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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The finished product was found to be clean microbiologically when examined directly after manufacturing. The product was packaged in 100 ml dark amber colored glass containers with white screw caps. Other ingredients included Xanthan gum, Disodium Edetate, Sucrose, Sorbitol solution, Poloxamer, Sodium Phosphate Monobasic, Sodium Phosphate Dibasic and Raspberry Flavor. The product showed no growth in Tryptone Soya Agar (TSA) when tested for the total viable aerobic count (TVAC) according to the United States Pharmacopeia (USP)[3] with results less than ten Colony Forming Unit …show more content…
All the chemical tests were within the accepted laboratory limits. The range of pH was 6.2-6.3, and the concentrations of Methyl and Propyl Parabens were 97.7-105.7% and 94.6-104.4 %, respectively, during the course of study. The microbiological count test was acceptable either accelerated or on-going with TVAC less than and ten Colony Forming Unit (CFU)/ml at three and six months stability points, respectively. However, at nine months of on-going stability point the microbiological count raised at a relatively higher rate with TVAC of 1475 CFU/ml. The breaking point of the generation time for the bacteria was expected to be between 3-6 mo with an slow initial rate from 0-3 mo and fast one from 6-9 mo. Since no count was detected till the point of 6 mo, the generation time was estimated to be between 1.89 to 41.28 mo (56.67 to 1238.49 d) with the average middle point (5 CFU/ml) to be 6.28 mo (188.25 d). The initial lag phase length could not be determined. Meanwhile, the higher rate section was determined to have a generation time of 1.49 mo (44.73 d). A simulated XY data study for less than ten CFU/ml count was performed using GraphPad Prism v 6.01 for Windows, and the result is illustrated in fig. 1. Based on a simulation
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The finished product was found to be clean microbiologically when examined directly after manufacturing. The product was packaged in 100 ml dark amber colored glass containers with white screw caps. Other ingredients included Xanthan gum, Disodium Edetate, Sucrose, Sorbitol solution, Poloxamer, Sodium Phosphate Monobasic, Sodium Phosphate Dibasic and Raspberry Flavor. The product showed no growth in Tryptone Soya Agar (TSA) when tested for the total viable aerobic count (TVAC) according to the United States Pharmacopeia (USP)[3] with results less than ten Colony Forming Unit …show more content…
All the chemical tests were within the accepted laboratory limits. The range of pH was 6.2-6.3, and the concentrations of Methyl and Propyl Parabens were 97.7-105.7% and 94.6-104.4 %, respectively, during the course of study. The microbiological count test was acceptable either accelerated or on-going with TVAC less than and ten Colony Forming Unit (CFU)/ml at three and six months stability points, respectively. However, at nine months of on-going stability point the microbiological count raised at a relatively higher rate with TVAC of 1475 CFU/ml. The breaking point of the generation time for the bacteria was expected to be between 3-6 mo with an slow initial rate from 0-3 mo and fast one from 6-9 mo. Since no count was detected till the point of 6 mo, the generation time was estimated to be between 1.89 to 41.28 mo (56.67 to 1238.49 d) with the average middle point (5 CFU/ml) to be 6.28 mo (188.25 d). The initial lag phase length could not be determined. Meanwhile, the higher rate section was determined to have a generation time of 1.49 mo (44.73 d). A simulated XY data study for less than ten CFU/ml count was performed using GraphPad Prism v 6.01 for Windows, and the result is illustrated in fig. 1. Based on a simulation