Ten proven strategies to overcome solubility challenges in drug development

Poor water solubility prevents drug candidates from reaching their therapeutic targets, causing promising compounds to fail during development. Drug Development Approaches for Poorly Soluble Compounds presents ten distinct strategies for overcoming this challenge, from altering drug structure and creating prodrugs to formulation techniques using nanosuspensions, microemulsions, micelles, co-crystals, and co-solvents. Each approach includes case studies from current pharmaceutical industry projects.

This reference covers strategies applicable to virtually every drug type, regardless of molecular size or chemical composition. Beyond formulation science, the book addresses solubility-related commercial and regulatory considerations essential for bringing drugs to market. Special attention is given to animal study requirements for poorly soluble compounds. Each chapter demonstrates approaches through examples from recent pharmaceutical development projects across small and large companies.

Readers will also find:

• Detailed explanations of ten formulation strategies including nanosuspensions, microemulsions, micelles, co-crystals, and co-solvent approaches for enhancing drug solubility
• Practical case studies drawn from recent pharmaceutical industry drug development projects demonstrating real-world applications of each solubility enhancement strategy
• Guidance on regulatory considerations specific to poorly soluble compounds, helping developers navigate approval pathways more efficiently throughout the development process
• Coverage of special requirements for conducting animal studies with compounds that exhibit poor solubility in biological fluids
• Commercial considerations for solubility enhancement strategies that reduce required drug substance amounts, lowering costs and minimizing potential side effects

Designed for medicinal chemists, pharmaceutical chemists, pharmacologists, and pharmaceutical industry professionals, this book ensures no drug candidate fails due to solubility challenges. The strategies presented here apply across compound types and development stages, providing practitioners with proven solutions for this common development obstacle.

Dr. Yogeshwar Bachhav, is a distinguished pharmaceutical professional with over 19 years of experience in drug development, spanning R&D, CMC, regulatory strategy, and business development. From his previous experiences working at Pantec Biosolutions AG (Licheteinstein), DebioPharm (Switzerland), AiCuris (Germany) and as a founder and Director of Adex Pharma, to date he has successfully contributed to the CMC development of several drug candidates from discovery to clinical and commercial phases. Currently, he also serves as an Independent Consultant at AiCuris Anti-infective Cures AG, Germany, leading formulation design, outsourcing, and regulatory documentation (IMPD/IND, ANDA) across global markets. Dr. Bachhav holds M.Pharm in Pharmaceutical Chemistry and PhD in Pharmaceutics and from ICT (Mumbai), an LL.B from the University of Mumbai, and a Global MBA from the University of Western Australia, along with an Advanced Business Management certification from IIM Kozhikode. With 19 peer-reviewed publications, 7 international patents, more than 50 invited talks globally and as an editor of 3 books , Dr Bachhav continues to advance pharmaceutical innovation through his deep scientific expertise and strategic leadership.

Helmut Buschmann

Jörg Holenz

Christa Müller