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Creating tablets with holes may not sound a very sophisticated approach to innovative drug delivery, yet the 'hole' idea is at the heart of a new generation of controlled-release tablets being introduced by GSK using its DiffCORE technology.

It’s a long-recognised problem that many patients do not adhere to their medical treatments. There are various reasons why they don’t, but one way the pharmaceutical industry is helping tackle the problem of compliance is by improving options for the delivery of medications.

Taking fewer tablets a day makes for better patient compliance. If the active ingredient of the drug can be delivered more effectively, then the number of tablets needed for the treatment might be reduced. One route here is to somehow control or time the release of the active ingredient into the body so the equivalent daily dose is the same or similar to taking several tablets a day.

It is not a new idea. GSK launched the first timed-release medicine 55 years ago. It used the Spansule drug delivery system of capsules loaded with pellets coated with medication that dissolved at different times. Today, the pioneering approach continues with DiffCORE technology.

DiffCORE technology
The GSK-developed DiffCORE technology involves creating holes of different size and number into coated tablets, allowing the active ingredient to be released in a much more controlled way than previously.

Making these 'tablets with holes' is, of course, not as simple as it sounds.

 It's not a matter of just drilling holes in our existing tablets - clinical trials are still involved as if they were a new product 

Gino Martini, director of Process Technologies in GSK's Pharmaceutical Development division, says the company has spent significant amounts of time and money on developing DiffCORE technology since it was purchased in its basic form from academia in 1999.

"Most conventional tablets and capsules release the active ingredient quickly, but by controlling the release rate we can often extend the therapy and in many cases reduce the dosing frequency from several times a day to once a day," says Gino.

Tablets that use DiffCORE technology are easily recognisable and look different to conventional ones. This is a feature that Gino reckons should make them unusually difficult for counterfeiters to copy.

Where the action is
When the tablet is swallowed, gastrointestinal fluids enter the tablet hole in the coat and penetrate the core, releasing the drug. The rate of release also depends on the make-up and composition of the internal matrix.

"It's not a matter of just drilling holes in our existing tablets - clinical trials are still involved as if they were a new product," says Gino. Alongside these pharmaceutical and patient safety considerations, a key part of the technology has been the design and development of the processing equipment needed for large-scale production.

GSK is using DiffCORE technology in an increasing number of products for treatments, including epilepsy and metabolic disorders, although Gino points out it may not be appropriate for all the company's tablet products.

And the future?
The future of drug delivery might well see, for example, microchips in capsules of medicines lodged in specific parts of the body programmed to release treatments at various times.

Until then, however, GSK is extending its offering of DiffCORE technology in its tablets while continuing a tradition of pioneering drug delivery systems that ultimately benefit patients.

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