A 28-days sub-acute toxicity study in swiss albino mice to evaluate toxicity profile of neurotol plus (mannitol and glycerol combination).

Osmotic agents are still the most common treatment options available for controlling intracranial pressure (ICP). Combining Mannitol and Glycerol provides a better alternative and is currently available as best therapy used for increased ICP. The aim of this work was to study the effects of repeated dosing (28 days) of Mannitol 20% and Glycerol 10% combined formulation, Neurotol plus on safety profile. A twenty eight days sub-acute toxicity study was conducted at three different dose levels of 5ml/kg, 10 ml/kg and 20 ml/kg. Mice were randomly divided into four groups of six animals each. Physical parameters, biochemical parameters related to liver toxicity & nephrotoxicity and hematological parameters were studied as end point of evaluation. We also carried out histopathlogical studies to assess any organ specific toxicity. The present study demonstrated that there were either no or very minimal changes (at high dose) were observed on various physical, biochemical and hematological parameters between Neurotol plus and control group. In conclusion the data of present study suggest that the combination of Mannitol and Glycerol is not associated with any serious adverse effects and is safe therapeutic choice for ICP reduction.