Abstract

DEVELOPMENT AND CHARACTERIZATION OF DOMPERIDONE MALEATE ORAL DISSOLVING FILMS: INFLUENCE OF POLYMER CONCENTRATION ON IN-VITRO DRUG RELEASE

Dharma Prasad Khanal*, Dhiraj Chaudhary*, Deepti Piya Baniya, Sabin Shrestha, Akhilesh Kumar Shah, Prem Paudyal

ABSTRACT

Background: The oral mucosa serves as an effective and selective site for systemic drug delivery due to its high permeability and large surface area, facilitating rapid absorption. Additionally, this route avoids the pain associated with injections and allows administration without the need for water, enhancing patient compliance. Domperidone, an antiemetic drug classified under Biopharmaceutics Classification System [BCS] Class-II, has low solubility and high permeability. Mouth-dissolving dosage forms are particularly beneficial for patients with dysphagia, the elderly, paediatric patients, and those undergoing anticancer therapy. Objectives: The primary objective of this study was to formulate and evaluate a mouth-dissolving film of Domperidone Maleate and investigate the effect of varying polymer concentrations on drug release characteristics. Methods: Mouth-dissolving films of Domperidone Maleate were prepared using the solvent casting method. Ingredients included Polyvinyl Alcohol (PVA), Glycerine, Aspartame, Vanilla flavour, Citric Acid, Cross povidone, Distilled Water, and Ethanol. The prepared films were evaluated for various physicochemical parameters, including thickness, weight variation, drug content uniformity, percentage elongation, folding endurance, surface pH, disintegration time, and in vitro drug release. Results: All physical parameters such as appearance, weight variation, thickness, disintegration time, pH, percentage elongation, and folding endurance were found within acceptable limits for all five batches. Drug content was also consistent across the batches. Among them, Batch DC-001 demonstrated the most promising results, showing rapid drug release within 2 minutes, with 91.27% to 99.78% of the drug released within 10 minutes. Conclusion: The concentration of polymer had a significant impact on drug release. Higher polymer concentrations retarded the release rate, whereas lower concentrations facilitated faster drug release. Additionally, polymer concentration influenced other film properties, including weight, thickness, folding endurance, and disintegration time.

Keywords: Formulation, Mouth Dissolving, Domperidone, Polymer, Drug Delivery.