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In fact, liquid-filled hard capsules have not been as popular as forecast, Opitz said. "It's a fantastic technology for insoluble APIs, and some years ago there was a big hope that a lot of products would come out, and there are some for sure. But it's not the boom that we expected at Bosch. We haven't sold that many liquid filling machines linked to the SMEDDS and SEDDS systems." Another of Patheon's technologies, Softlet gelatin enrobing, offers an alternative to over-encapsulation, the standard method of blinding clinical trial materials. "Sometimes the tablet is large and it's a challenge to fit into a blinded hard capsule," Kane said. "Actually, we are seeing more of that: fixed-dose combinations getting larger and larger, and it's a challenge to fit them in a blinded capsule, so a Softlet enrobing approach can help. It's all based on engineering, devising the tooling." Odd- shaped tablets, multiple tablets, and powder- or pellet- filled capsules can also be enrobed to blind clinical trial materials. "There is no one solution that solves all problems. Our approach is to provide the fastest and most cost-effective approach, whether it's a two-piece shell or softgel form." Softgels can also help formulators overcome the difficulty of delivering biopharmaceuticals via the oral route. "No major breakthrough in the effective oral delivery of peptides/proteins has been accomplished," said Shinji Yamashita of Setsunan University, Osaka, Japan [9]. At the same time, there is a trend in drug development toward bio-molecules over small-molecule compounds, he said, and that has increased the demand for oral delivery of biologics, especially of therapeutic peptides and proteins. Catalent, for one, is working on it, mainly via its OptiGel Bio technology, which aims to put proteins, peptides, and other biological molecules—normally delivered by injection—into an oral dosage form. One of 14 January 2015 Tablets & Capsules Patheon can take softgels from proof-of-concept, through clinical trials, and on to commercial production. Photo courtesy of Patheon Photo courtesy of MIT News Office Seven of the top 10 best-selling drug pro ducts are biologics, but none of them is de livered orally, said Shinji Yamashita of Setsunan University. "The oral delivery of biologics has attained a high level of science, but very few real-world products so far." Meanwhile, the science continues. Researchers at the Massachusetts Insti - tute of Technology and Massachu setts General Hospital have developed an oral capsule coated with tiny needles that injects drugs into the lining of the GI tract. In animal studies, the capsule deli vered insulin more efficiently than sub cutaneous injection, and its needles had no harmful side effects. In addition to insulin, the de vice may be capable of delivering anti bodies to treat cancer and autoimmune disorders, as well as vac cines, recombinant DNA, and RNA. Such biologics are difficult to deliver orally because their large molecular size prevents absorption in the GI tract. But the capsule's micro-needles overcome that barrier by directly injecting the pay load. Since there are no pain receptors in the GI, the injection is pain less. In tests on pigs, the device injected insulin into the stomach lining, small intestine, and colon. It took more than a week for the capsule to pass through the digestive tract. Although the needles had no harmful side effects, researchers are developing degradable needles that would break off, embed in the GI lining, and disintegrate as they release the drug. Researchers are now developing a cap - sule with needles made of degrad able poly - mers and sugar. They would break off, embed in the GI lining, and slowly disin - tegrate while releasing the drug. A summary of the study, "Micro needles for drug delivery via the gastro intesintal tract," appeared online Sep tem ber 22, 2014, in the Journal of Phar maceutical Sciences . — M.K. Breaking the GI barrier with micro-needles Illustration courtesy of MIT News