Properties of a Formulated Paediatric Phenobarbitone Oral Liquid

Aim: To formulate a stable and palatable paediatric phenobarbitone 10 mg/mL oral liquid and compare its physicochemical stability to the existing formulation compounded in some New Zealand hospitals. Method: Formulations were compounded from pharmaceutical standard ingredients according to good manufacturing practices and stored in glass bottles at different storage conditions. The physical stability of the formulations was determined by pH, appearance, viscosity and microbial studies; chemical stability was assessed using high performance liquid chromatography. Results: The new formulation and the existing hospital formulation remained physically stable for 28 days in terms of pH, appearance, viscosity and microbial stability. The phenobarbitone sodium concentration remained within an acceptable range (above 95% of the original concentration) after 28 days of storage at different conditions. The viscosity of the new formulation facilitated in masking phenobarbitone sodium's bitter taste, thus improving palatability. The palatability of the new formulation was superior to the hospital formulation. Conclusion: A palatable paediatric phenobarbitone oral liquid formulation with improved theological properties was developed. (author abstract)