Research Article

Microbiological Quality of Over-The-Counter (OTC) oral Drug Preparations Obtained From Some Retail Pharmacies in Katsina State, Nigeria

Mukhtar G.L.1*, Mukhtar, M.D.2, Magashi, A.M.3
1 Department of Microbiology Umaru Musa Yaradua University Katsina
2 Department of Science Laboratory Technology, School of Technology, Kano state polytechnic, Matan-fada Road, PMB 3348, Kano State, Nigeria
3 Department of Microbiology, Faculty of Life Science, Bayero University Kano, PMB 3011, Kano State, Nigeria.
* Corresponding author: mukhtargl@nsmjournal.org.ng
Published: Dec, 2019
Pages: 4732-4741

Abstract

Over the counter (OTC-drugs) oral preparations being classified as non-sterile pharmaceutical products are easily prone to microbial contamination. The presence of microbial contaminants in these products may cause spoilage resulting in physical and chemical changes, as well as risk of infection or potential health hazard to the patients. A study aimed at evaluating the microbiological quality of some OTC drugs commonly dispensed to patients in Katsina was conducted from April, 2017 to March, 2019. One hundred and twenty-five (125) samples of four different OTC drugs on sale were evaluated for microbial quality using standard procedures as described in the official monograph of the British and United Stated pharmacopoeia. Incidence of microbial contamination was observed in 60 (48%) of the tested samples with 23 (18.4%) of the tested preparations having microbial count exceeding the USP and BP acceptable limit for the microbiological quality of non-sterile oral dosage forms. Bacillus species were the predominant contaminants recovered from the tested products. The study revealed a considerable level of microbial contamination in the examined products and thus highlighted the need for the manufacturers of these products to pay more attention and adhere strictly to the guidelines of the current good manufacturing practices

Keywords

Microbial contamination Non-sterile OTC British and United States pharmacopoeia.

