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Rotary Agglomeration − A Process for Wet Spheronization of Bioadhesive Micropellets

Marcus Knoell^1,2, Rosario Lizio², Hans-Ulrich Petereit², and Peter Langguth¹

¹ Johannes Gutenberg-University Mainz, Institute of Pharmacy, Department of Pharmaceutical Technology and Biopharmaceutics, Mainz (Germany)
² Degussa, Röhm Pharma Polymers, Darmstadt (Germany)

Corresponding author: Prof. Dr. P. Langguth, Johannes Gutenberg University, Institute of Pharmacy, Department Pharmaceutical Technology and Biopharmaceutics, Staudinger Weg 5, 55099 Mainz (Germany); e-mail: langguth@uni-mainz.de

Bioadhesive micropellets consisting of sodium carboxymethylcellulose (Na-CMC), sodium-alginate and chitosan with average particle sizes ranging from 250 to 600 μm were developed using wet spheronization combined with rotary agglomeration (RA). These pellets unify the advantages of multi-particulate dosage forms with bioadhesion. The resulting micropellets are characterized by a lower friability (6 to 17 %) when compared with commercially obtained pellets composed of microcrystalline cellulose, Cellets  (41.5 %). Furthermore, they demonstrate acceptable tapped density (0.73 to 0.9 g/ml) and can be manufactured at high yields (> 80 %). The water content at the end of the spraying period and the liquid binder addition rate have been shown to be the most important process parameters.

Key words Controlled release • Micropellets • Multi-unit dosage form, process development • Oral drug delivery system • Polymer adhesion • Rotary agglomeration