Formulation And Stability Testing Of Pediatric Oral Suspension For Antibiotic Therapy: A Quality-By-Design Approach

Abstract

The purpose of this work was to apply Quality by Design Approch approach to improve stability, taste, and bioavailability of an antibiotic in a pediatric oral suspension formulation. The selected antibiotic amoxicillin was chosen for its broad-spectrum activity and its pediatric dosing that has already been established. Other additives such as xanthan gum, sucrose, and sodium benzoate were included to give correct viscosity, taste, and microbial properties. In formulation process, the API was micronised and the blending was carried out under aseptic conditions. A DoE strategy was used to determine the best factors and it was found that xanthan gum had a strong effect on viscosity while sweeteners affected taste masking. Stability studies such as accelerated and real time stability studies revealed that the formulation was physically and chemically stable under most of the conditions though there was slight increase in viscosity and API degradation under accelerated conditions. Microbiological analysis proved that the product was free from microbes and preservative efficacy was satisfactory throughout the shelf life of the product. The results show how the QbD approach can be used to design a stable, palatable, and safe pediatric oral suspension and how this can be applied to future pediatric antibiotic therapies.