Romanian Society of Pharmaceutical Sciences

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THE STUDY OF PIROXICAM DISSOLUTION FROM EUDRAGIT RS-COATED PELLETS

MIRCEA HÎRJĂU1*, DUMITRU LUPULIASA1, FLAVIAN ŞTEFAN RĂDULESCU2, DALIA SIMONA MIRON3

University of Medicine and Pharmacy “Carol Davila” Bucharest, Faculty of Pharmacy,
1 Department of Pharmaceutical Technology and Biopharmacy,
2 Department of Drug Industry and Pharmaceutical Biotechnologies,
3 Department of Pharmaceutical Physics and Informatics,

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The objective of this work was to study the dissolution process from piroxicam pellets, coated with Eudragit® RS 30 D by fluidized bed, in order to achieve an enteric release of the drug. The coating product contains a methacrylic copolymer which is insoluble, but permeable. The drug-loaded pellets were prepared by extrusionspheronization using microcrystalline cellulose (Avicel PH 101) as a spheronization agent, lactose as a filler and polyvinylpyrrolidone K30 as a binder. A dissolution study was performed using two dissolution media with different pH values, corresponding to the pH values of the stomach and intestinal environment (hydrochloric acid 0.1N, pH=1.2 for the first two hours of the test and phosphate buffer 50 mM, pH 6.8 for the next 4 hours interval of the dissolution test). The in vitro dissolution profile obtained for the piroxicam pellets coated with Eudragit RS 30 D was compared with the one corresponding to the piroxicam pellets coated with Eudragit RS 30 D associated with Methocel E5. The influence of the association of the pore-forming agent in the coating formula on the percentages of piroxicam dissolved was established.