Abstract
FORMULATION AND EVALUATION OF MOUTH DISSOLVING FILM LOADED WITH ANTIEPILEPTIC DRUG DIVALPROEX SODIUM
Ashish Mishra* and Anjana Bhardwaj
ABSTRACT
The main objective of the present work was to formulate mouth dissolving films containing divalproex to attain its maximum drug release with a very short time and also to have an easy and compliant administration of the drug through oral route. Xantham gum was used as polymer for the preparation of the films. It was able to provide adequate thickness to the films and PEG-400 used as the plasticizer was able to impart excellent flexibility to the films. The folding endurance was used as the index of flexibility of the films. All the formulated batches exhibited quick drug release, rapid disintegration and optimal mechanical strength. The formulations neither exhibited much loss nor much uptake of moisture as observed from the results of the study. The folding endurance was found to increase with increasing concentration of the plasticizer whereas thickness was found to be related to the amount of the polymer in the formulation. The amount of drug loaded in the films was independent of the polymer concentration though it was found that level 0 of the variable X1, the drug uptake by the polymeric matrix was slightly lower. All the formulations had drug content of more than 90% with the highest content in formulation DF4 (96.7±4.42%) and the lowest in DF5 (90.8±7.26%). The disintegration time of all the formulations was less than 40 seconds suggesting that all the batches of the films were quick dissolving and would be able to release the drug, rapidly. All the formulations were found to disintegrate in less than 40 seconds thereby paving the way for quick release of divalproex from the films. The ratio of polymer content and plasticizer was found to have no significant role in the disintegration time of the films.
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