Development and Stability Study of an Omeprazole Suppository for Infants

Area of Science:

• Pharmaceutical Sciences
• Pediatric Formulations

Background:

• Omeprazole is a proton pump inhibitor (PPI) crucial for acid suppression therapy in infants.
• Existing oral omeprazole formulations for infants can be challenging to administer and compound.
• Development of stable pediatric dosage forms is essential for effective infant treatment.

Purpose of the Study:

• To develop a pediatric omeprazole suppository with optimal physical and chemical stability.
• To ensure the formulation is suitable for pharmaceutical batch production.
• To provide a viable alternative to existing infant omeprazole preparations.

Main Methods:

• Formulation development involving omeprazole, witepsol H15, and L-arginine base.
• Optimization of stirring rate, temperature, and L-arginine concentration for uniform suspension.
• Validation of a modified HPLC-UV method for omeprazole quantification.
• Conducting a one-year long-term stability study under controlled conditions.

Main Results:

• Achieved uniform omeprazole suspension by adding 100 mg L-arginine, pouring at 34.7°C, and stirring at 200 rpm.
• The suppository exhibited no discoloration over one year of storage in the dark at room temperature.
• Stable omeprazole content, ranging from 90% to 110%, was maintained throughout the one-year stability study.

Conclusions:

• Successfully developed a stable pediatric omeprazole suppository formulation.
• This suppository offers a promising alternative to manipulated or extemporaneously compounded oral omeprazole for infants.
• Further clinical studies are required to confirm the efficacy and safety of this pediatric formulation in infants.