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,
1Department of Pharmaceutical Technology and Biopharmacy,
2Department of Drug Industry and Pharmaceutical Biotechnologies,
3Department 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.