Dissolution and stability of vigabatrin powder in water, fruit juice, milk, and infant formula
The prescribing information for the antiseizure medication Vigadrone® (vigabatrin) Powder for Oral Solution advises only reconstituting the powder in water prior to administration and discarding unused solution. However, caregivers may seek to reconstitute vigabatrin in a pediatric patient’s preferr...
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| Main Authors: | , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Elsevier
2025-09-01
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| Series: | Epilepsy & Behavior Reports |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2589986425000760 |
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| Summary: | The prescribing information for the antiseizure medication Vigadrone® (vigabatrin) Powder for Oral Solution advises only reconstituting the powder in water prior to administration and discarding unused solution. However, caregivers may seek to reconstitute vigabatrin in a pediatric patient’s preferred liquid rather than water to ease administration. We performed an in-use dissolution and stability study of vigabatrin powder reconstituted in 4 liquids—water, apple juice, whole milk, and infant formula—with testing performed 0, 24, and 48 h after preparation with storage at 2–8 °C in a capped, glass container. Vigabatrin reconstituted in each liquid was clear and free of visible particulates compared with matched drug-free liquid controls. In subsequent analyses using US Pharmacopeia (USP) procedures, high-performance liquid chromatography spectra and chromatograms for each sample solution matched the vigabatrin reference standard. At all time points, all sample solutions met USP-acceptance criteria of 95.0–105.0 % for product stability and USP-acceptance criteria for related substances/organic impurities testing for total impurities. Together, these results indicate that vigabatrin powder reconstituted in liquids other than water was stable for up to 48 h of refrigeration. This study provides useful information to help healthcare providers address real-world medication questions from caregivers. |
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| ISSN: | 2589-9864 |