Shelf life Studies of Pralidoxime Chloride Solution in Autoinjector Cartridges Stored at Room Temperature

Order of Publishing in Issue: 
3
Volume :2
Issue :2
March, 2008
Page No: 
31-39
Authors: 
Pravin Kumar,* R.Vijayaraghavan, D. Kumar, N. Jain, H.M. Swarnkar, C.K. Waghmare, B.K. Bhattacharya, M. Sharma and S. Jain
Address: 
Defence Research and Development Establishment, Gwalior – 474002, India

The pralidoxime chloride (PAM) cartridge in a reusable autoinjector consists of 300 mg/ mL of pralidoxime chloride in 2.2 mL solutionwith a shelf life of one year. The present study is aimed at evaluating the antidotal efficacy of PAMfilled in the cartridges at (stored at room temperature of 25-35°C) different time poin tsusing three different methods to determine the shelf life. The study showed that administrationof atropine sulfate or freshly prepared pralidoxime chloride alone did not offerappreciable protection as measured by Protection Index (PI) against either diisopropylphosphorofluoridate (DFP) or dichlorvos (DDVP) in male mice. The combinedtreatment of atropine sulfate and samples of pralidoxime chloride, one after the other but closein time, showed far better protection. Atropine sulfate antagonizes the actions of acetylcholineand PAM reactivates the inhibited acetylcholinesterase (AChE) enzyme. In the caseof DDVP, treatment with atropine sulfate and all the samples of pralidoxime chloride (freshlyprepared, and 3, 6, 12, 24 and 36 months old) offered a PI of 26.9. On the other hand, DFPintoxication and subsequent treatment with atropine sulfate and all the samples of PAMshowed varying PI. It was observed that maximum PI (38.3) could be achieved with 12months old PAM sample compared to freshly prepared solution. Minimum PI (13.3) wasobserved with 36 months old PAM sample. This decrease in PI can not be attributed to the lesspercent reactivation (91.3%) of isopropyl methyl phosphonofluoridate (Sarin) inhibited electric eelAChE by PAM, as both the parameters i.e. PI (26.9) of DDVP and estimation of active PAM(99.5±5.9%) are not in agreement. We assume that the said change may be due to biologicalvariation and high toxicity of DFP (4 times more toxic than that of DDVP). It may be concludedthat (i) Pralidoxime chloride filled and stored in autoinjector cartridges has storage stability ofmore than 2 years, (ii) it also has an appreciable activity in terms of protection index, percentreactivation of sarin inhibited electric eel acetylcholinesterase and (iii) estimation of activePAM for three years.

Keywords: 
Diisopropylphosphorofluoridate, Dichlorvos, Pralidoxime chloride, Atropine sulfate, Autoinjector
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