Modelling of the Effects of Triethyl Citrate and Curing Conditions on Drug Release from Film-Coated Tablets Hatim Samir AlKhatib* and Adel Sakr Industrial Pharmacy Graduate Program, University of Cincinnati Medical Center, Cincinnati, Ohio (USA) * Current address: Department of Pharmaceutics and Pharmaceutical Technology, Faculty of Pharmacy, Jordan University, Amman (Jordan) The aim of this work was to evaluate and model the effects of the level of triethyl citrate as a plasticizer and curing conditions on drug release from theophylline tablets coated with a blend of methacrylic acid ester copolymers using response surface methodology. A full-factorial design was used to evaluate the effects of triethyl citrate at 15, 20 and 25 % w/w, curing temperature at 40, 50 and 60 °C and curing time at 1, 2, 4, 8, 12, 24, 48, 96 and 192 h on theophylline release from tablets coated with a blend of Eudragit RL30D and Eudragit RS30D. Drug release was tested in 900 ml of purified water using the rotating paddle method at 50 rpm. Apparent release rate constant (Korsmeyer-Peppas) was used as an index of drug release. Second-order poly-nomial equations were developed to describe drug release as a function of triethyl citrate level, curing time and curing temperature. Triethyl citrate was found to accelerate drug release from film-coated tablets by leaching into the dissolution medium creating pathways for drug diffusion. Increasing curing temperature and time slowed down drug release by in-creasing film coalescence. Key words Eudragit® RL30D • Eudragit® RS30D • Film-coated tablets, curing conditions, plasticizer level, release rate • Methacrylic acid esters copolymers • Response surface methodology • Sustained release dosage forms • Triethyl citrate |
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pharmind 2005, Nr. 2, Seite 237