DESIGN AND DEVELOPMENT OF NOVEL MUCOADHESIVE GASTRORETENTIVE FORMULATION OF GLIPIZIDE

Abstract

The aim of the present study was to develop and characterize a gastroretentive formulati on for controlled drug release and to develop innovative gastro retentive formulation based on mucoadhesive patch systems using the solvent casti ng technique. Glipizide, an anti diabetic agent was used as model drug for formulating films. Mucoadhesive film was formulated using chitosan and HPMC K 4 M. PEG 400 was added as plasticizer in film preparation. 3 2 full f actorial design was used to formulate the novel gastroretentive formulation. Amount of HPMC K 4 M(X 1 ) and amount of chitosan (X 2 ) was selected as independent variable while swelling index, folding endurance, mucoadhesion force and Q 8 (% drug release after 8 h ) was selected as dependent variables. The film with zigzag folding in the capsule was shown to unfold and swell under acidic condi tions and provide controlled release of drug upto12 h in acidic medium. According to 3 2 full factorial design films , 9 batch es were prepared and evaluated for surface pH, folding endurance, mucoadhesion force, drug content, in - vitro drug release etc. Surface pH of F1 - F9 was in between 6.32 to 6.98. Thickness and % drug content for batch F1 - F9 was found to be in between 0.236 m m to 0.289 mm and 95.42 % to 99.32 %, respectively. In - vitro drug release study of F1 - F9 showed utmost 95 % drug release after 11 h. The results indicate that the dosage form is gastroretentive and can provide controlled release of drugs with narrow therap eutic window. Glipizide/ HPMCK 4 M / Chitosan (40:150:150) F8 was found to be optimized composition of mucoadhesive films that showed good swelling index, folding endurance, sur face pH, mucoadhesion force, Q8 and % drug content.