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Drug Delivery Technologies Q&A

  •   How much promise do new technologies exploring oral insulin analogues – many just entering human testing – have in diabetes drug delivery? Can the traditional hurdles in oral administration be overcome?

    Answered January 19th, 2010 by Expert: David M. Oakley, R.Ph., Ph.D.

    We can look at the progress made in the oral delivery of insulin and predict similar successes for oral delivery of insulin analogues. Numerous technologies have been applied to oral insulin delivery to overcome the two primary obstacles: degradation and low membrane permeability. Examples of these technologies include enteric coatings, micro- and nano- particulates, mucoadhesives, liposomes, permeation enhancers, and others. In many drug-delivery systems, multiples of these approaches are combined in a single platform. The fruits of these efforts are meeting the marketplace as shown by Oral-lyn, a spray buccal delivery system from Generex Biotechnology. Oral-lyn is available for sale in Ecuador, was approved in India in 2007, and is in Phase III clinical study in the United States, Canada, Russia, and several other countries. In late 2009, Novo Nordisk initiated a Phase I clinical trial of its oral insulin analog, NN1952, using the GIPET (Gastrointestinal Permeation Enhancement Technology) platform from Merrion Pharmaceuticals. The GIPET technology platform is a patented system that utilizes enteric coating and GRAS permeation enhancers to increase intestinal absorption of NN1952. We can expect the application of drug-delivery technology to the oral delivery of insulin analogues to accelerate.

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