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the first candidates was a very low-molecular-weight heparin, which the company studied at one of its European R&D sites. "While that is not a large-molecular- weight API, the results show the promise of our technology," said Jeff Browne, Catalent's R&D director of pharmaceutical softgels in the USA. The technology uses enteric-coated softgels to deliver the API and permeation enhancers to the small intestine, where they open. "Once they reach the instestine, they are designed to rupture quickly after dissolution of the enteric coat, even with the minimal volume of fluid that you have in the small intestine compared to the stomach," he said. "After they rupture and the shell dissolves, the fill is released, providing a very high local concentration of API and permeation enhancers at the area of the GI where absorption can occur." The permeation enhancers, typically medium-chain free fatty acids, are released from GRAS-listed ingredients in the fill formulation via normal biological processes, thereby opening the tight junctions between the GI cells. That allows the API to enter the bloodstream and exert its therapeutic effect. "We can't say this is the answer to delivering all proteins and peptides orally, but we have the promise of a technology that has shown what it can do for several model compounds that we've taken through animal studies." Catalent's latest offering is OptiGel Lock, an abuse- resistant technology that enables companies to comply with recent FDA guidelines for preventing abuse of opiates and other pain-management medications. "What we've shown, through in vitro data primarily, is that we have fill formulations and systems that are resistant to extraction and inhalation procedures that abusers use," Browne said. "Basically, we think [the technology] meets the major criteria to claim that we have an abuse- deterrent product" for extended- and immediate-release products. He said many pharmaceutical companies are scrambling to comply with the FDA guidelines, which in many cases will likely require them to reformulate existing products. "Whether those are tablets or hardshell capsules, we feel this softgel technology is as good or better than many of the other options on the market." Tablets & Capsules January 2015 15 Combination fills illustrate the flexibility of soft and hard capsules. Here multiparticulates are combined with a liquid fill in a hard capsule. Photo courtesy of Patheon The GKF 702 from Bosch fills capsules with tablets, powders, pellets, and liquids, either individually or in combination. For powder fills, it uses either tamping pins or dosators. Photo courtesy of Bosch Catalent's softgels include a variety of OptiGel technologies to deliver biopharmaceuticals orally, deter abuse, and modify release. Its OptiGel Micro softgels (bottom) are seamless and easy to swallow. Photo courtesy of Catalent