Can formulation and drug delivery reduce attrition during drug discovery and development-review of feasibility, benefits and challenges

Abstract

Drug discovery and development has become longer and costlier process. The fear of failure and stringent regulatory review process is driving pharmaceutical companies towards "me too" drugs and improved generics (505(b) (2)) fillings. The discontinuance of molecules at late stage clinical trials is common these years. The molecules are withdrawn at various stages of discovery and development process for reasons such as poor ADME properties, lack of efficacy and safety reasons. Hence this review focuses on possible applications of formulation and drug delivery to salvage molecules and improve the drugability. The formulation and drug delivery technologies are suitable for addressing various issues contributing to attrition are discussed in detail.

Keywords: Drug delivery technology; Drug discovery and development; Drugability; Formulation.

Graphical abstract

Figure 1

Representative scheme for drug discovery and development with reasons for attrition at each stage.

Figure 2

BCS classification system and possible ways make most of molecules into Class I.

Figure 3

Representative diagram of blood brain barrier and major pathways of drug transport across the BBB. Modified from Ref. .

Figure 4

Flow chart for showing various formulation/drug delivery solutions for drug attrition during discovery and development.