Research Article | Volume: 4; Issue: 11, November, 2014

Evaluation and study of mebendazole polymorphs present in raw materials and tablets available in the Brazilian pharmaceutical market

Aline Quelian Penna Garbuio,  Tássia Hanashiro,  Blanca Elena Ortega Markman,  Fernando Luiz Affonso Fonseca ,  ,  Fábio Ferreira Perazzo,  Paulo Cesar Pires Rosa   
Aline Quelian Penna Garbuio1, Tássia Hanashiro1, Blanca Elena Ortega Markman2, Fernando Luiz Affonso Fonseca1 , 3, Fábio Ferreira Perazzo1, Paulo Cesar Pires Rosa4

1Federal University of São Paul -Institute for Environmental, Chemical and Pharmaceutical Sciences, Laboratory of Natural and Synthetic Inputs, Campus Diadema-Unifesp,

2Center for Physical and Chemical Testing of Drugs, Centre for Medicines, Cosmetic and Sanitizing. Adolfo Lutz Institute,

3Clinical Laboratory, Faculty of Medicine of ABC, Santo André, SP, Brazil,

4University of Campinas, Faculty of Medical Sciences, Pharmacology Department, Campinas, SP, Brazil.

Open Access   

Published:  Nov 27, 2014

DOI: 10.7324/JAPS.2014.4111
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Abstract

The dissolution of a drug can be compromised by the presence of different polymorphs, which may have different solubilities. Importantly, the pharmacopoeiamonographs,usually not have tests for the characterization of these polymorphic forms of a drug. Was performed a study of polymorphic forms of mebendazole present in raw materials and also pills available in the Brazilian pharmaceutical market through the techniques of infrared (FTIR), differential scanning calorimetry (DSC), dissolution , solubility and X-ray diffraction pattern (XRPD). Through the analysis of FTIR and DSC curves showed that there are three main polymorphic forms of mebendazole present in raw materials and tablets that compound. The data obtained in the dissolution and solubility tests showed that Form A is less soluble than Form B which is less soluble than the C form, when using a dissolution medium without added surfactant. It has been found that in some tablets mebendazole there is a mixture of polymorphic forms, and that the raw materials present two major polymorphic forms. Then it is suggested the need of quality control regarding the type of polymorph used in the production of mebendazole tablets to ensure greater therapeutic efficacy.


Keyword:     MebendazolePolymorphismInfraredDissolutionDifferential Scanning Calorimetry

Citation:

Aline Quelian Penna Garbuio, Tássia Hanashiro, Blanca Elena Ortega Markman, Fernando Luiz Affonso Fonseca, Fábio Ferreira Perazzo, Paulo Cesar Pires Rosa. Evaluation and study of mebendazole polymorphs present in raw materials and tablets available in the Brazilian pharmaceutical market. J App Pharm Sci, 2014; 4 (11): 001-007.

Copyright:The Author(s). This is an open access article distributed under the Creative Commons Attribution Non-Commercial License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
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