Shantha Kumar G.S, Narayanacharyulu R, Divakar Goli, Roopa Karki, Venkatesh D.P
The purpose of this research was to design, develop and evaluate BC’s of enalapeil maleate using Carbopol 934P, HPMC 4KM, HPMC 15KM, and HPMC 100KM in various ratios such as 1:0, 1:1 & 0:1 by direct compression method. Effect of polymer type, proportion and combination was studied on the drug release rate, release mechanism and bioadhesive strength of the prepared formulations. The mixed blend was evaluated for preformulation parameters. The BC’s were evaluated for physical parameters, surface pH, Swelling studies, bioadhesive strength, content uniformity study, in vitro dissolution studies, ex vivo permeation studies and stability studies. The physical parameters and content uniformity of BC’s were found within specified limits. Swelling index studies and surface pH study results were found in the range of 131.19 to 378.33% after 6 hours and 5.73 to 5.95 after 4 hours. FTIR studies showed no evidence on interactions between drug, polymers, and excipients. In vitro drug release & ex vivo permeation for the formulation F2 was found 90.92 % & 85.23% at the end of 8 hr. Drug release and mucoadhesive strength were found to depend upon polymer type, proportion and viscosity. The release mechanism of was found to be of anomalous non-Fickian type. The stability studies revealed that there is no decrease in the drug content of F2 for the period of 3 months. This may be concluded that the stable formulation could be developed by incorporating carbopol and HPMC 4KM in the ratio of 1:1 controlling the release of enalapril maleate from BC’s.
