Formulation Development and Evaluation of Sustained Release Rectal Suppository of Domperidone Maleate

Abstract

The aim of present research was formulation development and evaluation of sustained release rectal suppository of domperidone maleate. By using Hot fusion method in that combination of PEG 4000 and poloxamer 188 was used as polymer and HPMC K4M was used for sustained released effect and surfactant was utilized for increasing bioavailability. The formulation was optimized based on Design expert software and Central Composite Design was used for study. Fourier transform infrared spectroscopy (FTIR) and differential scanning calorimetry (DSC) were performed to check any interaction between drug and excipients. The hardness, weight variation, friability, micro melting range test, disintegration time, dissolution studies and uniformity content of formulated batches were evaluated. All the results were within the acceptable pharmacopeial limits and were evaluated statistically by using one way ANOVA test for quadratic model. From the result, S7 batch was observed optimized formulation because upto 8 hrs 90.82% drug was released. kinetic studies of the drug release for optimized formulation follows zero order kinetics. This study was concluded that rectal route was more beneficial than oral route because it avoids first pass metabolism and enhance bioavailability of Domperidone maleate. The prepared Domperidone maleate suppository will be used for emesis caused due to chemotherapy in cancer patient and effective in the treatment of nausea and vomiting induced by drugs, migration and radiation sickness.