This project aims to develop a controlled release gastroretentive floating drug delivery system in the form of pellets using a polyurethane resin derivative from castor oil (RPDOM). The drugs selected to be separately incorporated into the RPDOM were domperidone and verapamil hydrochloride. Firstly, an analytical methodology for each drug will be developed in high performance thin layer chromatography (HPTLC), allowing the quantification of these in the formulations containing the RPDOM and in the dissolution assays. The pellets' cores will be the matrix release (drug/resin) that will be coated by two layers: an effervescent inner and a gas-entrapped polymeric membrane outer. The definition of the release matrix (core) and each pellet's layers will follow through an experimental design of factorial type and, as responses, the dissolution profiles, the physical properties of the pellets, the lag time and the floating time will be evaluated carrying out variance analysis and response surface methodology for selecting the most suitable formulations. Finally an accelerated stability study of the best formulations of each drug (elected after statistical analysis of the results) will be performed at 30 ± 2 °C and humidity of 75 ± 5% in a climatic chamber in order to be possible to evaluate its capability in maintaining, without significant changes, its dissolution profiles and physicochemical characteristics.
News published in Agência FAPESP Newsletter about the scholarship: