FORMULATION AND IN-VITRO EVALUATION OF FAST DISSOLVING FILM CONTAINING AMLODIPINE BESYLATE SOLID DISPERSION

摘要

Objective: This study concerned with preparation and in-vitro evaluation of fast dissolving film of amlodipine besylate solid dispersion, since amlodipine besylate is a sparingly soluble orally administered drug and the rate of absorption is often controlled by the rate of dissolution. Materials and method: The rate of dissolution can be increased by incorporating the drug in a fast dissolving dosage form as a solid dispersion that prepared using polyethylene glycol (PEG6000) or polyvinyl pyrrolidone (PVP) in different ratios and different methods of preparation. The fast dissolving films were prepared using sodium carboxy methyl cellulose (SCMC) in different concentration orhydroxypropyl methyl cellulose (HPMC) also different concentration of glycerin were used. Different factors affecting the dissolution rate of the solid dispersion and fast dissolving film were studied. Results: It was seen that as the ratio of drug to PEG6000 or PVP in solid dispersion increased the release rate increased and the solvent evaporation method gave greater release than fusion method. In fast dissolving film it was seen that as the concentration of SCMC increased the release rate decreased significantly and as the concentration of glycerin increased the release rate increased significantly. Discussion: The release rate increased with increasing the ratio of drug to PEG6000 or PVP in solid dispersionsince both of them are water soluble carriers; so increase their amount in solid dispersion leading to increase the wettability and dispersibility of drug from the dispersion resulting in dissolution of drug in hydrophilic carrier