Formulation Development and Optimization of Oral Thin Films of Zolpidem Tartarate

Abstract

The aim of the present study was to formulate and evaluate oral thin films of zolpidem tartarate. Zolpidem tartarateis used to treat insomnia. It affects chemicals in your brain that may become unbalanced and cause sleep problems (insomnia). Zolpidem tartarate oral thin films were prepared by using solvent casting method. In this method, water soluble polymer is completely dissolved in to form uniform clear viscous solution other ingredients including API are dissolved in a small portion of aqueous solvent by using a high shear processor. This viscous solution is degassed under the vacuum to remove the air bubbles. This bubble free solution is poured into a glass mold and kept in oven at 40 º-50ºC. Oral disintegrating films are prepared using three grades of polymers HPMC E5, GUAR GUM and SODIUM ALGINATE Compatibility of Zolpidem tartarate with polymers was confirmed by FT-IR studies. All the formulations were evaluated for their physical appearance, average weight and thickness, folding endurance, disintegration time, tensile strength, percentage elongation, drug content, content uniformity and in vitro drug dissolution studies. From the result, it was concluded that the fast dissolving films of Zolpidem tartarate can be made by solvent casting technique with enhanced dissolution rate and taste masking by using suitable combination of sweeteners, flavors and citric acid. The final composition optimized was drug to Guar Gum ratio of 1:1, plasticizer concentration of 15% w/w of polymer. The film had acceptable physical properties, assay and uniformity values and in vitro dissolution within 2 minutes.