Development of methodology for the study of API sensitivity to hydrolytic degradations at different pH conditions in solid-state

Result code in IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F60461373%3A22340%2F21%3A43922043" target="_blank" >RIV/60461373:22340/21:43922043 - isvavai.cz</a>
Result on the web
<a href="https://link.springer.com/article/10.1007/s11696-021-01630-x" target="_blank" >https://link.springer.com/article/10.1007/s11696-021-01630-x</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.1007/s11696-021-01630-x" target="_blank" >10.1007/s11696-021-01630-x</a>

Result language
angličtina
Original language name
Development of methodology for the study of API sensitivity to hydrolytic degradations at different pH conditions in solid-state
Original language description
The present study is focused on the development of methodology for testing drug sensitivity to hydrolytic degradation in different pH conditions in solid-state. To test hydrolytic degradations in solid-state, methodology using different silica and silicates with varying pH (3.9-9.7) was developed. Hydrolytic degradations in varying pH conditions of two drugs, bisoprolol and sofosbuvir were examined in solution as well as in solid-state using HPLC. Impurity profiles in solid-state and in solution differed for sofosbuvir. A bisoprolol hydrolytic curve measured in solid-state showed different dependence between pH and degradation than in solution. The main difference between testing the effects of pH on API stability in solution and in solid-state is that different degradation mechanisms are taking place. It was confirmed that degradation mechanisms observed in solid-state testing are much closer to degradation mechanisms observed for solid dosage forms than degradation mechanism observed while using standard method of testing in solution.
Czech name
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Czech description
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Type
J<sub>imp</sub> - Article in a specialist periodical, which is included in the Web of Science database
CEP classification
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OECD FORD branch
10406 - Analytical chemistry

Project
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Continuities
S - Specificky vyzkum na vysokych skolach<br>I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Publication year
2021
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

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