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

Abstract

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.

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Acknowledgements

The authors would like to thank to The PARC for all the support during the research.

Funding

This work received support from Zentiva, k.s and from the Specific University Research (project MŠMT no. 21-SVV/2019).

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JP was involved in concept, experimental work, writing. JH contributed to concept, supervising. PŘ was involved in supervising.

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Correspondence to Jakub Petřík.

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On behalf of all authors, the corresponding author states that there is no conflict of interest.

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Petřík, J., Heřt, J. & Řezanka, P. Development of methodology for the study of API sensitivity to hydrolytic degradations at different pH conditions in solid-state. Chem. Pap. 75, 5739–5747 (2021). https://doi.org/10.1007/s11696-021-01630-x

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  • DOI: https://doi.org/10.1007/s11696-021-01630-x

Keywords

  • Solid-state degradation
  • Hydrolysis
  • PH