Formulation and Evaluation of Taste-Masked Orally Disintegrating Tablets of Nicergoline based on β-cyclodextrin Inclusion Complexation

C omplexation of nicergoline with β-cyclodextrin (β-CD) into an inclusion complex has been used successfully to improve the drug’s solubility, dissolution rate and hence per oral absorption. In addition, masking of the bitter taste was also achieved . The preparation of inclusion complexes was performed using two different techniques, namely; physical mixing and kneading. The apparent stability constant (K c ) of the complex was calculated from the phase solubility analysis. Compatibility of nicergoline and β-CD complex with disintegrants and superdisintegrants were evaluated using powder x-ray diffractometry (PXRD), differential scanning calorimetry (DSC), and fourier transform infrared spectroscopy (FTIR). The morphology of complex particles was studied using scanning electron microscopy . Pharmaceutical characterization confirmed that all additives were compatible with the drug and no signs of physical or chemical interaction were detected. O rodispersible tablets (ODTs) of nicergoline complexed with β-CD and containing 7-9 % camphor had rapid disintegration time (7-12 seconds) and fast drug release profiles (90-100 % in 10 minutes). Therefore, nicergoline ODTs are considered a valuable choice dosage form with improved per oral absorption and taste acceptability.