Issue link: https://www.e-digitaleditions.com/i/446555
Branching out To capture that business, suppliers have been broadening the application of their products and expanding their offerings. Capsugel, one the largest suppliers of capsule shells, has added a number of technologies to its portfolio under its Dosage Form Solutions (DFS) business unit. In March 2013, it acquired Scotland's Encap Drug Delivery, giving it more expertise in liquid-filled lipid formulations and a commercial manufacturing facility. In October 2013, it acquired Bend Research, Bend, OR, which specializes in enhancing bioavailablity and modifying API release using spray- dried dispersions and hot-melt extrusions. Still, capsules remain Capsugel's foundation, a fact underscored by the posters it presented at the annual meeting of the American Association of Pharmaceutical Scientists (AAPS) in San Diego, CA, in November. "We want to educate people about the advances that are taking place in capsule technology," said Missy Lowery, Capsugel's senior manager of marketing for the Americas. "It's an extremely flexible dosage form." One example is a multi-compartment capsule under development at one of the company's R&D sites. In this variation of the capsule-in-capsule approach, one or more capsule caps are inserted into a standard capsule, enabling a single capsule to carry two or more formulations [1]. The AAPS poster presented experimental case studies that demonstrated the possible applications and concluded that the technique can be applied to combinations of all types of hard capsule polymers. "It's something that we have been developing just to see the feasibility," said Domique Cadé, Capsugel's director of polymer science. "It's part of our push to offer our ideas to the pharmaceutical industry, to see where it fits, the right application." Another poster summarized a study on the performance of Capsugel's acid-resistant DRcaps capsules after being band-sealed with an ammonia-neutralized cellulosic formula [2]. In vitro tests showed the band prevented the body and cap from separating until they reached a higher pH environment. Later this year, Capsugel will begin commercial trials of the banding technology among its pharmaceutical and dietary supplement customers. Getting capsules to the target destination was critical for Dr. Elizabeth L. Hohmann and her colleagues at Massachusetts General Hospital, Boston, MA. Their work involved transplanting donated fecal matter to the large intestines of patients suffering from clostridium difficile colitis [3]. The effectiveness of the transplantations was well established, but the first methods used— colonoscopies and intubation—were fraught with problems. Capsugel's acid-resistant HPMC capsules provided a solution. The HPMC polymer held up to the liquid fill, and the capsules' acid resistance ensured passage through the stomach intact, opening only when they reached the large intestine. Double encapsulation— a size 00 within a size 0—and deep-freezing kept the capsules intact until they were dispensed (15 capsules a day over 2 days). "Most people just close their eyes and take it right down," Hohmann said. "[The appearance] is really just an aesthetic concern because they're totally odorless and tasteless. And because they're frozen, they frost over a little bit when you get them in the air. So it doesn't matter that much." Eighteen of 20 patients were treated successfully using the capsules, and since the initial results were announced in October, Hohmann and her colleagues have treated 30 more patients with similar success. Tablets & Capsules January 2015 11 Capsugel conducted several experimental case studies of its multi-compartment capsule to demonstrate possible applications [1]. Photos courtesy of Capsugel Acid-resistant HPMC capsules give physicians a better method of transplanting fecal matter to the large intestine [3]. Photo courtesy of Dr. Elizabeth L. Hohmann