Issue link: http://www.e-digitaleditions.com/i/793410
Tablets & Capsules March 2017 21 These latest enteric capsules comply with relevant EP, JP and USP monographs and have been evaluated in vitro across a number of compounds. The results show they protect the stomach from aggressive APIs and delay release to provide maximum absorption. Vcaps Enteric capsules work with all but the most sensitive APIs. (For highly sensitive molecules—including peptides, nucleotides, and vaccines—enTRinsic capsules are a bet- ter option because they use an impervious polymer.) In addition to eliminating the need for enteric coating, Vcaps Enteric and enTRinsic capsules provide product differentiation, allow lifecycle management, and offer the potential to make intellectual property claims. In vitro and in vivo evaluations have confirmed that the capsules provide enteric protection. One test of their in vitro disintegration and dissolution performance involved esomeprazole magnesium trihydrate (EMT). In that test, enteric-coated EMT pellets in gelatin capsules (Nexium) were selected as an acid-labile model compound for which gastric stability is limited—similar to peptides, nucleotides, and vaccines. The EMT formulation was placed in enTRinsic capsules for comparison with capsules whose manufacturer claimed were acid resistant [7]. The results: The intrinsically enteric capsules showed no sig- nificant discoloration after 2 hours in acid media, indicat- ing little to no degradation. Conversely, the capsules said to be acid resistant showed clear evidence of degradation, deformation, and content release. The EMT capsules filled into the enTRinsic capsules also showed quick dissolution of the gelatin capsules with no dissolution of the pellets at the acid stage, and complete dissolution of the pellets at the buffer stage, with a mean of 94 percent of EMT dis- solved after 30 minutes. In late 2016, Capsugel introduced a functional capsule that provides a second alternative for enteric protection and delayed release without using a functional coating. The capsules, Vcaps Enteric, use a polymer blend of HPMC and hydroxypropyl methylcellulose acetate succi- nate (HPMC-AS). While the polymer blend differs from what the enTRinsic capsules use, Vcaps Enteric offer a similar benefit: simpler enteric delivery from early-stage development to commercial manufacturing. Vcaps Enteric capsules use a polymer blend of HPMC and HPMC- AS to provide enteric protection and delayed release without using a functional coating. YOUR BENEFITS > High accuracy feeders for optimal ingredient delivery > Innovative sanitary and hygienic pneumatic conveying solutions > ZSK twin screw extruders suitable for the continuous production of pharmaceutical compounds > Integrated systems controls for all operations > All systems designed with advanced pharmaceutical-grade engineering >>Accuracy at every process step. Feeding, weighing, conveying and extrusion systems provided by Coperion and Coperion K-Tron o er the highest in e ciency and reliability to ensure the optimum in product e cacy. >>www.coperion-pharma.com >extruders >feeders >components >pneumatic conveying >complete systems