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Microcapsule-based chronomodulated drug delivery systems of montelukast sodium in the treatment of nocturnal asthma

Background: Asthma is a chronic disease characterized by repeated attacks of breathlessness and wheezing, which occurs principally during night. This is due to circadian changes in ventilation and airway responsiveness. Hence, the chronomodulated therapy is more considering in the treatment of nocturnal asthma. Objective: The objective of the study was to prepare microcapsule-based chronomodulated drug delivery system of montelukast sodium (MLS) for the treatment of nocturnal asthma. Materials and Methods: Five batches of MLS microcapsules were prepared using pH-dependent polymer combination of Eudragit® S-100 with L-100. The optimized batch microcapsules were enclosed in a capsule to obtain chronomodulated pulsincap systems (CMPSs). In this system, natural gums were used as hydrogel plugs to achieve the required time lag. Microcapsules and CMPSs have been evaluated for their characteristic properties. Results: The developed microcapsules are spherical in shape with smooth surfaces. In vitro release studies predicted that M4 and M5 batches could control the drug release for a period of 12 h. The optimized batch microcapsules (M4) were used in the preparation of CMPSs. The natural hydrogel plugs, i.e. xanthan gum, gum kondagogu, and guargum used in CMPSs showed approximate lag phase of 5, 6, and 5.5 h and drug releases up to 16, 24, and 24 h, respectively. Conclusion: CMPSs containing Eudragit® microcapsules of MLS with programmable lag phase and prolonged drug release were successfully developed using natural gums as hydrogel plugs, which congregates the demands of chronomodulated therapy in asthma.