Accelerating Development of Poorly Soluble Drug Candidates Through Quality-by-Design

Accelerating Development of Poorly Soluble Drug Candidates Through Quality-by-Design

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Overview

Over 80% of candidate drugs have poor solubility, leading to low bioavailability. This challenge slows down pharmaceutical R&D pipelines, delaying availability of drugs to patients in need.

In this white paper, we introduce a Quality-by-Design (QbD) formulation approach to addresses solubility challenges. We discuss the use of key technologies such as lipid-based formulations and amorphous solid dispersions and how integrating QbD from early development can accelerate a drug candidates' journey to market.

Key Objectives:

Highlight the prevalence and impact of poor solubility on drug development pipelines
Introduce a QbD approach as a solution to improve solubility and accelerate timelines
Demonstrate through a case study how optimizing formulation can improve bioavailability

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