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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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Bibliographic Details
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
Format: Article
Language:English
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Summary: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.
ISSN:2093-5552
2093-6214
DOI:10.1007/s40005-023-00643-w