Design, Formulation, Evaluation and Statistical Optimization of Coated Floating Pulsatile Tablets for Modified Chronopharmacotherapy of Rheumatoid Arthritis

Abstract

Abstract Background Rheumatoid arthritis is the condition needs early morning medication according to biorhythms. Hence, the main aim of designing Coated Floating Pulsatile Tablets (CFPT) of Tramadol hcl for statistical optimization and to perform in vitro and in vivo buoyancy evaluation for modified chronopharmacotherapy of rheumatoid arthritis. Methods The formulation was designed with the immediate core covered with a compression coat followed by the upper buoyant and immediate layer. The best formulations of core tablets were compression coated with polymer HPMC K15M, Ispaghula gum (IG), and Tamarindus gum (TG) to assign a suitable lag time for formulation. HPMC K100M, Ispaghula gum, and their combination were compressed as the buoyant layers. Statistical optimization was done on parameters such as BLT, TFT, %SI, and % CDR. Results Immediate release layer and core tablets were optimized with formulation IF2 which contains sodium starch Glycolate 8%, and then in compression coated buoyant formulation CFPT was optimized by DoE optimization showing BL8 exhibiting good floating behavior and lag time, drug release for a period of 11 hrs. Conclusion As the formulation showed delay in drug release in vitro and also showed in vitro buoyancy, hence nighttime administration could be beneficial to reduce the rheumatoid arthritis complications in the early morning.