Formulation, in-vitro evaluation and stability studies of bilayer floating tablets of Trandolapril and nifedipine combinations
Kareem Unnisa, Syed Abdul Azeez Basha and Sana Ahmed
Hypertension is a long term medical condition in which the blood pressure in the arteries is persistently elevated. Combination of ACE Inhibitor & Calcium channel blocker is found to be effective for treatment of Hypertension. The present work focuses on the formulation and evaluation of bilayer floating tablets of Trandolapril and Nifedipine. The immediate release layer of Trandolapril consists of a gas generating agent sodium bicarbonate and floating sustained release layer of Nifedipine comprised of low density release retardant polymers like HPMC K4M, K100M. The prepared powder blends were subjected to FTIR/DSC for any interaction Direct compression method was adopted to prepare tablets from optimized layers of immediate release and sustained release and subjected to Pre- and Post-compression parameters and results were found to be reasonably within the limits. The optimized IR layer IR6 exhibited 99.2% drug release in 30 min and optimized SR layer SR2 showed 99.5% drug release in 12 hrs with buoyancy lag time of 130 sec. Optimized layers were compressed together and were subjected to evaluation of post compression parameters whose results were found to be reasonably within the IP limits. The final formulation of bilayer floating tablet showed drug release of Trandolapril as 99.6% at 30 min and 99.5% of Nifedipine at 12 hrs. The release data were fitted to various mathematical models such as Higuchi, First order and Zero order to evaluate kinetics and mechanism of drug release, and it was best fitted to First order and Higuchi's model. Stability studies revealed no significant changes.
How to cite this article:
Kareem Unnisa, Syed Abdul Azeez Basha, Sana Ahmed. Formulation, <em>in</em>-vitro evaluation and stability studies of bilayer floating tablets of Trandolapril and nifedipine combinations. Pharma Innovation 2018;7(9):306-313.