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| Effective Optimization of Enteric Film Coating of Pellets with a Miniaturized Top-Spray Coater Mirna Fernandez Cerveraa, Jyrki Heinämäkib, Elena Salgado Rodriguezd, Osmo Antikainenb, Antonio Iraizoz Colartea, and Jouko Yliruusib,c Institute of Pharmacy and Food, University of Havanaa, Havana City (Cuba), Pharmaceutical Technology Division, Department of Pharmacyb and Viikki Drug Discovery Technology Center DDTCc, University of Helsinki, Helsinki (Finland), and Department of Pharmacy, University of Complutense de Madridd, Madrid (Spain) Enteric film coating of pellets was studied and optimized using a miniaturized Caleva topspray film coating system. Each small-scale batch coated comprised 20.0 g of pellets and methacrylic acid copolymer (Eudragit®S), plasticized with dibutyl phthalate, was applied as an enteric coating material for the pellet cores. A face-centered central composite design (CCD) was used to evaluate the coating parameters of potential importance with re-spect to the final film coating properties of the enteric pellets. The parameters (i.e. independent variables) studied were inlet air temperature, atomizing air pressure and flow rate of coating solution. The total number of coatings, including the preliminary screening and final optimization batches, was approximately 40. The results indicated that an air flow top-spray film coating procedure of pellets in a small scale is sensitive to the flow rate of the coating solution, inlet air flow rate and air flow temperature. These parameters are critical, affecting both in vitro acidic resistance and batch quality (i.e. bulk appearance) of the methacrylic acid copolymer enteric-coated pellets. As regards in vitro acidic resistance, position (height) of the spraying nozzle also seems to be an important coating parameter. The present miniaturized film coating system used for preparing enteric (or colon-specific) Eudragit S-coated pellets was successfully optimized by using the response surface method. Key words Enteric film coating • Eudragit ® S • Fluid bed • Methacrylic acid copolymer • Miniaturized coater • Pellets |
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pharmind 2005, Nr. 2, Seite 231
