Preparation and evaluation of Ketoprofen beads by melt solidification technique

Ketoprofen exhibits short half-life, poor compressibility, caking tendency, gastrointestinal irritation & ulcerogenic effect. Hence, it is desirable to formulate into sustained release dosage form. Amongst different techniques, melt solidification technique is the recently developed technique used to produce sustained release dosage form. Ketoprofen beads were prepared by employing melt solidification technique with lower amount of excipient like cetyl alcohol. This technique involved emulsification and solidification of Ketoprofen-cetyl alcohol melt in an aqueous system followed by cooling and stirring. Cetyl alcohol being a wax, has ability to retard the drug release and acts as emulsifier. Hence, this technique was used to retard release of drug from waxy beads. Amount of Cetyl alcohol used was variable. The Ketoprofen beads were evaluated by DSC, FT-IR, XRD and SEM. Micromeritic and dissolution behavior studies were carried out. Beads exhibited decreased crystallinity and improved micromeritic properties. Release kinetics was studied in simulated gastric fluid and simulated intestinal fluid. No interaction was observed between drug and excipient. Beads obtained were spherical in shape and the yield was about 87%. XRD data were analyzed using Multidimensional minimization Programme, X- ray diffractogramms of drug and beads have shown no significant difference in the inter planar distance (d) values. Crystals of drug and beads were found to be of monoclinic. Drug release from the beads was by diffusion and followed first order kinetics. The study suggests that the Ketoprofen bead prepared by melt solidification technique is a novel approach to formulate sustained release dosage form.

Author(s): P. K. Kulkarni, Mudit Dixit, Yerur S Kumar, Ashwini G Kini and Akash Johri

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