title: Stability of Prednisone in Oral Mix Suspending Vehicle.
abstract: The stability of prednisone (5 mg/mL) formulated as a suspension in Oral Mix vehicle was evaluated. Oral Mix is a novel oral, dye-free suspending vehicle developed by Medisca Pharmaceutique Inc. for preparation of extemporaneous dosage forms. This drug was chosen based on its high frequency of prescription among the pediatric population. Suspensions were prepared from both pure active and commercial tablets utilizing two different container closures: amber glass bottles and polypropylene syringes (PreciseDose Dispenser Medisca Pharmaceutique Inc.). Formulations were stored at 5°C or 25°C and organoleptic properties, pH, and concentration were evaluated at predetermined time points up to 90 days. Validated stability-indicating high-performance liquid chromatography methods were developed. Beyond-use date was evaluated by statistical analysis of the overall degradation trend. Prednisone was stable for at least 90 days at 25°C. No changes in organoleptic properties or pH were observed for either of the formulations, and the global stability was roughly equivalent and sometimes superior to the stability of the same drugs in other previously used vehicles. Thus, Oral Mix was found to be a suitable dye-free vehicle for extemporaneous formulations.
authors.forename: Mihaela
authors.initials: M
authors.lastname: Friciu
authors.forename: Kevin
authors.initials: K
authors.lastname: Plourde
authors.forename: Grégoire
authors.initials: G
authors.lastname: Leclair
authors.forename: Panagiota
authors.initials: P
authors.lastname: Danopoulos
authors.forename: Taslim
authors.initials: T
authors.lastname: Savji
mesh_terms: D000284:Administration, Oral; D002626:Chemistry, Pharmaceutical; D004355:Drug Stability; D014677:Pharmaceutical Vehicles; D011241:Prednisone / Q000737:chemistry*; D013535:Suspensions
chemical_list: D014677:Pharmaceutical Vehicles; D013535:Suspensions; D011241:Prednisone