Quality and viability of probiotics sold in handling pharmacies in Cascavel-PR

Authors

DOI:

https://doi.org/10.33448/rsd-v10i14.21822

Keywords:

Microbial viability; Probiotics;; Good handling practices.

Abstract

To be considered probiotic, a product must present viable cells, at the dose described on the label, until the expiry date and when handled in the form of capsules must follow the quality criteria set out in the legislation. Therefore, the aim of this study was to evaluate the quality of capsules handled with probiotics, as well as to verify the viability of microorganisms in three masterful pharmacies in the city of Cascavel-PR. The labeling of products, the average weight and cell viability. Microorganisms were identified using morpho-tinrial characteristics and catalase test. Only the pharmacy label 2 presented the description recommended by the legislation, however, despite the proposed shelf life, the manufacturer's report indicated that one of the raw materials was expired. The average weight was in compliance in all pharmacies. Regarding cell viability, there were differences in repetition and between pharmacies. In the repetition, pharmacy 1 did not show viable cell growth and Pharmacy 2 demonstrated a loss of viability when compared to the first trial. Pharmacy 3, when compared to other pharmacies, showed satisfactory growth. This study demonstrated that there is no strict quality control for the manipulation of capsules containing probiotics, compromising the quality and efficacy of the product. Thus, it is necessary to standardize these products according to their concentration, shelf life and excipients used, in order to ensure the best treatment for the patient.

References

Allen Jr., L.V., Popovich, N G. & Ansel, H. C. (2007). Formas Farmacêuticas e Sistemas de Liberação de Fármacos. (8a ed.), Artmed.

Andrade, D. F., Carvalho, J. S., & Freitas, M. B. (2013) Qualidade de cápsulas de fluoxetina disponibilizadas pelo Sistema Único de Saúde: estudo in vitro das condições do ensaio de dissolução. Revista de Ciências Farmacêuticas Básica e Aplicada. 1-8.

Brasil. (2019). Agência Nacional de Vigilância Sanitária. Farmacopeia Brasileira. (6a ed). Anvisa, v.1.

Brasil. (2013). Agência Nacional de Vigilância Sanitária. Microbiologia Clínica para o Controle de Infecção Relacionada à Assistência à Saúde. Módulo 5: Fórmulas e produtos para provas de identificação laboratoriais.

Brasil. (2007). Agência Nacional de Vigilância Sanitária. Resolução RDC nº 67 de 08.10.2007: Boas práticas de manipulação de preparações magistrais e oficinais para uso humano em farmácia. Diário Oficial da União, Brasília.

Celandroni, F., Vecchione, A., Cara, A., Mazzantini, D., Lupetti, A., & Ghelardi, E. (2019). Identificação de espécies de Bacillus: implicações na qualidade de formulações probióticas. PloS one. 14 (5), e0217021. https://doi.org/10.1371/journal.pone.0217021

Chamberlain, C. A, Hatch, M., & Garrett, T. J (2019). Perfil metabolômico de probióticos de degradação de oxalato Lactobacillus acidophilus e Lactobacillus gasseri. PloS one, 14 (9), e0222393. https://doi.org/10.1371/journal.pone.0222393

Fenster, K., Freeburg, B., Hollard, C., Wong, C., Rønhave Laursen, R., & Ouwehand, AC (2019). A produção e entrega de probióticos: uma revisão de uma abordagem prática. Microorganisms, 7 (3), 83. https://doi.org/10.3390/microorganisms7030083

Ferreira, A. (2010). Guia prático da farmácia magistral. v. 1, (4a ed.). Pharmabooks Editora.

Ferreira, A., & Brandão, M. (2008). Guia prático da farmácia magistral. 2, (3a ed.). Pharmabooks Editora.

Grumet, L., Tromp, Y., & Stiegelbauer, V. (2020) O desenvolvimento de formulações probióticas multiespécies de alta qualidade: do banco ao mercado. Nutrientes. 12 (8): 2453. https://doi.org/10.3390/nu12082453

Hill, C., Guarner, F., Reid, G., Gibson, G. R., Merenstein, D J., Pot, B., Morelli, L., Canani, R. B., Flint, H. J. & Salminen, S. (2014) The International Scientific Association for Probiotics and Prebiotics consensus statement on the scope and appropriate use of the term probiotic. Nat Rev Gastroenterol Hepatol 11, 506–514 (2014). https://doi.org/10.1038/nrgastro.2014.66

Jackson, A. S, Schoeni, J. L, Vegge, C., Pane, M., Stahl, B., Bradley, M., Goldman, V. S, Burguière, P., Atwater, J. B., & Sanders, M. E. (2019). Melhorando a confiança do usuário final na qualidade dos produtos probióticos comerciais. Frontiers in microbiology, 10, 739. https://doi.org/10.3389/fmicb.2019.00739

Kim S. K., Guevarra R. B., Kim Y.T., Kwon J., Kim H., Cho J. H., Kim H. B., & Lee J. H. (2019). Role of Probiotics in Human Gut Microbiome-Associated Diseases. J. Microbiol. Biotechnol. 29:1335-1340. https://doi.org/10.4014/jmb.1906.06064

