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Formulation and Evaluation of Zolpidem Tartrate mouth dissolving Films

Zolpidem tartrate is a nonbenzodiazepine hypnotic drug, an agonist of GABA receptors. The present work was aimed to formulate and evaluate the mouth dissolving films of Zolpidem tartrate. Films of Zolpidem were formulated to enhance absorption of drug, which provide quick onset of action of drug. The mouth dissolving films were prepared by solvent casting method using gelatin as a film forming agent. Gelatin is a hydrophilic polymer, easily soluble in water, and has excellent carrier capacity for delivering the drug. Drug and excipients compatibility study was evaluated by FTIR study. In the present study, propylene glycol and tween-80 was used as plasticizer and surfactant respectively. Sucrose, aspartame, flavours, citric acid and menthol were used for taste masking of bitter taste of Zolpidem tartrate. The FTIR studies revealed that no chemical interaction present between excipients and drug. The results of Film evaluation parameters were match with expected criteria. All the formulation films have good mechanical strength, thickness (0.81mm), 99% drug uniformity and pH of film resemble with the pH of saliva. In less than 30 seconds film start to dissolve and in less than 5 min 100 % drug release.

Author(s): Bhingare. C. L Patidar M. K. Karjikar F. A. Patel F. A Sumbe R. B.

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