Objective: The objective of this research work was to develop and evaluate the floating– pulsatile drug delivery system
(FPDDS) of meloxicam intended for Chrono pharmacotherapy of rheumatoid arthritis. Methods: The system consisting
of drug containing core, coated with hydrophilic erodible polymer, which is responsible for a lag phase for pulsatile
release, top cover buoyant layer was prepared with HPMC K4M and sodium bicarbonate, provides buoyancy to increase
retention of the oral dosage form in the stomach. Meloxicam is a COX-2 inhibitor used to treat joint diseases such as
osteoarthritis and rheumatoid arthritis. For rheumatoid arthritis Chrono pharmacotherapy has been recommended to
ensure that the highest blood levels of the drug coincide with peak pain and stiffness. Result and discussion: The
prepared tablets were characterized and found to exhibit satisfactory physico-chemical characteristics. Hence, the main
objective of present work is to formulate FPDDS of meloxicam in order to achieve drug release after pre-determined lag
phase. Developed formulations were evaluated for in vitro drug release studies, water uptake and erosion studies, floating
behaviour and in vivo radiology studies. Results showed that a certain lag time before drug release which was due to the
erosion of the hydrophilic erodible polymer. The lag time clearly depends on the type and amount of hydrophilic
polymer which was applied on the inner cores. Floating time and floating lag time was controlled by quantity and
composition of buoyant layer. In vivo radiology studies point out the capability of the system of longer residence time of
the tablets in the gastric region and releasing the drug after a programmed lag time. Conclusion: The optimized
formulation of the developed system provided a lag phase while showing the gastroretension followed by pulsatile drug
release that would be beneficial for chronotherapy of rheumatoid arthritis and osteoarthritis.
In vivo
evaluation of a novel pH- and time-based multiunit colonic drug delivery system
