A Case of Rapidly Declining Contamination of Antimalarial Tablet by Stenotrophomonas maltophilia

Journal Title: Scholars Academic Journal of Pharmacy - Year 2015, Vol 4, Issue 7

Abstract

Abstract: A case of an oral antimalarial tablet was analyzed microbiologically for microbial contamination immediately on the same manufacturing day (zero time) and was found to be contaminated by an exceptionally out-of-trend (OOT) bioburden of total viable aerobic count (TVAC) equals to 1233 ± 275 colony forming unit (CFU) ± SD/g of the medicinal product. The result of the test was observed only after two days. Hence, resampling and retesting processes were conducted promptly and interestingly all culture plates showed no signs of growth even after five days of incubation. Thus, the outcome was recorded as <100 CFU/g. Thus, the logarithmic (log10) reduction (LR) within a couple of days was 1.08 ± 0.09. The test was repeated again after that 15 times from different locations from the batch and again no sign of microbial presence was detected. The contamination was from single species of Gram-negative rods which were identified using miniaturized biochemical identification kits. A bacterium was identified as Stenotrophomonas maltophilia. The case highlighted the importance of the test conduction time after manufacturing to detect the rapidly fading bioburden from the product otherwise misinterpretation of drug cleanliness and good manufacturing practice (GMP) will result. Another annoying issue also raised which is related to the possibility that the microbial cells may be still present but not able to grow. Thus, the microorganism may become viable-but-not-culturable (VBNC). This fact might allow for objectionable microbes to pass silently to the patients unnoticed. Keywords: antimalarial tablet, out-of-trend, total viable aerobic count, Stenotrophomonas maltophilia, good manufacturing practice, viable-but-not-culturable.

Authors and Affiliations

Mostafa Essam Eissa, Ahmed Mohamed Mahmoud, Ahmed Saber Nouby, Mostafa Saad Farag

Keywords

Related Articles

Pharmacoeconomic Analysisof Various Brands of Antipsychotic Drugs and Prescribing Pattern in a Secondary Care Hospital

Abstract:To analyze the cost effectiveness of antipsychotic medication and prescribing pattern. The cost of different brands of antipsychotics was sorted by referring CIMS, MIMS, and patient profile form. Antipsychotic p...

Migraine – A Malady: A Short Review

Migraine is a mysterious disorder and much misunderstood condition characterized by pulsating headache, restricted to one side, in the form of attacks lasting from 4-48 hrs. Family, friends and work colleagues often find...

Development and Evaluation of Polyherbal Tablet from Some Hepatoprotective Herbs

The objective of the present study was to develop and evaluate hepatoprotective polyherbal tablet because designing of oral herbal formulation is still a challenge in modern pharmaceutics and the tablet formulation prese...

Comparative Analysis on Nutritional and Antinutritional factors in Raw and Blanched Crotalaria laburnoidesKlotzschleaves from Iramba District, Tanzania

Abstract:This research aimed at investigating the nutritional and antinutritional contents of the leaves of wild edible plant, Crotalaria laburnoides (commonly known as ‘Nsonga’ by natives), in order to provide knowledge...

Chalcones in the Therapeutics of Diabetes Mellitus

Abstract: Diabetes mellitus is a metabolic disorder which affects the wide range of the population worldwide. Most of the pharmacotherapeutic agents available today might provide the symptomatic relief, but do not cure t...

Download PDF file
  • EP ID EP377460
  • DOI -
  • Views 127
  • Downloads 0

How To Cite

Mostafa Essam Eissa, Ahmed Mohamed Mahmoud, Ahmed Saber Nouby, Mostafa Saad Farag (2015). A Case of Rapidly Declining Contamination of Antimalarial Tablet by Stenotrophomonas maltophilia. Scholars Academic Journal of Pharmacy , 4(7), 347-350. https://www.europub.co.uk/articles/-A-377460