Although the US Food and Drug Administration (FDA) approved the first camera pill in 2001, no company has been able to combine this idea with an effective drug delivery mechanism. Philips hopes that its iPill, which uses precise pH monitoring to determine location, will be the breakthrough that drug developers have been waiting for.
Philips principal researcher Jeff Shimizu told in-PharmaTechnologist.com that the firm had taken on the ambitious project several years ago when it “recognised the success of the capsule endoscope- camera pill at a time when Philips was expanding its footprint in the healthcare area.”
Shimizu explained that one of the best indicators of position in the GI-tract is pH because it differs markedly between the gut and the small and large intestines. He added that: “using these two landmarks, in combination with transit timing, the iPill is able precisely determine its location and trigger appropriate drug release.
“The most obvious application of the technology is GI diseases, particularly those were the location differs between individuals and those that change over time, which is a really interesting proposition and one that is extremely difficult to treat using other means.”
He went on to say that: “the iPill could be combined with the existing camera technology to determine the location of lesions in the small-bowel and could then be specifically programmed for that individual to deliver at that location.”
“We are using crohns disease as an example but there are plenty of other GI-diseases and non-GI diseases were location and inter-patient variability would benefit from programmable targeting. However, once this beach-head application is established you allow people to start exploring other therapy options,” Shimizu added.
A revolution for early-stage development?
A more immediate use of the iPill is site absorption and pharmacokinetic studies for drugs under development, for which there is a more immediate need and less of a regulatory pathway.
Philips, which is thought to be in talks with several potential drug industry partners and contract research organizations (CROs), believes that the iPill can offer developers significant advantages in terms of both timescale and cost.
As Shimizu explained, “if you want to do a regional study you simply load the drug programme the iPill and monitor the data and if you are not getting the results you want you simply re-programme and alter the delivery profile slightly and you are off and running with the next experiment.
“You don’t have to reformulate, you programme, deliver, test and iterate. It is much quicker and reguires much less active pharmaceutical ingredient (API).”