Polymers in the Formulation and Characterization of Amlodipine Besylate Oral Mouth Dissolving Films

The purpose of the present work was to formulate oral dissolving films and enhance the drug release of amlodipine besylate by the incorporation of synthetic and natural polymers. The oral dissolving films loaded with Amlodipine besylate were prepared by solvent evaporation method using hydroxy propyl methyl cellulose-3cps& 5cps, Blanose, methyl cellulose and tamarind seed polyose by adding suitable plasticizer: PEG 400 and glycerin. The prepared oral dissolving films were evaluated for drug content, weight variation, thickness, pH, folding endurance, In vitro drug release and stability. The evaluation parameters of Amlodipine besylate were found to be satisfactory in terms of drug content, thickness and pH. Comparison of the dissolution profiles of Amlodipine besylate oral dissolving films in phosphate buffer (pH 6.8). The release profiles of films were analyzed by using UV- Visible spectrophotometer at 239nm. The optimized formulation AML 15 dissolution studies were Compared with pure drug and marketed formulation. AML 15 showed the highest drug release 100% in 10min, when compared to pure drug 88.2% in 30min and marketed AML 92.2% in 45min. showed. Preformulation studies of amlodipine besylate like compatibility studies with polymers using FTIR, DSC studies were carried out. The drug and polymers were found to be compatible with each other. These results were strongly suggested that the water soluble polymers were suitable for the formulation of oral fast dissolving films of amlodipine besylate. Effective drug release was achieved for amlodipine besylate by the way of preparation of oral dissolving films by solvent evaporation method.