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Abstract:  The stability of 10 active pharmaceutical ingredients was studied in SyrSpend SF PH4 or SyrSpend SF Alka at room and/or refrigerated temperature (2°C to 8°C). An oral suspension of each active pharmaceutical ingredient was compounded in low actinic plastic bottles at a specific concentration in SyrSpend SF PH4 or SyrSpend SF Alka. Samples were assessed for stability immediately after preparation (day 0) followed by storage at room temperature and/or at refrigerated temperature. At set time points, the samples were removed from storage and assayed using a high-performance liquid chromatographic stability-indicating method. The active pharmaceutical ingredient was considered stable if the suspension retained 90% to 110% of the initial concentration. Furosemide was stable for at least 14 days in SyrSpend SF Alka at refrigerated conditions. Prednisolone sodium phosphate in SyrSpend SF PH4 was stable for at least 30 days at room temperature and refrigerated conditions. Ranitidine hydrochloride suspensions in SyrSpend SF PH4 at room temperature and refrigerated conditions were stable for at least 30 days and 58 days, respectively. Hydrocortisone hemisuccinate and sodium phosphate retained greater than 90% for at least 60 days at both room temperature and refrigerated samples in SyrSpend SF PH4. Amiodarone hydrochloride and nifedipine suspensions at both room temperature and refrigerated conditions retained greater than 90% of the initial concentrations for at least 90 days in SyrSpend SF PH4. Refrigerated samples of simvastatin in SyrSpend SF PH4 were stable for at least 90 days. Spironolactone in SyrSpend SF PH4 at room temperature retained more than 90% of the initial concentration for at least 90 days. Phenobarbital in SyrSpend SF PH4 retained above 90% of initial concentration for at least 154 days at room temperature. This study demonstrated the stability of a wide range of frequently used active pharmaceutical ingredients, tested in SyrSpend SF PH4 and SyrSpend SF Alka at different storage conditions.

Related Keywords: Christine M. Geiger, MS, Bridget Sorenson, BS, Paul Whaley, BS, oral suspension vehicle, stability, SyrSpend SF, sugar free, storage temperature, amiodarone hydrochloride, furosemide, hydrocortisone hemisuccinate, hydrocortisone sodium phosphate, nifedipine, phenobarbital, prednisolone sodium phosphate, ranitidine hydrochloride, simvastatin, spironolactone

Related Categories: EXCIPIENTS, PEER-REVIEWED, STABILITIES, COMPATIBILITIES

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