Considerations related to the in-use stability of sterile pharmaceutical dosage forms

Background It is essential to ensure the in-use stability of sterile preparations because they may be vulnerable to microbial contamination during the opening and preparation process. Although some regulatory agencies provide general guidelines for in-use stability, there are no detailed guidelines...

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Published in:Journal of pharmaceutical investigation 2024, 54(1), , pp.1-12
Main Authors: Yoo, Hyelim, Na, Young-Guk, Jin, Minki, Won, Jong-Hee, Song, Bomin, Yun, Taek-Seon, Hwang, Yu-Rim, Lee, Hong-Ki, Cho, Cheong-Weon
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Biomedical and Life Sciences
Biomedicine
Review
약학
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container_title Journal of pharmaceutical investigation
container_volume 54
creator Yoo, Hyelim
Na, Young-Guk
Jin, Minki
Won, Jong-Hee
Song, Bomin
Yun, Taek-Seon
Hwang, Yu-Rim
Lee, Hong-Ki
Cho, Cheong-Weon
description Background It is essential to ensure the in-use stability of sterile preparations because they may be vulnerable to microbial contamination during the opening and preparation process. Although some regulatory agencies provide general guidelines for in-use stability, there are no detailed guidelines related to in-use stability testing specific to sterile pharmaceutical dosage forms. Area covered The guidelines of regulatory authorities and health-care associations related to the in-use stability of sterile pharmaceutical dosage forms were investigated. In addition, research trends on the in-use stability for each dosage form were reviewed. Expert opinion As a result of the study, we suggest that specific considerations of in-use stability by detailed sterile pharmaceutical dosage form include storage conditions, test period, test interval, withdrawal method, and test measurements.
doi_str_mv 10.1007/s40005-023-00643-w
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Review
약학
title Considerations related to the in-use stability of sterile pharmaceutical dosage forms
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