Development of time controlled chronomodulated tablet with swelling and rupturable layers: Optimization of factors influencing lag-time and drug release.

INTRODUCTION

A tablet system consisting of cores coated with two layers of swelling and rupturable coatings was prepared and evaluated as time controlled chronomodulated tablet.

MATERIALS AND METHODS

Cores containing Montelukast sodium as model drug were prepared by direct compression and then coated sequentially with an inner swelling layer containing a HPMC E 5 and an outer rupturable layer of Eudragit RL/RS (1:1). A three-factor, two-level, full factorial design was used to investigate the influence of amount of HPMC E 5 and Eudragit RL/RS (1:1) on the responses, i.e., lag time to release and time required for 80% of drug to releases. The dissolution tests were studied using the USP paddle method at 50 rpm in 0.1 N HCL for 2 hr and than in phosphate buffer pH 6.8.

METHODS

Cores containing Montelukast sodium as model drug were prepared by direct compression and then coated sequentially with an inner swelling layer containing a HPMC E 5 and an outer rupturable layer of Eudragit RL/RS (1:1). A three-factor, two-level, full factorial design was used to investigate the influence of amount of HPMC E 5 and Eudragit RL/RS (1:1) on the responses, i.e., lag time to release and time required for 80% of drug to releases. The dissolution tests were studied using the USP paddle method at 50 rpm in 0.1 N HCL for 2 hr and than in phosphate buffer pH 6.8.

RESULT

The lag time of the drug release decreased by increasing the inner swelling layer and increased by increasing the rupturing layer level.

CONCLUSION

The results obtain from present study suggest that swelling come reputable coating approach gives desire drug release after lag time.