Stability Assessment of 10 Active Pharmaceutical Ingredients Compounded in SyrSpend SF

Area of Science:

• Pharmaceutical Science
• Drug Stability
• Formulation Development

Background:

• Oral suspensions are crucial for administering medications, especially for pediatric and geriatric populations.
• Ensuring the stability of active pharmaceutical ingredients (APIs) in compounded oral suspensions is vital for therapeutic efficacy and patient safety.
• SyrSpend SF PH4 and SyrSpend SF Alka are commonly used vehicles for compounding oral suspensions.

Purpose of the Study:

• To evaluate the stability of 10 active pharmaceutical ingredients (APIs) when formulated into oral suspensions using SyrSpend SF PH4 and SyrSpend SF Alka.
• To determine the shelf-life of these compounded suspensions under various storage conditions, including room temperature and refrigeration (2°C to 8°C).

Main Methods:

• Ten APIs were compounded into oral suspensions at specified concentrations in low actinic plastic bottles using SyrSpend SF PH4 or SyrSpend SF Alka.
• Samples were analyzed for API concentration immediately after preparation (day 0) and at predetermined intervals during storage.
• High-performance liquid chromatography (HPLC) using a stability-indicating method was employed to quantify API concentrations.
• Stability was defined as retaining 90% to 110% of the initial API concentration.

Main Results:

• Furosemide remained stable for at least 14 days in SyrSpend SF Alka under refrigerated conditions.
• Prednisolone sodium phosphate, ranitidine hydrochloride, hydrocortisone hemisuccinate, amiodarone hydrochloride, and nifedipine demonstrated stability for extended periods (30 to 90 days) in SyrSpend SF PH4 under various conditions.
• Phenobarbital showed remarkable stability, retaining over 90% concentration for at least 154 days in SyrSpend SF PH4 at room temperature.
• Simvastatin and spironolactone also exhibited good stability, lasting at least 90 days in SyrSpend SF PH4 under refrigerated and room temperature conditions, respectively.

Conclusions:

• SyrSpend SF PH4 and SyrSpend SF Alka provide a stable vehicle for a wide range of frequently used active pharmaceutical ingredients in oral suspensions.
• The study supports the use of these vehicles for compounding medications intended for storage at room temperature or under refrigeration.
• These findings contribute valuable data for pharmacists and healthcare providers regarding the appropriate use and storage of compounded oral medications.