Encap Drug Delivery, a leading provider of development and manufacturing services to the pharmaceutical industry, has received confirmation that their DuoCap^TM, capsule delivery system has been granted patents for US and Europe.

DuoCap^TM, is a single oral dosage unit that comprises a capsule-in-a-capsule and offers broad therapeutic applications.  The inner and outer capsules may contain the same active drug providing multiple release profiles from the dosage unit e.g. an immediate release formulation from the outer capsule and a controlled release formulation from the inner capsule. In addition to modifying the release profiles it is also possible to target the inner and outer capsule to different areas of the GI tract (small intestine or colon) using Encap's coating expertise.  Alternatively the compartments may contain different actives for use with combination therapies or actives that are incompatible in a single capsule.  Combination therapies are of currently of significant interest, demonstrated by the recent launches of Combodart^TM (GSK) and Vimovo^TM (Pozen / AstraZeneca).

The inner capsule may contain liquid, semi-solid, powder or pellet formulations and the outer capsule contains liquid or semi-solid formulations, an area where Encap are recognised as world leading experts.  DuoCap^TM offers further flexibility in that the capsule shells may be coated with either enteric systems or with Encap's colonic delivery system, ENCODE^TM. 

The DuoCap^TM delivery system is already used in two probiotic combination products which are marketed worldwide.  The system is also being used by a number of major pharmaceutical companies for products in clinical development. Encap has recently signed a development and licensing agreement with a US company to develop a dual release dosage form of a drug.  Terms were not disclosed. 

The patented Duocap^TM technology can provide protection for clients interested in novel line-extension formulations for drugs coming to the end of their patent life.  Encap's business model is to provide clients with fee-for-service and license free formulation development and manufacturing service. DuoCap^TM provides clients with the additional opportunity to license a patent protected technology on a product by product basis if required. 

"The issuance of these patents is an important achievement in the strengthening of Encap's Intellectual Property portfolio," said Dr. Robbie Stewart, Sales & Marketing Director. "DuoCap was initially developed for use with probiotic treatments but now has huge potential for the delivery of many pharmaceutical active agents requiring controlled release.  Another real advantage is the flexibility of our manufacturing process.  Encap is able to manufacture DuoCap for clinical or proof-of-concept studies right through to full scale commercial volumes"