Kajal A Prajapati
PG Research Scholar, Department of Pharmaceutics, Sharda School of Pharmacy, Pethapur, Gandhinagar, Gujarat
Dhara B Patel
Associate Professor, Department of Pharmaceutics, Sharda School of Pharmacy, Pethapur, Gandhinagar, Gujarat
Anil G Raval
Assistant Professor, Department of Pharmaceutics, Sharda School of Pharmacy, Pethapur, Gandhinagar, Gujarat
Abstract
Mirabegron Orally Disintegrating Tablets were prepared using a direct compression approach with a novel approach of combining effervescence agents and super disintegrants to achieve a rapid disintegration. A screening study was performed using Crospovidone XL 10, Croscarmellose Sodium and Sodium Starch Glycolate at two levels to least Disintegration Time, which was achieved by Croscarmellose Sodium. The prepared tablets were evaluated for Weight variation, Thickness, Hardness, Disintegration time, Dissolution, and Water uptake study. A full factorial statistical optimization was carried out on the best optimized formulation to establish the design space for selected factors i.e., Level of Effervescence agents and Croscarmellose Sodium against Response Disintegration Time and Dissolution. A significant effect of both factors was found on DT as well as Dissolution rate, which justifies the use and rationale of the excipients.
Key words: Mirabegron, ODT, Direct Compression, Effervescence agents, Super disintegrants