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Influence of Pore-Former on Drug Release from Ethyl Cellulose Film Coated Mini-Tablets
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UPLOADED BY-ADMIN, N. G. RAGHAVENDRA RAO, MOHD ABDUL HADI
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| Abstract:
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Montelukast sodium is used in the treatment of chronic asthma, and to relieve symptoms of seasonal allergies. Montelukast sodium biological half-life is 2.5 to 5.5 h, thereby decreasing bioavailability up to 64%. In the present study, we have designed mini-tablets-in-capsule systems. The system comprises of immediate and sustained release mini-tablets filled in HPMC capsule. In this study the addition of hydrophilic pore-former HPMC, to an ethyl cellulose film coating applied in an ethanol: water (9:1) was studied. The effect of pore-former on drug release was studied. The prepared mini-tablets were subjected for pre and post-compressional parameters. The compatibility of drug with other ingredients was checked by FTIR and DSC studies. FTIR and DSC results were revealing that there was no interaction between dug and excipients. The values of pre-compression parameters evaluated were within prescribed limits and indicated good free flowing property. All the post-compressional parameter are evaluated were prescribed limits and results were within IP limits. The core mini-tablet of immediate release mini-tablets was found to disintegrate within 18 min. The in-vitro performance of our best mini-tablets-in-capsule systems showed the desired behavior, 24.56 % of montelukast sodium release was released in 1hr as an immediate-release phase and 94.69% of montelukast sodium was sustained for a period of 24 h. Dissolution rate increased with increasing concentration of pore-former. Stability study carried out as per ICH guidelines results revealed that the formulations were found to be stable. From this study, it can be concluded that the utility of HPMC as a pore-former in modulating drug release from organically applied ethyl cellulose film coatings.
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Pore-former, mini-tablets-in-capsule system, montelukast sodium, sustained release mini-tablets, immediate-release mini-tablets.
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