Stability of extemporaneously prepared preservative-free methylphenidate 5 mg/mL intravenous solution
Author(s)
Barra, Megan E; Edlow, Brian L; Lund, James T; DeSanctis, Katherine S; Vetrano, John; Reilly-Tremblay, Cherylann; Zhang, Edlyn R; Bodien, Yelena G; Brown, Emery N; Solt, Ken; ... Show more Show less
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Abstract
Purpose
To advance the implementation of consciousness-promoting therapies in patients with acute disorders of consciousness, the availability of potential therapeutic agents in formulations suitable for administration in hospitalized patients in the presence of complex comorbid conditions is paramount. The purpose of this study is to evaluate the long-term stability of extemporaneously prepared preservative-free methylphenidate hydrochloride (HCl) 5 mg/mL intravenous solution for experimental use.
Methods
A methylphenidate 5 mg/mL solution was prepared under proper aseptic techniques with Methylphenidate Hydrochloride, USP, powder mixed in sterile water for solution. Methylphenidate HCl 5 mg/mL solution was sterilized by filtration technique under USP <797>–compliant conditions. Samples were stored refrigerated (2-8°C) and analyzed at approximately days 1, 30, 60, 90, 180, and 365. At each time point, chemical and physical stability were evaluated by visual inspection, pH measurement, membrane filtration procedure, turbidometric or photometric technique, and high-performance liquid chromatography analysis.
Results
Over the 1-year study period, the samples retained 96.76% to 102.04% of the initial methylphenidate concentration. There was no significant change in the visual appearance, pH level, or particulate matter during the study period. The sterility of samples was maintained and endotoxin levels were undetectable throughout the 1-year stability period.
Conclusion
Extemporaneously prepared preservative-free methylphenidate 5 mg/mL intravenous solution was physically and chemically stable at 32, 61, 95, 186, and 365 days when stored in amber glass vials at refrigerated temperatures (2-8°C).
Date issued
2021-11-11Department
Picower Institute for Learning and MemoryJournal
American Journal of Health-System Pharmacy
Publisher
Oxford University Press (OUP)
Citation
Barra, Megan E, Edlow, Brian L, Lund, James T, DeSanctis, Katherine S, Vetrano, John et al. 2021. "Stability of extemporaneously prepared preservative-free methylphenidate 5 mg/mL intravenous solution." American Journal of Health-System Pharmacy.
Version: Author's final manuscript