Design and Characterization of Oral Dispersible Tablets of Enalapril Maleate Using a Co-Processed Excipient.

ABSTRACT

In the present work, oral dispersible tablets of Enalapril maleate were prepared using three different superdisintegrants and a co-processed superdisintegrant consisting of crospovidone and sodium starch glycolate in the ratio 11. Oral dispersible tablets of Enalapril maleate were prepared by employing direct compression technique using the above superdisintegrants, and evaluated for precompression as well as post-compression parameters, such as determination of weight variation, thickness, hardness, friability, wetting time, disintegration time, drug content, water absorption ratio, in vitro dispersion time, and in vitro drug release study. Formulation F-VII. F-VIII and F-IX were subjected to stability Studies as per ICH guidelines at temperatures and humidity of 25±5ºC/60±5%RH; 30±5ºC/65±5%RH and 40±5ºC/75±5%RH. Tablets didn’t reveal any appreciable changes in respect to hardness, disintegration time, drug content and dissolution profiles. From the results, it could be concluded that the formulation(F-VII) made with coprocessed super disintegrant (11) at a concentration of 5% w/w revealing a disintegrating time of 13.2 sec, and 97.84 % cumulative drug release emerged as the best formulation.