DEVELOPMENT AND EVALUATION OF FREEZING RESISTANT INTRAVENOUS FLUID
Keywords:Freezing Resistant Intravenous Fluid, Infusion, Pre-clinical, Serum biochemistry, Histopathology
Objectives: Hemorrhagic or hypovolemic shocks accounts for a large portion of civilian and military trauma deaths due to life-threatening blood loss which requires intravenous fluid infusion to prevent essential deficiencies of fluids. However, at low temperature (-150C) fluid bottles freeze out and can not be used in emergency. In view of that, objective of the present work is to develop a freezing resistant intravenous formulation (FRIV) and its in vivo safety and efficacy evaluation.
Methods: FRIV formulations were developed using standardized ringer lactate (RL) formulation protocol, in which varying concentrations of ethanol and glycerol were added to induce desired physiochemical properties. Efficacy of FRIV was evaluated in terms of survival percentage of hemorrhagic animal models (Swiss albino strain mice). Acute toxicity studies were carried out through an infusion at dose levels (0, 20 and 40 ml/Kg b. wt.).
Results: In vitro data showed that optimized FRIV (F-10) takes more time (360 Â± 21 min) for freezing and less time in thawing (50 Â± 4.50 min) in comparison to control which takes (110 Â± 15 min) in freezing and (80 Â± 7.25 min) in thawing. Formulations were found to be stable and sterile up to six months. In vivo efficacy data showed â‰¥ 75% survival in animals infused with FRIV as compared to control group in hemorrhagic animal models and no treatment related toxic effects of optimized formulation in terms of hematological, serum biochemistry and histopathological analysis.
Conclusion: Pre-clinical safety and efficacy data of the present study indicated that developed FRIV formulation could be used for fluid recovery during the hemorrhagic shocks conditions in the combat scenario.
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