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

Kód výsledku v 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>

Výsledek na webu

<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>

Jazyk výsledku

angličtina

Název v původním jazyce

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

Popis výsledku v původním jazyce

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.

Název v anglickém jazyce

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

Popis výsledku anglicky

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.

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

10406 - Analytical chemistry

Projekt

—

Návaznosti

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

Rok uplatnění

2021

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Název periodika

Chemical Papers

ISSN

0366-6352

e-ISSN

—

Svazek periodika

75

Číslo periodika v rámci svazku

11

Stát vydavatele periodika

SK - Slovenská republika

Počet stran výsledku

9

Strana od-do

5739-5747

Kód UT WoS článku

000668046200001

EID výsledku v databázi Scopus

2-s2.0-85109192108