9 Hygeia.J.D.Med.9 (1) July 2017; 9-21 Hygeia.J.D.Med. July 2017 – December 2017 ISSN 2229 3590 Hygeia :: journal for drugs and medicines July 2017 Open Accesswww.hygeiajournal.com Research article section: Pharmaceutics A Half Yearly Scientific, International, Open Access Journal for Drugs and Medicines DOI:10.15254/H.J.D.Med.9.2017.161 Research Article OPTIMIZED TRI-LAYERED PULSATILE TABLET OF SALBUTAMOL FOR CHRONODELIVERY IN ASTHMA A. J. CHACKO*, JYOTI HARINDRAN Dept. of Pharmaceutical Sciences, RIMSR, MG University, Rubber board PO. Kottayam. 686009 Key words: Chrono therapeutics, pulsatile, salbutamol sulphate, Trilayered tablet, Box-Behnken design, optimization. Correspondence A. J. Chacko M.Pharm. Dept. of Pharmaceutical Sciences, RIMSR, MG University, Rubber board PO. Kottayam. 686009 Received: 11 January 2017, Revised: 26 February 2017 Accepted: 11 March 2017, Available online:15 July 2017 ABSTRACT Plan: The study was aimed to develop a tri-layered pulsatile tablet of salbutamol sulphate for Chrono therapeutic delivery in bronchial asthma. Incidence of asthma is greatest in the early morning hours referred as “morning dip”. 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 eudragit L. Outcome: The formulation was optimized 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 6 th and 24 th hours INTRODUCTION Chronobiology is the study of biological rhythms and their mechanisms. The term ‘‘circadian’’ was coined by Franz Halberg from the Latin circa, meaning about, and dies, meaning day. Diseases, such as hypertension, asthma, peptic ulcer, arthritis, etc, follow the body's circadian rhythm. They are naturally synchronized by the internal body clocks and are controlled by the sleep wake cycle. Each bodily system exhibits a peak time of functionality that is in accordance with these rhythmical cycles. Similarly, disease states too exhibit a peak time of activity within a circadian rhythm. Therefore the timing of drug administration in has significant impact on treatment success 1- 4 . Corresponding author email: ajchacko01@yahoo.co.in Mob: 0091 9447473432 Hygeia.J.D.Med. Vol.9 (1), July 2017 © All rights reserved Hygeia journal for drugs and medicines, 2229 3590 Rid: F-1516 -2017