DEVELOPMENT AND IN VITROEVALUATION OF FUROSEMIDE ORODISPERSIBLE TABLETS BY 32 FACTORIAL DESIGN APPROACH

S. M. Shahidulla*, Konda Ravi Kumar and S. Md. Noorulla

ABSTRACT

The objective of the work was to develop Oro dispersible tablets of Furosemide with a view to enhance patient acceptance and rate of dissolution by direct compression method using 3² full factorial design. Croscarmellose sodium; X1 (2-10% w/w) was used as superdisintegrant and Microcrystalline cellulose; X2 (0-30% w/w) was used as diluent, along with Pearlitol SD-200 to enhance mouth feel. The tablets were evaluated for thickness, hardness, friability, drug content uniformity, in vitro dispersion time and wetting time. Based on in vitro dispersion time (approximately 30s); the formulation containing 10% w/w Croscarmellose sodium and 30%w/w Microcrystalline cellulose was found to be promising and evaluated for in vitro drug release pattern (in pH 6.8 phosphate buffer), short-term stability studies (at 40º/75% RH for 3 months) and drug-excipient interaction. Surface response plots are presented to graphically represent the effect of independent variables (concentrations of Croscarmellose sodium and Microcrystalline cellulose) on the in vitro dispersion time; Y1. The validity of the generated mathematical model was tested by preparing two extra-design check point formulations. The optimized tablet formulation was compared with conventional commercial tablet formulation for drug release profiles. This formulation showed nearly four-fold faster drug release (t50% 2.60 min) compared to the conventional commercial tablet formulation (t50% 7.90 min). Short-term stability studies on the formulation indicated that there are insignificant changes in drug content and in vitro dispersion time (p < 0.05).

Keywords: Furosemide, Orodispersible tablets, Croscarmellose sodium, microcrystalline cellulose, 3² full factorial design.