Characterization of enteric-coated erythromycin tablets by Raman mapping and its pharmaceutical evaluation
Enteric tablet coating thickness is a critical quality attribute of the coating process that can affect dissolution behavior in vitro as well as release in vivo. Raman mapping offers unique advantages in analyzing the distribution of active pharmaceutical ingredients and excipients in formulations....
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| Format: | Article |
| Language: | English |
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Frontiers Media S.A.
2023-10-01
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| Series: | Frontiers in Chemistry |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fchem.2023.1270737/full |
| _version_ | 1797657321927606272 |
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| author | Wenbo Zou Wenbo Zou Wanhui Liu Changqin Hu |
| author_facet | Wenbo Zou Wenbo Zou Wanhui Liu Changqin Hu |
| author_sort | Wenbo Zou |
| collection | DOAJ |
| description | Enteric tablet coating thickness is a critical quality attribute of the coating process that can affect dissolution behavior in vitro as well as release in vivo. Raman mapping offers unique advantages in analyzing the distribution of active pharmaceutical ingredients and excipients in formulations. In this study, Raman mapping was used to characterize the coating of enteric-coated erythromycin tablets coated by two different processes and compare the differences in their coating formulation, thickness, and uniformity. Furthermore, we aimed to select the appropriate pH of the dissolution medium at which the coating slowly cracks to release the drug and determine the dissolution profile. The differences in the coating thickness and uniformity of the two products resulted in differences in dissolution behavior. Although there are differences in the coating processes for the two types of enteric-coated erythromycin tablets, the thickness of the outer coating on the side is a critical quality attribute in both processes. The outer coating of product A is relatively thick, and the thickness of the outer coating on the side affects the dissolution amount. The outer coating of product B is relatively thin, resulting in a short cracking time and large variation and a significant difference in the initial dissolution amounts between tablets. Raman mapping can be used to analyze the differences in coating formulations and for process evaluation. |
| first_indexed | 2024-03-11T17:42:48Z |
| format | Article |
| id | doaj.art-5a29f23bf74649c4a7e949df5d28cab9 |
| institution | Directory Open Access Journal |
| issn | 2296-2646 |
| language | English |
| last_indexed | 2024-03-11T17:42:48Z |
| publishDate | 2023-10-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Chemistry |
| spelling | doaj.art-5a29f23bf74649c4a7e949df5d28cab92023-10-18T09:04:21ZengFrontiers Media S.A.Frontiers in Chemistry2296-26462023-10-011110.3389/fchem.2023.12707371270737Characterization of enteric-coated erythromycin tablets by Raman mapping and its pharmaceutical evaluationWenbo Zou0Wenbo Zou1Wanhui Liu2Changqin Hu3Key Laboratory of Molecular Pharmacology and Drug Evaluation (Yantai University), School of Pharmacy, Ministry of Education, Collaborative Innovation Center of Advanced Drug Delivery System and Biotech Drugs in Universities of Shandong, Yantai University, Yantai, ChinaNational Institutes for Food and Drug Control, Beijing, ChinaKey Laboratory of Molecular Pharmacology and Drug Evaluation (Yantai University), School of Pharmacy, Ministry of Education, Collaborative Innovation Center of Advanced Drug Delivery System and Biotech Drugs in Universities of Shandong, Yantai University, Yantai, ChinaNational Institutes for Food and Drug Control, Beijing, ChinaEnteric tablet coating thickness is a critical quality attribute of the coating process that can affect dissolution behavior in vitro as well as release in vivo. Raman mapping offers unique advantages in analyzing the distribution of active pharmaceutical ingredients and excipients in formulations. In this study, Raman mapping was used to characterize the coating of enteric-coated erythromycin tablets coated by two different processes and compare the differences in their coating formulation, thickness, and uniformity. Furthermore, we aimed to select the appropriate pH of the dissolution medium at which the coating slowly cracks to release the drug and determine the dissolution profile. The differences in the coating thickness and uniformity of the two products resulted in differences in dissolution behavior. Although there are differences in the coating processes for the two types of enteric-coated erythromycin tablets, the thickness of the outer coating on the side is a critical quality attribute in both processes. The outer coating of product A is relatively thick, and the thickness of the outer coating on the side affects the dissolution amount. The outer coating of product B is relatively thin, resulting in a short cracking time and large variation and a significant difference in the initial dissolution amounts between tablets. Raman mapping can be used to analyze the differences in coating formulations and for process evaluation.https://www.frontiersin.org/articles/10.3389/fchem.2023.1270737/fullRaman mappingcoating formulationcoating thicknessdissolutionenteric coated tablets |
| spellingShingle | Wenbo Zou Wenbo Zou Wanhui Liu Changqin Hu Characterization of enteric-coated erythromycin tablets by Raman mapping and its pharmaceutical evaluation Frontiers in Chemistry Raman mapping coating formulation coating thickness dissolution enteric coated tablets |
| title | Characterization of enteric-coated erythromycin tablets by Raman mapping and its pharmaceutical evaluation |
| title_full | Characterization of enteric-coated erythromycin tablets by Raman mapping and its pharmaceutical evaluation |
| title_fullStr | Characterization of enteric-coated erythromycin tablets by Raman mapping and its pharmaceutical evaluation |
| title_full_unstemmed | Characterization of enteric-coated erythromycin tablets by Raman mapping and its pharmaceutical evaluation |
| title_short | Characterization of enteric-coated erythromycin tablets by Raman mapping and its pharmaceutical evaluation |
| title_sort | characterization of enteric coated erythromycin tablets by raman mapping and its pharmaceutical evaluation |
| topic | Raman mapping coating formulation coating thickness dissolution enteric coated tablets |
| url | https://www.frontiersin.org/articles/10.3389/fchem.2023.1270737/full |
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