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FORMULATION DEVELOPNENT AND EVALUATION OF NADOLOL ORAL FAST DISSOLVING FILMS

Sk. Althaf, B. Valli Manalan, P. Prachet, N. Rama Rao

The main goal in the development of any drug formulation is to achieve the complete drug release within the time or prior to it. Most of the drug delivery systems are successful because of their safety, most convenient and most economical drug delivery with highest patient compliance. In this a very thin oral strap consisting of drug disintegrates very fastly in the mouth and releases the drug into circulation the oral cavity therefore absorbed into the systemic. The aim of the present study is to formulate the oral fast dissolving films of Nadolol using HPMC K4M and HPMC E50 as film forming polymers, Propylene glycol as a plasticizer, Tween 80 as a surfactant, and Sodium saccharin as a sweetening agent. Nadolol with the other ingredients is dispersed in the polymer solution and films are prepared by solvent casting method. The prepared films were found to satisfy the mouth dissolving time and other film parameters like thickness, folding endurance, weight uniformity, surface pH, tensile strength and drug content. 2 x 2 cm of film is required to be placed on to patient tongue whereby film instantly gets wet by saliva, rapidly hydrates, adheres to tongue, rapidly disintegrates and dissolves to release the drug. Time required for the film to dissolve and release the drug is 26 seconds and 2 minutes respectively. From this, it can be concluded that the ‘Oral-flash’ release films can be regarded as a potential novel drug delivery system for poorly water soluble drugs. Keywords: Fast dissolving drug delivery, fast dissolving oral films (FDOFs), oral thin film (OTF), oral–flash release films, Nadolol , HPMC K4M, solvent casting method, poorly water soluble drugs.

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