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Preparation and Characterization of Salt Forms of Enalapril

Preparation and Characterization of Salt Forms of Enalapril

Lokesh Kumar, Aeshna Amin, Arvind K Bansal

Pharm Dev Technol. 2008;13(5):345-57.

PMID: 18720234

Abstract:

Selection of an optimal salt form of a drug candidate is a vital component of preformulation stage of drug development. In this study, six salts of enalapril--citrate, mesylate, tartrate, malate, besylate and tosylate--were prepared and characterized by Mass Spectroscopy, Differential Scanning Calorimetry, Thermogravimetric Analysis, Microscopy, Powder X-ray Diffraction, Karl Fischer Titration, High Performance Liquid Chromatography, Fourier-Transform Infra-red Spectroscopy and Head Space Gas Chromatography. All the six salts were subjected to a tiered screening involving five stages in the following order: crystallinity, hygroscopicity, solubility, stability and flow/compactability. Enalapril malate showed encouraging profile because of its lower hygroscopicity, higher solubility, good solid state stability, and better flow and compactability, in comparison to the marketed maleate salt.

Chemicals Related in the Paper:

Catalog Number	Product Name	Structure	CAS Number	Price
AP76095164-A	Enalapril maleate salt		76095-16-4	Price

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