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Stability and Dissolution Behavior Changes After Drug Compounding for Pediatric Cardiovascular Pharmacotherapy
Jumpei Saito1, Akimasa Yamatani2, Yuna Kojima3
1Department of Pharmacy, National Center for Child Health and Development, 2-10-1 Okura, Setagaya-ku, Tokyo 157-8535, Japan.
Pharmaceutics
|April 26, 2025
Summary
Crushed pediatric cardiovascular medications in Japan remain stable and dissolve properly after compounding and up to 120 days of storage. This ensures pharmaceutical quality for children
Area of Science:
- Pharmaceutical Science
- Pediatric Pharmacology
- Drug Stability
Background:
- Pediatric medication often requires compounding to adjust dosages.
- Current practices in Japan involve crushing tablets, diluting them, and storing them for use.
- The stability and dissolution of compounded pediatric medications after crushing were previously unevaluated.
Purpose of the Study:
- To investigate the stability and dissolution of commonly compounded cardiovascular drugs for pediatric use in Japan.
- To assess the impact of different storage conditions on the quality of crushed and diluted medications.
Main Methods:
- Five cardiovascular drugs were selected and crushed, sieved, and diluted with lactose hydrate.
- Stability and dissolution were evaluated after 120 days of storage under closed, in-use, and laminated sachet conditions.
- Evaluations followed Japanese Pharmacopoeia standards for ingredient content and dissolution behavior.
Main Results:
- All five compounded cardiovascular drugs showed less than 10% change in ingredient content over 120 days.
- No significant impurities (>0.01%) were detected in any of the formulations.
- Dissolution rates remained unchanged across all storage conditions after 120 days.
Conclusions:
- Compounded pediatric cardiovascular drugs in Japan maintain their pharmaceutical quality.
- Long-term storage under typical conditions does not adversely affect the stability or dissolution of these medications.
- Findings support the continued use of current compounding practices for pediatric cardiovascular medications.
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