Capsugel announced the launch of its enTRinsic drug delivery platform to provide enteric protection and rapid release of oral drugs in the upper gastrointestinal tract without the use of a functional coating.
Enteric protection is a means of preserving drugs from the corrosive effects of gastric acid and stomach enzymes, and is most often achieved through a special coating, but Capsugel says some active ingredients cannot withstand the high temperatures associated with the coating application, or are sensitive to the coating itself.
Its coating-free platform for enteric protection is now available following an 18-month lead-user trial period that consisted of feasibility studies of new and existing pharmaceutical products, the company says.
|Capsugel's Hassan Benameur|
"Our lead-user program confirmed the enteric performance of our enTRinsic technology in multiple applications, as well as the viability of the formulation and manufacture of finished drug product at scale," said Keith Hutchison, Capsugel's senior vice president of R&D, in a statement. "We are now excited to move beyond the lead-user program and work with additional customers, while continuing to broaden the application of the technology to encompass gastric resistance, full enteric protection, and varied GI site targeting for an increasingly diverse range of APIs."
According to a release, the platform can be used to deliver a third party's vaccines, proteins and peptides. Dr. Hassan Benameur, Capsugel's senior director of pharmaceutical sciences, explains that enteric protection can also be used to the stomach from drugs, as in the case of enteric-coated acid.
He touts the enTRinsic platform as a method of speeding up drug development by eliminating the need to develop a coating for enteric protection. It also simplifies the manufacturing process, he says, writing that the platform provides protection "by incorporating pharmaceutically approved enteric polymers in the capsule shell using conventional pin-dipping capsule manufacturing processes."
Pfizer ($PFE) sold Capsugel to private equity firm KKR for $2.38 billion in 2011. The drug delivery specialist has been on an expansion spree of late. In July the company announced a 40,000-square-foot expansion of its Edinburgh, Scotland, facility, which makes liquid- and semisolid-fill hard capsules. In addition it recently completed a $25 million expansion in Bend, OR, where it has built a spray-dried dispersion facility, and is upping its production of vegetarian capsules at four sites in different parts of the world.
- read the release