Optimization of pulsatile compression coated floated tablets of tramadol HCL for chronopharmacotherapy of Rheumatoid Arthritic pain using 2³ factorial design

Objective: The main aim of study is to develop modified oral compression coated floated tablets for pulsatile delayed release of Tramadol HCL by applying design of experiments (DOE). Pulsatile release systems are generally formulated to undergo a lag-time of predetermined span of time of no release, followed by a rapid and complete release of loaded drugs. Methods: These systems consist of three steps in formulation. In the first step burst release core tablets of Tramadol HCL were prepared with superdisintegrants such as Cross Povidone, Sodium Starch Glycolate and Cross Carmellose Sodium. In second step, these core tablets were compression coated with polymers HPMC K4M, HPMC K15M, Ispaghula gum and Tamarindus gum to assign suitable lag time to formulation. In third step, top buoyant layer was compressed using suitable polymers such as HPMC K100M, Ispaghula gum and their combination. Results: In the preliminary two steps, immediate release core tablets were optimized with formulation CF2 which contains sodium starch Glycolate 8% as immediate release agent. Then in compression coated formulation CCF8 was optimized. Among complete coated floated formulation BF4 and BF8 shows significant lag time of 5hr and drug release for a period of 12 hrs. Conclusion: A modified oral compression coated floated tablets for pulsatile delayed release of Tramadol HCL was made possible with BF4 and BF8 which shows better drug release with suitable lag time and drug release and fulfilled my objective of work.