Archana Mehrotra
Hydrotropic solubility determinations and evaluation of dry powder for injection of poorly water soluble diuretic spironolactone
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Dry powder injection of spironolactone was developed using lyophilization and hydrotropic solubilization method. It is fast acting medication in emergencies like refractory edema associated with heart failure and hepatic cirrhosis. The ultimate aqueous based powder prepared showed 892.85 and 378.57 times increased solubility of spironolactone with sodium salicylate and sodium benzoate as compared to its water solubility. Amongst six hydrotropic agents, the solubility was increased in the order sodium salicylate > sodium benzoate > nicotinamide > sodium ascorbate > urea > sodium acetate. IR graph showed shift of wavenumber of characteristic peaks. Lyophilization technique produced more stable product against different temperature cycles and stability parameters. Degradation was only about 0.45% at room temperature and it was more about 1.3% at higher temperatures. Haemolytic activities of lyophilized formulations observed were 8.54% to 96.85% for sodium salicylate based hydrotropic lyophilized system and 3.50 to 88.17% for sodium salicylate based hydrotropic lyophilized system.
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