76 TABLETING
ANALYTICAL AND LABORATORY EQUIPMENT 9 SECTION NAME 3
Described by the company as a breakthrough in drug-delivery technology, it integrates industry- approved enteric polymers in the capsule design, enabling Capsugel to offer what it says is the first fully enteric dosage form without the need to apply functional coatings.
“Te advantages of this technology include minimal excipients needed for formulation, improvement of upper gastrointestinal safety and differentiated pharmacokinetic performance. It can also accelerate product development while supporting quality by design through scale-up and commercial manufacturing,” explained Amit Patel, president, dosage form solutions, Capsugel. As part of the company’s lead-user programme, selected customers are carrying out feasibility studies that target oral
vaccine and peptide delivery, as well as early-stage development programmes for small chemical entities that could benefit from an intrinsically enteric dosage form.
Te company hopes eventually to offer a range of applications for both large and small molecules as it advances the technology with additional customers to new and existing pharmaceutical compounds.
Ionic liquids In a separate development, Capsugel has acquired the intellectual property pertaining to proprietary ionic liquids technology developed at the Monash Institute of Pharmaceutical Sciences (MIPS) in Australia. Tis novel technology uses lipid-like counter-ion salts to improve the solubility of drugs in lipid-based
liquid, semi-solid and multi- particulate formulations.
Te two have a long history of collaboration in lipid-based drug delivery science, including co- founding the Lipid Formulation Classification System (LFCS) consortium to advance and standardise evaluation protocols for lipid-based drug-delivery systems.
Explaining the benefits of ion liquids technology, Keith Hutchison, Capsugel’s senior vice president of R&D, said, “It will allow us to significantly increase drug solubility, reduce absorption variability, decrease excipient levels and reduce pill burden. Tis represents a valuable addition to our capabilities in designing and developing innovative immediate and modified-release dosage forms.”
New technology centre opens in Germany Meanwhile, at its new technology centre in Ennigerloh, Bohle has merged all the steps of continuous tablet production for the first time.
“We have leveraged our acknowledged quality in the areas of granulation and coating and, with Gericke and Korsch, have taken on board another two technology leaders for continuous blending/dosing and tablet press technology,” explained project leader Lorenz Bohle.
At the technology centre, customers from the pharmaceutical industry can now experience the benefits of continuous production first hand.
“Te unique feature of this plant is that the tablet production can be implemented either without granulation or with dry or wet granulation, in one system,” added Bohle. Te
“A breakthrough in drug-delivery technology integrates industry-approved enteric polymers in a capsule design, enabling the first fully enteric dosage form without the need to apply functional coatings. ”
modular concept of continuous production offers substantial time savings since it does not require any time-consuming analyses of the product samples between the process steps. Moreover, producers benefit from greater flexibility because the plant can be quickly converted to different products.
“Te holistic approach of this new form of production is especially interesting; the objective is to link the individual process steps and to ensure consistency with constant parameters,” noted project partner professor Peter Kleinebudde of the University of Dusseldorf ’s Institute of Pharmaceutics and Biopharmaceutics.
So far the company has invested €2 million in the project, with several million more being made available in the coming years to further develop the concept of continuous production.
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