Active pharmaceutical ingredients (APIs) help patients. On their way through the human organism, however, they themselves need support. So-called carriers or excipients transport the pharmaceuticals and give them their specific shape. Moreover, excipients make sure the body absorbs APIs more easily. Liquid carriers are particularly effective – and a specialty of the chemical company BASF, headquartered in Ludwigshafen, Germany. Together with Bosch Packaging Technology, BASF investigated how these excipients can be efficiently filled in hard gelatine capsules.
Success through combined expertise
BASF contributed excipients and its formulation knowledge, while Bosch brought in process expertise and the GKF 702 capsule filling machine. At first, BASF analyzed and tested different combinations of APIs and excipients in the laboratory. Experts manually filled capsules and assessed the carriers’ flow properties as well as their interaction with various APIs. “Excipients must ensure the even distribution of the API in a given capsule batch,” says Nils Rottmann, Technical Service Manager Pharma Solutions at BASF. “In this respect, liquid excipients are a big advantage, since they make sure APIs are optimally dissolved.”
The lab tests were followed by trial filling runs on the GKF 702 with the different capsule sizes 00 (large), 1 and 4 (small). “The versatile platform was easy to configurate for various liquid formulations at constantly high levels of API,” Stephanie Otterbach, Process Engineer at Bosch Packaging Technology, points out. Further, the flexible GKF 702 handles different capsule sizes without requiring any additional format parts, allowing pharmaceutical manufacturers to save time and costs. Since the machine can process a number of different API formulations, the GKF 702 can also efficiently fill medications for rare diseases, so-called orphan drugs. Both companies are currently investigating further aspects of the liquid filling process, including API stability and alternative capsule materials.
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