Abstract
Background
The stability test after opening is conducted to establish an appropriate storage period during which the quality is maintained of multidose drug products that are opened and used repeatedly. While some of the regulatory agencies have provided guidelines for in-use stability study design, detailed guidelines covering various formulations are not provided. So, the guidelines are necessary to help the industry both understand and conduct stability studies. In addition, health-care professionals are required to provide patients or patient caregivers with information regarding the storage of medicines after opening. Furthermore, unless otherwise stated in marketing authorization, if the safety, efficacy, and quality of products are susceptible to inappropriate storage, then it is also necessary to prepare the related safe use guidelines.
Area covered
In this paper, trends in the stability after opening guidelines of international organizations and competent regulatory agencies were investigated. The safe use guidelines, such as storage period after opening for nonsterile preparations, were also reviewed.
Expert opinion
As a result of the study, regulatory guidelines for the formulation (product), target batch and testing time point, container closure system, and sample storage conditions of the in-use stability test are presented. Additionally, from the perspective of the safe use of pharmaceuticals, stability information to be recommended to patients and storage period after opening for each dosage form are also presented. Based on these presentations, we intend to prepare guidelines that pharmaceutical industry and health-care professionals can refer to in the field.
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Acknowledgements
This research was supported by a Grant (20173MFDS165) from Ministry of Food and Drug Safety in 2021.
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All authors (H.S. Lee, M.K. Jin, W.J. Jeon, H.U. Kim, M.W. Jung, H.L. Yoo, J.H Won and C.W. Cho) declare that they have no conflict of interest.
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Lee, H., Jin, M., Jeon, WJ. et al. Regulatory and safe-use considerations related to stability after opening of nonsterile dosage forms. J. Pharm. Investig. 52, 319–329 (2022). https://doi.org/10.1007/s40005-022-00564-0
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DOI: https://doi.org/10.1007/s40005-022-00564-0