro as well as in vivo and compared to the brand and generic commercial products. Evaluation of the corresponding release profiles suggested that coating material was the most critical factor. Enteric coating level determined the lag time before initiation of drug release, and subcoating level affected the drug release rate. Pharmacokinetic studies were performed in beagle dogs to further confirm the influence of formulation factors on drug absorption. Medium at pH 6.8 was a more biorelevant condition for in vitro drug release tests, although medium at pH 6.0 was better for discriminating release profiles of different formulations. A multiple level C in vitro/in vivo correlation was preliminarily established by which T max and C max of omeprazole formulations could be predicted with release parameters such as T lag and T 25 . These results may facilitate quality evaluation and potentially improve the clinical efficacy of generic omeprazole products. |
| first_indexed | 2024-12-11T23:23:46Z |
| format | Article |
| id | doaj.art-827a3d616d7d45f9b68e774baf7f0b79 |
| institution | Directory Open Access Journal |
| issn | 1559-3258 |
| language | English |
| last_indexed | 2024-12-11T23:23:46Z |
| publishDate | 2020-03-01 |
| publisher | SAGE Publishing |
| record_format | Article |
| series | Dose-Response |
| spelling | doaj.art-827a3d616d7d45f9b68e774baf7f0b792022-12-22T00:46:16ZengSAGE PublishingDose-Response1559-32582020-03-011810.1177/1559325820908980Factors Contributing to Drug Release From Enteric-Coated Omeprazole Capsules: An In Vitro and In Vivo Pharmacokinetic Study and IVIVC Evaluation in Beagle DogsCheng Cui0Jiabei Sun1Xueqing Wang2Zhenxi Yu3Yaqin Shi4 Drug Clinical Trial Center, Peking University Third Hospital, Beijing, China National Institutes for Food and Drug Control, Beijing, China Department of Pharmaceutics, School of Pharmaceutical Sciences, Peking University, Beijing, China National Institutes for Food and Drug Control, Beijing, China National Institutes for Food and Drug Control, Beijing, ChinaThis study was performed to explore factors influencing the release of the proton pump inhibitor omeprazole from enteric-coated capsules in vitro and absorption in vivo in beagle dogs. Enteric-coated pellets with different enteric coating materials and coating levels were designed and prepared. All self-prepared formulations were characterized in vitro as well as in vivo and compared to the brand and generic commercial products. Evaluation of the corresponding release profiles suggested that coating material was the most critical factor. Enteric coating level determined the lag time before initiation of drug release, and subcoating level affected the drug release rate. Pharmacokinetic studies were performed in beagle dogs to further confirm the influence of formulation factors on drug absorption. Medium at pH 6.8 was a more biorelevant condition for in vitro drug release tests, although medium at pH 6.0 was better for discriminating release profiles of different formulations. A multiple level C in vitro/in vivo correlation was preliminarily established by which T max and C max of omeprazole formulations could be predicted with release parameters such as T lag and T 25 . These results may facilitate quality evaluation and potentially improve the clinical efficacy of generic omeprazole products.https://doi.org/10.1177/1559325820908980 |
| spellingShingle | Cheng Cui Jiabei Sun Xueqing Wang Zhenxi Yu Yaqin Shi Factors Contributing to Drug Release From Enteric-Coated Omeprazole Capsules: An In Vitro and In Vivo Pharmacokinetic Study and IVIVC Evaluation in Beagle Dogs Dose-Response |
| title | Factors Contributing to Drug Release From Enteric-Coated Omeprazole Capsules: An In Vitro and In Vivo Pharmacokinetic Study and IVIVC Evaluation in Beagle Dogs |
| title_full | Factors Contributing to Drug Release From Enteric-Coated Omeprazole Capsules: An In Vitro and In Vivo Pharmacokinetic Study and IVIVC Evaluation in Beagle Dogs |
| title_fullStr | Factors Contributing to Drug Release From Enteric-Coated Omeprazole Capsules: An In Vitro and In Vivo Pharmacokinetic Study and IVIVC Evaluation in Beagle Dogs |
| title_full_unstemmed | Factors Contributing to Drug Release From Enteric-Coated Omeprazole Capsules: An In Vitro and In Vivo Pharmacokinetic Study and IVIVC Evaluation in Beagle Dogs |
| title_short | Factors Contributing to Drug Release From Enteric-Coated Omeprazole Capsules: An In Vitro and In Vivo Pharmacokinetic Study and IVIVC Evaluation in Beagle Dogs |
| title_sort | factors contributing to drug release from enteric coated omeprazole capsules an in vitro and in vivo pharmacokinetic study and ivivc evaluation in beagle dogs |
| url | https://doi.org/10.1177/1559325820908980 |
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