Loading…
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...
Saved in:
Published in: | Journal of pharmaceutical investigation 2024, 54(1), , pp.1-12 |
---|---|
Main Authors: | , , , , , , , , |
Format: | Article |
Language: | English |
Subjects: | |
Citations: | Items that this one cites |
Online Access: | Get full text |
Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
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 |