Diabetes, the silent killer, is a leading cause of mortality and reduced life expectancy. More alarming is the fact that the prevalence of diabetes has increased in recent decades in most developed and developing countries.

In a report, the International Diabetes Federation (IDF) have estimated that 451 million adults live with diabetes worldwide in 2017 with a projected increase to 693 million by 2045. The most upsetting fact is the prevalence of both type 1 and type 2 diabetes among children and adolescents which has increased, and the estimates of children and adolescents below age 20 with type 1 diabetes now exceed one million. Recombinant human insulin and its analogues are the only hope to handle this situation world over. The greatest disadvantage and crisis we now face is that the route of administration still remains subcutaneously. The most preferred option would be an oral insulin form which may have significant benefits among patients. In addition, it would prove to have a physiological advantage as it would replicate the natural route of insulin secretion and absorption. NBI’s sincere attempts have led to the development of a successful oral insulin formulation that will soon change the way diabetic patients would battle this metabolic condition.

The development of oral insulin by innovators across the globe has been challenging due to the innate nature of the protein which disintegrates due the gastrointestinal physiological conditions. The aim of NBI was to overcome the basic obstacles and identify the ideal combination of ingredients that would deliver insulin intact and in required dosages to manage elevated blood sugar levels without themselves interacting with the protein. Choice of stable and safe excipients and ingredients that are compatible with the insulin Glargine and ensuring that the physical properties allow tablet compression without denaturing the basic nature of the protein was achieved though multiple trials. Analytical methods were developed to identify and quantitatively analyse the insulin Glargine content in the novel formulation. These methods paved a way to include the correct ingredients and formulate oral insulin delivering required quantities insulin glargine.

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