Abstract

DESIGN, DEVELOPMENT AND OPTIMIZATION OF ORODISPERSIBLE TABLETS OF RABEPRAZOLE SODIUM BY DIRECT COMPRESSION METHOD USING DIFFERENT CONCENTRATIONS OF SYNTHETIC SUPER-DISINTEGRANTS

Musharraf Abbas Bhatti*, Muhammad Afzal, Muhammad Abbas Bhatti and Fatima Tariq

ABSTRACT

Improved bioavailability, rapid onset of action due to rapid systemic absorption and enhanced patient compliance in patients suffering from certain diseases such as peptic/duodenal ulcer, gastro-esophageal reflux disease, ulcers induced by NSAIDs or Zollinger-Ellison syndrome has increased the demand of orodispersible tablets. In the present study, orordispersible tablets of Rabeprazole sodium has been prepared by using direct compression method, in which different concentration of synthetic super-disintegrants such as croscarmellose sodium, crospovidone and sodium starch glycolate ranging from 2% to 7% has been used to formulate such dosage form with rapid disintegration and improved dissolution in order to increase bioavailability. In this study, nine formulations has been prepared and evaluated by different physicochemical parameters such as pre-formulation studies such as compatibility studies by using Fourier transform Infra-redspectroscopy, Differential scanning calorimetry analysis, thermo-gravimetric analysis were used to determine degree of crystallinity of the drug, pre-compression evaluation of powder blend such as Angle of repose, Bulk density, Tapped density, Carr’s index and Hausner’s ratio were carried out to determine the flow properties. After the formulation of tablets, post-compression studies were carried out for the evaluation of orodispersible tablets including the evaluation of hardness, thickness, diameter, friability, weight variation, content uniformity and stability studies. It is concluded that all the formulations have a disintegration time within official limits, but formulation T6 was an optimized dosage form having average disintegration time of 1.6 seconds that releases upto 102.15% drug in 15minutes.

Keywords: Orodispersible tablets, super-disintegrants, croscarmellose sodium, crospovidone, sodium starch glycolate, Carr’s index.