Microbial Evaluation Of Allopathic And Herbal Non Sterile Pharmaceutical Liquid Dosage Forms

Malik Asif Hussain; Farrukh Mehmood; Umar Farooq Gohar; Syeda Fatima Nadeem; Aamir Mushtaq; Hamid Mukhtar

doi:10.48165/

Authors

Malik Asif Hussain College of Medicine, University of Hail, Hail (Kingdom of Saudi Arabia)
Farrukh Mehmood Riphah Institute of Pharmaceutical Sciences, Riphah International University Lahore (Pakistan)
Umar Farooq Gohar Institute of Industrial Biotechnology, Government College University, Lahore (Pakistan)
Syeda Fatima Nadeem Institute of Industrial Biotechnology, Government College University, Lahore (Pakistan)
Aamir Mushtaq Department of Pharmacy, Institute of Chemical Sciences, Government College University Lahore (Pakistan)
Hamid Mukhtar Institute of Industrial Biotechnology, Government College University, Lahore (Pakistan)

DOI:

https://doi.org/10.48165/

Keywords:

Non-sterile products, allopathy, herbal products, pathogenicity, microbial contamination, naturopathy

Abstract

Nonsterile pharmaceutical finished products are not manufactured through aseptic processes so are not completely free from microbial contaminations, which can impact their efficacy due to the degradation of active ingredients. The aim of present study was to enumerate, isolate and identify the microbial contaminations in non-sterile liquid finished pharmaceutical dosage forms. A total of 50 nonsterile liquid products were collected from different pharmacies across Lahore city, Pakistan. Pour plate method was used to test the total microbial count as per USP guidelines. The results showed a microbial count of 140 cfu mL-1in nutraceuticals manufactured liquid dosage form, 60 cfu mL-1in multinational products, 120 cfu mL-1in registered herbal products, and 390 cfu mL-1inon-registereherbal liquid products. Major bacterial contaminants isolated from allopathic (local and multinational) products and herbal (registered and non-registered) products are reported.

Downloads

Download data is not yet available.

References

Adigwe, O.P., Fatokun, O.T., Esievo, K.B., Adamu, A., Olatunji, K., Ibrahim, J.A. and Mustapha, K.B. 2022. Post-market analysis of some neem products sold in Nigeria. Pharmacognosy Research, 14(2): 211-218.

Agaronyan, K., Sharma, L., Vaidyanathan, B., Glenn, K., Yu, S., Annicelli, C., Wiggen, T.D., Penningroth, M.R., Hunter, R.C., Cruz, C.S.D. and Medzhitov, R. 2022. Tissue remodeling by an opportunistic pathogen triggers allergic inflammation. Immunity, 55(5): 895-911.

Allen, L. and Ansel, H.C. 2013. Ansel's Pharmaceutical Dosage Forms and Drug Delivery Systems. Lippincott Williams & Wilkins, Oklohoma, USA.

Brown, S.P., Cornforth, D.M. and Mideo, N. 2012. Evolution of virulence in opportunistic pathogens: generalism, plasticity, and control. Trends in Microbiology, 20(7): 336-342.

Microbial evaluation of pharmaceutical liquid dosage forms 61

Cundell, T. 2019. Exclusion of objectionable microorganisms from non‐sterile pharmaceutical drug products. pp. 371-400. In: Pharmaceutical Microbiological Quality Assurance and Control: Practical Guide for Non‐Sterile Manufacturing. John Wiley & Sons, New York, USA.

Delgado-Pando, G., Cofrades, S., Ruiz-Capillas, C., Solas, M.T., Triki, M. and Jiménez-Colmenero, F. 2011. Low-fat frankfurters formulated with a healthier lipid combination as functional ingredient: Microstructure, lipid oxidation, nitrite content, microbiological changes and biogenic amine formation. Meat Science, 89(1): 65-71.

