Design and Optimization of Domperidone Fast Dissolving Tablet Using Central Composite Design

Area of Science:

• Pharmaceutical Technology
• Formulation Development
• Drug Delivery Systems

Background:

• Fast dissolving tablets (FDTs) offer improved patient compliance and faster drug absorption.
• Domperidone is an antiemetic agent requiring efficient delivery for optimal efficacy.
• Optimizing FDT formulations necessitates careful selection of excipients and manufacturing parameters.

Purpose of the Study:

• To optimize a Domperidone fast dissolving tablet (FDT) formulation using a response surface methodology.
• To achieve FDTs with enhanced disintegration characteristics and mechanical strength.
• To evaluate the pharmacokinetic profile and antiemetic potency of the optimized Domperidone FDT.

Main Methods:

• Response surface methodology was employed to optimize FDT formulation.
• Key formulation variables included sodium bicarbonate, citric acid, and Ac-Di-Sol (superdisintegrant).
• Pharmacokinetic studies in rats and conditioned place aversion studies in mice were conducted for efficacy and bioequivalence assessment.

Main Results:

• All studied factors significantly affected the FDT formulation.
• Optimized Domperidone FDTs exhibited rapid disintegration (31.08 seconds) and adequate hardness (4.1 kg/cm²).
• Pharmacokinetic studies demonstrated bioequivalence between the optimized FDT and the market product, with comparable Tmax values (0.5 h vs 0.75 h).

Conclusions:

• The optimized Domperidone FDT formulation achieved rapid disintegration and high mechanical strength.
• The optimized FDT is bioequivalent to the marketed formulation.
• The optimized FDT demonstrated superior antiemetic potency compared to the market product in preclinical studies.