MUCOADHESIVE BIO-FLEXY FILM OF PHOENIX DACTYLIFERA LOADED WITH PHENYTOIN FOR TRANSLABIAL DRUG DELIVERYAbstract
Translabial drug delivery system is an attractive approach for drug delivery system possess advantages as a bypass of the first-pass metabolism, prevent from digestive enzymes and rapid action of suitable drugs. The purpose of the current research work is to isolate the biopolymer from Phoenix dactylifera (date palm) and prepare mucoadhesive bio-flexy films loaded with Phenytoin. The isolated biopolymer was subjected to various physicochemical characterization procedures for analyzing the mucoadhesive and mucoretentive properties. The mucoadhesive and mucoretentive properties of isolated biopolymer were analyzed using the shear stress method and the MS mucoretentibility method. The formulated Phenytoin loaded bio-flexy films were evaluated for weight, thickness, folding endurance, swelling index, surface pH, tensile strength, etc. The in-vitro drug release studies were analyzed using the static MS diffusion apparatus. Phenytoin loaded with HPMC and sodium CMC was used as standard film, and then results were compared. The optimized bio-flexy films shows order PD6 > PD5 > PD4 > PD3 > PD2 > PD1 on the basis of percentage release. The percent release of optimized formulation (PD6) bio-flexy film was 97.1±2.08%. The Cmax, Tmax, and AUC for PD6 bio-flexy films were found out to be 9.80 μg/ml, 8 h, and 154.85 μg h /ml, respectively. Stability studies were performed for the optimized bio-flexy films as per ICH guidelines. The resultant bio-flexy film formulation possesses an improved drug release with good mucoadhesivity and stability. Thus, the bio-flexy film of Phoenix dactylifera, shows potential for a translabial drug delivery system.