References

  1. Adeola Anifowoshe R., Opara Morrison I. and Adeleye Isaac A. (2012). Microbial Quality of Some Non-sterile Pharmaceutical Products Sourced from Some Retail Pharmacies in Lagos, Nigeria. African Journal of Microbiology Research: 6(23), 4903-4907. http://www.academicjournals.org/AJMR DOI: 10.5897/AJMR11.158
  2. Adesoji, A.T., Ogunjobi, A.A. and Olatoye, I.O. (2015). Molecular characterization of selected multidrug resistant Pseudomonas from water distribution systems in southwestern Nigeria. Annals of Clinical Microbiology and Antimicrobials, 14:39 DOI 10.1186/s12941-015-0102-4
  3. Aisha, T.A, Taura, D.W and Mukhtar, M.D (2007). Microbiological Quality of Some Retailed Drugs in Kano Metropolis, Journal of Research in Biosciences 3 (2).
  4. Akerele J.O, and Godwin C.U. (2002). Aspects of microbial contamination of tablets dispensed in hospitals and community pharmacies in Benin City, Nigeria. Tropical Journal of Pharmaceutical Research. 1 1: 23-28.
  5. Atata, R.F, and Biyaosi, S.Y. (2016). Microbiological Quality of Some Selected Brands of Tablets and Syrups Produced in Nigeria. The Pharmaceutical and Chemical Journal, 3(3):191-196.
  6. Calistus D.N, Uduma E.O, Ogechukwu C.O, Christian C.O, Christopher E.N. (2011). Microbial and Physicochemical qualities of selected Co-trimoxazole and Metronidazole formulations in South Eastern Nigerian. Journal of Advanced Pharmacy Education & Research, 2: 81-89. ISSN 2249-3379
  7. Espicom. (2013). The pharmaceutical market: Bangladesh, opportunities and challenges. Available at:http://www.espicom.com/prodcat2.nsf/Product_ID_Lo okup/00000317? Open Document.
  8. Ewansiha ,J.U, Damaris, A.I, Ajunwa, O.M, Umar. A.Y, and Busari, M.B. (2014). Bacteriological Assessment of Spoilt Drugs Products Sold in Yola Metropolis Adamawa State, Nigeria. International Invention Journal of Medicine and Medical Sciences; 1(10) 151-156.
  9. Gad, G.F.M, Reham, I.A and Mohamed, S.E.A. (2011). Microbial Evaluation of Some Non-sterile Pharmaceutical Preparations Commonly Used in the Egyptian Market. Tropical Journal of Pharmaceutical Research; 10 (4): 437-445.
  10. Itah A.Y., Udokpoh A.E., and Ofum M.U., (2004). Bacteriological quality of some pharmaceutical products marketed by drug vendors in Uyo, Nigeria. African Journal of Health Sciences, 11(3-4):128-133.
  11. Kargar, Mohammad Z. M, Abbas Doosti, S.A. (2014). High Prevalence of Class I to 3 Integrons among Multidrug-Resistant Escherichia coli in Southwest of Iran. Osong Public Health Res Perspect. 5(4),193e198 http://dx.doi.org/10.1016/j.phrp.2014.06.003. Elsevier.
  12. Kilani AM and Olaifa KW. (2017). Microbiological Quality of Selected Non-Sterile Pharmaceutical Products Sold in Retail Outlets in Dutsinma Metropolis, Katsina State, Nigeria. Journal of Public Health in Developing Countries; 3(1): 339-346.
  13. Kolawole, J.A., Olurunmi, P.O., Okeniyi, S.O. and Shawrpshaka, Y.J. (2002). Quality and Availability of Ampicillin Products in Jos, Nigeria. Nigerian Journal of Pharmacy, 33:27-42.
  14. Lindsey R.L. Garcia-Toledo, L., Fasulo, D., Gladney, L.M and Strockbine, N. (2017). Multiplex polymerase chain reaction for the identification of Escherichia coli, E. albertii and E. fergusonii. Journal of Microbiological Methods. 140; 1-4.
  15. Manu-Tawiah W., Brescia B.A., et al. (2001). Setting threshold limitfor the significance of objectionable microorganisms in oral pharmaceutical products.PDA Journal of Pharmaceutical Science and Technology, 55: 171-175.
  16. Moniruzzaman, M.M.D Farukh F.A., and Zakaria M.I.A. (2012). Qualitative and Quantitative Microbiological Studies of Antacid and Paracetamol Suspensions from Different Drugstores of Dhaka. Dhaka University Journal of Biological Sciences, 21(1): 105ㅁ107.
  17. Mugoyela, V. and Mwambete, K.D (2010). Microbial contamination of nonsterile pharmaceuticals in public hospital settings. Therapeutics and Clinical Risk Management,6 :443- 448 DOI: 10.2147/TCRM.S12253
  18. Mukhtar, M. D., Oyeyi T. I. and Ameh, J. B. (2009). Determinants formulating oral antimicrobial suspensions in Nigeria. African Journal of Pharmacy and Pharmacology; 3(1). 031-036.
  19. Netish K.K, Chand S., Mohammad S.I, Md. Ashraf A, Marina K.A. H. M. Mazbah U, Pijush K.R, Rana A., Mahabubur R, Md. A.R (2018). Microbial and Physicochemical Evaluations of Paracetamol in Different Brands of Analgesic Syrups Sold in Bangladesh. Journal of Innovations in Pharmaceutical and Biological Sciences.
  20. Obuekwe CO, Obuekwe I.F., and Mohammad R., (2002). Surface contamination in some common available dosage forms. Medical Principles and Practice, 9(4): 290-299.
  21. Okunlola A, Adewoyin BA, Odeku OA. (2007). Evaluation of Pharmaceutical and Microbial qualities of some herbal medicinal products in Southwestern Nigeria. Tropical Journal of Pharmaceutical Research; 6 (1): 661-70.
  22. Osungunna, M. O, Mba, M. and Adebajo, O. (2016). Evaluation of Microbial Quality of Selected Blister-Packed Paracetamol Tablets and Paracetamol Syrups Marketed in Nigeria. African Journal of Clinical and Experimental Microbiology. 17 (2).
  23. Oviasogie F.E., Igbinosa E.O., and Evbuomwan R.O. (2015). Microbial assessment of some pharmaceutical products sold in Benin City: African health implication. African Journal of Pharmaceutical Research and Development; 7(1): 45-49.
  24. Rana J, Sultana T, Das KK, Noor R (2014). Microbiological analysis of topicals available in Bangladesh. Bangladesh International Journal 6 (2):330-332.
  25. Rania S.E, Mohammad M.A, Walid F.E, and Nadia A.H (2013). Recovery and Detection of Microbial Contaminants in Some Non-Sterile Pharmaceutical Products. Archives of Clinical Microbiology, (4) 6:1 doi: 10.3823/278.
  26. Sadia, K, Kamal K.D, Sourav B., and Rashed N. (2013). Microbiological Analysis of Liquid Oral Drugs Available in Bangladesh. International Journal of Pharmacy and Pharmaceutical Sciences, (5)4, 479-482.
  27. Senthiliraj Rajapandi, Ganduri Sathyanarayana Prasad, and Kunchithapatham Janakiraman (2016). Sequence-based identification of microbial contaminants in non-parenteral products. Brazilian Journal of Pharmaceutical Sciences; 52, (2).
  28. Shaqra Q.M, Abu S, Maissa T.S and Walid A.M. (2014). Microbiological Quality of Blister Pack Tablets in Community Pharmacies in Jordan. Tropical Journal of Pharmaceutical Research, 13 (2): 261-266.
  29. Zeitoun, H, Mervat, K., Dina, R., Hamida, A.S. and Nourhan F. (2015). Microbiological Testing of Pharmaceuticals and Cosmetics in Egypt. BMC Microbiology, 15:275. DOI 10.1186/s12866-015-0609-x
How to Cite

G.L., M., M.D., M., & A.M., M. (2019). Microbiological Quality of Over-The-Counter (OTC) oral Drug Preparations Obtained From Some Retail Pharmacies in Katsina State, Nigeria. Nigerian Journal of Microbiology, 33(2), 4732-4741.

M. G.L., M. M.D., and M. A.M., "Microbiological Quality of Over-The-Counter (OTC) oral Drug Preparations Obtained From Some Retail Pharmacies in Katsina State, Nigeria," Nigerian Journal of Microbiology, vol. 33, no. 2, pp. 4732-4741, December 2019.

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