Development of diclofenac sodium orodispersible tablets using wet granulation technique

Abstract

Introduction: Orodispersible tablets (ODTs) are defined as an uncoated tablet intended to be placed in the mouth where they disperse rapidly before being swallowed.  Diclofenac sodium (DICL) is a potent nonsteroidal anti-inflammatory drug having bitter taste. The objective of this study was to develop DICL ODTs by wet granulation technique using a taste-masking polymer and a diluent. Materials and methods: Taste-masked granules containing lactose anhydrous (LT) or dibasic calcium phosphate (DP) as diluent were prepared by using Eudragit^® NE 40D as binder before mixing with blank granules and tableting.  The ODTs were evaluated for the weight variation, hardness, friability, disintegration time, wetting time, water absorption, drug content, bitterness, and in vitro release. Results: All DICL ODTs formulations were met the criteria of “uniform of weight” and “friability”.  The formulation with DP 50 mg showed high percentage of friability.  The wetting time, water absorption and disintegration time of DICL ODTs was found to increase with the amount of diluent.  The formulations using LT showed shorter wetting time but higher water absorption as compared with those using DP.  The formulations using LT showed higher dissolution profiles in buffer stage.  Conclusion: DICL ODTs could be successfully formulated by wet granulation technique using Eudragit^® NE 40D as taste-masking polymer and lactose as diluent.