FORMULATION AND EVALUATION OF DUAL CROSS-LINKED PULSATILE BEADS FOR CHRONOTHERAPY OF RHEUMATOID ARTHRITIS

The present study was aimed at exploring the feasibility of time and pH dependent dual cross- linked pulsatile beads based drug delivery system of Lornoxicam to modulate the drug level in synchrony with the circadian rhythm of arthritis. In the present research work, the researcher had at tempted to develop novel dosage forms by using chrono pharmaceutical approach. A dual cross- linked pulsatile dosage form with 7-8 hrs lag time, taken at bedtime and start of drug release in early morning hours, can prevent the early morning stiffness and the sharp increase of pain in arthritic patients during the early morning hours and further maintenance for a longer period of time, thereby reducing the frequency of administration and hence assure patient compliance. The Pre formulation studies like pH, melting point, solubility UV-analysis and FTIR study of Lornoxicam were found to comply with of facial standards. The FTIR Spectra revealed that there was no interaction between the polymers and drug. Polymers used were compatible with Lornoxicam. Surface smoothness of the Lornoxicam beads was enhanced by increase in the polymer concentration, which was confirmed by SEM. Increase in amount of polymer increased the particle size and drug entrapment efficiency of the Lornoxicam beads. Invitro drug release of beads showed biphasic release pattern with initial minimum burst release effect, which may be attributed to the Lornoxicam loaded on to surface of the particles.

Keywords: Pulsatile release, solubility, partition coefficient, melting point, Bioavailability.