A controlled release system was developed using film coating as drug release controlling system, ketoprofen was used as model drug. The drug was prepared in tablets containing 15% Gelucire 50/13 as matrix forming material, and then it was film coated with ethylcellulose (300cps). The in vitro dissolution studies showed that the rate of ketoprofen release was sufficiently sustained for up to 8 hours with coating thickness 0.04 mm, and this was found to be comparable with the commercial reference preparation (Oruvail CR 100 mg) in terms of the release profile and extent of drug release. A 12 hours sustained release profile was achieved with coating thickness 0.06 mm. Thermal study of ketoprofen with each individual excipient at a ratio of 1:1 showed that ketoprofen has decreased in its melting endothermic characteristics with Gelucire 50/13, PVP (K30), and magnesium stearate, which was due to the lost of water (dehydration), while there were no changes in the melting point of ketoprofen with ethylcellulose and lactose. The absence of the melting endothermic characteristics of ketoprofen in the tablet indicates a strong interaction but does not necessarily of incompatibility. The FTIR studies showed that the ketoprofen functional groups were stable and did not have any interactions with any excipients in the form of physical mixture as well as in the form of tablet.
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