Matrix Tablet Containing Quaternary Inclusion Complex of Domperidone for Treatment of Diabetic Gastroparesis

Objective: The present investigation is aimed at development and optimization of a pH independent controlled release matrix tablet containing mannitol based quaternary inclusion complex (QIC) of domperidone (DOM) for the treatment of diabetic gastroparesis. Methods: The tablets were prepared by direct compression and central composite design was used to optimize the amount of sodium alginate (SA) and hydroxypropylmethylcellulose (HPMC) to obtain a final formulation with desired release characteristics. The drug release from the optimized formulation was compared with the tablets containing pure DOM, binary and ternary inclusion complexes. Results and Discussion: The formulations showed a zero order release profile. The design models suggested greater influence of SA on the drug release. The optimized formulation showed minimum burst effect and released 88.65±3.19% DOM at the end of 12 h. The comparative study revealed that the optimized formulation exhibited nearly complete release of DOM. Conclusion: It was concluded that the optimized formulation containing QIC may reduce the dose frequency and improve the bioavailability of DOM.