Issue link: https://www.e-digitaleditions.com/i/1022930
Tablets & Capsules September 2018 35 solid matrix [3]. For example, propranolol capsules con- tain a rapid-release phase of propranolol in oleic acid and a sustained-release phase of the API contained in an erodible matrix. Enteric and targeted-release capsules As previously mentioned, LFHCs can also be coated, allowing for enteric and targeted API release. Band seal- ing the capsule shell, as shown in Photo 2, protects the contents from the coating material and also smooths the edge between the capsule cap and body. For example, Colpermin capsules, manufactured by Tillotts Pharma, contain a thixotropic gel with 0.2 milliliter (187 milli- grams) of peppermint oil in an enteric-coated hard cap- sule for the treatment of irritable bowel syndrome. Making a tablet containing the same amount of pepper- mint oil would be very difficult. LFHCs are ideal for drug products requiring API release in the colon as well, where water content is low. The capsules can be coated with a starch that resists digestion in the upper GI tract but fer- ments in the colon, releasing the API. Abuse-deterrent formulations Liquid- and semisolid-filled capsules cannot be pow- dered or crushed to increase API release. Extracting the API from a LFHC is also difficult, which makes the dos- age form useful as an abuse deterrent for drug products that treat pain (such as opioids), anxiety, depression, and hyperactivity. For example, technology by Durect uses a high-viscosity base matrix of sucrose acetate isobutyrate to contain the API. In November 2017, the FDA issued a guidance for industry on general princi- ples for evaluating the abuse deterrence of generic solid oral opioid products [4]. Any generic solid oral opioid product should meet these requirements. Improved stability Softgel capsules contain about 30 percent glycerin as a plasticizer, which results in higher moisture absorption and can lead to migration of the API into the gelatin film. The plasticizer creates channels that increase the capsule Photo 2: In addition to preventing leakage, band sealing protects the LFHC's contents from the coating material and smooths the edge between the cap and body. Courtesy of ACG