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Characterization of polymorph transformations that decrease the stability of tablets containing the WHO essential

Marius Brits¹, Wilna Liebenberg, Melgardt M de Villiers

¹Research Institute for Industrial Pharmacy and CENQAM, North-West University, Potchefstroom 2520, South Africa.

Journal of Pharmaceutical Sciences

|August 20, 2009

Summary

Mebendazole polymorph C stability is compromised by heat and moisture, converting to less effective form A. This transformation significantly shortens mebendazole tablet shelf life and impacts drug efficacy.

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Area of Science:

Pharmaceutical Sciences
Solid-State Chemistry

Background:

Mebendazole polymorphic forms exhibit varying solubility and therapeutic efficacy.
Mebendazole form C is clinically preferred for its bioavailability and reduced toxicity.

Purpose of the Study:

To investigate the impact of moisture and heat on mebendazole polymorph C stability in tablets.
To determine the kinetics of solid-state transformation of mebendazole form C to form A.

Main Methods:

An accelerated stability study was conducted under ICH conditions (30°C/65% RH and 40°C/75% RH).
The Johnson-Mehl-Avrami-Erofeyev-Kolmogorov (JMAEK) model was used to describe the transformation kinetics.
Half-lives and shelf lives were calculated based on rate constants.

Main Results:

Increased temperature and moisture accelerated the conversion of mebendazole form C to the stable form A.
The presence of trace amounts of form A significantly increased the transformation rate.
Four out of seven tested products showed this transformation, with some shelf lives reduced to less than one month.
Tablet dissolution decreased, failing to meet USP and FDA specifications.

Conclusions:

Mebendazole form C is unstable under accelerated storage conditions, converting to form A.
The presence of impurities like form A can drastically reduce mebendazole tablet shelf life and efficacy.
Formulation strategies should consider preventing the transformation of mebendazole polymorph C to ensure therapeutic effectiveness.