FORMULATION AND EVALUATION OF MOUTH DISSOLVING FILM OF ZOLMITRIPTAN BY USING NATURAL POLYMERS
Shubhangi Daswadkar and Shivani B. Sontakke Patil*
ABSTRACT
Zolmitriptan is a BCS class III generation antimigraine drug that is used for the treatment of migraine and has low metabolism and permeability. This drug also undergoes first-pass metabolism. To overcome all these problems mouth dissolving films were prepared which helps to improve the bioavailability of drugs. Mouth films dissolve fastly along with drugs and mostly all the drug absorbs through oral mucosa in the systemic circulation. Mouth films were prepared by the solvent casting method. Various issues related to drug release and side effects of synthetic polymers, formulating mouth dissolving films of Zolmitriptan utilizing natural polymers was beneficial and effective, and it’s the main aim of present work.
Polymer concentration, Glycerol, and type of polymer i.e. maize starch, pectin and guar gum were optimized by using central composite 3 factors, 2 level design based on drug release, and folding endurance of films. A total of 39 batches were prepared from which batch containing 50% pectin and 20% glycerol, was found to be best with desirability 0.998. Oral films of the optimized batch show 27±2 no. of folds and show 98.12±0.1% drug release. The optimized film was further evaluated for drug content uniformity, physical appearance, solubility, stability, disintegration and dissolution study.
Keywords: Mouth dissolving films, Bioavailability, Zolmitriptan, Natural polymers.
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