Assessment of the physico-chemical and microbial quality of selected extemporaneous paediatric oral formulations frequently prepared at Komfo Anokye Teaching Hospital in Kumasi

Abstract

The Komfo Anokye Teaching Hospital (KATH) pharmacy prepares paediatric formulations of unavailable dosage forms on daily basis for children with a variety of acute and chronic diseases. This study assessed the physical and microbiological quality, and chemical stability of extemporaneous oral paediatric formulations prepared in this facility. The study team surveyed the hospital for unavailable formulations which were requested and prepared extemporaneously in the hospital's pharmacy. Stability studies were then conducted on the six (6) most frequently prepared paediatric suspension formulations namely; acetazolamide, spironolactone. propranolol, furosemide, phenobarbitone and lamivudine. These were prepared in accordance
with KATH approved formulation procedures. HPLC and the agar diffusion methods were employed in the analysis. The formulated suspensions of spironolactone and furosemide were microbiologically and chemically stable up to 30 days. Lamivudine suspension was stable both chemically and microbiologically up to 60 days. The acetazolamide suspension was not stable up to a 30 days' mark. Phenobarbitone and propranolol suspensions were highly unstable even within 30 days and therefore, might require refrigeration to maintain their stability. The results showed that the formulated suspensions had sufficient microbial integrity and a range of active content stability, which suggested suitability for use as follows; lamivudine suspension up to 60 days, spironolactone and furosemide suspensions up to 30 days; acetazolamide, phenobarbitone and propranolol suspensions possibly up to 2 weeks, after preparation.