Development and evaluation of prolonged release ketoprofen tablets
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Date
2006
Authors
Masoud Eid, Ahmad Mustafa
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Abstract
A prolonged release system was developed using film coating as drug release
controlling system and ketoprofen as model drug. The drug was prepared in
tablets containing 15% Gelucire 50/13 as matrix forming material, and then the
tablets were film coated with ethylcellulose (300cps). The results of physical
tests for the formulations and the coating materials were satisfactory. 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 1 00 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.
The rate of drug release was stable for the first six months of ageing at room
temperature 25°C, but the release was slightly decreased in the next six months
of ageing. The rate of drug release was essentially independent of the curing
effect.
Thermal study of ketoprofen with each individual excipient at a ratio of 1:1
showed that ketoprofen decreased in its melting endothermic characteristics
with Gelucire 50/13, PVP (K30) and magnesium stearate, which was due to the
loss of water (dehydration), while there was 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 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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Keywords
Prolonged , Ketoprofen tablets