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Abstract
Contamination of certain microorganisms in pharmaceutical products can potentially reduce or even inactivate therapeutic activity and harm patient health. Pharmacopoeia monograph determine the microbiological quality in medicinal products. One of them is P. aeruginosa parameters which should not be present in pharmaceutical preparations. Pharmacopoeia states that microbial detection methods must be able to detect microorganisms, including P.aeruginosa not more than 100 colonies, but the actual detection limit has never been set quantitatively and many variables can affect the microorganism recovery. This study aims to determine the range of Limit of Detection (LOD) values and the sensitivity of the P. aeruginosa method on pharmaceutical products. Detection method of P. aeruginosa refers to the specific microbial test of the Indonesian Pharmacopoeia VI (2020) is culture media methods. Experiments used eight pharmaceutical products representing five dosage forms contaminated with P. aeruginosa ATCC 9027 with three levels of concentration. The results determined LOD range and sensitivity of P. aeruginosa detection method in pharmaceutical products, and analyzed descriptively. This study shows that pharmacopeia method of P. aeruginosa testing can detect P. aeruginosa in various drug preparation matrices with a detection limit of 1-10 colonies and a sensitivity of 100%. Results of this study can be used as reference for LOD value in the verification of the P. aeruginosa detection in medicinal product.
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References
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References
Artini, M., Papa, R., Cellini, A., Tilotta, M., Barbato, G., Koverech, A., & Selan, L. (2014). Effect of Betamethasone in Combination with Antibiotics on Gram Positive and Gram Negative Bacteria. International Journal of Immunopathology and Pharmacology, 27(4), 675–682. https://doi.org/10.1177/039463201402700426
de Assis, P. A., de Andrade, S. B., de Oliveira, C. M. C., de Araújo, P. M., Grangeiro, S., & Ramos, S. V. V. (2011). Development and Validation of a Microbial Counting Method for Mebendazole Oral Suspension. Brazilian Journal of Pharmaceutical Sciences, 47(3), 555–563. https://doi.org/10.1590/S1984-82502011000300013
Djajusman, S. K., Tedjosasongko, U., & Irmawati, I. (2014). Daya Hambat Xylitol dan Nistation terhadap Pertumbuhan Candida albicans (in vitro) (Inhibition Effect of Xylitol and Nistatin Combination on Candida albicans Growth (in vitro)). Dental Journal (Majalah Kedokteran Gigi), 47(3), 164. https://doi.org/10.20473/j.djmkg.v47.i3.p164-167
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. https://doi.org/10.1016/j.bjbas.2016.08.005
Eissa, M., & Mahm, A. (2016). Evaluation of Microbial Recovery from Raw Materials for Pharmaceutical Use. Journal of Food and Pharmaceutical Sciences, 4(1), 6–11. https://doi.org/10.14499/jfps
El-Houssieny, R. S., Aboulwafa, M. M., Elkhatib, W. F., & Hassouna, N. A. H. (2013). Recovery and Detection of Microbial Contaminants in Some Non-sterile Pharmaceutical Products. Arch Clin Microbiol, 4 (6), 1–14.
Fujii, A., Seki, M., Higashiguchi, M., Tachibana, I., Kumanogoh, A., & Tomono, K. (2014). Community-acquired, hospital-acquired, and healthcare-associated pneumonia caused by Pseudomonas aeruginosa. Respiratory Medicine Case Reports, 12, 30–33. https://doi.org/10.1016/j.rmcr.2014.03.002
Guidance-Validation, N. G. A. (2018). Validation and Verification of Quantitative and Qualitative Test Methods.
International Conference on Harmonization. (2005). Validation of analytical procedures: text and methodology Q2 (R1). International Conference on Harmonization.
Kementerian Kesehatan Republik Indonesia. (2020). Farmakope Indonesia edisi IV. In Kementerian Kesehatan Republik Indonesia (VI). Kementerian Kesehatan RI.
Li, X., Liu, J., Du, Y., Wen, Z., Wang, J., & Yang, P. (2017). Antibacterial activity and mechanism of the ethanol extracts from Sonchus brachyotus DC . International Journal of Food Properties, 20(12), 2923–2931. https://doi.org/10.1080/10942912.2016.1261152
Montoro, V., Asensio, C., Martínez, Á., Lorente, J., Rodríguez, F. J., Montojo, J., Gavilanes, J., Sarría, P., Langdon, C., & Prades, E. (2018). Efficacy and safety of fluocinolone acetonide 0.025% otic solution in patients with otic eczema: a randomized, double-blind, placebo-controlled clinical trial. Journal of International Medical Research, 46(10), 4050–4060. https://doi.org/10.1177/0300060518765333
National Center for Biotechnology Information. (2021). Compound Summary Benzydamine hydrochloride. U.S. National Library of Medicine. https://pubchem.ncbi.nlm.nih.gov/compound/Benzydamine-hydrochloride
Nuryati. (2017). Farmakologi. In BPPSDM Kesehatan (Ed.), Bahan Ajar Rekam Medis dan Informasi Kesehatan. BPPSDM Kesehatan.
Pages-Monteiro, L., Marti, R., Commun, C., Alliot, N., Bardel, C., Meugnier, H., Perouse-De-Montclos, M., Reix, P., Durieu, I., Durupt, S., Vandenesch, F., Freney, J., Cournoyer, B., & Doleans-Jordheim, A. (2017). Strong incidence of Pseudomonas aeruginosa on bacterial rrs and ITS genetic structures of cystic fibrosis sputa. PLoS ONE, 12(3), 1–19. https://doi.org/10.1371/journal.pone.0173022
Ratajczak, M., Kubicka, M. M., Kamińska, D., Sawicka, P., & Długaszewska, J. (2015). Microbiological quality of non-sterile pharmaceutical products. Saudi Pharmaceutical Journal, 23(3), 303–307. https://doi.org/10.1016/j.jsps.2014.11.015
Sugiyono. (2013). Metode Penelitian Kuantitatif, Kualitatif, dan R&D. Alfabeta.
Tashiro, Y., Inagaki, A., Ono, K., Inaba, T., Yawata, Y., Uchiyama, H., & Nomura, N. (2014). Low concentrations of ethanol stimulate biofilm and pellicle formation in Pseudomonas aeruginosa. Bioscience, Biotechnology, and Biochemistry, 78(1), 178–181. https://doi.org/10.1080/09168451.2014.877828
The SAC Accreditation Programme. (2019). Guidance Notes C&B AND ENV 002 Method Validation of Microbiological Methods. Enterprise Singapore. https://www.sac-accreditation.gov.sg/files/documents/laboratory-accreditation/testing-and-calibration-documents/environmental-testing-field/Guidance-Note-CB-and-ENV-002-29-Mar-2019.pdf
The United States Pharmacopeial. (2019). United State Pharmacopoeia 2019 USP 42- NF 37. In The United States Pharmacopeial Convention (Ed.), United State Pharmacopoeia 2019 USP 42- NF 37. The United States Pharmacopeia (USP).
The United States Pharmacopeial. (2020). United State Pharmacopoeia 2020 USP 43-NF 38. In United State Pharmacopoeia (Ed.), United State Pharmacopoeia (42nd-NF 38th ed.). United State Pharmacopoeia.