Abstract

FORMULATION AND IN VITRO EVALUATION OF PULSATILE DRUG DELIVERY SYSTEM OF MONTELUKAST SODIUM BY PRESS COATED TABLETS USING NATURAL POLYSACCHARIDES

*Nagandla Samyuktha Soni, Dr. H.Padmalatha and A.Swapna

Abstract

The aim of the study was to develop press coated time release tablets of montelukast, to achieve the time controlled disintegrating or rupturing function with a distinct predetermined lag time and produce sustained drug delivery released to suite the chronotherapeutics of the disease i.e., bronchial asthma. The tablets, each consisting of a core and a coat, were prepared using compression coating technique. The core tablet was then coated with a natural polymers such sodium alginate, guar gum and mixture of it respectively. Fourier transform infra-red (FTIR) spectrometry, differential scanning colorimetry (DSC), were applied to investigate the drug-excipients compatibility of the formulation and the studies revealed no chemical interactions between drug and polymers used.Stability studies also were performed for 3 months at 40ºC and 55ºC at 75% RH as per ICH guidelines for optimized formulation and it was found to be stable. The effect of formulation composition on the barrier layer comprising both polymers, excipients on the lag time of drug release was investigated. It was observed that when compared with all other formulations developed, formulation P5F2 shows great ideal in pulsatile drug delivery. The release data from the formulation was found to fit in peppas model with R2 of 0.938.

Keywords: Press-coated tablet, lag time, Diffusion, pulsatile drug delivery, bronchospasm, Erosion.