Development and validation of a microbial counting method for mebendazole oral suspension

Authors

  • Polyana Araújo de Assis University of Brasília; Department of Pharmacy
  • Severino Borba de Andrade Federal University of Pernambuco; Clinical Hospital; Laboratory of Immunohematology
  • Clécia Maria Carvalho de Oliveira Federal University of Pernambuco; Clinical Hospital; Laboratory of Immunohematology
  • Patrícia Menezes de Araújo Federal University of Pernambuco; Clinical Hospital; Laboratory of Immunohematology
  • Severino Grangeiro Júnior Federal University of Pernambuco; Department of Pharmacy
  • Selma Verônica Vieira Ramos LAFEPE

DOI:

https://doi.org/10.1590/S1984-82502011000300013

Keywords:

Mebendazole^i1^soral suspens, Microbial count

Abstract

Mebendazole is an important medicine used to treat helminth infections. These infections affect more than two billion people worldwide. The LAFEPE® (Recife-PE, Brazil) produces the drug mebendazole oral suspension that contains the preservatives methylparaben and propylparaben in its formulation. Drugs that have antimicrobial properties due to preservatives must undergo neutralization of these compounds to allow microbial count testing according to recommendations by the official compendia. In order to obtain a validated method for microbial counting and to ensure its safety and reliability within the pharmaceutical industry, validation of preservative neutralization and of the method for microbial counting was performed according to the USP 30 and PDA Technical Report No. 33. The method used ATCC Gram positive and Gram negative microorganisms, yeasts, most and culture media Tryptic Soy Agar and Sabouraud dextrose agar. The neutralizers were polysorbate 80 and lecithin. Recovery levels of over 70% of the microorganisms used in the test indicated the neutralization of antimicrobial activity and proved the absence of toxicity of neutralizers. The microbial counting method validated proved accurate, precise, robust and linear and can be safely used in routine operations.

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Published

2011-09-01

Issue

Section

Articles

How to Cite

Development and validation of a microbial counting method for mebendazole oral suspension . (2011). Brazilian Journal of Pharmaceutical Sciences, 47(3), 555-563. https://doi.org/10.1590/S1984-82502011000300013