Abstract :
Plan: The study was aimed to develop a tri-layered pulsatile tablet of salbutamol sulphate for Chronotherapeutic delivery in bronchial asthma. The incidence of asthma is greatest in the early morning hours referred as “morning dipâ€.
Preface: A formulation which could deliver the drug in the right concentration just prior to the attack could effectively control the condition and staining drug release thereafter will further enable the dosage as once a day unit.
Methodology: This formulation consists of three layers with the first layer for sustain release and the second for the burst release after a predetermined lag time and the third layer determines the lag time. A novel two-stage coating was employed to achieve the burst followed by sustained release.The bottom and the sides of the tablets were coated with an insoluble polymer, ethyl cellulose which acted as a cage for the dosage form all sides except the top. The caged unit was finally dip coated with pH sensitive polymer eudragitL.
Outcome: The formulation was optimised by Box-Behnken design and the composition suggested by the design expert successfully achieved the lag time of 5 hrs and cumulative drug release of 32% and 95% respectively at 6th and 24thhours
Keyword :
Chronotherapeutics, pulsatile, salbutamol sulphate, Trilayered tablet, Box-Behnken design, optimisation.