Omeprazole suspension formulations
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Omeprazole Suspension Formulations: Stability, Vehicles, and Pediatric Use
Challenges in Compounding Omeprazole Suspensions
Omeprazole is not commercially available as a liquid in many regions, so pharmacists often need to compound suspensions from solid forms for patients who cannot swallow pills, such as children or the elderly. However, not all solid dosage forms are suitable for compounding, and the resulting suspensions can have issues with uniformity, sedimentation, and stability, which may lead to inaccurate dosing and reduced effectiveness 17.
Stability and Storage of Omeprazole Suspensions
Stability is a major concern for omeprazole suspensions. Studies show that suspensions made from certain brands of omeprazole capsules (such as Losec and Dr. Reddy's) in 8.4% sodium bicarbonate solution remain chemically and physically stable for up to 20 days at 4°C and protected from light, but only for 7 days at 25°C . Other research confirms that omeprazole suspensions stored at refrigerated temperatures (2–8°C) can remain stable for at least 90 days, while those kept at room temperature are only stable for about 7–14 days, depending on the formulation 38.
Formulation Approaches and Vehicles
The choice of vehicle and excipients is critical for omeprazole suspension stability and bioavailability. Sodium bicarbonate is commonly used to buffer the suspension and protect omeprazole from acid degradation, significantly improving stability and drug recovery compared to unbuffered formulations 279. Adding glycerin and other excipients can further enhance stability and palatability 23.
Recent studies have explored oily suspension vehicles, such as those containing Labrafil M 1944 CS, Span 80, and Aerosil 200, which provide improved dissolution rates and sedimentation properties, making them promising for pediatric use and for maintaining gastro-resistance 45. These oily suspensions also help protect omeprazole from the acidic environment of the stomach, reducing drug degradation .
Pediatric Applications and Clinical Performance
Omeprazole suspensions are especially important for pediatric patients. Both suspensions made from crushed pellets and those from pure omeprazole can be stored for extended periods under refrigeration and are suitable for children who cannot swallow tablets . Pharmacokinetic studies in children show that omeprazole suspensions prepared with sodium bicarbonate provide similar blood levels to granule formulations, making them a reliable alternative for pediatric therapy .
Novel Formulations and Future Directions
Innovative approaches, such as co-crystal dry suspensions and immediate-release powder suspensions with antacids, are being developed to further improve omeprazole’s solubility, stability, and bioavailability 69. These new formulations aim to address the limitations of traditional compounded suspensions, such as poor taste, low bioavailability, and rapid degradation in acidic environments 67.
Conclusion
Omeprazole suspension formulations are essential for patients who cannot take solid oral medications, particularly children. The stability and effectiveness of these suspensions depend heavily on the choice of omeprazole source, vehicle, and storage conditions. Buffered vehicles like sodium bicarbonate and innovative oily suspensions offer improved stability and bioavailability. Continued research and optimization are needed to ensure safe, effective, and patient-friendly omeprazole suspensions for all populations 12345789+1 MORE.
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