{"title":"盐酸沙普特林片剂的表征","authors":"Tapan Kumar Jena, R. Jat","doi":"10.22270/jddt.v14i6.6599","DOIUrl":null,"url":null,"abstract":"Characterization of Kuvan tablets involved thorough analysis of physical, chemical, and dissolution properties. Formulation development encompassed pre-formulation studies, feasibility trials, and process optimization. Kuvan tablets demonstrated variability in sapropterin dihydrochloride concentration but rapid dissolution across different media. Consistent mechanical strength, low impurity levels, and appropriate pH values were observed, ensuring efficacy, safety, and reliability. \nKeywords: Sapropterin dihydrochloride, Hyperphenylalaninemia, Kuvan tablets","PeriodicalId":15622,"journal":{"name":"Journal of Drug Delivery and Therapeutics","volume":"3 4","pages":""},"PeriodicalIF":0.0000,"publicationDate":"2024-06-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Characterization of Sapropterin Dihydrochloride Tablet\",\"authors\":\"Tapan Kumar Jena, R. Jat\",\"doi\":\"10.22270/jddt.v14i6.6599\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"Characterization of Kuvan tablets involved thorough analysis of physical, chemical, and dissolution properties. Formulation development encompassed pre-formulation studies, feasibility trials, and process optimization. Kuvan tablets demonstrated variability in sapropterin dihydrochloride concentration but rapid dissolution across different media. Consistent mechanical strength, low impurity levels, and appropriate pH values were observed, ensuring efficacy, safety, and reliability. \\nKeywords: Sapropterin dihydrochloride, Hyperphenylalaninemia, Kuvan tablets\",\"PeriodicalId\":15622,\"journal\":{\"name\":\"Journal of Drug Delivery and Therapeutics\",\"volume\":\"3 4\",\"pages\":\"\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2024-06-15\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Drug Delivery and Therapeutics\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.22270/jddt.v14i6.6599\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Drug Delivery and Therapeutics","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.22270/jddt.v14i6.6599","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0
摘要
Kuvan 药片的表征包括对物理、化学和溶解特性的全面分析。制剂开发包括制剂前研究、可行性试验和工艺优化。Kuvan 片剂显示出盐酸沙普特林浓度的可变性，但在不同介质中溶解迅速。此外，还观察到了一致的机械强度、低杂质含量和适当的 pH 值，从而确保了药效、安全性和可靠性。关键词盐酸沙泊三嗪 高苯丙氨酸血症 库万片
Characterization of Sapropterin Dihydrochloride Tablet
Characterization of Kuvan tablets involved thorough analysis of physical, chemical, and dissolution properties. Formulation development encompassed pre-formulation studies, feasibility trials, and process optimization. Kuvan tablets demonstrated variability in sapropterin dihydrochloride concentration but rapid dissolution across different media. Consistent mechanical strength, low impurity levels, and appropriate pH values were observed, ensuring efficacy, safety, and reliability.
Keywords: Sapropterin dihydrochloride, Hyperphenylalaninemia, Kuvan tablets
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