1. Stability assessment of levofloxacin in three different suspension vehicles.
- Author
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Tardif, Véronique, Lepage, Olivier, Friciu, Mihaela, St‐Jean, Isabelle, Forest, Jean‐Marc, Leclair, Grégoire, and Roullin, V. Gaëlle
- Abstract
Background: Levofloxacin is a broad‐spectrum antibiotic of the fluoroquinolone class used in the paediatric population to treat resistant bacterial infections. Because no commercial option exists, a stable liquid formulation of this antibiotic made with accessible vehicles would be useful. Aim: The aim of this study was to develop and assess the stability of levofloxacin suspensions made from commercially available tablets and three different accessible vehicles. Methods: Levofloxacin suspensions (50 mg/mL) were compounded using two different commercially available tablets (from Apotex; Toronto, ON, Canada and Sandoz; Boucherville, QC, Canada) and three different vehicles (Ora‐Blend, Oral‐Mix; Medisca, Saint‐Laurent, QC, Canada and Simple Syrup (SS); Laboratoire Atlas Inc., Anjou, QC, Canada). Suitable suspensions in Ora‐Blend and Oral‐Mix were stored at room temperature (25°C) as well as under refrigeration (5°C) in amber plastic bottles for 90 days. Suspensions made with SS were only stored at 25°C because of sugar crystallisation at 5°C. Suspension concentrations were assessed by HPLC. Results: Suspensions using Apotex levofloxacin tablets produced unsuitable high‐foaming, phase‐separated, non‐homogeneous suspension products in all vehicles tested that were therefore not tested for stability. Levofloxacin suspensions prepared using Sandoz tablets remained chemically and physically stable for 3 months, with >96% recovery according to United States Pharmacopeia criteria (90%–110%) in all three vehicles. Conclusion: The results show that the choice of generic levofloxacin tablets is important when preparing homogeneous suspensions. All three vehicles could be used to prepare levofloxacin suspensions using Sandoz tablets that were physically and chemically stable for 3 months. [ABSTRACT FROM AUTHOR]
- Published
- 2020
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