Formulation and evaluation of naproxen sodium rapimelts by direct compression method

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 Rapimelt tablet of naproxen, 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 bioavailability and also reduces the dose of drug. In this study, rapimelt 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. 2%, 4% and 6% along with other excipients. The prepared tablets were evaluated for weight variation, hardness, friability, disintegration time, wetting time and dissolution rate. In the present work efforts have been made to prepare and evaluate Rapimelt tablets of Naproxen with different concentrations of superdisintegrants sodium starch glycolate, CCS and Crospovidone by direct compression technique. Release profile of F-9 having 6% Crospovidone in direct compression method was found to have maximum release of 97.56 % at the end of 30 minutes. The drug release from all batches was found to be concentration dependent. Hence the formulation of F-9 fulfills the objective of the present study. of F-12 fulfills the objective of the present study. Key-Words: Rapimelts, Naproxen sodium, Sodium starch glycolate, Crosscarmellose sodium Introduction With the increase in the average human life, drug administration for elderly patients has become more important. Due to a decline in swallowing ability with age, a great many elderly patients complain that it is difficult to take medication in the form of tablets. Recently, useful dosage forms, such as rapimet tablets or rapidly disintegrating or dissolving tablets have been developed and applied clinically. This dosage form can also improve compliance in children, as well as, for local action within oral cavity as local anesthetics for toothache, cold sore or teething product. Rapimelt tablets may also be another option in emergency. Naproxen is a non-steroidal anti-inflammatory drug (NSAID), with analgesic and antipyretic properties. Naproxen sodium is an odourless crystalline powder, white to creamy in color. It is soluble in methanol and water.. * Corresponding Author E.mail: [email protected] The basic approach used in the development of the Rapimelt tablets is the use of superdisintegrates. The main objective of this research is to study the effect of concentration of different superdisintegrants on drug release of Naproxen Sodium by direct compression method. Material and Methods Tablets containing 250 mg of Naproxen Sodium were prepared by direct compression method and the various formulae used in the study. Total nine formulations with different concentration of CCS (F1, F2, F3), SSG (F4, F5, F6) and Crospovidone (F7, F8, F9) were prepared. The drug, diluents, superdisintegrants and sweetener are passed through sieve #60.All the above ingredients were properly mixed together (in a polybag). Talc and magnesium stearate were passed through sieve #30, mixed and blended with initial mixture in a poly-bag.The powder blend was compressed in to tablets on ten station rotary punchtableting machine(Rimek mini press-1, Model RSB-4, Karnavati Engineering, Ahmedabad). The prepared tablets were evaluated for various parameters like Research Article [Jekku et al., 4(4): April, 2013] CODEN (USA): IJPLCP ISSN: 0976-7126 Int. J. of Pharm. & Life Sci. (IJPLS), Vol. 4, Issue 4: April: 2013, 2615-262