The safety of any drug needs to be well established to ensure the safety of the consumer. NBI’s oral insulin has been established to be safe through in vitro cytotoxicity studies in Caco-2 and HeLa cells. The NBI strategic innovation team brough in Dr Sandeep Jain, Dr Madhukar Saxena and Dr Amit Pal. This team was coordinated by Atul Kumar (MD) and Dr Richa Srivastava.

The MTT assay in Caco-2 and HeLa cells showed that the viability of these cells increased with increase in dilutions of the test article in comparison to the control. No decrease in cell viability was observed at any concentration in both the cell lines.

The uptake of oral insulin formulation in Caco-2 cells was also evaluated through in vitro assays. NBI’s oral insulin was plated along with Caco-2 cells and its uptake was estimated through ELISA. Using this sensitive analytical technique, the percentage uptake of insulin by Caco-2 cells was analysed. NBI’s formulations showed significant uptake in comparison to the insulin glargine and placebo.

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