FORMULATION AND EVALUATION OF ORAL FAST DISSOLVING FILMS OF NAPROXEN SODIUM

Abstract

Objective: The aim of this investigation was to prepare ODFs containing Naproxen Sodium, an NSAID, using solvent casting method and to evaluate them to put together a dosage form which can be taken without water, is easy to administer, has a rapid onset of action and can surmount first pass metabolism. Six distinct formulations of naproxen sodium ODF (F1-F6) were created in this investigation by varying the quantity of croscarmellose sodium, a super disintegrant.
 Methods: Naproxen Sodium ODF’s were prepared by solvent casting method. Evaluation of prepared ODF’s was done by considering various parameters such as film thickness, folding endurance, disintegration time, surface pH, weight variation, in vitro dissolution test, content uniformity and FTIR.
 Results: F6 has shown to be the best fast release formulation in terms of disintegration time (less than 1 minute) and dissolution (103.5 % after 30 min). Formulation F6's other film characteristics, such as weight variation, thickness, pH, and folding endurance, were all within the USP limit.
 Conclusion: By virtue of quick disintegration self-administration without water or chewing, oral fast dissolving film (OFDF) is one such new technique to enhance consumer acceptance. The film is an excellent intraoral fast-dissolving medication delivery method by which a wide range of medicines, including neuroleptics, cardiovascular drugs, analgesics, anti-asthmatic, antihistamines and drugs for erectile dysfunction, can be manufactured. From the standpoint of the patient, oromucosal medication delivery is appealing since it allows for easy administration without the need to swallow, as well as better patient safety. As a novel delivery mechanism, the notion of a quick-dissolving dosage form has gained popularity. By lowering dose frequency, this method will deliver optimum therapeutic efficacy, improved bioavailability, and maximum stability. This will also surmount first-pass metabolism of drugs. This method allows for faster medication absorption from the pre-gastric region, perhaps resulting in a faster onset of action.