Formulation and Stability of Orally Fast Disintegrating Tablets of Amlodipine besylate

Abstract

The demand for fast disintegrating tablets has been growing during the last decade especially for geriatric and pediatric patients because of swallowing difficulties. Amlodipine besylate is commonly used for the treatment of chest pain, commonly known as angina, due to ischemia of the heart muscle and a result of obstruction or spasm of the coronary arteries. The study would involve the use of various disintegrants along with other excipients for the formulation of orally fast disintegrating tablets to achieve rapid disintegration and release. The stability studies of the prepared dosage form would be carried out according to the guideline of the ASEAN guideline. In this study, we researched on formulating orally fast disintegrating tablets containing 5 mg of amlodipine at pilot scale. Fast-dissolving amlodipine tablets were prepared by direct compression method. Formulations were designed by Design Expert v11 using D-optimal model and optimized by BC-PharSoft OPT software. Studied ingredients are disintegrants and fillers for directly compressed tablets. After successfully developing the optimal formulation, the batch size was scaled up to 10.000 tablets. Then the tablet stability study was proceeded and shelf life of the product under accelerated conditions was determined within 6 months according to Van’t Hoff principle. It was revealed that tablets had good stability and shelf life of 766.3 days (at 30oC). This satisfactory result may show a great promise for large-scale production.