Development and Evaluation of Cost Effective Formula of Nintedanib Esylate Soft Gelatin Capsule and Compare with Prepared Product Similar to Innovator

Abstract

Nintedanib esylate was invented by Boehringer Ingelheim Pharmaceuticals. Nintedanib esylate is an organosulfonate salt obtained by combination of Nintedanib with ethane sulfonic acid. It’s a kinase inhibitor used for the treatment of idiopathic pulmonary fibrosis and non-small cell lung cancer. Bioavailability and water solubility of Nintedanib esylate is very low and BCS class is not mentioned in the literature. Due to poor solubility of Nintedanib esylate at neutral conditions, the active substance cannot be formulated as solution and therefore innovator has prepared soft gelatin capsule with oil base i.e. suspended in a lipophilic fill mix. Innovator’s product (Ofev) is not available in India, so in this research, we first prepared innovator’s product (Derived on the basis of literature) and then prepared product similar to innovator’s product which is cost effective. For evaluation of product, in-vitro analysis data was compared with data available for innovator’s product literature. The product similar to innovator was successfully developed and compared with available literature. Keywords: Nintedanib esylate, idiopathic pulmonary fibrosis, Ofev, soft gelatin capsule