Fermentation Studies On Phenobarbitone Syrup (Paedriatic) Preparation At Kenyatta National Hospital (K.n.h.)

Abstract

The Kenyatta National hospital (K.N.H.) phenobarbitone syrup and syrup simplex 150 samples were investigated (2) for fermentation using the gasometnc method. Thus the amount of gas liberated as a by-product of fermentation was monitored. The phenobarbitone syrup fermented more than the syrup simplex. Factors such as tablet excipients and contamination due to extra manipulation of the syrup in preparing phenobarbitone syrup were investigated. This was done using the hospital syrup, pure phenobarbitone base and 10% starch to prepare phenobarbitone syrup. The above factors were found to contribute to fermentation. Laboratory prepared syrup simplex and phenobarbitone syrup were tested for fermentation to see if the results would mimic those of the hospital samples. These results were qualitative replicates of the hospital results. Official phenobarbitone B.P. and U.S.P. elixirs were also investigated for fermentation to compare with the hospital samples. Quite unexpectedly, the official preparations showed signs of fermentation. This result was unexplanable. The only possibility would be that there might have been a leak through the apparatus. This should have been checked with controls of water and about 45% absolute alcohol. The official preparation had absolute alcohol as a preservative. ^ Unfortunately, no controls were tested. Nevertheless, comparison of the official elixirs and hospital samples showed that the latter fermented at twice the rate of the former. Lastly, benzoic acid preservative at concentrations ranging from 0.1-0.2% were investigated for effective retardation of the fermentation of the hospital pheno- barbitone syrup. It was found to be effective. Recommendations have been made as to how problems encoutered in the phenobarbitone syrup as a dosage form with respect to dosage error (due to caking) and fermentation of the syrup can be rectified.