Raft-forming system for pantoprazole and domperidone delivery: in vitro and in vivo study

Abstract

The raft is an emerging drug delivery system that not only provides rapid relief from reflux disorders, but also sustains drug release. The objective of this work was to develop and characterize raft-forming bilayer tablets in which pantoprazole sodium sesquihydrate (PSS) was targeted at sustained release and domperidone maleate (DM) was used to obtain an immediate-release effect and perform pharmacokinetic studies. Tablets were prepared using the wet granulation method. Rafts were characterized in terms of strength, weight, volume, resilience, acid-neutralizing capacity, floating lag time and total floating time. Dissolution studies were performed using simulated gastric fluid with pH 1·2. Compatibility were performed by Fourier transform infrared spectroscopy (FTIR), X-ray diffraction and differential scanning calorimetry (DSC). Percentage release of the optimized R7 formulation was 94% for PSS and 98% for DM. First-order release kinetics were followed and a non-Fickian diffusion was observed; the value of n was greater than 0·7 in the Korsmeyer–Peppas model. FTIR and DSC studies showed chemical and thermal stability between the drug and polymers. C max values of the test and reference formulations of PSS were 46·080 ± 0·567, 46·350 ± 0·507 and DM were 14·090 ± 1·678 and 10·560 ± 1·098 μg/ml, respectively.