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

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 The molecules are withdrawn at various stages of discovery and development process for reasons such as poor ADME properties, lack of efficacy and safety reasons.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.

This paper provides insight into effective application of formulation strategies to reduce attrition of molecules during drug discovery/development. Comprehensive information on utilizing solubilzation, prodrug, proliposomes, polymer conjugation, targeted/timed release formulations, alternate routes of delivery to reduce attrition of molecules due to ADME, efficacy and toxicity issues is provided. Clinical success and challenges are documented.Figure optionsDownload as PowerPoint slide