Open Access Open Access  Restricted Access Subscription or Fee Access

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

Sonal S. Gaikwad, Meera C. Singh

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


Full Text:

PDF

References


CHMP assessment report for ofev capsule

Seidai sato, Shintaro shinohara, Shinya hayashi, Shun morizumi, Shuichi abe, Hiroyasu okazaki, anti-fibrotic efficacy of nintedanib in pulmonary fibrosis via the inhibition of fibrocyte activity, respiratory research (2017)

Center for drug evaluation and research application number: 205832orig1s000

Draft guidance on Nintedanib Esylate by FDA http:www.accessdata.fda.gov/scripts/cder/dissolution /.

Brochure for ofev capsule, copyright © 2016, boehringer ingelheim pharmaceuticals, inc. All rights reserved. (3/16) pc-of-0325-cons

Ronak savla, Jeff browneet.et.al ; review and analysis of fda approved drugs using lipid-based formulations issn: 0363-9045 (print) 1520-5762 (online) journal homepage: http://tandfonline.com/loi/iddi20

Pi-Ju Tsai, Chi-Te Huang, Research Article on Isotretinoin Oil-Based Capsule Formulation Optimization Hindawi Publishing Corporation The ScientificWorld Journal Volume 2013, Article ID 856967, 6 pages http://dx.doi.org/10.1155/2013/856967


Refbacks

  • There are currently no refbacks.


Copyright (c) 2018 Research and Reviews: A Journal of Pharmaceutical Science