DEVELOPMENT AND EVALUATION OF CHRONOMODULATED PULSINCAP DRUG DELIVERY SYSTEM OF KETOPROFENAbstract
Chronotherapeutic drug delivery systems have been recognized as potentially beneficial to the chrono-therapy (time optimized) of chronic diseases that display time-dependent symptoms. In pulsincap system, therapy can be optimized by tailoring the dosing schedule based on chrono-biological pattern. The safety and efficacy of the drug is achieved by coordinating the peak plasma concentration with circadian rhythm. People with rheumatoid arthritis, usually experience peak pain in the morning. The absorption kinetics of conventional dosage forms that have night time dosing indication is inadequate in the morning, when the need is more. Ketoprofen is a potent NSAID used to treat RA. In the present study, a modified pulsincap of Ketoprofen was developed and evaluated. Hard gelatine capsule bodies were treated with formaldehyde and are filled with best formulations of solid dispersion (β-cyclodextrin) for burst release and microsponge (ethyl cellulose) for sustained release after specific lag time attained by hydrogel plug. The filled capsules were completely coated with 5% CAP to prevent variable gastric emptying. The results indicated that formulated pulsincap of Ketoprofen with solid dispersion, microsponge and HPMC plug administered after meals at 9 pm starts releasing drug after about 7 hrs and provides sufficient plasma concentration in the early morning and thereafter sustain the release from microsponge for more than 24 hrs.