Formulating of compounded Omeprazole oral suspension for pediatric patients in Phra Nakorn Si Ayutthaya Hospital

Abstract

The standard formulation of omeprazole suspension using 8.4% sodium bicarbonate vehicle had an unpleasant taste, which affected the compliance of pediatric patients. Therefore, the researchers developed a formulation by adding chocolate syrup vehicle to improve the taste and studied the stability and quality of the developed formulations were evaluated through the preparation of five different suspension vehicles, consisted of 8.4% sodium bicarbonate 83.33, 66.66, 50.00, 33.33, and 16.66% v/v, adjusted to the final volume with chocolate syrup. The appropriate vehicle was selected based on its alkalinity (minimum pH of 7.8) and suitability as a suspension vehicle. The selected formula was then used to prepare 18 bottles of Omeprazole suspension for further analysis. Parameters assessed included API content, pH value, and physical stability under refrigerated storage conditions (2-8°C) at 0, 14, and 28 days. Additionally, a sensory evaluation was conducted with 20 volunteers to assess taste acceptability. The results demonstrated that the Omeprazole suspension developed using Formula 3 (8.4% sodium bicarbonate 50.00%) maintained its API content at 97.3%, 97.2%, and 97.3% at 0, 14, and 28 days, respectively. The pH values were stable at 8.1, 8.0, and 8.1 with no significant physical changes observed in any of the samples. Taste evaluation scores for the original and newly developed formulations were comparable, indicating improved palatability. In conclusion, the newly developed Omeprazole suspension formulation exhibits stability comparable to that of the original formulation under refrigerated storage conditions (2 - 8°C) for up to 28 days. Furthermore, the enhanced taste profile is expected to contribute to improved medication adherence in pediatric patients.