India clears Neotame for use in drugs

Neotame, a recently introduced high intensity sweetener developed by US company NutraSweet, has been approved by the health authorities in India for use in pharmaceutical preparations.

The sweetener is structurally similar to aspartame, but is 30-60 times sweeter, so less should be required in pharmaceutical formulations. It is about 8000 times sweeter than sucrose, and can also favourably enhance flavour and taste at or below sweetening levels, according to NutraSweet.

The company maintains that the sweeteners potency, sensory and safety characteristics will provide pharmaceutical manufacturers with 'substantial cost savings', given that it is cheaper to produce than other high-intensity sweeteners.

The ingredient maintains stability and functionality over a range of pH, temperature and storage times and is soluble in water and alcohol base formulation systems.

Neotame was developed by modifying the structure of aspartame, which is made by linking L-aspartic acid and L-phenylalanine, so that it does not break down into the amino acid phenylalanine. This means that products using it do not have to carry a safety warning for people with phenylketonuria, an inability to metabolise the amino acid.

The US Food and Drug Administration (FDA) approved it for general use as a sweetener and flavour enhancer in 2002. It was first registered in Australia a year earlier.