Drug Development Approaches for Poorly Soluble Compounds (Methods and Principles in Medicinal Chemistry) （1. Auflage）

Bachhav, YogeshwarEDT/ Buschmann, HelmutEDT/ Holenz, JoergEDT

Wiley-VCH（2026/08発売）

• 製本 Hardcover:ハードカバー版／ページ数 464 p.
• 言語 ENG
• 商品コード 9783527354788

Full Description

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.

Contents

1. Drug development approaches for poorly soluble compounds
2. Solid dispersion technique to improve solubility and, thereby, bioavailability
3. Nanosizing of drugs to improve the apparent dissolution and bioavailability
4. Pharmaceutical Co-crystals
5. Self-micro emulsifying and self-emulsifying drug delivery systems to improve solubility and bioavailability
6. Liposomes and mixed micelles for improvement of drug solubility
7. Improvement of solubility and bioavailability of poorly soluble drugs using mesoporous silica particles
8. Gastrointestinal Dissolution and Absorption of BCS Class II Drugs
9. Cyclodextrin-Based Formulations to Improve Solubility of poorly soluble drugs
10. Cosolvent-based formulations to improve solubility and bioavailability
11. First in-animal studies and formulation considerations
12. Improving aqueous solubility of drug candidates through structural modifications
1. Drug development approaches for poorly soluble compounds
2. Solid dispersion technique to improve solubility and, thereby, bioavailability
3. Nanosizing of drugs to improve the apparent dissolution and bioavailability
4. Pharmaceutical Co-crystals
5. Self-micro emulsifying and self-emulsifying drug delivery systems to improve solubility and bioavailability
6. Liposomes and mixed micelles for improvement of drug solubility
7. Improvement of solubility and bioavailability of poorly soluble drugs using mesoporous silica particles
8. Gastrointestinal Dissolution and Absorption of BCS Class II Drugs
9. Cyclodextrin-Based Formulations to Improve Solubility of poorly soluble drugs
10. Cosolvent-based formulations to improve solubility and bioavailability
11. First in-animal studies and formulation considerations
12. Improving aqueous solubility of drug candidates through structural modifications