Formulation and development of mucoadhesive tablets of lafutidine by using design of experiment

Abstract

residence time after oral administration. Formulations were prepared using 33
full factorial designs to explore the effects of
Gum Kondagogu, Gum Olibanum and Guar Gum (as independent variables) on mucoadhesive strength, drug release and
Ex vivo residence time (as dependent variables). The tablets were evaluated for various parameters such as compatibility
studies, drug content, weight variation, hardness, thickness, friability, swelling studies, in vitro drug release studies, in
vitro mucoadhesion strength , Ex vivo residence time test, In vivo tests, bioadhesion test in stomach, bioavailability, X-ray
studies and release rate kinetics. The drug-polymer interaction was also studied by conducting FTIR. The in vitro release
kinetics studies reveal that all formulations fits well with Zero order, followed by Korsmeyer-Peppas, Higuchi and the
mechanism of drug release is erosion. After analysis of different evaluation parameters and drug release kinetics,
formulation code F22 was selected as a promising formulation for delivery of lafutidine as a mucoadhesive
Gastroretentive tablet with best mucoadhesive strength and 99.54% drug release at 12th hour. The main effects and the
interaction terms were quantitatively evaluated by quadratic model. The stability studies were carried out at 40°C/75% RH
for 180 days. There was no significant change in the physical property and weight variation, hardness, thickness, friability,
in vitro drug release studies, in vitro mucoadhesion strength, and drug content during the study period.