Role of key physical parameters of andrographis paniculata (Burm. f.) Nees granules in their dissolution behavior / 中国药学杂志

ABSTRACT

OBJECTIVE: To establish the relationship between the physical parameters of granules and their dissolution behavior. METHODS: Andrographis paniculata (Burm. f.) Nees extract was utilized as a model drug. The extract was mixed with different excipients (MCC/soluble starch) at the ratio of 11 by weight using different methods. The granules were prepared by using high shear granulation and extrusion granulation methods. Then the dissolution behavior of the granules was evaluated by monitoring equilibrium dissolution quantity and dissolution rate constant. The effect of physical properties on the dissolution behavior was analyzed through stepwise regression. RESULTS: Particle size, critical relative humidity (CRH), moisture content, pore volume, and tapped density were the main factors related to the dissolution behavior of granules. CONCLUSION: A higher equilibrium dissolution quantity could be obtained with higher moisture content, smaller particle size, and lower CRH. There is a positive correlation between dissolution rate constant and tapped density of granules, and a negative correlation with particle size (D[4, 3]) and pore volume (PV).