Advances and challenges in Nintedanib drug delivery.

Velagacherla, Varalakshmi; Suresh, Akhil; Mehta, Chetan H; Nayak, Usha Y

INTRODUCTION Nintedanib (NTB) is an orally administered tyrosine kinase inhibitor that has been approved recently by USFDA for idiopathic pulmonary fibrosis (IPF) and systemic sclerosis-associated interstitial lung disease (SSc-ILD). NTB is also prescribed in COVID-19 patients associated with IPF. However, it has an extremely low bioavailability of around 4.7% hence researchers are attempting to address this drawback by different approaches. AREAS COVERED The review article focuses on enlisting all the formulation attempts explored by researchers to increase the bioavailability of NTB while also providing meaningful insights into the unexplored areas in formulation development such as targeting the lymphatic system and transdermal delivery. All the patents on the formulation development of NTB have also been summarized. EXPERT OPINION NTB has the potential to act on multiple diseases that are still being discovered but, its extremely low bioavailability is a challenge that is to be dealt with for obtaining the full benefit. Few studies have been performed aiming at improving the bioavailability but there are unexplored areas that can be used, a few of which are explained in this article. However, the ability to reproduce laboratory results when scaling up to the industry level is the only factor to be taken into consideration.