Abstract
The objective of this study was to evaluate the stability of diazoxide in extemporaneously compounded oral suspensions. Oral suspensions of diazoxide 10 mg/mL were prepared from either bulk drug or capsules dispersed in either Oral Mix or Oral Mix Sugar Free. These suspensions were stored at 5°C and 25°C/60%RH in bottles and oral syringes for a total of 90 days. At predetermined time intervals, suspensions were inspected for homogeneity, color or odor change; the pH was measured and the concentration of diazoxide was evaluated by ultraviolet detection using a stability-indicating high pressure liquid chromatography method. All preparations were demonstrated to be chemically stable for at least 90 days.
MeSH terms
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Capsules / chemistry
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Chromatography, High Pressure Liquid
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Diazoxide / analysis
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Diazoxide / chemistry*
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Drug Compounding
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Drug Stability
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Drug Storage
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Hydrogen-Ion Concentration
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Spectrophotometry, Ultraviolet
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Temperature
Grants and funding
This study was supported by an unrestricted grant from Medisca Pharmaceutique Inc. In compliance with Pr. Leclair's standard protocol, this study was conducted to evaluate the stability of extemporaneously compounded diazoxide suspensions prepared from bulk drug and commercial capsules in Oral Mix and Oral Mix SF vehicles and stored in plastic bottles and oral syringes. Oral Mix and Oral Mix SF are proprietary vehicles of Medisca Pharmaceutique Inc. Funding for this project was only conditional to the execution of the study and no commitments were taken regarding the outcome results of this study. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. If accepted for publication in PLOS One, the publication costs will be covered by Medisca Pharmaceutique Inc.