Document Type: Breif Report
Microbial contamination of pharmaceutical products constitutes a great concern for stakeholders and professionals in the field. Special attention is brought to multidose medicinal products with considerable water activities (aw). Such pharmaceutical products are prone to microbial spoilage with serious consequences on patients’ health and even their lives. The current investigation aimed to study new approach in the risk assessment of the contamination of oral antiseptic mouthwash in a quantitative manner using dose-response model of microbial infection. The present study combines both preservative efficacy test (PET) results with specific dose-response model of indicator bacteria. The risk was assessed at its maximum level using the worst case scenario of repeated contamination of the medicine bottle with each use. The indicator microbe selected was Escherichia coli with two models: exponential and beta Poisson based on antimicrobial efficacy test (AET) results. The mouthwash met the acceptance criteria of USP<51> PET, with notably strong effect on bacteria and yeast (not recovered from culture media) at any testing points (14 and 28 days). On the other hand, Aspergillus brasiliensis showed significant reduction after 28 days only. The current investigation showed that repeated product contamination with each use increased the risk of infection and different contaminating varies of the same microbial species constituted various hazard levels, although the antimicrobial properties of the product were sufficiently strong against the dedicated microbe (>3.00 log reduction (LR)). The current study provided new insight for the conventional pharmacopeial AET and demonstrated the limitation of it.
- Sutton S, Jimenez L. A Review of Reported Recalls Involving Microbiological Control 2004-2011 with Emphasis on FDA Considerations of âObjectionable Organismsâ [Internet]. Americanpharmaceuticalreview.com. 2016 [cited 15 February 2016]. Available from: http://www.americanpharmaceuticalreview.com/Featured-Articles/38382-A-Review-of-Reported-Recalls-Involving-Microbiological-Control-2004-2011-with-Emphasis-on-FDA-Considerations-of-Objectionable-Organisms/
- Eissa, ME, Mahmoud, AM. Assessment of Modified Preservation Formulae after Optimizing Preliminary Neutralization Evaluation Study. International Journal of Multidisciplinary Research, Studies and Developments. 2015; 1(2): 5-11.
- Cornick NA, Helgerson AF. Transmission and infectious dose of Escherichia coli O157: H7 in swine. Applied and environmental microbiology. 2004 Sep 1; 70(9):5331-5.
- DuPont HL, Formal SB, Hornick RB, Snyder MJ, Libonati JP, Sheahan DG, LaBrec EH, Kalas JP. Pathogenesis of Escherichia coli diarrhea. New England Journal of Medicine. 1971 Jul 1; 285(1):1-9. DOI: 10.1056/NEJM197107012850101
- Shulman JD, Wells LM. Acute ethanol toxicity from ingesting mouthwash in children younger than 6-years of age. Pediatric dentistry. 1996 Dec; 19(6):404-8.
- Litovitz TL, Schmitz BF, Bailey KM. 1989 annual report of the American Association of Poison Control Centers national data collection system. The American journal of emergency medicine. 1990 Sep 30; 8(5):394-442.
- Litovitz TL, Bailey KM, Schmitz BF, Holm KC, Klein-Schwartz W. 1990 annual report of the American Association of Poison Control Centers national data collection system. The American journal of emergency medicine. 1991 Sep 30; 9(5):461-509.
- Litovitz TL, Felberg L, White S, Klein-Schwartz W. 1995 annual report of the American Association of Poison Control Centers toxic exposure surveillance system. The American journal of emergency medicine. 1996 Sep 30; 14(5):487-537.
- Litovitz TL, Holm KC, Clancy C, Schmitz BF, Clark LR, Oderda GM. 1992 annual report of the American Association of Poison Control Centers toxic exposure surveillance system. The American journal of emergency medicine. 1993 Sep 1; 11(5):494-555.
- Litovitz TL, Clark LR, Soloway RA. 1993 Annual report of the American Association of Poison Control Centers toxic exposure surveillance system. The American journal of emergency medicine. 1994 Sep 1; 12(5):546-84.
- Litovitz T, Felberg L, Soloway R, Ford M, Geller R. 1994 Annual report of the American association of poison control centers toxic exposure surveillance system. The American Journal of Emergency Medicine. 1995; 13(5):551-597.
- United States Pharmacopeia General Chapter <51> Antimicrobial Effectiveness Testing, USP 34-NF29, US Pharmacopeia, Rockville, Maryland, USA, 2010.
- David P. Elder P, Crowley. Antimicrobial Preservatives Part One: Choosing a Preservative System [Internet]. Americanpharmaceuticalreview.com. 2016 [cited 20 February 2016]. Available from: http://www.americanpharmaceuticalreview.com/Featured-Articles/38886-Antimicrobial-Preservatives-Part-One-Choosing-a-Preservative-System/