Development and Evaluation of Combined Drug Formulation for Autoject-injector, for Emergency Application in Organophosphate Poisoning
Abstract
Atropine sulphate and pralidoxime chloride are considered as essential antidotes in the treatment of nerve agent poisoning. Now in India these antidotes are available in the form of self injectable autoinjectors. This study is designed with aim to replace two individual autoinjectors with single one. Stability of the components plays a vital role in the development of any dosage form, in this study we investigated the stability of the antidotes in combination (atropine sulphate+2 PAMCl) in single drug cartridges. In the present work shelf life of pralidoxime chloride (300 mg/ml) and atropine sulphate (1 mg/ml) solution in combination was evaluated by accelerated studies. The derived model is based on the rate equation and Arrhenius equation was used for extrapolation. Further, antidotal efficacy of atropine sulphate in vitro, using rat’s isolated ileum and pralidoxime chloride by survival studies in vivo against dichlorvas in mice were evaluated, for further confirmation of analytical findings. The constituted formulation was found to be stable for 24 months.
Defence Science Journal, 2012, 62(2), pp.105-111, DOI:http://dx.doi.org/10.14429/dsj.62.1130
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