BACTERIOLOGICAL SCREENING OF PAEDIATRIC COUGH SYRUPS MARKETED WITHIN PORT HARCOURT METROPOLIS, SOUTH-SOUTH NIGERIA
Abstract
Non-adherence to good manufacturing practice alongside improper handling during dispensing, packaging and inadequate post-marketing surveillance of pharmaceutical products accounts to product’s deterioration reduced therapeutic effect and adversely affects patient’s safety especially the paediatrics. This study evaluates the microbiological quality of various brands of paediatric cough syrups marketed and used within Port Harcourt metropolis. Twenty cough syrup brands were experimented on in duplicate, coded as USS and UNS (used and unused respectively). They were subjected to organoleptic assessment, pH, viscosity, total aerobic viable count, as well as resistance- susceptibility test of isolates using standard conventional techniques. Results showed viscosity value of 0.22 - 9.09 Pascal seconds (Pa.s), pH values of 3.13 - 8.34 across the UNS and USS categories respectively. While 80% of the UNS cough syrup samples were free from potential microbial threat, 20% fraction and all USS cough syrup (100%) samples were contaminated with objectionable microorganisms and non-compliant with USP permissible limit. The potentially pathogenic isolates were Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli and Klebsiella pneumonia, demonstrating varied resistance pattern to exposed antibiotic categories. Microbial contamination might have been caused by poor quality control and improper handling of the products during use. This calls for more stringent measures during product manufacturing and handling to ensure patient’s safety and forestall possible transference of resistance strain.
Keywords:
Pathogenic, Paediatric, Cough syrup, Contamination, ResistanceDOI
https://doi.org/10.25004/IJPSDR.2018.100203References
2. De Blasio F, Dicpinigaitis PV, Rubin BK, De Danieli G, Lanata L, Zanasi A: An observational study on cough in children: epidemiology, impact on quality of sleep and treatment outcome. Bio Med Central 2012; 8(1):1-6.
3. Denyer SP, Hodges NA, Gorman SP, Gilmore BF: Hugo and Russell's Pharmaceutical Microbiology: Wiley; 2011.
4. Mugoyela V, Mwambete KD: Microbial contamination of nonsterile pharmaceuticals in public hospital settings. Therapeutics and Clinical Risk Management 2010, 6:443-448.
5. Suvarna K, Lolas A, Hughes P, Friedman RL: Case studies of microbial contamination in biologic product manufacturing. American Pharm Rev 2011; 14(1):50-56.
6. Pullirsch D, Bellemare J, Hackl A, Trottier Y-L, Mayrhofer A, Schindl H, Taillon C, Gartner C, Hottowy B, Beck G et al: Microbiological contamination in counterfeit and unapproved drugs. BMC Pharmacol & Toxicol 2014; 15:34-34.
7. Pharmacopeia US: Microbiological examination of nonsterile products: Tests for specified microorganisms. Pharm Forum 2003; 29(5):1722-1733.
8. Okeke IN, Lamikanra A: Bacteriological quality of skin-moisturizing creams and lotions distributed in a tropical developing country. J of Appl Microbiol 2001; 91(5):922-928.
9. Parker MS: Microbiological contamination and preservation of pharmaceutical preparations. In: In Aulton ME, Pharmaceutics; the science of dosage form design. Hong Kong China: Churchill Livingstone; 2000: 220.
10. Razvi N, Awan R, Naqvi S, Anjum DF, Hussain Z, Farooqi S: Estimation of Microbial Contamination in Various Active Pharmaceutical Ingredients and Excipients. World J of Pharm & Pharm Sc 2014; 3(6):1771-1777.
11. Al Mamun A, Kumar Shaha T, Khan MM, Kabir M: Determination of Microbial Load in Multivitamin and Cough Syrups Sold in Dhaka City. Int J of Pharm Sci & Drug Res 2014; 6(3):235-238.
12. Clontz L: Microbial Limit and Bioburden Tests: Validation Approaches and Global Requirements: Taylor & Francis; 1997.
13. Sandle T: 5 - Microbiological culture media. In: Pharmaceutical Microbiology. Oxford: Woodhead Publishing; 2016: 47-61.
14. Kim S, Cho Y, N. Hogenauer W, R. Kensey K: A method of isolating surface tension and yield stress effects in a U-shaped scanning capillary-tube viscometer using a Casson Model. J of Non-Newtonian Fluid Mech 2002; 103(2-3):205-219.
15. Adeola A, Opara M, Adeleye I: Microbial quality of some non-sterile pharmaceutical products sourced from some retail pharmacies in Lagos. Afr J Microbial Res 2012; 6:4903-4907.
16. Institute CLS: Performance Standards for Antimicrobial Susceptibility Testing, Nineteenth informational supplement M100-S19, Wayne, Pa, USA. Clinical and Laboratories Standards Institute 2009.
17. Cheesbrough M: District Laboratory Practice in Tropical Countries, 2 edn. Cambridge: Cambridge University Press; 2006.
18. Ratajczak M, Kubicka MM, Kamińska D, Sawicka P, Długaszewska J: Microbiological quality of non-sterile pharmaceutical products. Saudi Pharmaceutical Journal: SPJ 2015; 23(3):303-307.
19. Eissa M, Seif El-Din Ashour M, Salah Mansy M: Microbiological Environmental Monitoring in Pharmaceutical Facility. Acad J Biolog Sci 2011; 3(1):63-74.
20. Baird R: Microbial Spoilage, Infection Risk and Contamination Control. In: Hugo and Russell's Pharmaceutical Microbiology. Blackwell Science Ltd; 2007: 263-284.
21. Khanom S, Das K, Banik S, Noor R: Microbiological analysis of liquid oral drugs available in Bangladesh. Int J of Pharm & Pharm Sci 2013; 5(4):479-482.
22. Ryan K, Ray C: Sherris Medical Microbiology 6th edn: McGraw Hills; 2014.
23. Dedeić-Ljubović A, Granov Đ, Hukić M: Emergence of extensive drug-resistant (XDR) Acinetobacter baumanniiin the Clinical Center University of Sarajevo, Bosnia and Herzegovina. Medicinski Glasnik 2015; 12(2):169-176.
Published
Abstract Display: 386 
PDF Downloads: 506 
