BURKHOLDERIA CEPACIA GROWTH IN PRESERVED PHARMACEUTICAL ANTIHISTAMINIC ORAL SUSPENSION
A chemically-preserved oral antihistaminic suspension based on fexofenadine as an active pharmaceutical ingredient and preserved with aminobenzoic acid esters (parabens) was found contaminated with Burkholderia cepacia (B. cepacia). This finding was detected only after six months from manufacturing. The bacterial count increased from 10, after six months, to 1475 Colony Forming Unit (CFU)/ml after nine months. The organism constituted continually increasing the hazard to the users long after passing undetected to the market. The current finding highlighted the importance of both appropriate neutralization method of the preservatives in the preservative efficacy test and the sensitivity of the method of bioburden enumeration and detection.
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