Optimization of the manufacturing process of a pediatric omeprazole enteric pellets suspension: Full Factorial Design

The purpose of the present study was to apply the design of experiments (DoE) to develop an omeprazole enteric pellets suspension for use in the pediatric population. This experimental study employed a Full Factorial Design for drug development, encompassing three factors (Aerosil^® R972, cetostearyl alcohol, and Span 80) at two levels (2% and 6% for factor A (Aerosil^® R972) and 2% and 4% for factors B and C (cetostearyl alcohol and Span 80, respectively)). Following the statistical optimization, the suspension F10 was formulated and subjected to a stability study for one month. The dissolution test results were suboptimal, achieving only an 22% release. Subsequently, eight additional suspensions were devised using hydrophilic oily vehicles (Labraphac Hydrophile WL 1219, Labrafil M2125 CS, and Labrafil M 1944 CS) and excipients (Gelucire 44/14 and Aerosil^® 200) to enhance the dissolution profile. Suspension F17 showed over 75% within 30 min, displaying superior sedimentation time when compared to all other formulations, along with effortless resuspension. The findings suggest that the optimal vehicle for the administration of omeprazole enteric pellets in suspension is the formulation comprising Labrafil M 1944 CS, Span 80, and Aerosil^® 200. This study has paved the way for an oily suspension vehicle, opening new avenues of research for developing pediatric omeprazole formulations that fulfill gastro-resistance requirements.