Handbook of Preformulation provides detailed descriptions of preformulation methodologies, gives a state-of-the-art description of each technique, and lists the currently available tools useful in providing a comprehensive characterization of a new drug entity.

Features:

• Addresses the preformulation of three different types of new active entities-chemical, biological, and proteins, and the first book to discuss
• Preformulation studies of the newly established class of active ingredient classified by the FDA, the botanical drug entity
• Clearly illustrates the activities comprised in preformulation studies and establishes a method of tasking for drug development projects
• Includes extensive flow charts for characterization decision making
• Gives extensive theoretical treatment of principles important for testing dissolution, solubility, stability, and solid state characterization

Contents

1. Drug Discovery Trends
2. Intellectual Property Considerations
3. The Scope of Preformulation Studies
4. Dissociation, Partitioning and Solubility
5. Release, Dissolution and Permeation
6. Solid State Properties
7. Dosage Form Consideration in Preformulation
8. Chemical Drug Substance Characterization
9. Characterization of Biopharmaceutical Drugs
10. Characterization of Phytomedicines

Index

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