Formulation and Evaluation of Orodispersible Tablet of Naproxen Sodium

Naproxen sodium is an analgesic NSAID (non steroidal anti inflammatory drug) used for the treatment of pain, inflammation, fever and stiffness caused by conditions such as osteoarthritis, rheumatoid arthritis, juvenile arthritis, gout, migraine and dysmenorrhea. However, the gastric discomfort caused by drug results in poor patient compliance associated with its conventional dosage forms. Hence the present investigation was undertaken with a view to develop orodispersible tablet of naproxen sodium, which offers quick onset of action of drug and minimizes the problem of gastric discomfort associated with it. Thus improves patient compliance, generates rapid response, enhances bio-availability and also reduces the dose of drug. In this study, orodispersible tablets were prepared by direct compression method using three different superdisintegrants e.g. sodium starch glycolate, croscarmellose sodium and crospovidone in three different concentrations e.g. 3%, 5% and 7% along with other excipients. The tablets were evaluated and the results compared for all three superdisintegrants revealed crosspovidone to be the most efficacious superdisintegrant to formulate orodispersible tablet of naproxen sodium as suggested by the dispersion time, disintegration time and drug dissolution profiles. INTRODUCTION: Oral drug delivery is the most widely accepted route of administration. But conventional oral dosage forms like tablet and capsule bear certain drawbacks such as difficulty in swallowing to pediatric and geriatric patients, need of water for ingestion, adverse interaction of drug with GIT (like gastric degradation, first pass hepatic metabolism of drug), slower onset of action of drug and inconvenience to patients suffering from nausea and vomiting. So as to overwhelm these loopholes of conventional oral dosage forms there is a need of an alternative delivery system that can be an orodispersible tablet (ODT). An ODT is a solid unit pharmaceutical dosage form that contains medicinal substances and disintegrates rapidly (within seconds) without water when placed on the tongue. It dissolves rapidly in mouth to provide quick onset of action of drug and overcomes the problems of swallowing. There is no risk of obstruction of this dosage form, which is beneficial to travelling patients who do not have access to water. Pregastric absorption of drugs through ODT avoids first pass hepatic metabolism and gastric degradation, which reduces the dose and increase the bioavailability. Thus, ODT enhances safety and efficacy of drug molecule by being a convenient and more patient compliant dosage form 1, 2, .