FORMULATION, DEVELOPMENT AND EVALUATION OF FAST DISSOLVING ORAL FILM OF AMLODIPINE

Fast dissolving films are a new arising oral dosage forms used by patient’s world widely. These dosage forms can be used even in acute condition for getting instant relief. Fast dissolving films have gained vast attention on the market because of its various advantages along with an extended shelf life of 2-3 years. Amlodipine is commonly used in the treatment of high blood pressure and angina. Amlodipine has antioxidant properties and an ability to enhance the production of nitric oxide (NO), an important vasodilator that decreases blood pressure. The option for single daily dosing of amlodipine is an attractive feature of this drug. Amlodipine is used alone or together with other medicines to treat hypertension (high blood pressure). The aim of this study is to formulation, development & evaluation of fast dissolving oral film of Amlodipine. The film was formulated and tested for all parameters. The results showed that the formulated film was white in colour with no odour & bitter taste. It was freely soluble In methanol & chloroform, soluble in ethanol & phosphate buffers. Slightly soluble in 0.1 N HCL & 0.1 N NaOH The melting points of Amlodipine range were found to be 198-199°C. The pH of Amlodipine was found to be 6.64. The thickness & weight variation was found to be 0.161±0.05 & 23.27±0.05respectively. The folding endurance of film was more than 100. The disintegrating time was 5±0.2 sec. The % moisture content was 0.118. From the results it can be concluded that the formulated oral film have all ideal characteristics.

Keywords: Fast dissolving, oral film, Amlodipine, Blood pressure.