Objective:

To reconstitute vigabatrin powder in liquids beyond water and determine stability of the solution for up to 48 hours refrigerated.

Background:

It is common for caregivers to seek information on reconstituting Vigadrone (vigabatrin) Powder in a child’s preferred liquid rather than water to improve patient acceptance.  The Instructions for Use only advise reconstituting the powder in water, prior to administration, and then discarding unused solution.

Design/Methods:

Three lots of Vigadrone Powder were selected for reconstitution in four liquids – water, Motts® apple juice, Horizon organic whole milk, Similac® 360 Total Care infant formula.  For each sample, 3 sachets containing 500 mg each were dissolved in 30 mL of each fluid according to the Instructions for Use.  All solutions were tested at time zero, 24, and 48 hours after preparation according to the current USP monograph.  The samples were stored in the refrigerator at 2-8⁰C in a capped glass container.

Results:

Vigadrone reconstituted in each respective liquid passed the Description test when compared with the matched control (liquid with no drug). The spectrum and retention time of the USP Identification test matched the vigabatrin reference standard based on HPLC analysis.  The USP Assay test for all sample solutions met the USP acceptance criteria of 95.0-105.0% at all three time points. The USP Related Substances/Organic Impurities testing for total impurities met the acceptance criteria for each sample at time zero, 24, and 48 hours.

Conclusions:

The reconstitution of Vigadrone powder in four liquids passed the USP monograph testing criteria for vigabatrin for oral solution at each time point with storage in a refrigerator at 2-8⁰C. Based on these findings, reconstitution of Vigadrone powder in water, apple juice, whole milk, or infant formula results in a solution that is stable for up to 48 hours when stored in the refrigerator.