Development and Validation of a Discriminatory Dissolution Testing Method for Orally Disintegrating Tablets (ODTs) of Domperidone

The orally disintegrating tablet (ODT) is a novel dosage form that disintegrates in the oral cavity using saliva as the disintegrating medium and is swallowed as a fine dispersion. Due to rapid disintegration, the dissolution rate is controlled by the intrinsic solubility of the API; therefore, it is difficult to evaluate the effect of formulation and processing parameters on in vitro drug release. Thus, a dissolution method that can discriminate among in vitro release profiles of ODTs with varying natures is needed. The objective of the present study was to develop and validate a discriminative dissolution testing method for ODTs of domperidone. Different experimental conditions such as dissolution medium composition, dissolution medium volume, and paddle rotation speed were evaluated. Analysis of dissolution samples was carried out by HPLC using a combination of water at pH 3 and acetonitrile (65:35 v/v) as the mobile phase. The developed dissolution method was validated according to ICH guidelines for various parameters such as specificity, accuracy, precision, and stability. The discriminatory nature of the method was confirmed by determining the dissolution rate of ODTs containing pulverized and unpulverized domperidone. The best in vitro dissolution profile was obtained using purified water containing 1% Tween 80 as the dissolution medium (900 mL) stirred at 50 rpm. Complete dissolution (100.09 ± 0.37%) was achieved within 60 min, and the dissolution medium did not interfere with sample analysis. All the validation parameters were in an acceptable range (RSD > 2%). A comparison of the dissolution profiles in official and developed media showed significant differences based on f1 and f2 values. The developed dissolution test exhibited a higher capacity than the compendial methods in differentiating the release profiles of ODTs. It can be applied during formulation development and quality control analysis of ODTs for evaluation of the effects of formulation and processing parameters.