development and characterization of bilayered floating tablets containing novel sglt2 inhibitors and metformin hcl

Abstract

The formulation of A bi-layered floating tablet of SGLT2 inhibitors such as Dapagliflozin, Canagliflozin and biguanide such as Metformin Hydrochloride were prepared to improve the medication and for patient compliance.. In which one layer made up of immediate release (IR) layer with the help of super disintegrating agents which acts as loading dose. In the immediate release layer Dapagliflozin/Canagliflozin is given for the immediate pharmacological action for the control of the high sugar levels. newline In the initial stage the blood sugar level is controlled by Dapagliflozin/Canagliflozin and after that the blood sugar level is maintained by Sustained release layer of Metformin Hydrochloride. Thus the present study aims to develop bilayered floating dosage form by incorporating two active ingredients to provide maximum therapeutic effect with minimal side effects and to improve the patient compliance. So, efforts are made to prepare such modified release dosage form newlineTo evaluate prepared tablets for physical and chemical parameters and to study the sustained release effect of tablets by in vitro dissolution testing. In my study the Final formulation and optimization batches were processed for individual fraction. newlineHPMC K100M used as release retarding polymers in SR layer, Kyron T314 as superdisintegrant in IR layer. There was a decrease in the floating lag time when the ratio of HPMC K100M increased. The Superdisintegrant Kyron T314 found promising which released the IR drug layer within 30 min. HPMC K100M have the ability to maintain the matrix integrity and sustained the drug release up to 12hrs. B17 and C17 are the optimized bilayered formulations of Dapagliflozin / Metformin HCL and Canagliflozin / Metformin HCl and are compared with the innovator products where only B17 shows better drug release. B17 formulation was further subjected to factorial design study the results revealed that increased concentration of polymer and change in the ratio of polymers increases the release retardation, floating lag time and to