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

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.

Bibliographic Details

Main Authors:	Assis,Polyana Araújo de, Andrade,Severino Borba de, Oliveira,Clécia Maria Carvalho de, Araújo,Patrícia Menezes de, Grangeiro Júnior,Severino, Ramos,Selma Verônica Vieira
Format:	Digital revista
Language:	English
Published:	Universidade de São Paulo, Faculdade de Ciências Farmacêuticas 2011
Online Access:	http://old.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502011000300013
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