Accelerated Predictive Stability Study of a Pediatric Drug Product for a Supplemental New Drug Application

In this paper, we report two Accelerated Stability Assessment Program (ASAP) studies for a pediatric drug product. Whereas the first study using a generic design failed to establish a predictive model, the second one was successful after troubleshooting the first study and customizing the study cond...

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Bibliographic Details
Published in:AAPS PharmSciTech 2024-06, Vol.25 (5), p.128, Article 128
Main Authors: Rakers, Viktoria, Wang, Jin, Kou, Dawen
Format: Article
Language:English
Subjects:
Biochemistry
Biomedical and Life Sciences
Biomedicine
Biotechnology
Chemistry, Pharmaceutical - methods
Child
Drug Compounding - methods
Drug Packaging - methods
Drug Packaging - standards
Drug Stability
Drug Storage
Excipients - chemistry
Humans
Humidity
Pediatrics - methods
Pharmaceutical Preparations - chemistry
Pharmacology/Toxicology
Pharmacy
Research Article
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Summary:In this paper, we report two Accelerated Stability Assessment Program (ASAP) studies for a pediatric drug product. Whereas the first study using a generic design failed to establish a predictive model, the second one was successful after troubleshooting the first study and customizing the study conditions. This work highlighted important lessons learned from designing an ASAP study for formulations containing excipients that could undergo phase change at high humidity levels. The stability predictions by the second ASAP model were consistent with available long-term stability data of the drug product under various storage conditions in two different packaging configurations. The ASAP model was part of the justifications accepted by the health authority to submit a stability package with reduced long-term stability data from the primary stability batches for a Supplemental New Drug Application (sNDA). Graphical Abstract
ISSN:1530-9932
1530-9932
DOI:10.1208/s12249-024-02848-0