Kolaček, S., Hojsak, I., Berni Canani, R., Guarino, A., Indrio, F., Orel, R., Pot, B., Shamir, R., Szajewska, H., Vandenplas, Y., van Goudoever, J., Weizman, Z., & ESPGHAN Working Group for Probiotics and Prebiotics (2017). Commercial Probiotic Products: A Call for Improved Quality Control. A Position Paper. Journal of pediatric gastroenterology and nutrition, 65(1), 117–124. https://doi.org/10.1097/MPG.0000000000001603

Liao, N., Luo, B., Gao, J., Li, X., Zhao, Z., Zhang, Y., Ni, Y., & Tian, F. (2019). Oligosaccharides as co-encapsulating agents: effect on oral Lactobacillus fermentum survival in a simulated gastrointestinal tract. Biotechnology letters, 41(2), 263–272. https://doi.org/10.1007/s10529-018-02634-6

Mazzantini, D., Calvigioni, M., Celandroni, F., Lupetti, A., & Ghelardi, E. (2021). Spotlight on the Compositional Quality of Probiotic Formulations Marketed Worldwide. Frontiers in microbiology, 12, 693973. https://doi.org/10.3389/fmicb.2021.693973

Morovic, W., Hibberd, A. A., Zabel, B., Barrangou, R., & Stahl, B. (2016). Genotyping by PCR and High-Throughput Sequencing of Commercial Probiotic Products Reveals Composition Biases. Frontiers in microbiology, 7, 1747. https://doi.org/10.3389/fmicb.2016.01747

Nazir, Y., Hussain, S. A., Abdul Hamid, A., & Song, Y. (2018). Probiotics and Their Potential Preventive and Therapeutic Role for Cancer, High Serum Cholesterol, and Allergic and HIV Diseases. BioMed research international, 3428437. https://doi.org/10.1155/2018/3428437

Oliveira, A. E., Hoffmann, L. C., Costa, M. P., & Block, L. C. (2014) Análise e validação do procedimento de manipulação de cápsulas por encapsulamento manual por nivelamento. Revista de Ciências Farmacêuticas Básica e Aplicada, 35 (1): 59-65.

Pereira, A. S., Shitsuka, D. M., Parreira, F. J., & Shitsuka, R. (2018). Metodologia da pesquisa científica. Santa Maria, RS: UFSM.

Schimitt, J. A. D., Fariña, L. O., Simões, M. R., & Kottwitz, L. B. M. (2018). Evaluation of the Probiotic Profile of Lactobacillus Acidophilus Used in Pharmaceutical and Food Applications. Acta Scientiarum. Health Sciences (Online), 40, 1-9. https://doi.org/10.4025/actascihealthsci.v40i1.36664.

Shehata, H. R., Ragupathy, S., Shanmughanandhan, D., Kesanakurti, P., Ehlinger, T. M., & Newmaster, S. G. (2019). Guidelines for Validation of Qualitative Real-Time PCR Methods for Molecular Diagnostic Identification of Probiotics. Journal of AOAC International, 102(6), 1774–1778.

Terpou, A., Papadaki, A., Lappa, I. K., Kachrimanidou, V., Bosnea, L. A., & Kopsahelis, N. (2019). Probiotics in Food Systems: Significance and Emerging Strategies Towards Improved Viability and Delivery of Enhanced Beneficial Value. Nutrients, 11(7), 1591. https://doi.org/10.3390/nu11071591

Thompson, J. E., & Davidow, L. W. (2013). A prática farmacêutica na manipulação de medicamentos. (3a ed). Artrued.

Tripathi, N., & Sapra, A. (2021). Gram Staining. StatPearls Publishing. https://pubmed.ncbi.nlm.nih.gov/32965827.

Troche, J. M. R., Adame, E. C., Díaz, M. Á. V., Escudero, O. G., Chávez, M. E. I., Barrera, J. A. C., Mondragón, F. Z., Velasco, J. A. V., Tavares, G. R. A. & Pedrín, M. A. L. (2020). Lactobacillus acidophilus LB: a useful pharmabiotic for the treatment of digestive disorders. Therapeutic advances in gastroenterology, 13, 1756284820971201. https://doi.org/10.1177/1756284820971201

Vorländer, K., Kampen, I., Finke, J. H., & Kwade, A. (2020). Along the Process Chain to Probiotic Tablets: Evaluation of Mechanical Impacts on Microbial Viability. Pharmaceutics, 12(1), 66. https://doi.org/10.3390/pharmaceutics12010066

Published

26/10/2021

How to Cite

SILVA, E. C. de S. H. da; BENDER , S. Quality and viability of probiotics sold in handling pharmacies in Cascavel-PR . Research, Society and Development, [S. l.], v. 10, n. 14, p. e87101421822, 2021. DOI: 10.33448/rsd-v10i14.21822. Disponível em: https://rsdjournal.org/index.php/rsd/article/view/21822. Acesso em: 14 dec. 2024.

Issue

Section

Health Sciences