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Abstract:  The objective of this study was to evaluate the stability of 10 commonly used active pharmaceutical ingredients compounded in oral suspensions using SyrSpend SF PH4 (atenolol 1.0 and 5.0 mg/mL, clonazepam 0.2 mg/mL, dexamethasone 1.0 mg/mL, diclofenac sodium 5.0 mg/mL, diltiazem 12.0 mg/mL, enalapril maleate 1.0 mg/mL, ketoprofen 20.0 mg/mL, lamotrigine 1.0 mg/mL, penicillamine-D 50.0 mg/mL, thiamine 100 mg/mL) and stored both at controlled refrigerated (2°C to 8°C) and room temperature (20°C to 25°C). Stability was assessed by means of measuring percent recovery at varying time points throughout a 90-day period. The quantification of the active pharmaceutical ingredients was performed by a stability-indicating, high-performance liquid chromatographic method. The beyond-use date of the products was found to be at least 90 days for all suspensions (except atenolol 1 mg/mL, which was stable up to 60 days), both for controlled refrigerated temperature and room temperature. This confirms that SyrSpend SF PH4 is a stable suspending vehicle for compounding with a broad range of different active pharmaceutical ingredients.

Related Keywords: Sharlene Loures, Bbiomed, atenolol, clonazepam, dexamethasone, diclofenac sodium, diltiazem, enalapril maleate, ketoprofen, lamotrigine, penicillamine-D, thiamine, oral suspensions, liquid suspending vehicles, liquid dosage forms, stability, storage conditions, beta blocker, beta adrenergic antagonist, benzodiazepine, corticosteroid, nonsteroidal anti-inflammatory drugs, NSAID, non-dihydropyridine calcium channel blocker, angiotensin converting enzyme inhibitor, ACE inhibitor, anticonvulsant agent, mood stabilizer, chelating agents, chelator, immunosuppressant, immunosuppressive agent

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

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