Development, Feasibility Assessment and in-vitro Evaluation of Diclofenac Potassium Multilayered Tablets

Abstract

Introduction: Diclofenac potassium has widely been utilized as an analgesic and anti-inflammatory agent. To achieve rapid onset of action with prolonged therapeutic action is an immense need of time. In present project a study was conducted on preparation with physicochemical determination of diclofenac potassium tablets, this unique tablet have duel characteristics like rapid onset of action due to orodispersible coat and extended release of API due to sustained release core. Methodology: As diclofenac potassium is not sensitive to water so wet granulation method was efficiently employed to prepare the granules of sustained release core, while direct compression was done to prepare orodispersible outer coat layer in order to give rapid release. Results and Discussion: In evaluations granules characteristics and tablet properties were studied.  Result of both pre compression and post compression studies were coming in pharmacopeia acceptable ranges. The orodispersible layer disintegrated with in 18sec, which  gives sufficient amount of API as loading dose, in order to maintain the plasma drug concentration in therapeutic range the core will release drug in sustained manner within 10 hours in gastrointestinal tract (GIT) fluid (pH 6.8). The results of kinetic models were complying with Higuchi model. Conclusion: In present work, a rapid release outer dispersible layer of drug was constructed on a sustained release core. Results of study gives expected outcomes to maintained initial concentration of drug which persist for long time. The combination of sodium starch glycolate, dry starch, and cross povidone exhibited promising super disintegrant efficiency while Hydroxypropylmethyl cellulose K15 showed excellent sustained release properties.