Encap in colonic drug delivery licensing deal with London University

10 September 2009

Encap Drug Delivery, a provider of development and manufacturing services to the pharmaceutical industry, has entered into a licensing agreement with The School of Pharmacy, University of London for the use of their drug delivery system, Phloral. This unique coating technology is designed to target the release of drugs to the colon and will form part of a range of colonic delivery systems promoted by Encap under the name Encode (Encap colonic delivery).

Recently colonic drug delivery has gained increased importance, not just for treatment of local diseases associated with the colon, eg Crohn's disease, ulcerative colitis, colorectal cancer and IBS, but also for its potential as a site for the absorption of certain molecules due to the decreased levels of efflux transporters and membrane-bound metabolic enzymes known as cytochromes. Its potential suitability for the oral delivery of peptides and proteins, oligonucleotides and vaccines is also an area of increasing interest.

Existing colonic systems generally involve coating the dosage unit with polymeric materials that will not normally dissolve in the low pH of the stomach or upper intestine but will dissolve in the higher pH of the lower intestine. Coatings that rely on a pH dependant system have the potential to be unreliable due to the large intra and inter patient variability in transit times and luminal pH. The new Phloral technology represents a significant improvement in colonic delivery providing ‘fail-safe’ delivery of drug to the target site by employing two complimentary mechanisms to trigger drug release. As well as a pH dependant coating it also incorporates a component which is broken down specifically by the microbiota in the colonic region.

The power of the new technology has been demonstrated in a recently published scintigraphic study in healthy volunteers (Ibekwe, Khela, Evans and Basit, Alimentary Phamacology & Therapeutics 28(7):911-6, 2008). Dosage units with the combination coating all disintegrated in the colonic area as desired whereas many units coated exclusively with a commercially available pH coating passed through the gastrointestinal tract intact and failed to disintegrate.

One of the drawbacks to colonic delivery is the relatively low amount of water that is available for dissolution of dosage forms in this part of the gastrointestinal tract. The combination of a reliable colonic targeting technology and the delivery of drugs in a liquid dosage form using Encap’s liquid fill technologies may provide a significant advance for the delivery of a wide range of drugs to the colon.

Encap’s Chief Operating Officer, Dr Stephen Brown said “This deal with The School of Pharmacy is an ideal strategic fit for Encap Drug Delivery as we already have a portfolio of drug delivery technologies available for oral dose forms. The ability to use the Phloral technology combined with the flexibility afforded by our liquid fill hard capsule technology, allows us to now offer clients a system with the confidence that colonic delivery will be achieved.”

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