{"title":"水分对固态稳定性的影响","authors":"Stanko Srčič, Zoran Lavrič","doi":"10.20883/medical.e908","DOIUrl":null,"url":null,"abstract":"Water is omnipresent during pharmaceutical product manufacturing and may interact with the drug substance, excipients, and the drug product in either solvent or vapor form, resulting in several physico-chemical changes, ultimately affecting product performance. Therefore, understanding the mechanisms behind such moisture-induced changes is necessary at every stage of pharmaceutical development and manufacturing to obtain the target formulation. Characterization tools, such as water sorption, spectroscopy, thermal analysis, diffraction, and more sophisticated approaches like simulations and PAT techniques, can help in the selection of the appropriate solid form, manufacturing method, excipients, and storage conditions, enabling the manufacturing of a stable drug product formulation.","PeriodicalId":16350,"journal":{"name":"Journal of Medical Science","volume":"54 1","pages":"0"},"PeriodicalIF":0.0000,"publicationDate":"2023-09-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Effect of moisture on solid state stability\",\"authors\":\"Stanko Srčič, Zoran Lavrič\",\"doi\":\"10.20883/medical.e908\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"Water is omnipresent during pharmaceutical product manufacturing and may interact with the drug substance, excipients, and the drug product in either solvent or vapor form, resulting in several physico-chemical changes, ultimately affecting product performance. Therefore, understanding the mechanisms behind such moisture-induced changes is necessary at every stage of pharmaceutical development and manufacturing to obtain the target formulation. Characterization tools, such as water sorption, spectroscopy, thermal analysis, diffraction, and more sophisticated approaches like simulations and PAT techniques, can help in the selection of the appropriate solid form, manufacturing method, excipients, and storage conditions, enabling the manufacturing of a stable drug product formulation.\",\"PeriodicalId\":16350,\"journal\":{\"name\":\"Journal of Medical Science\",\"volume\":\"54 1\",\"pages\":\"0\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2023-09-29\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Medical Science\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.20883/medical.e908\",\"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 Medical Science","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.20883/medical.e908","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
Water is omnipresent during pharmaceutical product manufacturing and may interact with the drug substance, excipients, and the drug product in either solvent or vapor form, resulting in several physico-chemical changes, ultimately affecting product performance. Therefore, understanding the mechanisms behind such moisture-induced changes is necessary at every stage of pharmaceutical development and manufacturing to obtain the target formulation. Characterization tools, such as water sorption, spectroscopy, thermal analysis, diffraction, and more sophisticated approaches like simulations and PAT techniques, can help in the selection of the appropriate solid form, manufacturing method, excipients, and storage conditions, enabling the manufacturing of a stable drug product formulation.
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号
