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
- EP ID EP377460
- DOI -
- Views 112
- Downloads 0
Assessment of Dose Calibrators Performance in Nuclear Medicine Department in Sudan
This study managed to evaluate the performance of the dose calibrators which work in nuclear medicine departments in Sudanese centers by using four quality control tests accuracy, constancy, linearity and geometry. These...
Lantana Camara Linn. Chemical Constituents and Medicinal Properties:
India has a rich tradition of plant based knowledge in health care. Among the large number of herbal drugs existing in India, very few have been studied systematically so far. Lantana camara is an evergreen plant found t...
Production of Herbal Cosmetic for Hair Care: Highly Commercially Used Plant Lawsonia inermis
Abstract: In the present era Herbal Science has emerged as a major focus for trade as there has been a worldwide acceptance of herbal products. However new innovations and an increased willingness to adopt new techniques...
A Valuable Insight Impact of Pharmacist in Pharmacogenomics
Pharmacogenomics is the study of genetic variations that influence individual response to drugs. Knowing whether a patient carries any of these genetic variations can help prescribers individualize drug therapy, decreas...
Formulation and Evaluation of Immediate Release Tablets of Zaltoprofen
Zaltoprofen is a nonsteroidal anti-inflammatory drug (NSAIDs) with powerful analgesic action on inflammatory pain. The purpose of this research work was to formulate an immediate release tablet of Zaltoprofen for the tre...