Title

Comparative Stability Study of Unit-dose Vancomycin Hydrochloride Oral Solutions in Plastic Capped Oral Syringes and Plastic Sealed Dosage Cups

Document Type

Article

Publication Date

5-1-2020

Description

The objective of this study was to evaluate the stability of vancomycin hydrochloride oral solution prepared using FIRST Vancomycin and FIRVANQ compounding kits, prepared in oral syringes and heat-sealed dosing cups, stored at refrigerated and room temperatures. Triplicate batches of vancomycin hydrochloride oral solution (50 mg/mL) were prepared using FIRST Vancomycin and FIRVANQ kits, aliquoted into plastic oral syringes and sealed dosing cups, stored at refrigerated and room temperatures for a total of eight sample groups. Additionally, remaining samples from FIRVANQ batches were unit-dosed in clear Luer-Lok syringes and stored under refrigeration as a ninth batch. Samples were removed and analyzed for vancomycin recovery using a previously validated high-performance liquid chromatography with ultraviolet detection method over a 30-day period. Recovery was quantitatively assessed by comparing to a freshly prepared United States Pharmacopeia reference standard on each day of sampling. Stability was defined as recovery of 90% to 110% of labeled amount. For all batches and storage conditions tested, the percent recovery of vancomycin remained within the 90% to 110% range throughout the entire 30-day study period. Statistically significant differences based on storage conditions were detected between some test groups, with higher recoveries associated with refrigerated storage. The stability of FIRVANQ is comparable to the solution prepared using the FIRST Vancomycin kit. FIRST Vancomycin and FIRVANQ solutions can be unit dosed, using capped oral syringes or sealed plastic cups, and stored at room temperature or under refrigeration for up to 30 days, which helps improve pharmacy workflow and reduce errors.

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