ABSTRACT

Background: Bilayered tablets are formulations containing two different drugs or single drugs which are of different characteristic features. Objectives: The goal of this research was to develop bilayered tablets with a loading dose. of Dapagliflozin and maintenance dose of Metformin to achieve and maintain peak plasma concentrations rapidly. Materials and Methods: Twenty formulations were prepared, out of which F1- F10 comprises of optimizing Dapagliflozin immediate layer and F11 to F19 comprised sustained release layer of Metformin The loading dose was provided by an immediate release layer attempting several super disintegrants, while the maintenance dose was delivered through sustained release layer optimized using HPMC K-15, HPMC E-50, and HPMC K-100 polymers. Results: No drugexcipient interactions discovered. Both the immediate and sustained release layers were optimized separately before being merged to create the Bilayered tablets. The F10 formulation featured complete drug release within 30 minutes, whereas the F17 formulation had extended drug release of 97.36% w/v within 12 hours. F20 formulation, which was developed by mixing formulations F10 and F17, had a drug release of 96.63 percent w/v in 12hrs. The optimized formulation (F20) was found to have a Zero order release rate with a regression coefficient of 0.992, and the drug diffusion from the system was found to be Non-Fickian Diffusion. After three months, the optimized formulation (F20) was determined to be stable, with no changes in physical properties. Conclusions: The optimized formulation (F20) provided the loading dose of Dapagliflozin giving the immediate pharmacological effect, thus maintained the effect with sustained action of metformin. Keywords: Dapagliflozin, Metformin, super disintegrants, hydrophilic polymers
Publication date: 01/11/2022

https://ijbpas.com/pdf/2022/November/MS_IJBPAS_2022_6607.pdf

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https://doi.org/10.31032/IJBPAS/2022/11.11.6607