Design Space Determination of Mode of Addition of Superdisintegrants on Flecainide Acetate Tablets

The purpose of the study was to formulate immediate release tablets using various types of disintegrants (crospovidone, sodium starch glycolate and sodium carboxymethylcellulose), in order to investigate the effect of mode of incorporation (intragranular, extragranular, intra and extragranularly) of disintegrants on release mechanism from tablets. Flecainide acetate, a class IC anti-arrhythmic drug was used as a model drug to evaluate its release characteristics from different formulations. The tablets were prepared by the wet granulation technology. F1 to F9 formulations were prepared with the difference in mode of disintegrants addition. Preformualtion studies and evaluation studies were carried. Drug excipient compatibility studies were performed by FTIR & DSC. The USP paddle method was selected to perform the dissolution profiles at 100 rpm in 900 ml of 0.1N Hcl. Significant differences were found in the trials having croscarmellose sodium and the formulation having intragranular/extragranular addition showed better release. Based on dissolution results, best release was achieved with SSG containing formulations with 100.1% drug release. Usage of crospovidone showed lesser drug release irrespective of the mode of addition when compared to other trials. From the all formulations corresponded, best release was observed with the SSG extragranular addition. Stability studies conducted for a period of 60 days showed no significant changes in all the parameters.