Highly potent pellets
A smart approach
Originale
Abstract
Handling highly potent active compounds is a challenge for pharmaceutical processes and operator safety. With the coated pellet and micropellet (<500 μm) concept, contamination of production rooms and staff with dangerous active pharmaceutical ingredient (API) dust is minimized. The fluid bed Wurster (bottomspray) technology is a single-unit process. Based on the quality by design (QbD) development concept, the coating steps following the initial application of a drug layer are performed without the need to interrupt the process or discharge the product. The dangerous pure API must be handled during the weighing step only. At the end of the single-pot production process, the pellets are coated, dust-free and safe to handle.
(Micro)pellets are an ideal process technology platform enabling a great variety of oral drug products and flexible dosage strengths. Coatings provide different drug release profiles and taste masking of bad-tasting APIs. The (micro)pellet formulation facilitates combination of products and individualized dosing.
Correspondence:
Norbert Pöllinger, PhD
Glatt Pharmaceutical Services GmbH & Co. KG,
Werner-Glatt-Str. 1, 79 589 Binzen
norbert.poellinger@glatt.com
 | Andreas Flückiger, M.D. has a background in internal and occupational medicine with diplomas from the Universities of Bern and Basel as well as the Bavarian Academy of Occupational, Social and Environmental Medicine in Munich. For 32 years, he was in charge of occupational health in the Roche Group, |
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