PREPARATION AND CHARACTERIZATION OF ATENOLOL-β-CYCLODEXTRIN ORALLY DISINTEGRATING TABLETSAbstract
Atenolol is a hypertension drug that has a low solubility characteristic in water and gastric fluid. The rate of absorption of the drug with poor solubility characteristics is determined by the dissolution process. In this study, an attempt has been conducted to increase the dissolution of atenolol by increasing its solubility. The solubility of atenolol has been enhanced by the inclusion complex using β-cyclodextrin made by several methods (physical mixing, kneading, and solvent evaporation). Evaluation and characterization of atenolol-β-cyclodextrin inclusion complex consist of drug content, dissolution test, Fourier Transformed Infrared analysis (FT-IR), Differential Scanning Calorimetry (DSC), X-ray Diffraction (XRD) and Scanning Electron Microscope (SEM). The results of the drug content analysis, dissolution test, and characterization showed that atenolol- β-cyclodextrin inclusion complex, which has been made by the solvent evaporation method was the best approach. Therefore, a solvent evaporation method was chosen to formulate orally disintegrating tablets of atenolol-β-cyclodextrin using direct compression technique. Orally disintegrating tablets of atenolol-β-cyclodextrin were prepared using crospovidone as disintegrant. The results of pre-compression test and the post-compression test revealed that orally disintegrating tablets of atenolol-β-cyclodextrin inclusion complex disintegrate within 8.17 ± 0.41 sec. In-vitro dispersion time in simulated saliva was found to be 45.33 ± 0.58 sec and the percentage of atenolol dissolved from this formula was 92.22% in 30 min. Hence, this formula shows good physicochemical characteristics and fulfill pharmaceutical quality requirements of orally disintegrating tablet.
K. C. Rani *, N. Parfati and Stephanie
Department of Pharmaceutics, Faculty of Pharmacy, University of Surabaya, Surabaya, East Java, Indonesia.
08 April 2019
23 August 2019
24 December 2019
01 January 2020