Scaling up and evaluation of Dyphylline controlled release matrix tablets

Abstract

The aim of the current study was to scale up controlled release matrix tablets of Dyphylline, used for the management of various respiratory conditions such as asthma, cardiac dyspnea, chronic bronchitis, and emphysema. The tablets were scaled up to 3500 tablets scale then the optimized formulations were further scaled up to 35000 tablets. Tablets were manufactured using direct compression, wet granulation, and hot melt methods. The prepared tablets were evaluated for Hardness, Friability, content uniformity, in-vitro drug release, and stability study. The results obtained showed that the ten prepared tablets showed accepted values for the hardness, friability, and content uniformity tests. The formulations showed controlled drug release profiles with high similarity to our target release profile (f values ranged from 63.9 to 84.9). The release profiles showed a better fit to zero order than diffusion model. The Exponent n of Korsmeyer-Peppas model ranged from 0.67 to 0.692 indicating non-Fickian diffusion. The stability study indicating good stability of the selected formulation. All these results concluded that formulation prepared by wet granulation can be manufactured on large scale perfectly.