Many drugs used in paediatric are often not available in suitable dosage forms and have to be
extemporaneously prepared by pharmacists to make them suitable for the body weight, body
surface area, or age of the children. Phenobarbitone is the main anti-epileptic drug (AED) for
the treatment of seizure in paediatric patients. The objective of this study is to evaluate the
physicochemical and microbiological stability of an extemporaneously prepared
Phenobarbitone Oral Suspension using commercially available tablets and X-temp Oral
Suspension System. The Phenobarbitone Oral Suspension (10mg/ml) was stored at 4ºC and
30ºC / 75%RH protected from light and were examined at the interval of 0, 1, 2, 3 and 6
months. The content of Phenobarbitone was determined using a validated high-performance
liquid chromatography (HPLC) method. The visual appearance, odour, pH and specific
gravity remained fairly unchanged throughout the study period and the content of
Phenobarbitone remained above 98% of the original concentration throughout the course of
the study for both temperatures. The extemporaneous preparation was not susceptible to
microbial contamination. The results from the stability studies confirmed that X-temp Oral
Suspension is a suitable suspending vehicle for preparing extemporaneous liquid formulation
of Phenobarbitone Oral Suspension with the added advantage of alcohol-free, colourant-free
and sugar-free. Based on the data collected, the shelf-life of this liquid formulation is at least
6 months when stored at 4ºC (refrigeration) and 30ºC / 75%RH (room temperature).