Dou, J. 2022. Microbial contamination of pharmaceutical product in industries and preventive methods. Journal of Evolutionary Medicine, 10(6): 1-2.

Eissa, M.E. 2016. Distribution of bacterial contamination in non-sterile pharmaceutical materials and assessment of its risk to the health of the final consumers quantitatively. Beni-Suef University Journal of Basic and Applied Sciences, 5(3): 217-230.

Folashade, O., Omoregie, H. and Ochogu, P. 2012. Standardization of herbal medicines - A review. International Journal of Biodiversity and Conservation, 4(3): 101-112.

Gad, G.F.M., Aly, R.A.I. and Ashour, M.S.E. 2011. Microbial evaluation of some non-sterile pharmaceutical preparations commonly used in the Egyptian market. Tropical Journal of Pharmaceutical Research, 10(4): 437-445.

Gorrie, C.L., Mirčeta, M., Wick, R.R., Judd, L.M., Lam, M., Gomi, R., Abbott, I.J., Thomson, N.R., Strugnell, R.A., Pratt, N.F. and Garlick, J.S. 2022. Genomic dissection of Klebsiella pneumoniae infections in hospital patients reveals insights into an opportunistic pathogen. Nature Communications, 13(1): 1-17.

Hu, S.C., Shiue, A., Liu, H.Y. and Chiu, R.B. 2016. Validation of contamination control in rapid transfer port chambers for pharmaceutical manufacturing processes. International Journal of Environmental Research and Public Health, 13(11): 1129. [https://www.mdpi.com/1660- 4601/13/11/1129].

Hussain, M.A., Shaukat, H. and Gohar, U.F. 2021. Coagulase-negative staphylococci and their pathogenic role: A focus on nosocomial infections. Applied Biological Research, 23(2): 113-121. Jangra, S., Khunger, S. and Chattopadhya, D. 2022. Antimicrobial resistance in Staphylococci special emphasis on methicillin resistance among companion livestock and its impact on human health

in rural India. In Bovine Science - Challenges and Advances. IntechOpen, India. Jimenez, L., Smalls, S. and Ignar, R. 2000. Use of PCR analysis for detecting low levels of bacteria and mold contamination in pharmaceutical samples. Journal of Microbiological Methods, 41(3): 259-265.

Khana, M., Teotia, U.V.S. and Singh, Y. 2018. Effect of storage on microbial quality of non-sterile liquid dosage form. Journal of Pharmacognosy and Phytochemistry, 7(2): 479-481. Lee, H., Jin, M., Jeon, W.J., Kim, H., Jung, M., Yoo, H., Won, J.H. and Cho, C.W. 2022. Regulatory and safe-use considerations related to stability after opening of nonsterile dosage forms. Journal of Pharmaceutical Investigation, 52: 1-11.

Myemba, D.T., Bwire, G.M. and Sangeda, R.Z. 2022. Microbiological quality of selected local and imported non-sterile pharmaceutical products in Dar es Salaam, Tanzania. Infection and Drug Resistance, 15: 2021-2034. [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9038149/].

Owusu-Apenten, R. and Vieira, E. 2023. Food microbes, quality and fermentation. pp. 149-170. In: Elementary Food Science. Springer, Cham. [https://doi.org/10.1007/978-3-030-65433-7_7]. Salem, N.M.A., Elbarrawy, M.A. and Azzam, N.F.A.E.M. 2021. Microbiological quality of non sterile pharmaceuticals in Egypt. Beni-Suef University Journal of Basic and Applied Sciences, 10(1): 1-6.

Roesti, D. and Goverde, M. (eds.). 2019. Pharmaceutical Microbiological Quality Assurance and Control: Practical Guide for Non-sterile Manufacturing. John Wiley & Sons, Switzerlamd. Yazgan, H., 2022. Antimicrobial activities of emulsion-based edible solutions incorporating lemon

essential oil and sodium caseinate against some food-borne bacteria. Journal of Food Science and Technology, 59: 4695-4705.