Diseño, desarrollo y caracterización in vitro de un producto mucoadherente bucal cargado de pioglitazona

Abstract

Aim: The mucoadhesive buccal patches were developed and evaluated for systemic administration of Pioglitazone in the oral cavity. Pioglitazone belongs to a novel class of oral antidiabetic drugs known as Thiazolidinediones. Materials and Methods: The mucoadhesive buccal patches of Pioglitazone was formulated using Eudragit RS100 and HPMC K4M (mucoadhesive polymer) and were prepared by solvent casting method. Different patch formulations were evaluated for its physical parameters like thickness uniformity, swelling index, surface pH, uniformity of weight, folding endurance, mucoadhesive strength and in vitro parameters like drug content uniformity and drug release studies, and ex vivo parameters like mucoadhesion time. Results: Data for the parameters was found to be: thickness uniformity (0.27±0.45mm); uniformity of weight (40.81±0.66 mg), surface pH (6.5), folding endurance (>300), drug content uniformity (98.58±2.05%), swelling index (131±0.79%), mucoadhesive strength (38.20±1.75), in vitro drug release studies (95.18±1.98%) and ex vivo mucoadhesion, time of optimized formulation (4±1.26 h). The data was also fitted to different kinetic models to illustrate its anomalous (non-fickian) diffusion. Conclusions: The result revealed that Pioglitazone loaded buccal patches was most suitable mode of drug delivery for promising therapeutic action. Buccal patches of Pioglitazone can prove to be potential pharmaceutical dosage form for sustaining the drug release and reducing the dose frequency.