In vitro Characterization of Press Coated Zafirlukast Chrono Formulation (Research Article)

Author(s): M. Swetha*, J. N. Suresh Kumar and D. Sathayavthi

Abstract: The aim of the study was to develop press coated time release tablets of Zafirlukast, to achieve the time controlled disintegrating or rupturing function with a distinct predetermined lag time and produce sustained drug delivery released to suite the chrono therapeutics of the disease i. e ,asthma. The core tablets were prepared by using compression coating technique with two novel disintegrants i.e ludiflash, lycoat in different concentrations after doing the post compression parameters analysis & drug release F12 was optimized and then coated with a PH sensitive polymers such HPMC K200M and Ethyl cellulose mixture of it respectively. Fourier transform infra-red (FTIR) spectrometry, Differential scanning calorimetry (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 C4F12 shows great ideal in pulsatile drug delivery and compared with marketed product. The release data from the formulation was found to fit in peppas model with R2 of 0.983.

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